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FDA Panel Recommends Stricter Approval Process for Transvaginal Mesh

Following the conclusion of a rigorous two day meeting concerning the use of transvaginal mesh products for pelvic organ prolapse repair, a 15-member FDA panel appeared to be largely in favor of requiring more stringent approval requirements for the controversial devices.

Following the conclusion of a rigorous two day meeting concerning the use of transvaginal mesh products for pelvic organ prolapse (POP) repair, a 15-member FDA panel appeared to be largely in favor of requiring more stringent approval requirements for the controversial devices. Despite pleas from the watchdog group Public Citizen to ban transvaginal mesh altogether, the committee made no call for this action. 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 Update 6/26/12: Healthcare behemoth Johnson & Johnson (J&J) continued to sell its controversial Gynecare Prolift transvaginal mesh patch for nine months after the FDA ordered it to stop, according to court records. In a letter sent Aug. 24, 2007, the administration asked the company to halt sales of the Prolift until it could determine whether the device was ‘substantially equivalent’ to other products on the market. 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.

Transvaginal Mesh Update 3/22/12: Multi-national pharmaceutical and biotech giant Johnson & Johnson sold a transvaginal mesh implant for three years before the device was officially approved by the U.S. Food & Drug Administration (FDA). The product, known as the Gynecare Prolift, is currently the subject of more than 550 lawsuits filed on behalf of women who claim it injured them. 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 Vaginal 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 FDA’s Obstetrics & Gynecology Devices Advisory Committee has concluded in favor of requiring stricter pre-marketing tests for transvaginal mesh, as well reclassifying these products as Class III devices.

Under current federal laws, vaginal mesh is listed as Class II in the FDA’s 510(k) approval process, in which 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.

The 15-member panel, which convened last week in Gaithersburg, Maryland, considered the risks and benefits of vaginal mesh used for POP repair given the available data from the FDA’s Manufacturer and User Device Experience (MAUDE) database.

Side Effects of Transvaginal Mesh

According to MAUDE, transvaginal mesh has been linked to the following preoperative risks:

  • organ perforation
  • bleeding
  • mesh exposure into the vagina, bladder, or rectum
  • pelvic pain
  • infection
  • pain during sexual intercourse (dyspareunia)
  • the need for additional revision surgeries to correct the problems
  • urinary problems
  • vaginal scarring / shrinkage
  • recurrent prolapse
  • neuromuscular problems

Over the past three years alone, the FDA has received nearly 3,000 adverse event reports of transvaginal mesh complications following surgery to repair POP and stress urinary incontinence (SUI).

Although there was no formal vote on the issue, the vast majority of the panel seemed to support the administration’s plans to conduct ‘section 522’ postmarketing studies on transvaginal mesh devices. However, much to the chagrin of consumer advocate groups like Public Citizen, the panel made no recommendation to remove vaginal mesh products from the market.

Tommaso Falcone, MD, professor of surgery and chair of obstetrics and gynecology at the Cleveland Clinic Foundation in Ohio, noted a lack of comprehensive data regarding transvaginal mesh devices currently on the market. Postmarketing ‘studies are ongoing but…until [the data] are there, they don’t exist,’ Falcone said.

‘It’s possible that the ongoing studies are already available to address the need [for postmarketing studies],’ said George Flesh, MD, from Harvard Medical School in Boston, Massachusetts. However, any studies ‘need to be randomized, controlled studies or cohort studies and need to go on for at least 3 years,’ he said.

Additionally, Cook Biotech Inc., a major manufacturer of surgical graft products, has urged the administration to consider the variable myriad of vaginal mesh materials when making decisions about these devices:

‘There are significantly different types of mesh products and grafts used, i.e., synthetics (both absorbable and non-absorbable) vs. biologics,’ the company wrote. And while the FDA raises legitimate concerns about these products, the agency ‘only briefly acknowledges that there are significantly different types of mesh products and grafts used, i.e., synthetics (both absorbable and non-absorbable) vs. biologics.’

Interested in learning more? Click here for additional information about transvaginal mesh from Schmidt & Clark, LLP.

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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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