Dr. Christopher Walker, Urogynecologist, Orlando, FL

Mesh News Desk, August 19, 2015~  MND editor, Jane Akre asked many of you on our Facebook page to pose questions to Dr. Christopher Walker, a urogynecologist located in Orlando,  Florida.   He is one of the new doctors around the country who is capable of addressing mesh explants (removals) with a minimum of harm to the women.  Dr. Walker is also a sponsor of MND.

The following are your questions and his answers.  The women will remain anonymous as many are still represented by legal counsel.

 

 S. asks:” First of all do you often recommend a full mesh removal?  If a woman wants a full mesh removal, what issues do you weigh and how often are you able to do a full  removal? 

Dr. Walker: “Each patient will require an individualized treatment plan.. many variables have to be taken into consideration when deciding if a partial vs. full mesh implant removal is required such as the patients presenting complaint, presence of a fulminant mesh infection etc…; With the above said, most patients do not require a full mesh implant removal.”

Statue, WikiCommons

 

T. asks: “I’d love to know if after partials, then finally full removal of my mesh if there is ever hope for pain relief in the pudendal, and obturator nerves. I have severe scarring, and have seen little if any improvement.” 

Dr. Walker: “Due to the process of scarring and nerve entrapment, some patients have permanent lifelong nerve injuries and the sequelae thereof, which includes pain and dysesthesia.”

​
S. asks: “What causes stabbing, like a knife in the vagina five years later?”

Dr. Walker:  “This symptoms is most likely due to nerve injury which is manifesting as sensory neuropathy.”   ​

  

J. asks: “As far as surgical questions does mesh removal from a TVT-O do more harm than good? Why does a partial removal cause more pain?
Dr. Walker:  “A partial mesh implant removal should not cause more pain. In fact most patients (>80%) have a resolution of their pelvic pain with this procedure.”

 

TVT-O from IFU

E. asks: “Yes, I had 3 partial removals and each was worse plus 4 fistulas and infections. The  pain never stopped and I still have pain. Wonder what made the bladder stop working?

Dr. Walker: “The process of scarring and tissue fibrosis which will occur after each surgical repair in addition to the severe tissue inflammation in response to a fistula can result in nerve entrapment and permanent pelvic pain. The location of the fistulas to the bladder neck can affect the continence mechanism and thus result in a permanent voiding dysfunction.”

 

S. asks:  “How do we get a Dr to listen to us?? What can we say that would make a difference in the way we are treated?? Getting really tired of hearing; “ITS ALL IN YOUR HEAD, YOUR JUST DEPRESSED”!!  I’m thinking anyone would be depressed if they put on our shoes!!!!

Dr. Walker: “Firstly, pelvic pain and the many complications that can result from a mesh implant are not imaginary!!!. I suggest seeking the assistance of a Board Certified Urogynecologist.”

 

L. asks: “Does Dr Walker believe that the ingredients that Mesh is made of have a long term effect in a person’s body? And the more years you have it in, the more distributed it goes in body and filters into organs?”

Dr. Walker: “The Polypropylene mesh usually has an impact locally versus general side effects. It is, however, known that some patients demonstrate an allergic reaction to Polypropylene and thus may have IgE-mediated-like reactions such as contact urticaria and a possible systemic reaction.”

Prolene mesh and particles

 

D. asks: “What can we do to rid our bodies of the toxic substance that mesh leaves behind in our cells?”

Dr. Walker: “Unfortunately the scientific literature is sparse in this arena and thus we truthfully do not know what possible systemic effects may arise in the future from polypropylene mesh implants.”

 

S. asks:
“Is it possible to be allergic to the mesh implant?

Dr. Walker: “There have been cases reported to suggest an IgE-mediated-like reaction such as contact urticaria and a possible systemic reaction. To confirm if one has an allergy to the Polypropylene mesh a Patch test could be performed by an Allergist.”

 

 

The post Dr. Walker Answers Your Questions About Pelvic Mesh appeared first on Mesh Medical Device Newsdesk.

MND, August 20, 2015 ~ The goal of this website, Mesh News Desk (Mesh Medical Device News Desk)  is to provide information to survivors of pelvic and hernia mesh and medical devices to create empowered patients about the dangers and pitfalls of mesh implants. Over the past six months or so, we’ve seen some blogging which we believe is abusive and does not benefit our readership in any way but more than likely causes confusion and ill feelings. In order to protect the quality of our content and to prevent anyone from misleading our readership we feel that it is necessary to set some standards and create procedures for dealing with abuse. 

Your opinions are valued to this matter. Here are some of our initial thoughts. 

*   Since many negative or attacking bloggers seem to have an alias or multiple identities. With multiple names, the same person can increase the volume of negative comments on the same topic. The goal appears to be to hide behind a new identity. This is often accomplished by an entirely new name or by using one’s middle name as a last name. In the future, that practice will be a red flag and the poster will be required to stick to one name only.  

*   Comments that include sweeping generalizations will be discouraged especially if they are disparaging in nature. For example, “Most patients have bad outcomes like I did”  is likely not quantified or even accurate.  Only post what you know to be true!  If it is your opinion, state it as such.

*   Comments that use abusive language, and especially if it is aimed at another person, including, but not limited to profanity, name calling and gross over generalizations, will not be tolerated.

Looking forward to your thoughts on this issue.  Thank you!! 

In the meantime, hernia mesh surgeon Dr. Kevin Petersen of Las Vegas has come up with a policy on his own website (No Insurance Surgery) also offering guidelines in the blogosphere. 

 

“Open response to negative bloggers,” was created by Dr. Kevin Petersen, general surgeon who specializes in non-mesh hernia repair and treatment of patients with hernia mesh complications.
http://www.noinsurancesurgery.com/open-response-to-negative-bloggers.htm#gsc.tab=0

 

The post Policy for Comments on Mesh News Desk appeared first on Mesh Medical Device Newsdesk.

Federal courthouse, Charleston, WV

There have been some new developments in Ethicon transvaginal mesh litigation.  The first news is that the upcoming trial of Edwards v. Ethicon (2:12-cv-09972) will not commence August 24 but is rescheduled for January 11, 2016.

Tonya Edwards, 43, a Georgia resident, was implanted with a TVT-O by Dr. Harold Wittcoff. She is represented by Mark R. Mueller, an Austin, Texas attorney.   According to a Judicial Order (Doc #222) filed August 12, the Pretrial and Final Settlement Conference is moved from August 17, 2015 to December 22, 2015, pushing the trial back to Monday, January 11, 2016.

BACKGROUND- What’s Ahead with this Trial

Christy Jones, from Linda Gross trial Feb 2013

Johnson & Johnson defense attorneys Christy Jones and David Thomas (document #74) wanted to exclude the expert opinion of Dr. John T. Steege. He would testify the TVT0-O was defective and caused her present day pain.  Ms. Edwards had delivered three children vaginally and experienced stress urinary incontinence (SUI) before being implanted with pelvic mesh as a treatment.

The mesh explanted from Edwards was not properly preserved by Dr. Vladimir Iakovlev, argues Defense. For their part Defense used Dr. Elizabeth Kavaler, previously seen in the Linda Gross trial, to issue an expert report as well as Dr. Stanley Zaslau.

Defense planned to raise the usual defenses, Edwards was obese, had experienced hip and back pain prior to her mesh implant and had a small rectocele and cystocele as well as urethral hypermobility all prior to her implant.  Treatments such as injections had not treated her SUI.  She had had about 60 occasions to consult with various medical providers and did not report pelvic pain until more than six years after her implant, says the Defense. It was only after seeing a television ad for pelvic mesh litigation that she filed her case.

Eventually she sought treatment with Niall Galloway, MD with complaints of repeated urinary tract infections and pelvic pain.

Judge Joseph Goodwin

JO HUSKEY TRIAL -VERDICT WILL STAND 

Pending before Judge Goodwin was Defendant Ethicon, Inc.’s (Johnson & Johnson) Motion for Judgment, or a directed verdict in its favor in the Huskey v. Ethicon trial, which Judge Goodwin denied. (See Husky #441 Motion for Judgment, August 19 2015).

The Huskey case (2:12-cv-05201) was the first bellwether jury trial for Ethicon before Judge Goodwin in this Multidistrict Litigation.  At the present time the MDL contains over 26,000 cases filed against the subsidiary of J&J.  Jo and her husband Allen Huskey, filed the action after she was implanted with the TVT-O (Obturator) used to treat incontinence.  Her implanting physician was Dr. Gretchen Byrkit and the date was February 23, 2011.  The mesh eroded and caused her pain. Another physician, Dr. Sohail Siddique attempted a mesh removal on November 18, 2011. He removed about one-third of the mesh from what he described as a “chronically infected space.” An athlete, Ms. Huskey now has limited ability to participate in physical activity and still experiences SUI, pain in her bladder, dyspareunia and joint pain.

Judge Goodwin could have granted the judgment as a matter of law, essentially setting aside the jury verdict.  He did not.

On September 5, 2014, a West Virginia jury decided the TVT-O was defectively designed and awarded Ms. Huskey $3.27 million.  Judge Goodwin wrote “While courts should not simply rubber stamp a jury’s verdict, judgment as a matter of law is a remedy to be applied sparingly and only in the most extraordinary circumstances.” 

Because the state is measured under Illinois law, her home state, the design defect decision must conclude the design made the product unreasonably dangerous and it injured the Plaintiff.  Illinois Civil Jury Instructions say,

“When I use the expression ‘unreasonably dangerous,’ I mean that the risk of danger inherent in the design outweighs the benefits of the design when the product is put to a use that is reasonably foreseeable considering the nature and function of the product.” See Ill. Pattern Civ. Jury Instructions § 400.06A.3

Ethicon says no reasonable juror could conclude the TVT-O is unreasonably dangerous, but Judge Goodwin recounts the evidence in the case in a very compelling manner. It’s worth a read.

“From this evidence, a reasonable jury could conclude that the high risks of the TVT-O are not justified by the benefits, and as a result, the TVT-O cannot, as a matter of law, qualify as an unavoidably unsafe product. Ethicon, having failed to meet its burden, cannot save itself from the jury’s verdict on design defect by appealing to comment k’s exemption.”

On design defect the Plaintiffs presented evidence that the polypropylene mesh material had a tendency to erode, that laser-cut mesh was defective and that the placement in the obturator space of heavyweight mesh.  Judge Goodwin says,

“I FIND that the plaintiffs demonstrated sufficient circumstantial evidence to support proximate causation for at least one of these defects such that a reasonable jury could find in their favor on the design defect claim.”

The IFU was inadequate a jury could reasonably conclude and Dr. Byrkrit said to the jurors she would not use a TVT-O in an athletic woman, said Judge Goodwin, allowing those jury decisions to stand.  Judge Goodwin also allowed to stand the negligent design and negligent failure to warn claim.

Ethicon has not made the required showing to warrant a new trial, Judge Goodwin writes.

200 CASES READIED FOR TRIAL

In a pretrial order, Judge Joseph Goodwin orders TWO HUNDRED Ethicon cases to start the pretrial process.

The oldest cases filed before Judge Joseph Goodwin in the Ethicon MDL will now become Wave 1 cases. Judge Goodwin has just outlined a schedule to bring these cases to court. The discovery process, expert depositions must be completed by March 28, 2013 and the cases should be trial-ready.
Because there are so many Plaintiffs, the Defense is limited to ten Interrogatories or questions put to the Plaintiff and there will be a limit of 10 requests for admission per Plaintiff.  There will be a limit of no more than five experts per case. Both sides will meet by January 11, 2016 and decide the venue which other federal court the case may be tried or in the Southern District of West Virginia.

This is the corrected Docket Order.
http://www.wvsd.uscourts.gov/MDL/ethicon/pdfs/PTO_193.pdf

#

LEARN MORE

MND, July 24, 2014 ~ Huskey case survives Summary Judgment 
http://meshmedicaldevicenewsdesk.com/huskey-v-ethicon-case-survives-summary-judgment

MND, September 5, 2014- Jury Decides for Huskey $3.27 Million in Pelvic Mesh Trial 
http://meshmedicaldevicenewsdesk.com/awesome-jury-decides-for-huskey-3-27-million

Huskey #441 Motion for Judgment, August 19 2015 

 

The post Edwards Pelvic Mesh Trial Delayed, Huskey Trial Verdict Will Stand, 200 J&J Cases Readied for Trial appeared first on Mesh Medical Device Newsdesk.

Social Security image, CNN

Many Mesh News Desk readers find the complications they suffer as a result of their pelvic mesh or hernia mesh implant has left them unable to work.  This is no small matter but society provides a safety net in the form of Social Security, a federal program to help the retired, disabled, or children of deceased parents. Social Security Disability pays benefits if you’ve worked long enough and cannot work any longer, but many find it challenging to break through and actually receive Social Security after they’ve suffered a mesh-related injury. 

Bruce Feifer of Farah & Farah, a law firm in Jacksonville, Florida specializes on social security and workers’ compensation. He talked to Jane Akre, editor of Mesh News Desk. The following is sponsored content. 

Jane Akre, Editor MND

Bruce Feifer, Social Security attny. Farah & Farah

Q: Bruce, let’s first define the terms under Social Security because it can be confusing.

Feifer: “There is Social Security Retirement (SSR), Social Security Disability Insurance (SSDI) and Supplemental Security Income (SSI). Social Security (SSR) is intended to be received after you retire. SSDI can be received if you are disabled medically from all work, permanently, not temporarily. SSDI is based on your work record.  You must have worked five of the last ten years.”

“SSI is less dependent on your work record and it provides just the basics. SSI requires that the claimant meet the same medical criteria as one collecting SSDI but it is paid to those who have not worked the requisite time required to collect SSDI. That person is considered financially indigent per The Social Security Administration (SSA).”

“SSI provides for basic needs. While it doesn’t have a work requirement, it does have economic requirements – if you’re single you can’t have assets greater than $2,000 excluding one car and your primary residence. The car could be a Rolls Royce or Bentley as long as there is just one car. If you are married, $3,000 in assets is the limit.  You still have to meet the same medical criteria.”

Q: SSI comes from the states? 

Feifer: “SSI is paid by the state of Florida. Disability (SSDI) is paid by the federal government.”

Q: So for someone disabled and not near retirement, does anyone get Social Security Disability on the first pass?

Feifer: “Yes some do. Typically the people who will get it and qualify earlier are over the age of 55 (classified as being of advanced age) where transferrable skills from their past work history are considered by Social Security. If they can’t transfer their skills, they qualify.  Under age 55, it’s assumed you can assimilate.”

“So if they have a severe medical condition which is either terminal or expected to last greater than one year and they cannot perform their past relevant work (any past work performed within last 15 years) and that work also does not have transferable skills to a lighter level of work to which they are capable; they are found disabled.”

“Claimant’s between the ages of 50-54 (classified as closely approaching advanced age) and those under 50 ( classified as younger individuals) will have a tougher time of being accepted as they must prove the inability to perform past work plus the inability to perform any other type of work; irrespective of transferable skills. In other words, it’s perceived that it’s easier to teach a young dog new tricks!”

Q: What’s needed?

Feifer: “Objective medical evidence, X-Rays, MRI, diagnostic studies. And the treating physician outlining stringent restrictions.  He can’t say they’re disabled. That’s for the administrative law judge (ALJ). You have to have evidence that shows you can’t work.”

President Roosevelt signs Social Security Act into law August 14, 1935

Q: The word of a doctor alone is not enough?

