FDA Panel: More Transvaginal Mesh Studies Needed

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Despite urging from the watchdog group Public Citizen to ban transvaginal mesh devices, an FDA panel of advisors has recommended keeping the products on the market with the addition of more stringent testing requirements. The topic of vaginal mesh for use in pelvic organ prolapse (POP) has become a controversial topic as of late, with thousands of reports of severe side effects being linked to the devices. The transvaginal mesh lawyers at Schmidt & Clark, LLP are currently investigating potential lawsuits on behalf of victims injured by vaginal mesh side effects.

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.

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 9, 2011 – The first session of a two-day meeting of the FDA’s obstetrics and Gynecologists Devices panel has largely supported the administration’s plan to reclassify all transvaginal mesh products as Class III devices. If vaginal mesh is moved to Class III, manufacturers would be unable to fast-track device approval and would have to undergo detailed clinical trials before being allowed to go to market. However, despite calls from consumer advocates to ban all vaginal mesh devices, the products would continue to remain on the market under the proposed plan.

Vaginal mesh products are currently classified as Class II devices, which means that manufacturers can apply for approval through the FDA’s controversial 510(k) approval process. Under 510(k), a manufacturer must only show that a transvaginal mesh device is ‘substantially similar’ to an existing product already on the market, without requiring pre-clinical testing. Certain varieties of vaginal mesh date back to before the current approval system was put in place, which means that a number of these devices have never even been tested and were grandfathered into the market decades ago.

Last month, the watchdog group Public Citizen called for a ban on all non-absorbable surgical mesh for POP repair, and petitioned the FDA to issue a vaginal mesh recall. The group pointed out the fact that even the FDA has found that transvaginal mesh offers little if any benefit over safer, more traditional methods of treatment.

“Given the absence of evidence for clinically significant benefit and the overwhelming evidence of very serious, common risks, use of synthetic surgical mesh products for transvaginal repair of POP is not ethically justifiable,” Dr. Michael A. Carome, Public Citizen’s deputy director of health research, testified.

Transvaginal mesh patches are surgically implanted devices that stretch across the vaginal wall to add extra support to damaged tissues. By adding strength to damaged vaginal walls, transvaginal mesh patches can be effective treatments for a number of conditions including pelvic organ prolapse (POP) – a condition in which organs of the lower abdominal region slip out of place – and stress urinary incontinence (SUI), which is characterized by the inability to control urination when increasing pressure within the abdominal region. Unfortunately, the failure of transvaginal mesh devices can lead to the need for multiple operations to remove the mesh and to repair the extensive damage caused by the products.

On July 13, 2011, the FDA issued a press release warning the public that transvaginal mesh products had been linked to a number of severe side effects and complications including:

• erosion of the mesh into the vagina
• pain
• bleeding
• organ perforation
• recurrence of POP
• other complications following surgery

The FDA also stated that all available evidence has failed to establish any health benefit of transvaginal mesh over more traditional forms of POP repair. Yet despite these facts, an estimated 75,000 women undergo vaginal mesh operations each year.

If you were the recipient of a transvaginal mesh product and suffered from any of the complications listed in this article, you may be entitled to compensation. Contact the transvaginal mesh lawyers at Schmidt & Clark, LLP today for a free case evaluation. Act now – there is a limited amount of time in which to file your claim.

Click here to learn more about transvaginal mesh from Schmidt & Clark, LLP.

Do You Have a Transvaginal Mesh Lawsuit?

The Product Liability 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.