A Small Victory: But Justice Would Stop PREVENTABLE Harm

ZIMMER HIP IMPLANT LAWSUIT RESULTS IN $2M AWARD FOR FAULTY HIP REPLACEMENT

By Heba Elsherif   FiDA highlight

April 17, 2017

Two million dollars has been awarded to an Albuquerque man for a faulty Zimmer hip implant.

Plaintiff Brian M., a former University of New Mexico economist, received a metal hip replacement in 2010. Shortly following the surgery, however, Brian suffered from metallosis, the medical condition that involves the accumulation and deposition of metal debris specifically in the body’s soft tissue. Metallosis occurs when the metallic parts grate or abrade against one another in implant surgeries such as joint replacements.

Brian was 62 at the time of his surgery and suffered from extensive excruciating pain in his hip. He claims that the pain was limiting his enjoyment of his active life and that he had to, inevitably, cut his golf and tennis days short, according to the Zimmer hip implant lawsuit.

The U.S. District Judge Nan Nash said that, “Zimmer Inc., created a faulty device and should pay for past expenses, lost wages, and future medical expenses necessary to remove the dead flesh.”

The judge also contended Zimmer was responsible for causing the infection that further developed because of the hip replacement surgery.

Brian claims that before his surgery, there were already lawsuits being filed about the occurrences of metallosis from hip replacement surgeries. As a result, he had looked at a multitude of option beforehand with his surgeon, and concluded that such incidences with hip replacement surgeries had been resolved, the Zimmer hip implant lawsuit explains.

According to Brian, however, that problem with the device that had been inserted, stemmed from metal debris deriving from the femoral joint, and not the hip socket joint. That metal debris resulted in sending the toxic metal into his leg and drove the deterioration of his leg muscle.

After surgery was performed to remove the metal pieces from his leg, a third operation had to take place to remove the deteriorated muscle that had been killed by the infection.

Treatment for the infection was prescribed and he had to have intravenous antibiotics twice a day for several weeks. Per the Zimmer hip implant lawsuit, “the threat of that infection re-emerging remains for the rest of his life.” Judge Nash had taken this into account when allotting the plaintiff, the $2 million.

Personal injury attorneys throughout the nation celebrate the victory and say that the lawsuit is one of many more to come against Zimmer..

Brian is unable to play as many sports but he sustains his walking ability.

He states of his success that although he was not surprised that the Zimmer hip implant lawsuit developed the way it had, the award granted is a “pleasant end to an ugly ordeal.”

https://topclassactions.com/lawsuit-settlements/lawsuit-news/611511-zimmer-hip-implant-lawsuit-results-in-2m-award-for-faulty-hip-replacement/

Surgical mesh survey shows 'horrific' patient outcomes.

Surgical mesh survey shows 'horrific' effects

By Simon Wong

Wednesday 31 Aug 2016 3:03 p.m.

The severe after effects of surgical mesh implants have been quantified for the first time in a survey, which suggests many problems could go unreported.

Lobby group Mesh Down Under is pushing for change in the way surgeons use the product and is raising awareness for the problems it can cause.

Fifty-seven of the group's 197 members responded to the survey, in which 87 percent said they weren't warned about the potential risks and 91 percent weren't offered an alternative treatment.

The mesh is used in a number of surgeries, including for pelvic organ prolapse and stress urinary incontinence.

The survey's results appear contrary to Medsafe's advice to DHBs and private hospitals last year, which said clinicians should consider research and talk to patients about treatment options, including the risks and benefits "in clear and simple terms".

Mesh Down Under survey results:

• 70 percent experienced painful sex since surgery
• 20 percent of cases reported to Medsafe
• 80 percent needed one or more follow-up surgeries
• 44 percent had their condition return after surgery
• Of those who reported complications, 75 percent said GP didn't know about the adverse effects

Group spokesperson and registered nurse Patricia Sullivan said Medsafe had touted the benefits of mesh outweighing the risks.

"The risks are so horrific, that if people knew the risks, really knew how life-changing they are, they wouldn't do it.

"When it goes bad, it goes really bad," she says.