Feifer: “The medical opinions and reports are allowed in, but just saying “My patient is totally disabled” is not enough. There is a durational requirement. The inability to work has to be proven to last greater than one year. If they have problems now but a doctor says they may be able to go back to work in less than one year, then they would not qualify for Social Security.”

Q: If one has to reapply, what additional information is needed or helpful at the reconsideration phase?  How long should one expect the entire process to take?

Feifer: “The process can be lengthy and there are possibly three stages one will go through by which one may or may not be accepted. The Initial Application process typically takes 4-6 months with the SSA gathering medical reports from the applicant’s doctors and also sending the applicant and possibly third parties questionnaires about their daily living and functional capacities. All of this information is then considered along with their work history to make a decision as to whether they meet the criteria to be found disabled. If medical evidence is lacking, the SSA may send the applicant to one of their doctors – known as a conductive examination (CE) – for testing and a physical or mental examination.”

“The Reconsideration Stage is typically shorter lasting 2-4 months. Another team at the local SSA office will make an independent evaluation of the file again having the opportunity to gather further information through questionnaires to the claimant and third parties, a possible CE and most commonplace updated records from the treating physician.”

“The Hearing Stage is the longest with it typically taking up to 18 months for one to get their case heard before the Administrative Law Judge (ALJ). The claimant appears at the hearing and gets to present medical evidence as well as direct testimony as to both their work history and their current medical conditions and how they impact their ability (or inability) to perform their activities of daily living and general functioning. The ALJ has the opportunity to put a face to the black and white reports in the file and further develop deficiencies found at the lower levels by directly questioning the claimant. It is the level by which most people fund themselves being accepted.”

Q: Is there a lot of fraud, is that why so many are rejected on the first pass?

Feifer: “While there is fraud in every system, the rate of denials has more to do with so many people applying and their inability to meet the stringent requirements established by the SSA to qualify for benefits. In addition to having to be either terminal or have a condition lasting greater than one year, you also have to prove (especially those under 55 years of age) that you can’t do any other lighter area of work in the workforce such as be a ticket taker, a parking garage attendant or security monitor who sits in a surveillance room at Wal-Mart.”

“The SSA does not consider employer prejudices toward hiring the disabled; the fact that one cannot meet their financial obligations performing lighter and unskilled jobs to which the applicant is deemed capable; or even whether the jobs to which one is potentially capable are available in the local economy. The SSA can expect you to relocate to perform work. They find nothing wrong with concluding you can perform simple unskilled jobs as a ticket taker, security monitor, or silverware wrapper even though in their past careers they earned greater salaries than the jobs suggested garner.”

Q: If you move to another state are the benefits transferrable?

Feifer: “Your SSI may change but the federal disability would continue to pay. Usually cases are subject to review every three to five years regardless.”

Jade R graphic

Q: If you are rejected and you need to hire an attorney should the person be local or regional?  

Feifer: “The SSA has become much more technologically advanced in recent years and this includes the use of video conferencing capabilities that allow applicants to appear in one part of the country and their attorney and/or the judge in another region. Further, many firms service multiple regions. For example from our Jacksonville office we service not only the local community but also have attorney’s handling claims in Orlando, Gainesville, Tallahassee and Brunswick, Georgia where we routinely make live appearances before ALJ’s.”

“So the technology is there. Given the technology that allows all of the information to be electronically transferred, it’s really communication and gathering of records and reports from doctors. The laws are the same throughout the country. New York has the same laws as Florida since it’s a federal program.”

Q: How is an attorney paid?

Feifer: “The SSA pays the attorney directly out of back due benefits secured for the applicant. The fee is 25% of the past due benefits secured with a maximum fee of $6,000. In rare circumstances, such as when appeals are filed beyond the ALJ, hearing level fees may exceed the $6,000 sum upon application of a fee petition documenting that a larger fee is deserved for a greater amount of work performed. All fees require the approval of the SSA.  Basically it’s 25 percent of the back due benefit or $6,000, whichever is less.”

“In addition to fees, the applicant is responsible for costs incurred by their representative for such as items such as medical records, special reports from a treating physician etc. These costs are not overly burdensome and typically from $150-$350 per case.”

Q: Should one attempt to go it alone the first time around?

Feifer: “Retaining an attorney early on is highly recommended. We get involved in the case so we can direct clients how to fill out the forms. The forms the applicant is sent by the SSA may seem rather simplistic and easy to complete, however in reality, detailed answers regarding ones capabilities is important as is consistency in one’s responses throughout each stage of the application process.”

“If you go it alone, they may require too much information that is detrimental to the case. Experience and knowledge with regard to what information the SSA needs to know to make a well-grounded favorable decision is what an attorney specializing in SSDI and SSI brings to the table. For most applicants a successful outcome is the difference between having money and medical benefits to survive until reaching age 65 and becoming eligible for retirement and alternatively losing everything they worked so hard to gain prior to becoming ill.”

“So I do not recommend anyone go it alone. Representation is on a contingency fee so if they don’t win they don’t pay the attorney a single cent. Further, if they get picked up early on at the initial level, the fees will be nominal or perhaps nothing if there are no back due benefits secured. There is really nothing to lose and far much more to gain hiring an experienced representative.”  #

LEARN MORE:
Lawsuit Financing – What you need to know before you borrow, Mesh News Desk, May 28, 2016
http://meshmedicaldevicenewsdesk.com/lawsuit-financing-what-you-need-to-know-before-you-borrow

Expecting a Mesh Settlement? Will a Special Needs Trust Work for You, July 7, 2015, Mesh News Desk
http://meshmedicaldevicenewsdesk.com/expecting-a-mesh-settlement-will-a-special-needs-trust-work-for-you

 

The post Social Security Disability for the Mesh-Injured – What You Need to Know appeared first on Mesh Medical Device Newsdesk.

New Day segment King-TV, Seattle July 22, 2015

 MND, August 25, 2015 ~ King 5-TV in Seattle did a health segment in July on pelvic floor problems including prolapse and incontinence.  Featured was Dr. Una Lee of Virginia Mason Hospital, a urologist who trained under Dr. Shlomo Raz at UCLA.

“Better Understanding the Female Body with Dr. Lee”  was sponsored by Virginia Mason Hospital.

See it here:

Dr. Lee says she sees many patients who are uncomfortable about their pelvic area. She wrote a blog, “Five Things Worth Knowing About the Vagina,” to help educate patients.

Childbirth injury and aging can cause the pelvic organs to prolapse.

The patient featured in this segment, Amy Cunningham, noticed discomfort when she stood. She was experiencing prolapse and had no idea what was going on. In her case, she tried a pessary and kegel exercises.  Dr. Lee performed a vaginal hysterectomy and repair of the prolapse using fascia. She tells the segment host, Margaret Larson, she believes in starting conservatively.

Dr Lee believes in the judicious use of synthetic mesh and uses it in rare circumstances. Instead, she prefers alternative therapies such as native tissue repair.

Virginia Mason does research in the area of pelvic floor disorders. For example, Cook Medical is working on a clinical trial currently using a patient’s own cells removed from the thigh to grow cells to regenerate the urethra part of natural regenerative therapy.  There are 20 sites in the country and Dr. Lee is part of this trial.  Dr. Lee is a member of SUFU, AUGS.

Patient Amy Cunningham says she “feels great,” and can play tennis and hike. Her recovery took 3 or 4 months to return to herself.  #

 

LEARN MORE:

Dr. Una Lee, Virginia Mason Hospital, Seattle
https://www.virginiamason.org/body.cfm?id=1175&action=detail&ref=1025

Dr. Lee on Facebook
https://www.facebook.com/VMcares/posts/444852638885975

Dr. Lee- Five Things Worth Knowing About the Vagina
http://blog.virginiamason.org/2015/04/06/five-things-worth-knowing-about-the-vagina/

 

The post Better Understanding the Female Body with Dr. Una Lee Offers Help to Pelvic Prolapse Patients appeared first on Mesh Medical Device Newsdesk.

Pacemaker, Courtesy WikiCommons, Steven Fruitsmaak

MND, August 30, 2015 ~When you have a new car that develops a “safety” issue i.e. braking, steering, airbags, wiring, engine cooling, unintended acceleration etc, the auto dealer reports the problems to the manufacturer, who by law, must report the issue to the National Highway Traffic Safety Administration within five days.

But when a patient has a problem with a medical device, don’t depend on mandatory reporting. Or any reporting at all. Your doctor may report the problem, but then again he or she may not. A problem may reflect badly on his surgical skills.

But you should still report your adverse event.  How many patients understand how to report an “adverse event” to the Food and Drug Administration? (Disclosure- this story first was published on this day August 30, 2011, on Mesh News Desk).

An adverse event can be any complication from a drug or medical device and it is the only way the federal agency can track problems.

The FDA reported in July that from Jan. 01, 2008 through Dec. 31, 2010, it received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs.

Because of the lapse in reporting, problems that are reported are suspected of reflecting just a fraction of what occurs in the real world – as little as one percent.

How to Report an Adverse Event

You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online:

• By phone- 1-800-FDA-1088
• By FAX – obtain a fillable form online and print it out and fax it to 1-800-FDA-0178
• By mail – or mail it to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787

MedWatch Online Voluntary Reporting Form (3500) is here.

Look up Adverse Events:

Manufacturer and User Facility Device Experience (MAUDE) data

As it stands now, the injured have to find the FDA’s MAUDE database (Manufacturer and User Facility Device Experience Database) and understand the criteria to enter to pull up injuries resulting from your mesh. It can be intimidating, and if they are involved in litigation are generally advised not to enter information.

For example, in the case of mesh patient, Suzanne McClain (Suffering in Silence- Part 1) finding data on Ethicon’s Gynecare Tension Free family of mesh products involves knowing the criteria:

1.) Product Class: Mesh, Surgical, Polymeric (You will have to scroll through the M’s to find this phrase.)
2.) Brand Name: Tension Free
3.) Date Report Received by the FDA: (Date Range) 05/12/1999 to Current Date.
4.) Records Per Report Page: Change to 500 and click Search.

A National Registry

The purpose ultimately of  the patient advocacy group, Truth in Medicine, is to stop the marketing and implantation of synthetic surgical mesh.  Information collected on an international user-friendly registry would be passed onto Congress to accomplish that goal.

Surgeons who remove surgical mesh (Suffering in Silence– Part 3) also support a registry to get some idea of the big picture of complications of synthetic surgical mesh.

Getting More Information

At the FDA’s Office of Surveillance and Biometrics by e-mail at phann@fda.hhs.gov or by phone at 301-796-6640.

Enroll to receive Public Health Notifications here.

The post How to Post an Adverse Event with the FDA appeared first on Mesh Medical Device Newsdesk.

A young Linda Batiste

MND, August 31, 2015 ~

WHO WAS LINDA BATISTE?

The story of Linda Batiste’s life and death is best told by her only biological child, James Clinton, who shared a home with his mother and helped her through her final months before she died of brain and stomach cancer on Saturday, August 8.

Batiste, 65, was a pioneer among mesh-injured women. In April 2014, she was David in a Goliath-size standoff with Ethicon, a division of Johnson & Johnson, and the maker of the TVT-O (trans-obturator tape) she was implanted with in 2007 as a treatment for incontinence. After a three-week trial, the Dallas-based jury decided that J&J’s TVT-O mesh was defectively designed and awarded Batiste $1.2 million in compensatory damages. The healthcare giant immediately appealed the winning verdict. The family has not seen a dime. And, J&J’s TVT-O remains on the market.

Despite the landmark, precedent-setting decision, her son, James, says Linda remained the same humble person. During a recent visit to a doctor’s office, Linda was shocked when the staff had her picture on their computer desktops. “You’re kind of a big deal,” said Aaron Horton when Linda called to tell her of the day’s events. Horton became a friend of the family’s while covering the Batiste v. Ethicon trial for Mesh News Desk last year.

“Mother had no idea she was a living legend,” says her son.

In her last months, Linda lived in a Dallas apartment with her son.  Clinton says his mother never regained her health after receiving the J&J TVT-O implant from Dr. James R. McNabb, a surgeon at Baylor University Hospital. Linda worked as a nurse until about 10 years ago. In 1990, she left her Deridder, Louisiana home to help James raise his children in Dallas. James had moved to Texas for a job as a telecommunications contractor.

James Clinton and his children

When Linda was diagnosed with cancer in April; it was medically deemed to be terminal, as it had invaded several vital organs.

“Mother had been sick off and on… heart, allergies, but the cancer, we didn’t know,” he says. “She had some surgeries to have mesh taken out, but still, there were days Mama couldn’t walk. She had a walker. Pastor Reese got her a wheelchair later on. We gave her pain medicine; it would temporarily help but never take the pain away- they never could that much. She couldn’t come up a flight of stairs to visit us.”

HELPING OTHERS

“Mother always liked helping people. She would take the first step toward a person to help, regardless of the way it would hurt her or not. That’s the way she was. She would make you smile and laugh even in the midst of her pain,” says James. “I’m still amazed she’s gone; I’m still amazed about the strength she had while dying.”

Linda was always thinking about other people, especially her caregiver son. “I was her arms, her hands, her feet, whatever she needed, I was her Mama. She needed me to be.”

Clinton’s oldest son, James “KC” Carheel, would help carry Linda, when she had no strength to stand. Granddaughter, Sara Clinton, would provide for her also, helping with medical needs and reading to her. Granddaughter, Tasha, would come over to read and sit with Linda. Two-year-old Trinity, Sara’s daughter, would make her smile as did five-year-old James Clinton Jr., who the family often calls “Lil’ Man.”

Joshua singing

“Mother would always smile when she saw him; she would smile even when she couldn’t hardly speak, and when she heard his voice, she’d smile and make a sign to recognize him,“ remembers James. She also loved to hear her grandson, Joshua, sing. He would come over and sing to her, and she would encourage him to follow his heart and his dreams. Everyone in the family agrees: Joshua has a rare gift for singing. His voice was of great comfort to his grandmother, throughout her life, but also in her last days.  (Click to hear Joshua sing    or go to:
http://tinyurl.com/nm4q3q9). 

Others came over too: Ms. Patricia Williams, Linda’s best friend, helped day and night; as did Evelyn Gardenhire, Patricia’s daughter.

“We had Fay Harden, a nurse’s aide also here to help with mother as well. Our Pastors, Thomas and Phyllis Reese, were here as well. We needed that help, those prayers and physical support as well,” says Mr. Clinton.

The musical family is known to sing gospel hymns, and Horton says she too was drawn into singing with the most heavenly voices each family member displayed. Linda loved hymns, and the family sang every day until she passed. A keyboard, amp and set of drums still reside in a corner of Linda’s one-bedroom apartment, where the family still often breaks out into spontaneous singing.

Linda Batiste died at home on August 8. That was the way she wanted it.

James reflects fondly, “She believed in cooking for someone. Taking in people. Brought home youth around Joshua’s age who didn’t have nobody.” Josh is 24 now, but James recalls Linda’s kindness towards her grandson’s friends, even when Josh was in his teens. “Color, race, it didn’t matter. She was very diverse. They all called her ‘Grandmother.’”

Aaron says, “If you were around her, you became like an adopted child. She was like a mother to everyone. She had so much wisdom.”

Linda’s recipe for Gumbo was a family favorite along with chicken, smashed potatoes, macaroni and cornbread. She brought her Louisiana hospitality to her kitchen in the Lone Star State without missing a beat.

Aaron and Linda, April 2014

AT TRIAL

Did Linda Batiste realize she was a pioneer as the first woman whose trial found Johnson & Johnson’s TVT-O to be defectively designed?

