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FDA Panel: Additional Studies Needed to Determine Transvaginal Mesh SUI Risk

Last week’s meeting of an FDA advisory committee concluded with the recommendation that the 510(k) approval process for mesh devices used to treat stress urinary incontinence be left in place, but that more clinical data for the controversial products is urgently needed.

Last week’s meeting of an FDA advisory committee concluded with the recommendation that the 510(k) approval process for mesh devices used to treat stress urinary incontinence (SUI) be left in place, but that more clinical data for the controversial products is urgently needed. Over the past three years, the FDA has received thousands of reports of transvaginal mesh injuries, malfunctions, and even deaths. The vaginal mesh lawyers at Schmidt & Clark, LLP are currently investigating potential lawsuits nationwide on behalf of women injured by transvaginal mesh side effects.

Transvaginal Mesh Lawsuit Update 8/1/12: According to a plaintiff’s attorney in what appears to be the latest in a string of transvaginal mesh (TVM) lawsuits filed around the country over the past several months, Boston Scientific Corporation knew – or should have known – about the health risks associated with its products. The plaintiff, from Tennessee, was reportedly implanted with a Boston Scientific Obtryx Tansobturator Mid-Urethral Sling System, and subsequently suffered debilitating personal injuries. Click here to learn more.

Vaginal Mesh Lawsuit Update 7/26/12: Last Friday, a jury ruled that medical technology giant C.R. Bard and a doctor must pay a total of $5.5 million in damages over a vaginal mesh implant that left a woman with persistent pain and potentially irreversible injuries.The landmark case is the first to go to trial among hundreds of lawsuits alleging that vaginal mesh implants made by Bard, Johnson & Johnson, and Boston Scientific caused severe organ damage and other serious injuries. Click here to learn more.

Transvaginal Mesh Lawsuit Update 6/21/12: A judge has lifted the discovery stay in the federal transvaginal mesh (TVM) litigation, as scores of new cases continue to be filed on behalf of women in courthouses around the country. All discovery was stayed earlier this year in federal lawsuits involving transvaginal mesh products used for surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Click here to learn more.

Vaginal Mesh Lawsuit Update 5/16/12: The first trial date in the federal litigation involving women allegedly injured by vaginal mesh products manufactured by C.R. Bard has been set for early next year. Although the specific lawsuit has yet to be selected, the trial will involve a claim filed on behalf of a woman who allegedly suffered injuries after being implanted with a Bard vaginal mesh product. Click here to learn more.

FDA 510(K) Approval Process Update 2/14/12: House Democrats have overwhelmingly supported the notion that federal health regulators should have the authority to block medical devices that are based on past products with safety issues from entering the market. A bill introduced earlier this month would close the FDA’s controversial 510(k) loophole that lets manufacturers win swift approval for devices like the much-beleaguered transvaginal mesh implants made by Johnson & Johnson and C.R. Bard inc. Click here to learn more.

Free Transvaginal Mesh Lawsuit Case Evaluation: If you or a loved one has been injured by vaginal mesh, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

September 12, 2011 – The Obstetrics and Gynecology Devices panel, which convened last week in Gaithersburg, Maryland, made the recommendation after hearing presentations by FDA staff reviewers suggesting that reclassification was not needed, but additional data might be useful.

Since the early 1990’s, the FDA has approved nearly 80 surgical mesh devices for the treatment of SUI under the controversial 510(k) process. Under 510(k), manufacturers do not have to conduct preclinical testing and are only required to show that a device is ‘substantially equivalent’ to an existing device already on the market.

Between 2008 and 2010, the FDA received 1,371 adverse event reports involving transvaginal mesh to treat SUI. Of these reports, there was three deaths, 1,131 injuries, 236 malfunctions, and one event curiously labeled ‘other.’

Of the three deaths attributed to vaginal mesh products, two were bowel perforations “related to the mesh placement procedure … but unrelated to the mesh itself,” the reviewers noted. “One death was related to complications from mesh removal.”

Other side effects reported to the FDA included:

  • severe pain (34.9% of events)
  • erosion (31.8%)
  • infection (18.9%)
  • urinary problems (16.0%)
  • organ perforation (8.3%)

Less prevalent problems associated with vaginal mesh reported to the FDA included:

  • recurrence
  • bleeding
  • pain during sexual intercourse (dyspareunia)
  • vaginal scarring

The Obstetrics and Gynecology Devices panel also found that between 9% and 17% of all women who had SUI treated with transvaginal mesh reported urinary problems after surgery, although the rates varied significantly depending on the type of material used.

“The FDA does not believe that mesh used for SUI repair should be reclassified from Class II to Class III,” the reviewers concluded. Moving transvaginal mesh products to Class III would be devastating for manufacturers, as this classification requires extensive randomized controlled trials to demonstrate safety and efficacy, whereas devices in Class II do not.

Instead of moving transvaginal mesh to Class III, the panel ‘centered upon pre-clearance data before the devices came to market, and whether for those [devices] already on the market we should have … studies to collect additional data,’ Herbert Lerner, MD, acting director of FDA’s Division of Reproductive, Gastro-Renal, and Urological Devices, said in a phone interview with MedPage Today after the meeting.

The panel didn’t feel any additional research was needed for older vaginal sling products, since the FDA has about 15 years of safety data on them. But for the newer mini-slings, the panel recommended postmarketing data for those already on the market as well as premarketing data for new products seeking FDA approval.

The panel’s discussion about SUI ended very differently from the previous day’s debate regarding transvaginal mesh use in the treatment of pelvic organ prolapse (POP). In that discussion, the majority of the participants supported reclassifying vaginal mesh into Class III because of safety concerns.

Surgical mesh products have been the subject of considerable controversy as of late. In July, the FDA issued a press release warning the public and medical communities of the dangers associated with transvaginal mesh. The administration stated that vaginal mesh to treat POP carries far greater risks than other surgical options, without any evidence of greater overall benefit.

Do You have a Transvaginal Mesh Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in transvaginal mesh lawsuits. We are handling individual litigation nationwide and currently accepting new vaginal mesh injury cases in all 50 states.

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