Problems with the mesh can sometimes take years to be felt, with 45 percent of respondents saying they'd had complications between five and nine years after surgery.

Ms Sullivan, who had an implant in 2008, says that makes it difficult for medical professionals to diagnose, with surgeons reluctant to re-operate.

"It took me four years for it to be diagnosed, and in those four years I saw six different specialists."

Ms Sullivan says the implants are faulty products, and pointed to three US states - Kentucky, Washington and California - suing Johnson & Johnson after they allegedly "concealed and misrepresented" the risk of surgical mesh.

Last week, the Government said it would consider creating a registry for the use of surgical mesh along with other recommendations from the health select committee.

The committee recommended:

• Investigate options for establishing a centralised mesh registry, consistent with international recording of mesh complications;
• Review best practice around informed consent for surgical mesh patients;
• Encourage health providers to ensure coding information is consistent so that patients with mesh complications can be identified and monitored;
• Encourage utilisation of the adverse events reporting system;
• Endorse ongoing education for surgeons around the use of mesh and mesh removal;
• Consider expanding Medsafe's role to assess quality and safety of medical devices.

Fellow campaigners Charlotte Korte and Carmel Berry say the recommendations don't go far enough and backed Labour health spokesperson Annette King's call for a full inquiry.

New Zealand First health spokesperson Barbara Stewart says the survey's numbers are concerning and congratulated those who had been "working tirelessly" on the issue.

She urged the Government to adopt all of the committee's recommendations.

"New Zealanders have suffered for long enough. The Government must show leadership," she says.

ACC Minister Nikki Kaye says cost of surgical mesh claims in the 10 years to May 2015 was $7,752,000.

Ms Sullivan says the survey could be considered a pilot study into the effects of surgical mesh because data hasn't been collected by other authorities, including Medsafe.

Newshub.

http://bit.ly/2bNPnfs

http://bit.ly/2bNPnfs

@wimon_song 

simonwong@mediaworks.co.nz

Wellington, NZ

@NewshubNZ

Criminal behavior, but no jail time. Lives lost, PREVENTABLE harm. Follow the money.

Los Angeles Lawyer Wins $119 Million Settlement Against Massachusetts-based Medical Company

Published : Friday, May 15, 2015 | 2:50 PM  (FiDA highlight)

Several hundred women that were represented by a Los Angeles-based attorney were a part of a $119 million settlement against a Massachusetts-based medical company over claims that its vaginal mesh product did not work and caused serious injuries.

“Most of the claims assert that the device manufacturer failed to properly test the pelvic mesh implant, ignored warnings, or that the device implanted into human tissue did not work and sometimes caused very serious problems,” said Los Angeles lawyer Dana Taschner, representing hundreds of women in the national medical device litigation involving several device

manufacturers.

Surgical mesh products were implanted in women in an effort to treat pelvic organ prolapse, stress urinary incontinence, and following hysterectomies.

Medical Device Company Boston Scientific agreed to settle thousands of lawsuits involving a vaginal mesh product, including the claims of an area woman claiming injury from the company’s transvaginal mesh medical device. Boston Scientific is paying $119 million to resolve almost 3,000 cases around the country, Taschner said.

“The trial that settled this week is one of thousands of transvaginal mesh lawsuits in federal and state courts across the country alleging product flaws” he said.

Boston Scientific claimed no admission of wrongdoing in the settlements, and insists their mesh medical device is not faulty or to blame for alleged problems.

Payments in the settlement are to be paid into a settlement escrow by the device manufacturer by October 1, 2015. Boston Scientific has reportedly set aside close to $1billion to cover costs, liabilities, legal expenses, and settlement associated with continuing transvaginal mesh and bladder sling claims.

Two other recent cases involving Boston Scientific resulted in significant and expensive defeats for the company.  In Miami, Florida, a federal jury returned a verdict of $26.7 million after plaintiffs argued that the company’s Pinnacle mesh device design was faulty and caused serious problems.

In another case in West Virginia, the jury returned a verdict of $18.5 million after the plaintiff sued Boston Scientific for injuries the plaintiff claims are a result of the medical device.