Referring to her victory, Mr. Clinton says, “She didn’t make a big noise or celebration about it with us. She let us know she won and hoped others would be blessed as well. Those were her words – that other women will come out well including men who might also have mesh. She was grateful in general.”

The dignity continued even when attorneys representing Johnson & Johnson did what a defense team must do – attack the credibility of the plaintiff.

“It was horrific to witness one of the defense attorneys try to enter into evidence some incidents of past domestic violence against Linda, as some kind of proof somehow that her suffering from the mesh was related in some way, which is ridiculous,” says Horton. “The audacity of them trying to connect the two is disgusting. It really is. It’s unconscionable. Judge Molberg did not allow the information to be presented to the jury. He saw straight through it.”

Horton says Linda would sit up straight in her chair, on a pillow with her legs crossed under her chair and her hands on top of her cane. “As dignified as Audrey Hepburn,” Horton says describing her regal manner. “Linda was known to pray quietly to herself.” recalls Horton. “She never showed disdain or malice to the other side. She never even really looked at the other side of the courtroom.”

At the end of the day, it was another story.

“She would always say, ‘Pray and be careful for nothing,’ says James Clinton reciting the Bible verse Linda revered. She knew they were trying to hurt her in court by digging up her past. ‘Pray and be careful for nothing,’ she would always repeat,” he says.

A young woman in her 20s showed up at Linda’s memorial service, August 15. She too had been implanted with J&J’s TVT-O mesh – by the same Dallas doctor. She too was suffering. After reading an article about Linda in the Dallas Observer last May, she realized the connection the two had. The woman told Aaron, the story changed her life; that Linda changed her life by speaking out.

UNWELCOME ADVANCES

Linda died on Saturday, August 8, and a day later, her family posted a Go Fund Me fundraiser to rally extended family, friends and church members to help with the expenses for a funeral, which seemed far from possible at the time. Linda, and her family wished for her to be buried, which can quickly add up to thousands of dollars. At the request of the family, Horton, through The Mesh Warrior Foundation’s website also lobbied for funds from her own family, friends and the mesh community at-large, stating that 100% of the proceeds would go to the family for expenses for a traditional burial, including a headstone. “We also desperately needed funds for food, as Linda’s influence and impact was clearly widespread. Family and friends came to honor her, and we needed help to feed the immediate family and extended family, as mourners poured in to offer their condolences.”

“I asked Aaron to help us,” says James. “I gave her permission and my daughter, Sara, and son, Joshua, asked her. We were okay with it all. We still support Miss Aaron 100 times more and back. Miss Aaron is a part of the Clinton-Batiste family. She’s one of us. We took her in,” he says. Joshua Clinton, Ms. Batiste’s grandson, had spent time with Aaron after the trial and was trying to reach her during Linda’s last days. “My grandmother asked me to find Aaron. She told me Aaron would help – that Aaron would be there.”

Regretfully, as Joshua tried to contact Aaron, another person contacted the family. By Tuesday, both James and Joshua became aware that the unsolicited messages from another woman were not from Aaron or anyone affiliated with The Mesh Warrior Foundation. Two days after Linda died, the family was contacted via text message. Another message came from an unknown source through Facebook. A separate account, a false account, designed to look like Aaron’s The Mesh Warrior Facebook site, contributed to the family’s confusion. The imposter site led the family to believe they were messaging with Aaron when, in fact, they were delayed in reaching Aaron because of the confusion. Apparently, the “dummy” account had a picture of a blue, smurf-like creature on its home page, “Mesh Warrior,” an account which impersonated Horton’s page, which is called “The Mesh Warrior.” The two could be easily confused by anyone, Horton believes.

The advances, including Facebook posts, messages, and blogs, when put online, hurt the family’s momentum in raising funds through Horton’s website, erected with the family’s written approval – an effort to amplify the family’s message.

In a message sent to the family, the same unwelcome contact said,

“Ok I see you’ve contacted the “mesh warrior” … warning … she is a wacko who if you have a loved one with mesh problems will not be providing any useful information.” The family didn’t know the woman and asked Aaron if she knew her.  Click here to see text message.

At Linda’s home on Monday morning Grandson, Joshua, Aaron, and the family began to put together the pieces. In thinking he was talking to someone from The Mesh Warrior Foundation, Joshua was deceived. “If not Miss Aaron herself was here, we wouldn’t know,” James says. (Disclosure, your editor is on the board of The Mesh Warrior Foundation, though I’ve never met Aaron in person). Among other false information, The Foundation has since found another “dummy” account, set up by someone, not Aaron, or anyone affiliated with The Mesh Warrior or The Mesh Warrior Foundation.

“On Monday, the family and I set out to find a way to raise funds to have a traditional burial for Ms. Batiste. We had the same goal: to honor her with the dignity and respect she deserved. By Monday evening, we had not raised enough funds even to cremate Ms. Batiste. By Tuesday, information had been circulated online that TMWF did not have the family’s permission to raise funds, which couldn’t be further from the truth. By Tuesday afternoon, we had raised $195 for a headstone and the immediately needs for food for the family. After the rumors began, not another dollar came in, and ultimately TMWF was only able to donate the $195 initially raised,” says Aaron Horton. “I was so disappointed for the family, because I know the TMWF community is filled with generous people who are united, a group of people that has such great power to help one another in the most desperate of times.”

Under the guidance of the family, Linda’s granddaughter, Sara, warned the unwelcome messenger, who also initiated the false information about fundraising efforts: “Do not use my grandmother’s name in any way.” The unwelcome messages stopped; however the damage had already been done.

“Still, we didn’t give up,” Aaron says.

Linda and grandchildren

At that point, Aaron began to call personal friends to ask for donated food and services to meet the family’s needs. “By the end of the week, we had an outpouring of community support, despite the rumors. Boston Restaurant and Sports Bar in Dallas donated generous portions of pizza, Jambalaya Pasta, Buffalo Wings and salads; and TMWF was able to work on behalf of the family with Linda’s property manager to get rental fees waived, for use of the apartment complex community room for the family gathering after the service. “I was so grateful, and the family and I celebrated at the generosity of the community here in Dallas. More than one plaintiff’s firm chipped in. TMWF also worked, together with the family, to make arrangements with Chamberland Funeral Home. “Chamberland, and its owners understood the uphill battle we faced, and they generously waived many fees to make a possible service more affordable. With all of us working together, we made it happen. It wasn’t an easy task, but we continued to believe the best about our neighbors, and they stepped up to honor Linda in a big way. It was truly amazing. All of us were overwhelmed with gratitude.”

Supportive and encouraging messages from women all over the world began pouring in – via text, blog posts, and phone calls. Women wanted the Clinton-Batiste family to know they cared. Women were also scared – worried about their own health, their own legal matters. Many wondered, “What does Linda’s death mean for my fate?” An even greater reality set in. The news of Linda’s passing left many mesh-injured women fearful in the shadow of the death of a woman they believed to be so strong.

Horton describes the tense few days before Linda’s memorial service, “After we overcame the damages of the false information about our fundraising efforts, a blog, authored by the same woman who launched the unwelcome messages, continued to make our remaining tasks even more difficult. After the family asked for the unwanted contact to stop; the messages stopped, but misleading and deceptive blog posts continued to skew the truth. One such blog said:

“There was a death a week ago in the mesh community.  Someone placed in the spotlight for winning a million dollar lawsuit.  Out of respect… I will never use her name.  She deserves more dignity than being used for fame as the fame media vultures….. At the funeral. Smurf has apparently set her sights on making it her own personal advertising platform. Crappy ribbons have been made and are being pass out with her logo. This is a disgusting abuse of what people do who prey upon others.”

In actuality, the family demanded this woman NOT to use Linda’s name in association with her messages or writings.

“Another false and harmful outburst,” Aaron says about the incident. “I was having dinner with the family when James showed me a Facebook message from this unknown woman, and I hung my head thinking, “Oh, my gosh, I have inadvertently brought a most unwelcome and harmful person into this family’s life, but James assured her saying, “You look at me Miss Aaron. This family knows the difference between right and wrong and don’t you worry about that. We love you and you are welcome in our family.”

“I was speechless because of the genuine nature and kindness of this family,” says Aaron. “I was also speechless at the behavior of this woman, who continued to harm the family of a mesh-injured woman, a family she doesn’t know. A casserole or a card sent with condolences would have been the kind and appropriate action to take in this situation. There is no question that the unwelcome advances confused and troubled this family, and during their most vulnerable time. In the end, the trouble caused made little difference when compared to the enormous impact of the goodness and provision that came as a result of those who surrounded this family with generosity; with words of encouragement; with real friendship; and financial assistance.”

CONDOLENCES COME IN

On August 15, in the small sanctuary at Macedonia Baptist Church, supportive comments from women all over the world were read. It honored Linda. It educated people. It reminded everyone just how big of a legacy this small-framed woman left. A sampling of the sentiments, read at from the mesh-injured community, read at Linda’s Celebration of Life, are below:

LK – So Sad To See This…My Prayers And Thoughts Are With Her Family And Friends…She Left Us Way Too Soon…

DW – My condolences (Innige deelneming) to the family and friends……it’s too soon….

JLJ – Heart breaking. Prayers for her family and all who loved her…

SH – Prayers for her family. When I seen her story one night searching about mesh that got me started understanding the dangers I was in due to mesh.
Rest in peace

AV – Reading the article about her trial listing our doctor gave me the power and strength to make a doctor listen to me that this mesh was hurting my body in many ways. After I read her article I went right to the hospital to get my records. Without physically knowing her or ever talking, she has greatly changed my life. I owe so much to her!

HZ – So sad to hear this! She was brave and strong through her fight. The tribute is beautiful.

FL – Father god spared her from feeling any more pain – that he called upon her to come home, she is with the lord now. May her soul rest in peace. Amen.Sister…

NJ – I went for my annual checkup Thursday. I was told a year ago by my OB-GYN that the time had come to seriously consider mesh as the answer to my prolapse. As I sat in the parking lot, dreading the ride in the elevator up to see the doctor, I was checking my emails and saw the notice you sent the day before regarding Linda Batiste. What a sweet face; and I’m sure a sweet person. I’m so sorry. This email gave me the courage to tell the doctor ‘No’ when she asked if I was ready to “get this over with.” I don’t know if you realize the impact you have on troubled, prolapsed lives…You are our eyes, ears and voices as we wait for a safe alternative.

“These are but a few of the hundreds of beautiful comments of love and encouragement that were sent by our suffering community,” says Horton.

Linda Baptiste

TO BE REMEMBERED

While the J&J/Ethicon appeal is slowing moving through the court, the family cannot talk about the case or jury award. However, nothing is stopping James from picking up where his mother left off. He wants to join the global fight against mesh injuries that continue today, to bring awareness where the media has failed.

“I would like my mother to be remembered in a small way for winning a shield of justice for all women around the world, regardless of mesh, cancer, violence or domestic abuse, she’s a shield for all woman. She speaks from the grave. She stood in front of them – all the women – who will follow what she did.”

James would like the world to know the family will win any appeal, and the other women, whose verdicts have also been appealed (the cases of Ms. Gross case, Ms. Husky, Ms. Perry) will also win theirs.

“I would like women around the world to say, “’I am Linda Batiste,’ that her name would be remembered. Anybody can still come out victorious. They can say it now. . . around the world, set a day to say ‘I am Linda Batiste,’ because they all share the same pain. Our family still has to figure how to go on with birthday, holidays. I believe if every woman around the world [could] one time say, “I am Linda Batiste,’ judges, juries, doctors – everybody will hear one time. . . [That] will show grace and mercy for the other women. Mother has the spirit of David from her grave; she is still calling out. The whole world will know her as a person as small as she was, an ordinary woman. Let every other woman know the giant still can be defeated with justice.”  #

LEARN MORE:

Mesh News Desk,  August 14, 2015, Linda Batiste Mesh-Trial Pioneer to be Laid to Rest
http://meshmedicaldevicenewsdesk.com/mesh-trial-pioneer-linda-batiste-to-be-laid-to-rest

Mesh News Desk, April, 2014, Batiste’s Trial Ends with $1.2 Million Jury Award
http://meshmedicaldevicenewsdesk.com/batiste-trial-ends-with-defective-tvt-o-pelvic-mesh-jury-award-1-2-million

 

If you have been the victim of online harassment, there are steps you can take.

• First, ask the harasser to stop contacting you immediately. If any contact continues, including references to you or your name via social media sites or blogs, document the harassment.
• Repot the harassment to your local police station.
• If you are unable to put a stop to the harassment, you may file a complaint with the federal government here: http://www.ic3.gov/default.aspx
• Take time to understand and familiarize yourself with your state’s laws concerning the online harassment of adults and disabled adults.
• Once your local authority is informed, you may wish to retain legal services.
• Click on the links below to learn from a PEW Research Study on the prevalence of online harassment. You are not alone.
  • http://www.pewinternet.org/2014/10/22/online-harassment/
  • http://www.pewresearch.org/fact-tank/2014/10/30/5-facts-about-online-harassment/

 

PROTECT YOURSELF FROM ONLINE HARASSMENT

Here is a stalking helpline, which offers advice to those suffering online harassment.
0-808-802-0300, or email  for advice to: advice@stalkinghelpline.org

 

The post Linda Batiste’s Legacy appeared first on Mesh Medical Device Newsdesk.

Deconstructing “The Lien Machine”

MND, September 3, 2015 ~A recent series of Reuter’s articles takes a broad swipe at the industries that helps women find the resources they need to obtain mesh-removal surgeries.

With 100,000 plaintiffs now joined in litigation against seven mesh manufacturers, removal of the polypropylene mesh implant may be the only avenue to find some relief for those disabled by the permanent medical device, used to treat incontinence and prolapse.

As a result of “The Lien Machine,” HERE many women may be scared off from seeking and funding the surgeries they desperately need now, rather than later when their case settles if it ever does.

Knowing what questions to ask is an important tool for women who need surgery. Most mesh injuries do not improve over time, in fact, they often get worse, leaving a woman to suffer.

The following is intended to offer some clarity to this story for those who may seek medical management of their mesh cases to make the road an easier one. (Disclosure- no surgical lending or debt buying firm is a supporter of Mesh News Desk).

Drawing courtesy of JadeR.

CASH ADVANCE OR DEBT PURCHASE 

There are two ways to obtain financial help to fund your mesh removal surgery when private insurance does not.   A recent story on MND on Lawsuit Financial LLC, (one-time supporter of this site) provides consumers with guidance on how to borrow conservatively.  These cash advances, used to finance surgery or pay a lapsed mortgage, accrue interest, just like a credit card over time, and therefore can become very expensive.

Dollar sign Scott Steiner, WikiCommons

See What You Need to Know Before You Borrow” HERE.

The cash advance company places an uncollateralized lien on her eventual settlement or jury award.  It is expensive money because there is no assurance it will ever be repaid. The percentages accrue over time.

Another vehicle to fund mesh-removal surgery is provided by MedStar, an Austin-Texas-based company that was the focus of the unflattering Reuters reports. In this type of assistance, MedStar, known as a factoring company, buys the discounted medical debt counting on it to eventually be paid by placing a lien on a plaintiff’s settlement or a jury award.

The medical provider determine the debt. There is no interest accruing. It is not unlike the exchanges between banks offering home mortgages. Your bank may sell your mortgage to another lender to collect. It does not change what you owe on your home.  The downside- the cost is often not discounted to the extent it would be for an insurer, Medicare or Medicaid. That is disclosed up front in the fine print.