In addition to Boston Scientific, several other medical device companies are defending lawsuits for alleged transvaginal mesh problems.

“Boston Scientific is still exposed to claims from thousands of women claiming injury from the medical devices” said Taschner.

As of February, more than 25,000 product liability cases or claims regarding the mesh products had been made against the company, according to Boston Scientific filings.

Boston Scientific spokesperson Kelly Leadem said in an e-mail Tuesday that when it comes to those other cases and claims, the company will continue to look at all of its options.

“If there are opportunities to settle cases at reasonable terms in the future, then we will consider settling,” said Leadem in the e-mail. “Otherwise, we will continue to contest these claims

vigorously.”

$73M verdict: Observations on Martha Salazar v Boston Scientific Obtryx Surgical Mesh Trial

The $73M (compensatory and punitive) Martha Salazar (MS) v. Boston Scientific (BS) Obtryx verdict is in.  The Dallas jury (Texas 95th District) that was mixed racially, by age and gender executed the highest civilian peacetime service.  The were aware that even with an appeal it is likely that their unanimous verdict on punitive damages will stand.  The 10-day trial ended Monday, September 8, was conducted by Judge Ken Molberg with great decorum and attention to Texas state law.  Each side had excellent lawyers who vigorously defended their rights.  The jury was spared the convoluted and weak logic of FDA involvement in implanted medical device clearance for the U.S. market. Judge Molberg and the plaintiff attorneys had recently 'done that dance' at the Linda Batiste v Ethicon surgical mesh trial that ended with a $1.2M verdict(compensatory) in May 2014 and it was agreed by both parties that FDA 510(k) blessing was meaningless.
Instead, talk was about standard of care and standards of the industry.  Boston Scientific reasoning was akin to "everyone else is doing it" and "we have all been doing it this way forever, so it is OK".  In light of the excellent presentation of the plaintiff Martha Salazar on the stand, I believe the jury found BS reasoning not credible particularly when the MSDS (material safety data sheet) from the manufacturer of the resin in 2004 warned that the product was not to be medically implanted in a human body.  Martha Salazar's injuries began with the implantation of the surgical mesh at the time of a hysterectomy for another medical reason.  Her SUI(stress urinary incontinence) was not a recurrent, serious or main complaint, but an afterthought.  She was not given adequate warning of the irreversibility, severity, permanence or cascade of harm she may encounter with the implantation:  the doctor was not informed.  The jury learned from BS internal 'discovery' documents presented by Salazar's attorneys showing that BS knew of the potential for these injuries and suppressed the information so that it was not in the DFU (directions for use).
The jury verdict reflects an elevated communal decision to send a strong and irrefutable message to businesses that would knowingly harm for profit.  Both compensatory and punitive verdict figures far exceed the estimates of the plaintiff expert life planner witness and her attorneys.

The next trial in Dallas is Figueroa v. Boston Scientific beginning October 6, 2014.

More references:
http://www.classaction.org/blog/boston-scientific-to-pay-73-million-what-next-for-tvm-suits

Billion: That is $2.5 billion !!! Settlement is not justice for harmed patients!

DePuy to pay $2.5 billion for hips

Warsaw firm to settle thousands of implant lawsuits

Paul Wyche | The Journal Gazette  Published: May 31, 2014 3:00 a.m.

DePuy Orthopaedics, a unit of Johnson & Johnson, has waived its “walk-away rights,” which means the Warsaw company agrees to pay more than $2.5 billion to settle thousands of hip implant lawsuits, court documents show.

Officials at the medical device company have decided that enough plaintiffs exist to proceed with the settlement, according to paperwork filed last week with the U.S. District Court for the Northern District of Ohio in Toledo.

“While Settlement Program enrollment forms are still being processed, most (eligible) patients have opted into the program,” court documents stated.

“The company is, therefore, moving forward before the June 1 decision deadline provided for in the Agreement. The exact timing and amount of compensation will depend on a number of factors and circumstances specific to each claim,” the documents continued.

“However, eligible patients with allowed claims can expect payment now that there is certainty the program is moving forward,” the court papers said.

In November, the parent company agreed to pay plaintiffs who received the DePuy-made ASR hip implants.

The settlement gives money to patients based on several factors, including age, extent of injuries and whether they had to replace the defective implant. That agreement set the base rate at $250,000 per patient.

The DePuy ASR recall was announced in August 2010 after post-market data indicated that 12 percent to 13 percent of recipients required revision surgery within five years, according to Bernstein Liebhard, a New York law firm offering free legal evaluations to patients.

Attorneys with Bernstein Liebhard said that by the time the recall was announced, nearly 100,000 people worldwide had received the devices. Evidence revealed during DePuy ASR lawsuit trials indicated that the implant’s actual failure rate may be closer to 5 percent.

Other circumstances could entitle plaintiffs to a supplemental award if, for example, they required multiple revision surgeries, or if they experience “certain extraordinary injuries” in the future, attorneys said.

“DePuy remains committed to the well-being of ASR patients, as demonstrated by the worldwide voluntary recall and the global Broadspire program providing support for recall-related care,” said Mindy Tinsley, a DePuy spokeswoman, in an email Friday.

Broadspire is an independent, third-party claims processor available to patients not eligible for the U.S. Settlement Program, DePuy said.

pwyche@jg.net

Mounting Patient Harm and FDA history of medical device disasters!

ArtifactsTell the Story of Our Culture and FDA’s History

Posted on May 13, 2014 by FDA Voice  FiDA highlight

By: John Swann, Ph.D.

Looming sentry-like over the collection of artifacts that document FDA’s  history, the products  we regulate, and our interactions with the public is a rather large and curious figure. It is a green velvet head with bulbous, languid eyes and two upper teeth in an otherwise large and empty mouth. It doesn’t have ears or hair, but is marked by a few bright green pustules.  This is part of a life-size costume, an element of a public education campaign called Fight Bac! in which FDA was a major participant. It began in the 1990s to alert the public, young and adult alike, to the dangers of food-borne diseases and how to avoid them.

Countless objects in our collection tell the decades-long tale of FDA’s educational activities. For example, the agency still has a cabinet and some of its contents from the “Chamber of Horrors” exhibit that traveled around the country in the early 1930s to alert citizens, legislators, the press and others of the need for a stronger consumer protection law, drawn from egregious examples of how the law then in place fell short.  FDA officials also communicated through a variety of other displays for Congressional testimony and other purposes.

Much of the collection captures the problems that gave rise to the laws and regulations we have today, a regulatory arc often originating with a problem product—sometimes of disastrous proportions. Thus one can find specimens of:

▪                Elixir Sulfanilamide, a poisonous preparation of a wonder drug in 1937;

▪                thalidomide,  the globally marketed sedative that caused thousands of grave birth defects in the 1950s and 1960s;

▪                Bon Vivant vichyssoise, a botulism threat in the early 1970s;

▪                the ill-designed Dalkon Shield intrauterine device that caused thousands of pelvic infections; and

▪                ephedra-containing dietary supplements from the 1990s that killed several users.

These are among the objects that eerily illustrate why we have the laws and regulations we do.

Decision-making in the agency depends to a considerable extent on investigations and analyses, some of the tools of which are documented here. These artifacts of the growth of regulatory science include:

▪                balances and early calculating devices used in the laboratories of the Bureau of Chemistry from the 1900s to 1920s to analyze questionable foods and drugs;

▪                triers, tools used for routine sampling of various foods to ensure compliance with the law, from the mid-20th century; and

▪                advanced analytical devices from the 2000s to detect sophisticated counterfeiting of medicinal products.

Treatments of dubious value for both serious and non-serious diseases make up a significant part of the collection as well. There are hundreds of fraudulent medications, primarily up to about World War II, as well as hundreds of medical devices from the 1950s and 1960s that offered hope with no scientific underpinning.

In addition, how the public came to engage FDA and its work, especially from the 1970s forward, can be seen in a number of objects, including protest buttons and placards from the past two decades.