Bottom Line- Eventually the woman will be expected to pay for her surgery from the settlement money is she is receives or is awarded by a jury. If there is no settlement or award, the bill will be excused by a cash advance company. It may be adjusted or reduced by a factoring company though she is technically on the hook to pay that debt.

WHAT SHOULD A PELVIC MESH REMOVAL SURGERY COST?

In the OR, Miklos and Moore

The fundamental problems with the Reuters story is it cites insurance reimbursement as indicative of the relative value of a mesh surgery. The insurance industry is slow to catch up with the realities of mesh complications, called by removal surgeon Dr. Veronikis, one of the “darkest chapters in women’s health.”

The Reuters report accuses the surgeon in the story of charging an “inflated bill,” however, without knowing the cost of a surgery, it’s difficult to accuse someone of overcharging.

So what should a pelvic mesh removal surgery cost?

First, it can take anywhere from 20 minutes (partial removal in the office setting usually) to a 4, 5 or 6 hour difficult surgery maneuvering around pudendal nerves, scar tissue, mesh fragments, bladder, urethra, mesh arms, etc.- in other words, a challenge not fit for an amateur.

Dan Christensen of MedStar concurs; there is no standard sticker price for a mesh surgery.

“The surgeries come in all shapes and sizes, all done by different doctors in different geographical areas with different levels of experience. It may depend where they practice and their level of expertise. You will see widely differing costs of surgeries also because the surgeon doesn’t know what they are going to encounter.”

In questioning readers what their surgeries cost, Mesh News Desk got the following answers:

One woman from the Midwest said her bill tallied $14,188; another from Canada has been quoted $39,800 by the hospital. That number does not include travel from another country or accommodations.  A woman from Florida says her surgery and three-night hospital stay was $76,894.63.

Those numbers may or may not include the cost of a consult ($1,000) the translabial ultrasound ($1,000), or the urodynamics test (upward of 5,000 to 8,000).

Another woman from New Zealand raised $100,000 to cover the cost of travel to the States to have her mesh removed.

Meanwhile insurance reimburses as little as $350 to $1,600 at UCLA, according to Dr. Shlomo Raz, a leading mesh removal surgeon at UCLA.

Because insurance reimburses so little, many doctors say they are not being adequately compensated for their skill-set or time and do not want anything to do with removal or excision surgeries, not to mention the potential liability.

The doctor in the Reuters story charged $17,000 for a mesh removal surgery, which is in line with the findings of our unscientific survey but again, the reporters used the anemic insurance reimbursement as a standard to declare it an “inflated bill.”

Adding concierge care, that is, book hotels, arranging flights, covering the cost of an OR, thousands more can easily be added to the bill you’re expected to pay.

Bottom Line- Comparing an insurance reimbursement to the actual cost of a surgery is inaccurate and minimizes the severity of these injuries and surgeries needed to correct complications.  Insurance companies and the government receive a discount. In the case of a factoring company, the discount essentially benefits the company purchasing the debt. That’s how they’re paid.

Know what you are buying and what it will cost. Like any purchase- get it in writing. Get the surgical estimate in writing as well. The patient, doctor and lawyer should all have a good idea what the surgery will cost after a medical assessment by an experienced mesh-removal expert. 

WHO IS EXPECTED TO PAY THE BILL?

Every time we see a doctor, we are promising to pay the full amount of the charges.  A trip to the emergency room and often the first question is – ‘Who will pay the bill?’  Despite the fact you are bleeding, you often must first sign a paper agreeing to pay the charges.

In the case of a factoring company, the company buys the debt (the medical bill) and becomes the assignee that expects to be paid, whenever. The win-win is the doctor is paid immediately instead of waiting years to receive payment.   The bill is dictated by the medical care she provides and according to MedStar it must be, “usual, customary and reasonable.” In other words, not inflated.

Rick Tadrick, National Director of Business Development for Medfin, another factoring company says in practical terms, if the lawsuit fails, the medical provider and/or the funder is not going to be able to collect anything.

“If it’s diminish value did not reach the threshold we did not estimate it to be, MedFin will sit down with attorney and have to discuss some aspect of a reduction. Everyone participates in the pain of a case that does not meet the threshold we anticipated in recovery.”

Tadrick adds he may not work with that attorney again.

Bottom line– That’s why it is so important a mesh-injured woman has an accurate assessment from a mesh-removal expert, not a doctor who is unfamiliar with mesh complications. The latter may devalue the case.  The former not only makes it easier to obtain funding but eventually it will reflect the actual value of her case when it comes time to settle.

IS THE PATIENT TOLD WHAT THAT SURGERY WILL COST?

There should be no surprises.  After a medical workup, the patient and lawyer consult with the doctor to determine an estimated cost of the surgery.

Absolutely, says Christensen of MedStar.

“We inform the patient and the lawyer what the expected charges will be before the procedures are done.  If the patient or her attorney feel the charges are too high, they can elect to shop around to other providers.  To say someone doesn’t know it was going to be that much in the end means she didn’t read the documents.”

As far as the need to obtain surgery, it could be construed as malpractice if a lawyer knows of a way to a client to receive aid and they neglect or refuse to inform the client of that solution.

Christensen says as far as MedStar, there is no “referral fee” or “kickback” for the lawyer who contacts them.

For her part, the only patient quoted in “The Lien Machine,” said she was not adequately informed about the costs. MND asked Traci Rizzo if she received paperwork and estimates in advance of her surgery.

“No comment lol” she said via email.

Bottom line– If a middleman provides you “concierge services” such as travel, hotel airfare, expect that will increase your bill as well. Get an estimate in writing. Read the fine print which appears in Rizzo’s contract. “PATIENT further acknowledges that medical providers typically receive more for their services when paid by contractual arrangements, such as this, than if they were paid by health insurance companies, government programs such as Medicare or Medicaid, or  by the patient in cash.”

Doctors, WikiCommons, Olga

ARE MIDDLEMEN OPERATING IN THE SHADOWS?

A Mesh News Desk story HERE originally reported in October 2013, may have been the basis for the Reuters story.

The allegations of a “scheme” to profit from transvaginal mesh injuries were made by American Medical System after it was tipped off by one of their consultant/doctors. It refers to middlemen who work in the shadows as brokers. AMS deposed the participants last year though there has since been no follow-up.

Dan Christensen, owner of MedStar, is also an attorney, therefore is required to be an officer of the court. He says AMS alleged the doctor was told to falsify information in a medical report to increase the value of cases. He says that was a misunderstanding.

“I would never be involved with someone who would do something like that.  All anyone saying is whatever you do or don’t do or observe, on these cases you need to document everything!   Treatment notes could be a few lines of chicken scratch and that’s it.  That may suffice in a managed care case being submitted to Blue Cross. When you talk about litigation, it’s important to document everything he sees or does.”

In the case of TVM (transvaginal mesh) litigation, MSO’s (Medical Service Organizations) typically are the middlemen that assist in coordinating care.

Christensen gives an example of how an MSO works.

“Take a surgical facility.  It’s empty Saturday morning. The MSO will say ‘I can fill it where it will otherwise go empty and I will pay you x-dollars whether I use it or not.  The facility will say yes.  Now this MSO says I will buy that block of time at this rate.  Through those relationships, the MSO can negotiate good pricing and guarantee payments to make the medical providers comfortable about doing these surgeries. “

Mesh News Desk has reported on another type of middle man – lead generators who solicit clients to sign up for litigation, whether or not they are injured. How they obtain your name and number is a mystery.  Your editor was even called by one that promised I might be able to recoup dollars by joining in litigation. See the story of “Patrick” HERE.

Bottom Line- Hang up if someone is trying to solicit you over the telephone.  A mesh-injured woman should seek a qualified law firm, preferable one that specializes in cases naming her mesh manufacturer.  See the Southern District of West Virginia, HERE, a federal court in Charleston, where 80,000 mesh cases are consolidated. Click on your manufacturer then on your mesh maker and in the fine print above see which law firms are taking these cases to trial (See Steering committees, Lead and Liaison Counsel).

CAN A WOMAN WALK AWAY WITH NOTHING?

If a woman receives a settlement that doesn’t cover the cost of her medical bills, she can simply refuse it.  Her lawyer will not be happy.  He or she is paid only when the plaintiff agrees to accept the settlement offer and some law firms have spend a million dollars or more to bring one plaintiff to trial. Medicare will get nothing and neither will the doctor.

In that case, MedStar’s Christensen says the companies will put their heads together and come up with a compromised amount and try to get something in her pocket.

Another factoring company that buys medical bills is Arizona-based MedFin.  Rick Tadrick, National Director of Business Development for MedFin says that is why it’s so important a realistic medical assessment of her injuries be done before the surgery is performed.

“Miklos and Moore may say she is not surgical; They will not do one simply to do one.  No doctor will. Any of these others, I don’t believe they will do one to bump up a case either.”

If she qualifies for surgery, Tadrick will more likely buy that debt after a review with her attorney to make sure it is a solid case.

Bottom Line – If your case offers a disappointing settlement, most companies will work with you and your attorney to make sure the woman has something. If a jury does not award anything on a case, the debt may be excused completely, even though technically you are still obligated to pay.

HOW THIS ARTICLE MIGHT HURT THE MESH-INJURED PLAINTIFFS

Scales of Justice, WikiCommons

The fundamental problems with “The Lien Machine” is it cites insurance reimbursement as the relative value of a mesh surgery.  In the process it diminishes the seriousness of a mesh-injury and the degree of complication involved in removing an implanted medical device that was intended to be permanent, though never tested on humans before being marketed.

Mesh News Desk has interviewed many doctors who complain that insurance reimbursement rates are an insult to those already hurt by the medical profession and mesh makers. Unless they receive a salary, many opt to do the mesh explants only if insurance is not involved.

Christensen defends MedStar and the way it does business.

“The procedures we have in place I am completely satisfied with in that we do notify what the expected charges are. We have no control over the charges, they are dictated by the medical provider.  Unfortunately they are trying to characterize MedStar is trying to take advantage or gouging these patient but that’s not the truth,” he tells Mesh News Desk.

Reuters takes a swipe at trial attorneys as well. In a follow-up story, it asked the American Tort Reform Association (ATRA) to weigh in on trial lawyers and medical funders. ATRA is behind the tort reform movement and funded by the very big industries, asbestos, tobacco that attorneys take to trial.

Christensen is concerned that the story is being repeated on the internet and held up as an authoritative piece of journalism when in fact, no one from Reuters talked to him or anyone from his company before writing, “The Lien Machine.”

How then as he quoted for the article? Christensen’s comments were taken from his deposition with AMS last year, he says, therefore were out of context.

He has a point.  The Society of Professional Journalists (SPJ) Code of Ethics makes it clear – Give the focus of your story an opportunity to answer all criticisms. It says “Diligently seek subjects of news coverage to allow them to respond to criticism or allegations of wrongdoing.”

See the code HERE.

“Clearly these journalists had an agenda. What could be the net effect is funding entities decide they don’t want anything to do with mass tort clients because of the target they could become if they are trying to help.

“The market needs to be informed, not incited,” he says. #

POSTSCRIPT

Defendant manufacturers are now citing the Reuters articles to delay paying hip replacement cases that DePuy (Johnson & Johnson) was ordered to pay in that litigation that covered the medical expenses to have the defective metal-on-metal hips removed.

The post Media Coverage Leaves Tainted Impression of Mesh Injury Surgeries and Medical Lien Companies appeared first on Mesh Medical Device Newsdesk.

TVT Secur

MND, September 8, 2015 ~ After a long spring and summer that was supposed to encourage settlement to pelvic mesh litigation, there were few pelvic mesh trials scheduled. This fall should see a surge in the number of pelvic mesh trials, especially against Ethicon/ Johnson & Johnson.

The healthcare giant indicates it wants to continue to take pelvic mesh product liability cases to trial rather than offer mass settlements as some other manufacturers have done.

In the meantime J&J is busy paying off other crimes against consumers.  Between 2010 and 2013 J&J accrued $5.4 billion in fines and settlements for wrongdoing including pleading guilty to the criminal misbranding of the off-market promotion of the antipsychotic drug, Risperdal.  The company’s policy appears to be – accept the fines and violations and move on – it’s the cost of doing business. But consider their credo that their ‘first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products.”

*Note- The first Prolift cases will soon be hear as well as TVT (transvaginal tape).

There are presently 83,019 cases consolidated in Charleston, WV in multidistrict litigation. Johnson & Johnson/Ethicon has the largest number of cases (28,777 as of September 8).  The following calendar updates several delayed cases.

SEPTEMBER 2015

Prolene mesh particles

Cavness v Ethicon,  September 21, 2015, Case No. DC-14-04220, 95^th Judicial District before Judge Ken Molberg, See the documents listed here:

According to her petition, Carol Cavness is suing her doctor Teresa Kowalczyk  MD, Hunt Memorial Hospital in Texas, Hunt Regional Medical Center, Baylor Healthcare System, J&J and Ethicon in this product liability action. She was implanted with the Gynecare Prosima Pelvic Floor Repair System. The suit notes polypropylene material sparks an immune reaction; pathogens attach when the mesh is implanted vaginally (transvaginal); the mesh shrinks; the mesh causes friction with the underlying tissue causing the tissue to degrade; the mesh injures major nerve routes in the pelvic region and degrades over time taking with it the internal tissues;  the welding of the mesh during production creates a toxic substance that contributes to the degradation of the mesh and host tissue; and the design of trocars potentially penetrates nerve-rich environments.

The complaint says J&J/ Ethicon withheld information about the propensity of these mesh products to fail and cause injury and complications and have misrepresented the efficacy and safety of the products intentionally misleading the public; the company failed to perform any tests to determine the risk and failed to design a safe, effective procedure for removal of the pelvic mesh. Additionally, Ethicon/J&J provided incomplete and misleading training to physicians, many who were not trained surgeons, to implant these medical devices. In many cases the training took place in a weekend cadaver clinic or with a sales rep in the operating room.

In the case of Ms. Cavness, her doctor knew or should have known the pelvic mesh products have a high rate of failure, injury and complications and failed to perform as intended, say attorneys for Ms. Cavness. Despite that, Dr. Kowalczyk implanted Ms. Cavness on April 24, 2012, nearly a year after the U.S Food and Drug Administration said that complications from a mesh implant are “not rare.” The doctor was negligent in the care and treatment to her patient and did not act as a reasonably prudent physician in caring for her patient, says the complaint.

The Cause of Action includes negligence; a failure to warn the Plaintiff prior to implantation; defective design of a product that was unreasonably dangerous; defective manufacture, breach of an implied and express warranty the products were safe for the purpose for which they were intended.

Cavness claims she is in physical and mental pain that will likely continue into her future, she is disfigured, that likely will not improve. She says she has lost the ability earn a living, lost wages and will have medical care and expenses now and in her future.

She is represented by William Blankenship III of Dallas and Tim Goss of Freese and Goss of Dallas.

Prolift on eBay July 2013

Wicker v Ethicon  September 28, 2015, in Bergen Co. New Jersey.  Prolift pelvic mesh  Case No. L-13702-14 to be heard before Judge Brian R. Martinotti. The case was reassigned from Atlantic Co to Bergen Co in October 2014. 

This case may echo earlier ones presented by Adam Slater of Slater Mazie (Linda Gross, Joan Budke).  In July, the Defendant requested photos from the Plaintiffs’ family weddings, an overseas trip, a vacation home. Defense is allowed to use three photos to show to the jury, not unlike the vacation shots presented to jurors in the Coleen Perry’s California trial last year.  That motion was granted. But what was denied was information from her treating physician for additional treatments.

See the New Jersey court schedule here. 

There are presently 8,341 cases filed against Gynecare in New Jersey.

OCTOBER 2015

TVT SEcur

Rabiola v. Ethicon, Austin, Texas. October 26, 2015  Case no.  D-1-GN-13-002039

Josephine Marie Rabiola will appear in an Austin, Texas court October 26 in her product liability case against Ethicon. She too is suing her doctor, Tomas G. Antonini MD, Lone Star Urogynecology and Continence Center, Seton Healthcare, and Johnson & Johnson/ Ethicon.  She was implanted with the Gynecare TVT Secur System and the Gynecare Prosima Pelvic Floor System. 

On May 24, 2010, the Plaintiff was implanted with the TVT Secur System, made with Ethicon’s Prolene mesh in Austin to treat stress urinary incontinence (SUI). By November 2, 2011 Dr. Antonini recommended another mesh to treat her SUI and pelvic organ prolapse- the Prosima Pelvic Floor System.

Ms. Rabiola would not have consented to the surgeries had she been adequately informed, according to her complaint.

As is the case with Cavness, lawyers for Plaintiff Rabiola allege negligence; design defect, manufacturing defect; a failure to warn her; a breach of implied warranty and express warranty. She too is represented by Tim Goss of Freese and Goss of Dallas and David Matthews of Matthews and Associates of Houston.

Denise Kilgore v. AMS, in Kansas City District Court October,  The case no. is 14CV01312. Johnson County, Kansas state court has an electronic docket. 

NOVEMBER 2015

Sherrer v Boston Scientific, November 30, 2015, Kansas City Mo. State Court (Bertram & Graf, David, Bethune & Jones, Wagstaff & Cartmell)

DECEMBER 2015

Mullins v. Ethicon, Charleston, WV, December  7, 2015.  (Case No. 2:12-cv-02952.)   This case consolidates 37 plaintiffs who have similar actions in one trial naming Ethicon/ Johnson & Johnson.  They all have a TVT (transvaginal tape) implant and were implanted by different surgeons in West Virginia. Those are the common issues of law and fact that allow them to be consolidated into one trial.  All of the mesh implants, used to treat incontinence, were made by Ethicon, a division of Johnson & Johnson.  See a Mesh News Desk story here.

Hammons v. Ethicon, December 7, 2015, Philadelphia, Kline & Specter, Prolift mesh 

JANUARY 2016

Edwards v. Ethicon, Charleston WV, January 11, 2016, Mueller Law

Delacruz v. Ethicon, Philadelphia, Kline & Specter, Prolift mesh, January 11, 2016

Carlino v. Ethicon, Philadelphia, Kline & Specter, TVT mesh, January 25, 2016

FEBRUARY 2016

Way v. Ethicon, February 22, 2016, Volusia Co Florida, Daytona Beach, FL

Vanderveer v. Ethicon, Philadelphia, Kline & Specter, Prolift and TVT, February 8, 2016

McGee v. Ethicon, Philadelphia, Kline & Specter, TVT Secur, February 22, 2016

MARCH 2016

Hansen v. Ethicon, Philadelphia, Kline & Specter, Gynemesh PS, March 7, 2016

Navarro v. Ethicon, Philadelphia, Kline & Specter, TVT and Pelvitex PP mesh

The post Updated Transvaginal Pelvic Mesh Trials Ahead, 83,000 Pelvic Mesh Cases Filed in One Court! appeared first on Mesh Medical Device Newsdesk.

MND, September 9, 2015 ~ Does your lawyer have a life care plan to take care of your present and future medical costs from a pelvic mesh implant?  The following is an article by Dr. Greg Vigna, JD and MD who can provide your lawyer with a realistic cost of your care for life to help you receive a settlement that more realistically matches your needs.  This is sponsored content by Life Care Solutions Group, LLC .  Essay by Greg Vigna, MD, JD. 

Dr. Greg Vigna, MD, JD

https://www.lifecare123.com/

Drs.Vigna and Hibner e-book on pudendal nerve injury. TVM_Ebook_Dr.Vigna

Historically, pharmaceutical attorneys involved in mass torts rarely need to deal with catastrophic injuries that are diverse in nature and require extended individual attention.   For example, in recent cases such as the Seroquel Litigation, there was a side effect of diabetes and in the case of the Actos Litigation, there was the link to causing bladder cancer.  These are simply cases when it comes to damages because the range of problems are known and easily measured so they can be easily placed on a Matrix to fairly apportion damages among the injured.

Why the Transvaginal Mesh Debacle is Different

Pudendal neuralgia is a catastrophic injury as disabling as paraplegia and it occurs in approximately 1-2 percent of claimants involved in the transvaginal mesh litigation.  It has future care costs of at least $950,000 to $1.6 million typically, numbers derived at by creating several life care plans.  Because mesh injuries are so individualized, there is no ‘Matrix’ that can provide for the diverse injures and future care cost for a pudendal nerve-injured women.

Settlements to Date

Smartly, the Plaintiff Steering Committees provided for various procedures that involve appeals and hearings before a Special Master that potentially allow for additional compensation beyond what is provided by the Matrix.  But as we know from the numbers coming in, many settlements are nowhere close to providing the monies she will need for a lifetime of care due to her pelvic mesh injury.

Attorneys Need Adequate Preparation before bringing their clients before the various Special Masters?

From what I’ve seen, there are just a few attorneys who are investing in their pudendal injured woman’s case.  No catastrophic injury attorney should goes into mediation with the Defendant companies without a life care plan that describes future medical and non-medical care and the cost of these services.  A pudendal injured women is such a client and needs to be prepared by her representing attorney.

How the worst 1-2 percent prepare for the Settlements before the Special Masters

They need to request their attorney to obtain a life care plan from a physician certified in life care planning or at least understand the reason why they are not being afforded this service.

How a Life Care Plan Can Help

I have the staff available to meet the challenge of providing four to five hundred plans over the next two to five years.  If the attorneys can’t afford to invest in the necessary life care plan I will accept a Letter of Protection from the attorney, but I can’t stress enough what a difference a thorough life care plan can make on the outcome of a case.  I’ve seen it happen time and time again in other catastrophic injury cases.

A life care plan is a 30 to 50-page document that includes psychological testing, psychological interviews, physician interviews, medical records summary, and local costing of goods and services where the women resides.  It is a huge project that takes several individuals with diverse skill sets and generally takes 30-50 hours to produce.   It is the best protection to prepare these women for what’s ahead- a review with a Special Master and the various appeals and hearing ahead as well as potentially future individual litigation.

The plan is for this project to result in the compensation that affords injured women the standards of care going forward into the future within the Settlement and affords them the knowledge to truly make an informed decision in the future related to the adequacy of their particular Settlement Offer.

What additional benefits can be obtained by having a life care plan done by Life Care Solutions Group, LLC? 

Simply, they will be part of roster of women who represent the most injured pudendal clients who are trial ready.  Whatever settlement amount they accept is their business and is confidential among the parties involved.  With the women’s consent, we can amass the names of women who reject their settlement offers so they and their attorneys, who ethically must continue their representation, understand that they are not alone and that they may become a deep and dangerous docket of women going forward in the future.

I am providing all services as a medical expert in pudendal neuralgia, Board Certified in Physical Medicine and Rehabilitation, Certified Life Care Planner, who remains a full-time physician practicing at an academic hospital.  I am not their attorney.

Visit the Life Car Plan LLC Website here. 

The post Catastrophically Injured Pudendal Nerve Damage from Pelvic Mesh: Is Your Attorney Seeking Adequate Compensation? appeared first on Mesh Medical Device Newsdesk.

MND, September 8, 2015 ~ This week, NBC News investigated a blood clot filter made by C.R. Bard, and the questionable way the controversial medical device was approved for market. Bard also makes a number of pelvic meshes which are the focus of thousands of defective product lawsuits. 

The Recovery blood-clot filter, is associated with 27 deaths so far and other complications. It was cleared by the U.S. Food and Drug Administration in 2002.  See the story here.

After her car accident, Dodie Froehlich received the Recovery in the large vein in the body to block clots. Bard is one of 11 companies that makes these filters in the U.S. Instead a one-inch piece of metal from the Recovery pierced her heart.  She survived. Others did not.

Forged Documents? 

NBC unveils that a regulatory specialist, Kay Fuller did not sign the FDA application document in 2002, even though her name appears on the document.

After the Recovery was initially rejected by the FDA, Bard hired Fuller to try again.  Bard refused to give her the safety testing she requested.  She said she would not sign an FDA application until safety concerns were addressed. With no response to her request, Fuller resigned from Bard.  She talked to NBC News.

As of 2006 there are at least 20,000 patients walking around with a Recovery blood-clot filter in their body.

The Cissons enter court, Aaugust 2013

Bard and Cisson Trial

C.R. Bard was showed to have falsified documents in the pelvic mesh trial of Donna Cisson.  The raw material used to create the Avaulta mesh was a polypropylene (PP) resin in pellet form which was purchased from petroleum company Phillips Sumika.  The PP was spun into a monofilament which makes up the mesh of the Avaulta Plus.  

A Material Data Safety Sheet from Chevron Phillips clearly stated the material should not be used in medical applications especially
“involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”  

E-mails presented at trial by Cisson’s attorney, Henry Garrard, showed Bard created a dummy company, Red Oaks, to buy the polypropylene pellets so the supplier would not link Bard to the polypropylene purchase, therefore the creation of a medical device.   See MND coverage here.

Cisson was awarded $2 million by a Charleston, WV jury in August, 2013. Bard has appealed her case. See the MND coverage of her trial conclusion here. 

A year earlier in a Bakersfield, California court, Christine Scott was awarded $5.5 million by a jury over her pelvic mesh injuries.  Her  implanting physician was found to be responsible for a portion of the award for damages.

The Cisson case was the first bellwether against C.R. Bard in multidistrict litigation in Charleston, WV.  As of today, Bard is facing 12,521 product liability cases over its pelvic mesh as well as numerous other pelvic mesh actions filed in state courts around the country. #

The post NBC: C.R. Bard Forged Documents on Controversial Blood Clot Filter to Gain FDA Approval appeared first on Mesh Medical Device Newsdesk.

MND, September 11, 2015 ~ It’s been four years this past week (September 8, 9, 2011)  that the FDA convened a panel of “experts”  to form the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee.

Their goal was to discuss the five-fold increase in complications associated with pelvic mesh.  

The FDA database had received a jump in reports, from mesh erosion, to chronic pain, mesh infections, UTIs, dyspareunia even death.  You can read the agenda here.  Mesh News Desk was there and covered the story here.

The expert panel convened with a consensus to reclassify mesh used for pelvic organ prolapse to “high risk” or Class III that would require greater scrutiny before it could be marketed such as a Premarket Approval (PMA) and clinical trials on humans.  This reclassification proposal applied only to pelvic mesh used for pelvic organ prolapse, (POP) generally a larger piece of polypropylene mesh.

FDA gathering Sept. 9, 2011

In May 2014 the agency issued two proposed orders filing them in the Federal Register, one to reclassify and the other to require a PMA.

The public comment period was opened for 90 days and concluded at the end of July 2014. See the comments here.  Many readers of Mesh News Desk voiced their opinion including hundreds of name gathered by the consumer group Corporate Action Network, which then had joined forces with MND gathered signatures and submitted them electronically.

What’s happened since then?  

The Federal Register still lists the 2014 proposals as a “Proposed Order.”   In other words, nothing.

History of FDA and Pelvic Mesh

* October 2008 ~  In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.”  See here. 

Even with the jump in reports, the agency concluded mesh complications are “rare.”

* July, 2011 ~ The  FDA reported complications from pelvic mesh are “not rare” and that alternative surgeries may offer less risk.  The FDA recommends “…that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.”

The FDA promised to “Continue to monitor adverse events reported to FDA associated with surgical mesh used to repair POP and SUI, as well as assessing any and all data as it becomes available.” By 2013 SUI complication reports were up 36 percent. See MND story here.

* September 2011 ~ The expert panel recommended surgical mesh be reclassified from class II to class III and require a PMA.

* January 2012 – The FDA issued orders for manufacturers of pelvic mesh to conduct postmarket surveillance studies (522 studies) to address safety and effectiveness concerns of pelvic mesh used for POP. See Press Announcement here.   Companies had three years (January 2015) to complete the studies.   See the letter and companies who received orders here.  As of September, 2015 they are not completed.   See the www.Clinicaltrials.gov.

* May 2014  ~ The FDA posted a proposed order for POP surgical mesh to require a PMA. The 90 day comment period ended July 2014. See it here.  The same day a proposed order went out to upgrade moderate to high risk for POP mesh to a Class III which would require special controls and a higher level of scrutiny.  See it here.   Here are your comments.

The proposal ended July 2014.  The order has not be approved by the FDA.  The 522 studies are not complete.  Pelvic mesh remains Class II, a moderate risk, even though it is a permanent implant that is not designed to be removed, despite complications.

What Can You Do? 

Contact your member of Congress. Sen Charles Grassley, Sen. Claire McCaskill, Rep Donna Edwards, Rep. Darrell Issa might be receptive.

The Government Accountability Office (GAO) advises Congress on how to make government more responsive.
http://www.gao.gov/about/

GAO on Facebook
https://www.facebook.com/usgao

Sen. Claire McCaskill Facebook video

FDA’s Office of Ombudsman- Dispute Resolution
http://www.fda.gov/downloads/aboutfda/centersoffices/oc/execsec/ucm164330.pdf

Office of Criminal Investigations- OCI
http://www.fda.gov/ICECI/CriminalInvestigations/default.htm

The post Four Years Ago: FDA Where Are You on Pelvic Mesh Proposals? appeared first on Mesh Medical Device Newsdesk.

Your co-editors

MND, September 17, 2015 ~ For those of you new to the complications of pelvic and hernia mesh, Mesh News Desk has been covering the issue for more than four years now.   We’ve been to several trials and listened to the evidence.  It’s quite clear that there are problems with pelvic mesh and hernia mesh.  It’s also abundantly clear that doctors are still not up to speed on those complications.  One woman said recently her doctor made circles around her ear (ie crazy) when the patient said she suspected her complications started after an implant. 

Adding insult to injury.

Pelvic mesh and hernia mesh is almost all made from polypropylene (PP) and the manufacturing process is similar to the PP used for fishing line. It was not intended to be made into medical devices,according to the Material Safety Data sheets that accompany the raw resin.

Not to say all complications are mesh-related. Some may be from preexisting conditions. But the high number of pain, infections, autoimmune reactions, rashes, fibromyalgia, and lupus readers complain of are too many to explain away.

This month we have a study that indicates better trained high-volume doctors have fewer complications.  What we’ve learned from trials defies that logic.   Many high volume doctors, who were hired as consultants and preceptors to mesh makers have patients who complain of complications. Could it be the polypropylene?

Four years ago this month, the FDA began looking to reclassify mesh for pelvic organ prolapse as High Risk. What’s happened?  Nothing.  September 24th the FDA will look at another medical device harming women, the Essure birth control permanent implant, made by Bayer.  Stay tuned.  The hearing promises to be well-attended.

After a lull in trials this spring and summer, as the court hoped each side would come to some settlement talks, trials will start gearing up this fall. Johnson & Johnson and its Ethicon division will be the subject of much litigation. The company already has an unfavorable running from two juries that its TVT-O mesh was defectively designed. Still it remains on the market.