Artifacts like these tell the story of how our many laws and regulations came to be, how FDA has carried them out, and how the public and FDA have engaged each other in the interest of the public health.

John Swann, Ph.D., is an Historian at FDA

- See more at: http://blogs.fda.gov/fdavoice/index.php/2014/05/artifacts-tell-the-story-of-our-culture-and-fdas-history/#sthash.XEiRd40Z.dpuf

San Antonio, TX: Women harmed by implanted surgical mesh

Women claim mesh implants ruiningtheir lives

by Deborah Knapp / KENS 5

@DeborahKnappTV5

Posted on May 1, 2014 at 9:52 PM

 Follow link above to watch the video.  FiDA highlight

SAN ANTONIO -- More than 20 million women in the United States have urinary incontinence.  Yet, the topic is often taboo.

A device that was supposed to help the condition is now at the center of thousands of lawsuits from women who say it's ruined their lives.

Jennifer Ramirez is one of those women who says she is in constant pain after receiving a mesh implant that was supposed to cure incontinence.

In Ramirez's case, she didn't even have a serious condition, it was used to prevent it from developing further.

"I have pelvic pain, constant pelvic pain," said Ramirez.

 Life is also painful for 64-year-old Linda Batiste.

The condition that brings both women to tears is embarrassing to discuss.

"It actually does feel like a scouring pad in your body.  You can feel in your women parts, what it is.  It's there," said Batiste.

That feeling comes from a product left inside her body to fix urinary incontinence.

In thousands of cases, including Batiste and Ramirez, doctors use a pliable, gauze-like mesh sling to support the bladder and other organs.

But, what the women got was not relief.

"I have never been pain-free, since then," said Batiste.

After the birth of her third child, Ramirez underwent a hysterectomy and then got the mesh sling.

"I had it as a precautionary when I had my hysterectomy because I had some stress incontinence from coughing or sneezing or jumping on a trampoline," said Ramirez.

The pain forced her to have the device removed just months later. 

"Now my life has to revolve around having a restroom right there because when you have to go you have to go or you will have an accident. It's embarrassing and depressing," said Ramirez.

Other complications from mesh implants develop when it becomes embedded in organs and it can make sexual intimacy painful.

"The polypropylene mesh, it degrades, it disintegrates, it extrudes, it frays, it ropes and it has particle loss.  And all of those problems cause other problems. like scarring, chronic pain, for example," said Tim Goss who represented Batiste in a product liability case against the Johnson & Johnson subsidiary Ethicon.

Surgical mesh is a synthetic material. 

It's manufactured by several companies and routinely used for urinary incontinence, pelvic prolapse and hernia operations. 

The American Urogynecologic Society said it's "safe, effective, and has improved the quality of life for millions."

The FDA first issued a "Public Health Notification" in 2008, saying it had received "over 1,000" reports of "adverse events" "for surgical mesh devices"

In 2011, The FDA sent out another warning, saying "serious complications associated with surgical mesh" "are not rare."  and that mesh "may expose patients to greater risk" than traditional procedures.

Since then, women across the country have formed organizations and online support groups, trying to get mesh removed from the market.

Linda Batiste just won a $1.2 million verdict against the maker of her mesh in the first case of its kind in the nation to go before a jury.

"It's significant because there are almost 100,000 other cases pending around the country regarding this type of product," said Goss.

Goss, who represents 9,000 mesh cases himself including Jennifer Ramirez's, says the lawsuits have the potential to become the largest mass-tort in history, bigger - even - than the phen-fen diet drug mess.

Linda Batiste has had several surgeries to try to removed the mesh, which is embedded in her tissue.

And, her original problem of incontinence is back.

"And it's compounded the pain that I normally would have had.  I never wish for any other woman to feel this way or to have it happen to them, " said Batiste.

Tuesday, the FDA announced it wants stricter safety rules for the mesh implants.

It is proposing labeling the female incontinence device as "high risk"  after years of reports of pain among women who have received the implants.

Right now there are more than 100,000 cases in the U.S. pending against the makers of the mesh. 

The attorney we spoke to said since the mesh implants are still being used, he expects that number to increase.

They recall cars: but not failed hips?

The Hip Generation: Recalls,redoes agony for some with new joints

by BYRON HARRIS

WFAA   FiDA Highlight

Posted on May 1, 2014 at 10:00 PM

Updated today at 7:30 PM

Your car may be a lemon. But is your artificial hip?

So many Americans have artificial hips that we could be called the hip generation. But, Americans may know more about their automobiles than what’s inside their bodies and as many as a million may be suffering damage they don't know about.

Generally, a hip replacement is very effective, but the process remains costly, unregulated and, some say, potentially harmful.

Right after her total hip replacement, Rebecca Thompson said she felt a “clicking” in her new joint. But, her DePuy hip had been on the market for years — tried and true, the company said.

Not until several years after Thompson, who lives in Burleson, got her hip did DePuy publicly admit it had a problem and recalled the device.

“It was like, ‘They recall cars, they don’t recall body parts. What’s going on?’” she recalled.

A total hip replacement consists of a cup and a ball. From the early 2000s until 2010, those components were often made of chromium cobalt metal in what's called metal-on-metal hips. As the parts grind against each other, they can produce particles of chromium cobalt that can cause a dangerous condition called metallosis in which metal debris builds up in the soft tissues of the body.

It’s a condition Dr. Stephen Tower of Anchorage Alaska knows firsthand.

As an orthopedic surgeon, he has replaced more than a thousand hips. An active outdoorsman, when his own real hip started bothering him, he had a new one installed in himself.

But soon the artificial hip was as painful as the real hip it replaced.

“The toxic effect of the cobalt destroyed all the ligaments around the hip,” he said. It also produced “pseudo tumors,” or non-cancerous fleshy growths.

He began studying the chromium cobalt levels in his own blood, as well as his patients.

“They were clearly experiencing neurologic toxicity or psychological toxicity or cardiac toxicity from that hip,” he said.

He said that in the last decade, up to “90 percent of the hips that have been replaced in the United States are potentially at risk for problems.”

Artificial hips are increasingly sold as products, with advertisements appearing in, among other things, national newscasts. And for most Americans, their new joints work very well.

“In the United States we perform about 400,000 hip replacements each and every year,” said Dr. Jay Mabrey, chief of the Department of Orthopedic Surgery at Baylor University Medical Center and a Professor of Orthopaedic Surgery at the Texas A&M School of Medicine.  He’s also former chairman of the FDA’s Orthopaedic Device Panel.

“Total hip replacement is one of the most successful orthopedic procedures,” he said.

That said, Mabrey added, “metallosis is a huge problem for certain types of implants.”

“I have a lot of patients with these metal on metal hips,” Mabrey said, and “when they move after sitting for a while, they get that click… That’s metal on metal. Just like your car engine, you really don’t want metal rubbing up against metal.”

Science is starting to view the amount of chromium cobalt in the bloodstream with more concern than in the past. The threshold for concentration in the bloodstream, Mabrey says, used to be 7 parts per billion of chromium cobalt. “Some people think you should be concerned at 2 to 3 parts per billion.”

On April 19, Texas Rangers fans got a firsthand look at what a successful hip operation can do.

Pitcher Colby Lewis got his first win on the mound since 2012. It was his second major league start since having his hip resurfaced, an operation similar to a total hip replacement. And it has, so far, helped turn around his career.

The price for miracles like this hard to determine – even for doctors.

“A lot of this is confusing to surgeons,” said Dr. Stephen Tower in Alaska. “A lot of this is funny money. People get these incredibly high bills and what actually gets paid is a percentage of that.”

A hip can easily cost more than a car.

Scott Abram has had three total hip replacements. One has been problem free; the other, a source of constant paint that ultimately had to be replaced.

Hospital records show his insurance company was billed more than $20,000 for his most recent hip. The total bill for that one was $60,000. He doesn't know how much was finally paid by his insurance company.

The price pales in comparison to the agony he’s endured for eight years.

“I'm in pain every minute of every day and all night long,” he said.