This is not just a U.S. problem as we export our mesh products globally and the number of pelvic mesh injured women exceed 100,000 globally.

Settlements are coming in from a few mesh manufacturers.  There is a disclosure clause with any settlement, however many tell MND they’re being told to sign papers that will end any chance of future litigation in exchange for a few thousand dollars. In some cases for zero dollars after Medicaid, the law firms, insurance and lenders are all paid. Many women are just saying “No.”  Some fire their law firms and look for other representation.

If you have not checked into it, please consider a further medical workup for pudendal nerve damage.  Life Care Solutions and Dr. Greg Vigna, who is a sponsor, is offering to work with your law firm on that diagnosis and a life care plan to outline your medical needs in the future. The dollar amounts will be considered as part of your settlement before the Special Master.

There are now 81,000 lawsuits filed in one court, consolidated before Judge Joseph Goodwin in Charleston, WV.  That will be the location of many of the upcoming trials.  Expect rallies outside of the court.

As a publisher, Mesh News Desk will do what it can to provide information to empower those injured.  This is not intended to substitute for advice from your law firm (your editor is not a lawyer or a doctor). Unfortunately, there are far too many stories of law firms failing to communicate with their clients. Firms can file press releases on these pages to speak to their clients and reach thousands of readers a day.  Our policy is to label sponsored content as such. Comments on this site may result in enrollment in a Mesh Newsletter, which is published occasionally.

Please consider writing for Mesh News Desk. You can remain anonymous.  Your opinions are welcomed and valued.

PayPal donations are much appreciated. See Page One. My co-editors appreciate it!

Stay well everyone. I’d love to hear your thoughts.   Let’s carry on shall we?

~ Jane Akre, Editor
Mesh News Desk
janeakre@meshnewsdesk.com

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MND September 17,2015 ~ Huffington Post has collaborated with attorney and  reporter Steven Brill to produce a 15-chapter expose on Johnson & Johnson.   J&J is frequently in the pages of Mesh News Desk as one of the major mesh manufacturers which promises to be the last to settle its outstanding pelvic mesh injury cases.   Here Brill digs into the drug Risperdal, given to children with behavioral problems even though the FDA told the company NOT to market it to children.  (Check out the Legos campaign marketing to kids).

Here Brill outlines how the muscle of the healthcare giant plowed through the restrictions on any use of its drugs to bring it to blockbuster status. The series is entitled “America’s Most Admired Law Breaker.”

Here is an opening page.  Enjoy!

http://highline.huffingtonpost.com/miracleindustry/americas-most-admired-lawbreaker/?ncid=edlinkushpmg00000090

The post Huffington Post and Steven Brill on “America’s Most Admired Law Breaker” J&J appeared first on Mesh Medical Device Newsdesk.

Linda Batiste

MND, September 20, 2015 ~ Linda Batiste was awarded $1.2 million by a Dallas jury last year as compensation for the injuries she suffered from her defective pelvic mesh implant made by Johnson & Johnson (J&J). Now the healthcare giant wants that award overturned.

The 65-year-old Batiste died from cancer last month. She never saw her compensation award which is to be paid to her family whenever J&J runs out of appeals.

Law360 reports that one of those appeals was presented before a judicial panel at the Fifth Court of Appeals in Dallas, September 16.

Attorney Stephen Brody spoke on behalf of J&J. Besides failing to establish the TVT-O mesh was defectively designed, Brody said Plaintiffs failed to prove her injuries were caused by the mesh used as a treatment for stress urinary incontinence.

Dr. M. Tom Margolis, urogynecologist

Batiste had numerous health problems and J&J told jurors at trial her mesh injures were caused by previous surgeries.

Representing Batiste to the appellate panel, attorney Sarah Turman-Vedral argued the expert doctor at trial, M. Tom Margolis MD, who removed Batiste’s mesh and is considered a mesh removal specialist, testified her injuries resulted from her TVT-O implant.

The Batiste trial was the first to show the TVT-O was defectively designed. Transvaginal tape-obturator requires the polypropylene mesh to  hammock the urethra and then exit through a woman’s obturator space which includes up to eight layers of muscle, ligaments and tissue.

In Huskey v. Ethicon, (here) jurors also found the TVT-O to be defectively designed.  The mesh medical device remains on the market.

At trial, attorneys for Batiste showed jurors there were safer alternatives to TVT-O that could have been used by her doctor, but Brody for J&J argued on appeal Plaintiffs did not prove those meshes had less risk than TVT-O.  Turman-Vedral countered some alternatives, shown to jurors, are not yet approved for use by the U.S. Food and Drug Administration.

The Batiste case was tried under Texas law which requires Plaintiffs show another product existed that was a safer alternative to the defective product used – creating a higher burden for the Plaintiff.

According to Law 360 (subscription required) here:
“Justice Bob Fillmore asked Turman-Vedral several times to point out the specific evidence that Batiste’s injuries were caused by the TVT mesh the jury found to be defective. Justice Bill Whitehill said he didn’t know how to draw a line between evidence that injuries like those Batiste suffered can result from a design defect and evidence that Batiste’s injuries were in fact caused by that defect. “

C. Lewis, art by Akre

The J&J argument directly echoes the directed verdict it achieved in the case of Carolyn Lewis in February 2014. See MND coverage here  and here.

At the end of the Plaintiffs’ case in Lewis, J&J asked for and received a directed verdict in its favor because of alleged failures in the Plaintiffs’ case.  Brody’s letter arguing the failings of the Lewis case can be found here. 

The Lewis case was also tried under Texas law, though heard before Judge Joseph Goodwin in multidistrict litigation proceedings in Charleston, WV where more than 83,000 pelvic mesh product liability lawsuits are consolidated.

Besides Brody, J&J attorneys included Charles Lifland of O’Melveny & Myers LLP and Scott Stolley of Cherry Petersen Landry & Albert LLP.

Batiste attorneys included Peter de la Cerda of Edwards & de la Cerda PLLC, Richard A. Capshaw of Capshaw & Associates, Tim Goss and Sara Turman-Vedral of Freese & Goss PLLC and David P. Matthews of Matthews and Associates.

The case is Johnson & Johnson et al. v. Batiste, case number 05-14-00864-CV, in the Texas Court of Appeals for the Fifth District.

LEARN MORE:

Lewis v. Ethicon is Over!  Judge Grants Ethicon’s Motion to End Trial, February 18, 2014, MND
http://meshmedicaldevicenewsdesk.com/lewis-v-ethicon-is-over-judge-grants-ethicons-motion-to-end-trial

Day Five: Lewis v. Ethicon: Ticking Time Bomb
http://meshmedicaldevicenewsdesk.com/day-five-lewis-v-ethicon-ticking-time-bomb

Please use the Search Bar on MND page one and put in “Lewis ” for all coverage. 

The post J&J Tries to Overturn Batiste’s $1.2 Million Verdict appeared first on Mesh Medical Device Newsdesk.

Prosima for sale on ebay, Sept 21, 2015

MND, September 21, 2015 ~ CAVNESS V. JOHNSON & JOHNSON 

Jury selection got underway Monday in the pelvic mesh case of case of Carol Cavness v. Ethicon DC-14-04220.  This is the third pelvic mesh trial before Judge Ken Molberg in the 95^th Judicial District of Texas. Last April the trial of Linda Batiste resulted in a $1.2 million jury award for Ms. Batiste who had been injured by Ethicon’s TVT-O, which jurors also found defectively designed.

Ethicon is as division of Johnson & Johnson (J&J).

Last October, also before Judge Molberg, Plaintiff Martha Salazar was awarded an unprecedented $73.4 million against Boston Scientific due to the injuries from her Obtryx mesh implant.  Both jury awards are being appealed. See story here.

A total of a dozen jurors would be chosen this day and two alternates out of a pool of sixty potential jurors.

Richard Freese, Freese & Goss

Dave Matthews and Richard Capshaw represent Ms. Cavness. William Gage, previously seen as an attorney for Defendant Johnson & Johnson in the Linda Gross trial, again represents J&J.

William Gage, Butler Snow for J&J

Adam Evans of Hollis Law Firm, Prarie Village, Kansas is also in attendance. He has clients who were also implanted with the Prosima mesh.

Ms. Cavness was implanted with the Prosima Pelvic Floor Repair System by Dr. Teresa Kowalczyk, MD.  The Plaintiff is suing her doctor, Hunt Regional Medical Center, Baylor Healthcare System.

Mesh News Desk will cover the trial courtesy of a feed from Courtroom View Network and will abide by the restrictions imposed on MND coverage.  Court watcher, Joleen Chambers of FIDA (Failed Implant Device Alliance) sat in the proceedings today for jury selection.

Dave Matthews

PROSIMA PELVIC FLOOR SYSTEM

This is the first trial of the Prosima pelvic floor system, implanted in women to treat prolapse to determine if it was defectively designed and manufactured.

Dr. Kowalczyk, implanting physician

In her complaint, Ms. Cavness said her doctor knew or should have known the Prosima had a high rate of failure, injury and complications and failed to perform as intended. Despite that, Dr. Kowalczyk implanted Ms. Cavness on April 24, 2012, nearly a year after the U.S Food and Drug Administration (FDA) said that complications from a mesh implant are “not rare.” The doctor was negligent in the care and treatment to her patient and did not act as a reasonably prudent physician in caring for her patient, says the complaint.

The Cause of Action includes negligence; a failure to warn the Plaintiff prior to implantation; defective design of a product that was unreasonably dangerous; defective manufacture, breach of an implied and express warranty the products were safe for the purpose for which they were intended.

Cavness claims she is in physical and mental pain that will likely continue into her future. She says she has lost the ability earn a living, lost wages and will have medical care and expenses now, and in her future.

The upcoming case of Rabiola v Ethicon to be held in Austin, Texas, October 26 will also examine the Prosima and the TVT-S, both taken off the market.

ETHICON

Surgical mesh was retrofitted from hernia mesh in the late 1990’s to be used to support the pelvic organs. Pelvic mesh was approved through the FDA’s 510(k) approval process that does not require clinical trials or assurances of safety before being marketed.

In a June 4, 2012 letter by Butler Snow, the law firm representing J&J, Ethicon agreed to “stop commercializing” the Gynecare Prosima Pelvic Floor Repair System, along with three other meshes – the TVT Secur System, Gynecare Prolift and Gynecare Prolift +M.

Prosima on ebay, Sept. 21, 2015

Ethicon attorney’s requested the FDA allow it 120 days to “cease commercialization” however, Mesh News Desk found a Prosima for sale in “New Condition”  on eBay September 21, 2015. 

Within that letter, Ethicon’s attorneys requested the FDA’s place on hold the agency’s orders to conduct three-year additional safety studies on mesh already on the market.

Johnson & Johnson/ Ethicon has the largest number of pelvic mesh product liability cases filed in Charleston, West Virginia. At this writing there are 28,868 cases filed against J&J in that federal court where multidistrict litigation is consolidated and a total of 83,301 cases have been filed against seven manufacturers.

J&J continues to fight women in trial rather than offer settlement dollars as some of the other six mesh manufacturers have done.

JURY INSTRUCTIONS

Three pages of jury questions helped both sides select those who will listen to this case. Among the questions typically are – have you ever been arrested or involved in a lawsuit, what is your job, what were your parent’s occupations, what bumper stickers do you have on your car,  do you listen to the radio, what are your sources of news,  what are your political leanings, among other questions.

The Defendant wanted the judge to instruct jurors not to use the internet during the proceedings.

The jury will reconvene for opening arguments Tuesday. #

LEARN MORE

Cavness Complaint  – Cavness Dallas Original petition

MND, October 19, 2014 ~ Salazar $73 Million Transvaginal Mesh Award Slashed in Half Due to Tort Reform
http://meshmedicaldevicenewsdesk.com/salazar-73-million-transvaginal-mesh-award-slashed-in-half

MND, September 8, 2014 ~ Boston Scientific Must Pay Salazar $73.5 Million
http://meshmedicaldevicenewsdesk.com/breaking-news-boston-scientific-must-pay-salazar-72-million

Clinical Trial of Prosima, by Ethicon, 2007
https://clinicaltrials.gov/ct2/show/NCT00521066

FDA MAUDE Adverse Event Report: Prosima, 7/24/2012
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2819037

 

The post Ethicon’s Prosima Latest Pelvic Mesh Trial Gets Underway appeared first on Mesh Medical Device Newsdesk.

Dallas courtroom, 95th District, Texas

Mesh News Desk, September 22, 2015 ~ Jury selection continued for a second day in the trial of Carol Cavness v. Kowalczyk et al., case # DC-14-04220, being heard in the 95th District Court of Dallas County, Texas before Judge Ken Molberg who has presided over two other pelvic mesh cases (Batiste, Salazar) which resulted in a total of $75 million in jury awards for the mesh-injured women.

In this product liability and medical malpractice trial, Carol Cavness was implanted with the Ethicon Prosima Pelvic Floor Repair System, a polypropylene mesh used to treat pelvic organ prolapse. The Prosima was taken off the market by parent company, Johnson & Johnson in 2012.

Prosima for sale on ebay, Sept 21, 2015

Courtroom View Network will begin providing a live feed to Mesh News Desk (MND) Wednesday.  Court watcher Joleen Chambers provided the following observations to MND.

Tuesday, the group of 60 potential jurors was honed down to a dozen and two alternates after questions posed by both sides such as – have you ever had a surgical procedure, would you consider yourself conservative, moderate or liberal and do your rent or own your home, among other questions.

Richard Capshaw asked jurors if they could use the standard to find for the Plaintiff in a civil case – “the preponderance of the evidence” rather than beyond a reasonable doubt, the standard for a criminal action.

DON’T ACCESS THE INTERNET

Judge Ken Molberg, 95th Judicial District, TX

There was some discussion with jurors about accessing the internet before Judge Ken Molberg. He told the jurors to only consider evidence presented at trial not what they might read elsewhere. In these days of on-line news, jurors are always cautioned against accessing the internet but J&J attorney Kat Gallagher, a partner with Houston-based Beck Redden LLP, made a special point of discouraging jurors from watching the news or conducting research online. In a courtroom discussion, the Defense objected to the blog, The Mesh Warrior. Blogger Aaron Horton had attended the Linda Batiste trial in the same courtroom last year and befriended the Batiste family.

Aaron and Linda, April 2014

Do not allow anyone to investigate on your behalf, warned Judge Molberg. Mistrials are expensive.

Cavness is represented by Tim Goss and Richard  Freese of Freese & Goss PLLC, Bill Blankenship of William F. Blankenship III PC, Richard Capshaw of Capshaw & Associates, Kevin Edwards and Peter de la Cerda of Edwards & de la Cerda PLLC, and Julie Rhoades and David Matthews of Matthews & Associates.

Ethicon is represented by William Massie Gage and Helen Kathryn Downs of Butler Snow LLP and Kathleen Gallagher of Beck Redden LLP.  Dr. Kowalczyk is represented by Philipa Remington and Cathryn Paton of Thiebaud Remington Thornton Bailey LLP.

A jury was finally selected after the late lunch break with an approximate even number of men and women.

Judge Molberg told the jurors that the Plaintiff will go first to present its case, followed by the Defense.  A rebuttal phase will be allowed. Jurors will be allowed to take notes. Only six were willing to do so.

Carol Cavness was brought into the court after the jurors were seated. Chambers says she was nicely dressed in a dark pantsuit with stylish dark hair and small gold hoop earrings. You could tell from her face she was experiencing pain, observed Chambers.

She appeared to be able to sit and did so without any special accommodations.