He’s an airline pilot, but the pain has kept him from working for nearly a decade. . 

“There wasn’t a great deal that was explained to me ahead of time,” he said. 

What he didn’t know was that his hip was never rigorously tested. Like other devices, it was approved by the FDA in a shortcut process called 510 k. 

“If they were similar to other products on the market then you could release these other models onto the marketplace, without adequate testing or data,” said Dr. Shezad Malik, a Dallas physician who is also a lawyer. He is suing the company that made Scott Abram’s hip.

Hips are failing, he says, at a rate higher than the public realizes.

“In Australia and the UK, they’ve found actually double digit failures,” Dr. Malik said. “And the failure rate can be as high as 50 percent at five years.” 

In the last 10 years, there have been 578 different recalls of hip implants from six major manufacturers, according to the Safe Patient Project, which is affiliated with Consumers Union.

The problem is, most patients don’t even know what kind of hip is in their body.

“We don’t know how many of those patients have died. Others may not be mobile. Families don’t know what’s going on,” Dr. Malik said.

One manufacturer, DePuy, has already settled a class action lawsuit for $2.5 billion. It faces another class action lawsuit for another of its artificial hip models. Other manufacturers are being sued as well.

But lawsuits won't solve the problem for the 1 million people with chromium cobalt in their hips across the country. Like owners of recalled cars, they could be headed for a crash and don’t know it.

Email bharris@wfaa.com

Public Citizen blasts FDA for weak regulation of implanted surgical mesh.

FDA Wants High-Risk Label forTransvaginal Mesh

Published: Apr 29, 2014

By Charles Bankhead, Staff Writer, MedPage Today, 

Public Health & Policy

FiDA highlight

WASHINGTON -- The FDA has proposed reclassification of surgical mesh for transvaginal repair of pelvic organ prolapse (POP) as a "high-risk device," a designation that mandates an FDA review of safety and effectiveness prior to considering approval.

The agency also wants to reclassify certain instruments used to perform POP repair as "intermediate-risk devices," as opposed to the current low-risk designation.

"The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products," William Maisel, MD, of the FDA's Center for Devices and Radiological Health, said in a statement. "If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair."

The proposal does not affect surgical mesh used to treat stress urinary incontinence (SUI), abdominal POP repair, hernia repair, and other nonurogynecologic indications. The proposal is subject to a 90-day public-comment period prior to a final decision.

The proposed reclassification follows other FDA actions and statements related to transvaginal POP repair materials going back 6 years:

         October 2008 -- Released a Public Health Notification about serious complications associated with transvaginal placement of surgical mesh for POP and SUI

         July 2011 -- Released an updated safety communication about serious complications associated with transvaginal POP repair with surgical mesh

         July 2011 -- Released a review of urogynecologic surgical mesh adverse events and scientific literature, identifying serious safety and effectiveness concerns

         September 2011 -- FDA's Obstetrics and Gynecology Devices Panel recommended reclassification of surgical mesh for transvaginal POP repair from class II to class III and require premarket approval

         January 2012 -- FDA ordered manufacturers to conduct postmarket surveillance studies to address specific safety and effectiveness concerns about surgical mesh used for transvaginal POP repair

Some materials to repair POP come as kits that include the mesh and instruments used to place, attach, and secure the mesh. Instruments also are sold separately from the mesh, and the FDA proposal to reclassify instruments pertains to the instruments that are not included in kits.

The FDA action represents a case of "too little, too late," according to Michael Carome, director of Public Citizen's Health Research Group, a Washington-based public health advocacy group. Public Citizen has petitioned the FDA to recall all surgical mesh products from the market.

"Today's action comes nearly 3 years after our petition and after an FDA advisory committee recommended such action," Carome said in a statement. "Moreover, the proposed timeline for full implementation of the FDA's order, if finalized, will take several more years.

"As a result of the FDA's reckless delays and inadequate action regarding surgical mesh for transvaginal POP repair, thousands of women will continue to be unnecessarily exposed to a wide array of serious risks, many of which can permanently alter women's quality of life."