PLAINTIFF OPENING- DAVID MATTHEWS  

David Matthews, Attorney for Cavness

Opening arguments got underway around 4 pm with both sides given about an hour.  Dave Matthews opened for Cavness. According to Chambers, Matthews told the jury that J&J had had several meetings with the U.S. Food and Drug Administration about the Prosima pelvic floor mesh to treat pelvic organ prolapse. By June 2012, the company said it would “de-commercialize” (ie no longer sell)  Prosima. (See the letter Butler Snow taking four meshes off the market 2012).

Why would a company do that unless there were problems with the product, he asked.  One year earlier, the FDA had issued a Safety Communication that mesh used for POP repair had complication rate that was “not rare” and that it might not be more effective than a non-mesh repair of pelvic organ prolapse (POP).”  See FDA Notice here.

By January 2012, the FDA ordered three years of safety studies to be conducted by mesh makers, J&J among them.   See the MND story here.

When the Prosima was lifted from the market, J&J asked the FDA to lift its requirement to study the safety of the Prosima, despite the fact the polypropylene mesh had already been permanently implanted in countless women.

The FDA agreed.

Safety studies for the Prosima were not ordered and its safety and efficacy had not been established, something Ms. Cavness doctor did not know, according to her deposition.  She had already implanted 25 to 30 women with Prosima. A sales representative from Ethicon was even in the room during some surgeries.

That sales rep will be one of the witnesses called.

Mr. Matthews described the Prosima as a 4 inch by 4.5 inches piece of polypropylene with two arms that are pushed into a blind area of the pelvis. Much of it remains in Cavness’ body. The damage has been done, he said.

Matthews told jurors that Ms. Cavness was trying to keep up with the demands of her job as a Class A aviation mechanic. Juries tend to grant greater awards to women who work in demanding jobs, such as the Martha Salazar case against Boston Scientific that resulted in a $73 million verdict for Ms. Salazar last year.

Chambers say the attorney for Ethicon did not introduce herself to the jury.

Kat Gallagher, Attorney for J&J

DEFENDANT OPENING- KAT GALLAGHER

Kat Gallagher indicated the problems with pain Ms. Cavness experienced were due to her pelvic floor muscles giving out. Laying a foundation of doubt as to what ended Cavness in the emergency room during an episode of intense pain, she indicated previous pelvic floor problems were the cause. Pelvic organ prolapse (POP) is generally uncomfortable but not painful.  The demands of her job require her to lift all the time and Ms. Cavness is working with a physical therapist to address the pain issues.

Ms. Cavness has had a partial removal of her Prosima mesh. The arms remain behind and she experiences pain UTI’s and difficulty voiding. Still she is trying to remain on the job. She sees Dr. Michael Carley, a urogynecologist at Baylor Medical Center for the pain.

Ms. Cavness shouldn’t have tried to take out the mesh, Gallagher told jurors.

Peggy Pence P.h.D

FDA expert Peggy Pence should appear on the stand Wednesday. As she has in the Linda Gross case and the  Budke case heard in Missouri earlier this year, Ms Pence will outline the introduction  of the mesh used for pelvic meshes, Prolene. It was too stuff for the vagina insiders warned.  Still it was cleared in February 2007 after J&J found a substantial equivalent already on the market, allowing the company to bypass clinical trials.

Ethicon is facing 29,000 other product liability cases consolidated in multidistrict litigation in Charleston, West Virginia and thousands more defective product cases filed by women from around the globe.   The company indicates it will continue with litigation rather than to begin to offer settlement to resolve the outstanding actions. #

The post Opening Argument Lays Doubt to Cavness’ Claim of Pelvic Mesh Injury appeared first on Mesh Medical Device Newsdesk.

Peggy Pence, PdD and team at Symbion Research Intl.

MND, September 23, 2015 ~ Wednesday was day three of the Cavness v Ethicon (Cavness v. Kowalczyk et al., trial, case # DC-14-04220) being heard in the 95th District Court of Dallas County, Texas before Judge Ken Molberg.

Dr. Peggy Pence took the stand all day.  Pence, a PhD and expert in regulatory affairs has more than 40 years in the business of bringing drugs and medical devices to market.

Her background is not only in designing clinical trials, but in analysis of that data. She’s worked with more than 50 companies and has prepared numerous regulatory submissions to the U.S. Food and Drug Administration (FDA).

Dr. Pence has been an expert brought into numerous pelvic mesh trials including Jo Husky, Linda Batiste, Linda Gross and Joan Budke, among others.

She is clearly experienced at giving expert testimony, turning to the jury frequently to explain, in a concise, calm manner, terms to a layman audience.

Tim Goss, Freese & Goss

Thanks to Courtroom View Network for allowing Mesh News Desk to observe a feed of the proceedings before Judge Ken Molberg.

Predicting the questions that Defense will ask, Tim Goss (Freese and Goss) asked Pence if she is being compensated?  Yes, she said, at a rate of $500 an hour, a common rate of compensation for an expert witness, Pence said was her understanding.

PROSIMA PELVIC FLOOR REPAIR SYSTEM

Prosima was to be the newest pelvic floor polypropylene mesh intended to  treat pelvic organ prolapse (POP).  J&J was in catch-up mode. Competitors had launched their own version of POP repair kits to hold up sagging pelvic organs – the Pinnacle (Boston Scientific) and Elevate (AMS).

Piet Hinoul MD, Ethicon Medical Affairs

Piet Hinoul, a young ambitious urogynecologist had left a small practice in Belgium in September 2008 to join Ethicon in Europe as director of Medical Affairs for Women’s Health and Urology. Dr. Hinoul said in an email exhibit shown to the jurors,  “As both these products are ready to start hitting Europe, and Pinnacle is already giving us a headache in the US, there can  no delay with proceeding with Prosima with its current mesh.”

Dr. Marcus Carey, U of Melbourne AU

No worries. Prosima was predicted to bring in $300 million each year it was used in a projected 500,000 surgeries annually.

In 2004, Dr. Marcus Carey, a surgeon from the University of Melbourne, Australia had the idea for Prosima. Ethicon ( J&J) purchased the intellectual property rights from Dr. Carey in September of that year for $500,000. After marketing began he would make another $400,000, then $100,000 with the publication of his work in a peer-reviewed journal. Dr. Carey would also receive royalties based on sales.  His studies, along with a Dr. Mark Slack, would provide  the data needed for a projected mid 2007 launch. It never happened. 

Prosima received FDA 510(k) clearance in February of 2007. It was finally launched for sale in the U.S. in January 2010, despite a chorus of waving red flags.

Ms Cavness received her implant on April 24, 2012, a date that would be repeated often as Tim Goss (Freese & Goss) recounted the chronology of events that brought Prosima to market.

THE RED FLAGS 

Prosima was made with Gynemesh PS (Prolene Soft) the same mesh used in the Prolift, another large mesh kit launched by Ethicon in 2005.  Prosima would be a smaller mesh kit, anchorless unlike the Prolift, with only two fixation points. Its predicate device, the basis for an FDA clearance, was Prolene Soft, a hernia mesh.

Dr. Pence continued in her chronology of the lifetime of Prosima.

Dr. Lucente, preceptor for Ethicon

Key Opinion Leaders (KOL) were an important part of acceptance of a new product in the medical community.  Dr. Vince Lucente worked as a consultant for Ethicon and was considered a KOL and one of the original three surgeons in the U.S. to teach the procedure. He was also a preceptor (teacher/consultant) for the TVT (transvaginal tape) since its introduction in the late 1990s.

As the KOL of the Prosima project called Project Mint, and even though he was paid a total of $1.7 million for his work, Dr. Lucente didn’t feel Prosima was an effective procedure for a serious prolape as Ms. Cavness had, considered a Grade 3.  During a trip to Australia, one doctor reported about Dr. Lucente “he was quite scathing of Prosima being a reckless product.”

Doctors who had tried Prosima felt it  “might not provide an adequate apical support; the procedure was felt insufficient to treat lateral defects regarding the posterior repair, it was felt that just placing the arm of the mesh in contact with the sacrospinous ligament would not provide a strong attachment such as would suture or passage of the arm of the mesh through the ligament (Prolift).”

Lucente’s comments during a visit to Australia for the company “if true were unhelpful,” said Jonathan Meek in an email April 24, 2008.    “It appears that Dr Lucente may have some concerns that are being voiced via inappropriate channels that are unresolved” it said.

He was not alone. Dr. Martin Weisberg, the medical director of Ethicon, had earlier voiced his opinion in an email to the marketing director in September 2, 2005. “Why would we want to introduce a synthetic graft product that does no better than a native tissue repair?”

In other words, Pence reminded the jury, the benefit must outweigh the risk and an early failure rate of a prospective observational study at eleven investigation centers found a 28.4% failure rate. In fairness, some of the women did not show for their followups. Still, in research, that’s considered a failure, said Dr. Pence because usually they are having problems.

Dr. Pence called approval of Prosima then a clear “No Go.”  In April 2008 the Prosima failed to be launched for a second time under current CEO Alex Gorsky.

FDA’s FIRST PELVIC MESH WARNING

The U.S. Food and Drug Administration (FDA) was at work preparing to issue in October 2008 the first Safety Communication warning about pelvic mesh. It noted 1,000 reports of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.

“Although rare, these complications can have serious consequences.”   Complications  coming into the FDA from surgical mesh manufacturers included mesh perforations, erosion  a significant decrease in the quality of life, discomfort, pain and dyspareunia (painful sex).

Dr. Pence reminded jurors as few as one in 100 event are ever actually submitted to the FDA’s MAUDE database of complications.

That could be one in 100,000? asked Goss?  Right, she said.

ETHICON’S KEY OPINION LEADERS 

Johnson & Johnson celebrated its successes at a conference in the Orange Blossom Bowl in Orlando February 7, 2009. with opening remarked by Renee Selman, World Wide President.  The Prolift pelvic mesh kit was on the market and on the agenda as was Prosima, which was 11 months from being launched.   The TVT-Secur, a polypropylene single incision sling marketed for use in SUI had bad results coming in. The perception of the product was a negative for the company.

In an email from Andrew Meek, Professional Education manager for the US team, to marketing’s Jonathan Meek on the day of this summit, says a number of KOLs (key opinion leaders) liked the +M (Prolift) and planned to use it, the feelings were very negative towards Prosima.  Concern was expressed about the lesser experienced surgeons or “less skilled generalists.”

“At a time when the scrutiny against mesh is at an all time high, why would we want to put a product with questionable date in this groups hands?”  “One KOL said they would no longer work with the company as matter of principle if we launched Prosima.” Others called it a “Big mistake” Don’t do it.” 

Another surgeon, Fah Che Leong, MD a Professor of Female Pelvic Medicine and Reconstructive Surgery at Saint Louis University School of Medicine wrote to Scott Jones, a marketing director at Ethicon, as shown in an exhibit:

“I am currently involved in getting a patient to the OR who had an anterior and posterior Prolift implanted by another physician. She will likely lose any coital function as her vaginal length is now 3 cm, and there is mesh extruding literally everywhere. Also there is a large stone in the bladder from a bladder perforation with the anterior arm.”  “I will hold off on doing any of these procedures. The bottom line is that I bet a majority of the practitioners using these mesh kits are not qualified to do so. I taught perigee apogee in the past – no longer.  This patient will have a permanently destroyed vagina and I am only hoping to get her out of this without more morbidity.” 

Pence told jurors the comparisons are fair because the Gynecare Prolene Soft mesh is the same in the Prolift as the Prosima.

Even Dr. Piet Hinoul, warned against overpromising success with the Secur SUI mesh  (90%) and the Prosima.

“I feel that sticking to one of the predefined outcome measures would be more appropriate and less misleading: I’d quote that 88.3% of patients  were above the level (not at) of the hymen in the treated compartment. This is still a very good result and will strike the surgeons as believable. Quoting a 94% success may lead the surgeons to have unrealistic expectations.”

Pence called this good behavior for a company but not enough to delay the launch of the Prosima. Remember, Piet Hinoul was mindful that his company must compete with the Pinnacle and Elevate and “aggressive sales techniques.”

Goss: “Would a reasonable manufacturer put this on the market?”  “No,” said Pence.

What was the next thing they did?   Launch the product in January 2010.

By the end of the first quarter a inner company email from Kevin Frost said:
Subject: 1 Million Dollars !!!!!! “We have hit a very significant milestone with the Prosima launch, $1 million dollars in sales! This makes Prosima one of the fastest launches ever, in the mesh kit market!” 

THE FDA CAN’T SEE THE FOREST

The FDA continued to monitor the MAUDE database of adverse events coming in concerning pelvic mesh and hernia mesh products.   Two months short of a second Safety Communication notice, which would now call mesh complications “not rare,” Ethicon requested a meeting with FDA officials to have an “open dialogue about SUI (stress urinary incontinence) and PFR (pelvic floor repair). That meeting took place May 3, 2011.

“FDA is in learning mode” said the talking point notes.  “Listening to advocacy groups and KOL’s.”   The FDA Ob/gyn branch admitted it was “Green” in understanding the use of surgical mesh for SUI and POP repairs.  Even with sparse information, the agency concluded that adverse events for stress urinary incontinence are low and said it “understood the risk vs. benefit of mesh in SUI vs. traditional repair.”  

The opinion notes say the “FDA is overwhelmed by all of this and cannot see the forest.”  Ethicon promised individual product meetings would help show the FDA the safety and effectiveness of new products.

“This will be easier in SUI vs PFR (pelvic floor repair) mesh.”

The second FDA notice in July, 2011 came at a time the agency was under investigation by the Office of Criminal Investigation.  It is now ten months before Ms. Cavness is implanted. The FDA had received an additional 1500 reports of mesh complications associated with POP mesh.

Did the new adverse event reports make it into the product’s label, the Instructions for Use asks Mr. Goss.   No, answered Dr. Pence.  Is there anything in the IFU about multiple surgeries will not resolve the complications. Is that in the IFU?  No, she said.

Should a reasonable manufacturer do that? “Absolutely,” said Pence.

Would a reasonable and prudent manufacturer put that inability to engage in sexual intercourse in the IFU?  Did the company change the IFU at all after the FDA warning?  No, it did not.  Would a reasonable and prudent manufacture take action to make sure surgeons knew about this notice?

“Yes,” said Dr. Pence. “The doctors are on the front line if they are not aware of this information they are missing this safety information helps to guide them in making appropriate choices to offer their patient.”

The FDA expert panel convened in September 2011 and concluded “vaginal placement of mesh for POP repair may not be more effective than native tissue without mesh,” and that “the  risk benefit of vaginal placement of mesh for POP repair is not well established.”

THE WITHDRAWL OF PROSIMA FROM THE MARKET

In January 2012, the FDA ordered manufacturers including Johnson & Johnson to study its controversial meshes. The adverse event reports were coming in.  Under Section 522 of the Federal Food, Drug and Cosmetic Act, the FDA had the authority to require postmarket surveillance of the devices.  They would be called the “522 studies.”

Emails within Ethicon show the next step the company would take. If the Prosima and other problematic meshes were removed from the market, the company would likely not have to conduct the 522 studies.  The company would save face and save an estimated $4 million to $5 million dollars doing research.  Notes, shown to the jury and taken by a company rep chosen to do a deposition, said the decision to withdraw four meshes came before the FDA announced the 522 studies.

An email from marketing’s Laura Angelini said they arrived at the decision to withdraw four mesh products in June 2012  “after considering the commercial viability of the product in the United State in light of the complex of the clinical study requirements, the significant adverse publicity and the litigation environment. The size and competitiveness of the market place and the availability of other treatment options for women were also a factor in our decision.”

Attorney Goss reminds the jury 45 days before Ms. Cavness surgery, “this company has in place an exit plan” which was not communicated to anyone, especially her surgeon.

J&J CREDO

Tim Goss concluded the day by asking Dr. Pence, with her 40 years of experience if Ethicon had violated the postmarket safety of Prosima; a standard of care; the premarket development of Prosima and its own credo in putting Prosima on the market?

Yes, she said, they did.

“They violated their own credo and did not put patient safety, their doctors and patients first.” she concluded.  #

The post Plaintiff’s Expert Outlines J&J’s Push to Market Prosima Pelvic Mesh appeared first on Mesh Medical Device Newsdesk.

William Gage, Butler Snow for J&J

MND, September 24, 2015 ~ On this Day Four of the Cavness v Ethicon (Carol Cavness v. Kowalczyk et al., case # DC-14-04220) trial being heard before Judge Ken Molberg in a Dallas courtroom, William Gage, an attorney for Ethicon, had to do damage control to the testimony by an expert for the Plaintiff, Dr. Peggy Pence Wednesday.

THANKS TO COURTROOM VIEW NETWORK FOR ACCESS TO THE LIVE FEED IN THE COURTROOM. 

Dr. Pence is often called into testify for the injured in these cases because her expertise is in how to bring drugs and devices to market, and presumably, how not to.

Peggy Pence P.h.D, Expert for Cavness

Dr. Pence was calm, pleasant and concise in her language, often speaking to the jury directly to further dissect a point about U.S. Food and Drug Administration (FDA) regulations.

One day earlier, (See Day Three) Dr. Pence had outlined how there were two “no-go” points in bringing the Prosima to the market. Dr Marcus Carey, an Australian doctor, had sold the intellectual property rights to the company for millions if his study met certain benchmarks for safety and efficacy.  It did not.

THE MARCUS STUDY

Under cross examination by attorney William Gage, for Defendant J&J, documents from the day earlier were revisited.  Mr Gage would attempt to tell the rest of the story on the successes of Prosima.

In the Carey study, conducted by the doctor who would benefit from a positive outcome, after examining 95 patients who had been implanted with a prototype Prosima, its objective success rate (exam of the women to determine an anatomic fix) was 92 or 86 percent at 6 and 12 months, Mr. Gage pointed out.

Dallas Judge Ken Molberg

Dr. Pence interjected that is correct but does not take into account the many patients were lost in follow-up. Gage moved to strike that comment as nonresponsive. Sustained, said Judge Molberg. (One has to wonder if jurors make a special mental note to remember the nugget of any objection).

Dr Pence had told jurors the day earlier that when a woman does not follow-up in a study, it generally indicates she is not having a good outcome. Gage continued.

The subjective success rate (filling out a questionnaire) was 91 and 86% at 6 and 12 months, he stated. Doctors in the study were concerned the “procedure would not provide enough support even with the vaginal support device,” was one of the key comments within the study among doctors who used the Prosima prototype.

That wasn’t an issue was it, asked and stated Mr. Gage at the same time. Can you answer that?

I can’t answer yes or no, Dr. Pence said.

(In sort of a mixed message to the jury, Mr. Gage told jurors Ms Cavness had a posterior colporrhaphy or native tissue repair in addition to the Prosima.)

Dr. Carey made some changes to the prototype Prosima during the course of the study. He made alterations in shape and to the procedure as he was moving toward completion of his study “Vaginal surgery for pelvic organ prolapse using mesh and a vaginal support device,” M. Carey, M. Slack, P. Higgs, Feb. 2008. See it here.

You weren’t critical of that, asked Mr. Gage referring to the alterations made to the Prosima.

“All accurate data is good data,” Dr. Pence reminded Gage with a smile.

Mr. Gage continued with the good news about the Prosima prototype outcomes.

Sexual dysfunction was reported by 58% of the women before the Prosima.  After the implant was in the body for 12-months, that number declined to 23%.  That’s more than a 100 percent improvement in sexual dysfunction! he asked and stated at the same time.

Going deep into the data, Mr. Gage questioned Dr. Pence’s statement that a lack of follow-up in study participants indicates a failure. Remember the Prosima data showed 15 women not examined last 12 months were considered objective failures creating a failure rate at 28.4%.    If they had returned the failure rate would be 12.6%, insisted Mr. Gage.

“Don’t you think the jury should have heard that,” Gage asked rather aggressively.

Dr. Pence would not be shaken. She exudes confidence without being arrogant.

“The key when you are doing clinical trials, you have to look at the overall and include those who are lost to follow up,” she replied calmly turning to the jury.  “As I said yesterday, the data speaks for itself.”

Marcus Cary, MD story on Prosima prototype

PROSIMA – A GAME CHANGER

The concept of the Prosima pelvic floor mesh was intended to be an improvement over the Prolift mesh, a large amount of polypropylene mesh with arms that would anchor deep in a woman’s pelvis.  Prosima offered less mesh than the Prolift and less dissection. The concept didn’t turn out as expected.

Mr. Gage reminded the jury Ethicon could have marketed Prosima once it got FDA clearance in 2007.  You can market it the next day, he said. Ethicon chose not to market it once it got FDA 510(k) approval. In fact, Prosima was held back from launch after it received FDA clearance. ( It was finally marketed in January 2010).

Didn’t that show the company was being careful,  he the expert witness Pence.

Gage: “Ethicon went above and beyond the standard of the industry by conducting a study on live woman and waiting for a couple of years before marketing, wouldn’t you agree with that?”

Pence: “I’d say they complied with the standard at the time and it was a good thing to require study.”

Clearly, Pence said, they had disappointing results in the Marcus study and as a result, bad results would impact its acceptance in the market. That’s why they didn’t launch, she said firmly.

Mr. Gage showed company emails that showed the Prosima was being well received in the medical community.  “Some preliminaruy results from doctors that have used Prosima have been very favorable and the results have looked good,” said an inner office email. Dr. Ahmet Bedestani, board certified female pelvic medicine surgeon from Louisiana, who was glowing in his praise.

Dr. Ahmet Bedestani, female pelvic medicine surgeon

“Prosima represents my central thought process. I cannot have this product fail.  I have become identified by this and believe me there are many who would like nothing more than this product to not do well.  …”I believe in my bones that this technology represents a quantum leap forward for the patients.  40% of my Bussiness [sic] is redos of other peoples surgery and let me just say it is scary out there. Prosima is a game changer and it is my mission to make sure everyone knows it.”

 

MORE ON THIS STORY IS AHEAD!!! 

The post J&J’s Prosima Pelvic Mesh – A Game Changer? appeared first on Mesh Medical Device Newsdesk.

THANKS TO COURTROOM VIEW NETWORK FOR PROVIDING A LIVE FEED TO Carol Cavness v. Kowalczyk et al., case # DC-14-04220, in its fifth day in a Dallas courtroom.

MND, September 25, 2015 ~ Carol Cavness sued Ethicon in 2014 after having a Prosima polypropylene mesh device implanted transvaginally two years earlier to treat pelvic organ prolapse (POP).

The Cavness case is the sixth product liability case filed against Ethicon over its pelvic mesh. Three of those cases have yielded jury awards ranging from $1.2 to $11.1 million. Other cases filed against Ethicon, a division of Johnson & Johnson, have beeen quietly settled, though the healthcare giant has offered no large settlements in this mass tort. J&J is facing about 35,000 product liability filings over pelvic mesh, more than any of the other six manufacturers.

So far, two juries have found the TVT-O, mesh used for incontinence, and made of the same mesh as the Prosima, to have been defectively designed and manufactured.

Prolene Mesh

Ethicon knew the mesh used in the Prosima could prompt an immune system response that would cause degradation of pelvic tissue, but that information was withheld, says her complaint.   Instead the company called the mesh “safe and effective” in its marketing efforts.

“Contrary to the representations and marketing of defendants J&J and Ethicon, the pelvic mesh products have high failure, injury, and complication rates, fail to perform as intended, require frequent and often debilitating revision surgeries, and have caused severe and irreversible injuries, conditions, and damage to a significant number of women,” Cavness’ complaint states.

Cavness is seeking compensatory damages for disfigurement, impairment, past and future medical expenses and mental anguish. Punitive damages will also be allowed, reports CVN, after Judge Ken Molberg denied Ethicon’s motion to deny punitive damages against the company.

The Plaintiff’s complaint says Dr. Teresa Kowalczyk was negligent in the care and treatment of her patient and failed to disclose the risks associated with the medical device. But what did the doctor actually know about the risks?

Dr. Kowalczyk, implanting physician

THE IMPLANT PHYSICIAN

Dr Teresa Kowalczyk was the Ob/Gyn who implanted Carol Cavness with the Prosima mesh on April 24, 2012. Jurors will have to decide if her failure to care for the patient was due to being ill-informed about the dangers of mesh or whether she practiced poorly.

Originally from Poland, she works in the underserved area of Greenville, Texas about 50 miles northeast of Dallas. Both Dr. Kowalczyk and her hospital, Hunt Regional Medical Center, are being sued by the Plaintiff for the care she received.

Dr. Kowalczyk began using the Prosima mesh in 2010. Previously she had used some mesh for pelvic organ repair made by American Medical Systems but generally she had rejected most meshes, instead relying on native tissue repair.

She appeared nervous. Her answers were precise and complete and spoken with a slight accent.

Prosima prototype

Sometime in 2010, the doctor met the sales rep for Ethicon products, Paul Quartz. She trusted him. They met once or twice a week. Sometimes he would bring lunch to the office. He got to know her staff.  He seemed to know about the Prosima Pelvic Floor Repair System.  Dr. Kowalczyk liked what she heard. Prosima didn’t have the long arms of the Prolift Pelvic mesh used for POP, it didn’t use trocars, stainless steel tubes to pass the mesh into place, and it was a much smaller mesh.

Dr. Kowalczyk liked to read all of the materials herself, she said and she didn’t remember if the sales rep was in the operating room when she implanted Ms. Cavness.  

David Matthews, Attorney for Cavness

Plaintiff attny. Matthews: “Is Paul Quartz why you first started using Prosima?”

Dr. K: “Yes. He said it was softer and promoted quick recovery.  He said any problems would be a technique issue, that any problems with Prosima are rare.”

Matthews: “Did he ever tell you the FDA was questioning Ethicon about the safety of Prosima?”

I don’t recall, she said. On cross examination, Dr. Kowalczyk said some practices don’t let the sales reps in. She tries to be nice to them.

Sales rep Quartz wanted to get the word out in Greenville so he prepared the invitations sent out to the community for a meet-and-greet luncheon to learn about the Prosima and other gynecological issues with Dr. Kowalczyk hosting the get-together.

“All surgical procedures involve risks,” said the brochure.

To encourage her acceptance of the Prosima, Paul Quartz gave Dr. K a study authored by Halina Zyczynski, at the University of Pittsburgh. One-Year Clinical outcomes After Prolapse Surgery with nonanchored mesh and vaginal support devices, Here,  which concluded “vaginal support, pelvic symptoms and sexual function improved at one year….” but the co-authors included David Robinson, and others working for Ethicon, directly or indirectly, as part of the Prosima Study Investigators.

The study says under “Performance” the inflammation is transient and that the mesh remained soft and pliable.

That was not what the FDA had concluded a year earlier. In a Safety Communication, the agency said a posterior repair with mesh did not represent added benefit to native tissue repair, and complications with POP (pelvic organ prolapse) mesh were “not rare.” Dr. Kowalczyk did not know that.

“Would that be important for you to know,” asked Matthews. She acknowledged it would.  The IFU (Instructions for Use) contained nothing under adverse reaction that would lead a surgeon to believe chronic permanent pain could result from a Prosima implant, or that it should not be used for a Grade 3 or 4 rectocele.  She admitted the IFU admitted none of those things.

Was she adequately warned about the risks of Prosima? No, she said.

Pelvic organs, FDA

SURGERY SCHEDULED

Ms. Cavness had first gone to Dr. Kowalczyk on April 23, 2012 after a trip to the emergency room with abdominal cramps two days earlier. The symptoms were abrupt and had been constant for about one week. She had a Grade 3 rectocele, one step away from the most serious, where the vaginal wall next to the rectum bulges out of the vagina. It was difficult to walk, Dr. Kowalczyk noted in a follow-up visit note.

The surgeon said Ms. Cavness was in a lot of pain but she wanted to go back to work.  Surgery was suggested, but Dr. Kowalczyk said she always encourages patients to ultimately to make their own decision.  The Plaintiff was a smoker and the doctor warned her that tissues have poorer healing due to smoking.  Lifting heavy items as an aircraft mechanic represented a risk of a recurrence.

Surgery done by Dr. Kowalczyk on April 24, 2012 included a Prosima mesh to reinforce a native tissue repair for added security.  Things improved for a few weeks but by June, Ms. Cavness returned crying with lower abdominal pain worse than before surgery, she said.

The doctor suspected the symptoms could indicate interstitial cystitis, or painful bladder syndrome. She never had the testing.

Eventually Dr. Kowalczyk referred Ms. Cavness to a pain doctor.

Today, what does Dr. Kowalczyk do for a Grade 3 rectocele, she was asked under direct examination.

“I do a native tissue repair,” she said.

Kat Gallagher, attorney for J&J

Under cross-examination, attorney Kathleen Gallagher for Ethicon asked, “You would use the Prosima today if it was available, but for the legal environment and fear of being sued, you would use it, right?”

The Defense expected an affirmative. They did not get it.

“I would not use it,” said Dr. Kowalczyk looking defiant.  

LIFE CARE PLAN AND MEDICAL NEEDS

Absent from most of these pelvic mesh product liability trials has been an economic forecast of what the Plaintiff will need financially and medically to live the rest of her life.   The Linda Gross case against Ethicon’s Prolift mesh yielded $11.1 million, still the highest jury award against Ethicon. It had a life care plan.

An economist was brought into Cavness v. Ethicon. Dr. Thomas Meyer projected that her job as an aircraft mechanic would result in wages lost of upward of $935,460. The Plaintiff has been trying to return to work but her pay stubs show months of lost wages due to the pain of her medical condition.

The Plaintiff has had two mesh removal surgeries and has incurred medical expenses. She would need $573,383 worth of medical care over a 25-year period with adjusted growth of 1.25% a year, plus inflation, the economist said.  That does not account for any further deterioration of her condition.

A DAUGHTER’S CONCERN 

The day ended with testimony by Ms. Cavness’ daughter, Brandy. Married with three children she lives nearby in Campbell, Texas. Brandy had witnessed her mother change from a happy, vibrant, outgoing personality who loved her work as an airline mechanic to someone who watches TV all day.  Ms. Cavness no longer enjoys yard work, remodeling, family outings, and playing with her grandchildren. The family bought her an iPad to entertain her at home.

Vaginal spotting, discharge, UTI’s and pain are part of her life today. Two mesh removal surgeries with a Dr. Carley did not resolve the issue. Neither did a surgical repair with Dr. Phillippe Zimmern of Dallas.

“It’s a struggle for her to go to work every day. To be honest I don’t know how she does it,” said Brandy who described her pain as intense as childbirth.

“She’s sad and lonely. She has to ask for help in a lot of different things… She’s a strong woman (she starts tearing up her voice breaks up).  She has to ask for help,” said Brandy.

Her mom moved in with Brandy’s family last February. Ms. Cavness and her husband have subsequently divorced. There was not a lot for them to do together anymore, said Brandy.  #

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