FDA Calls for Reclassification of Vaginal Mesh Devices Due to Serious Health Risks

Health Risks of Surgical Mesh

Written by Faith Anderson on May 1, 2014
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FDA Calls for Reclassification of Vaginal Mesh Devices Due to Serious Health Risks

Transvaginal mesh may soon be classified as a high-risk medical device. Contact a surgical mesh attorney today if you believe you have been harmed by the potentially dangerous product.

In light of the tens of thousands of adverse event reports the FDA has received involving women who suffered serious complications from transvaginal mesh, federal health officials are calling for the products to be reclassified as high-risk medical devices, which would establish a more stringent approval process for surgical mesh makers. The FDA’s proposal, which was issued on April 29, would elevate vaginal mesh from a Class II moderate-risk device to a Class III high-risk device, and would result in a new pre-market approval process for the potentially dangerous products. If the FDA proposal is finalized, mesh manufacturers would be required to prove their products are safe and effective before they can be sold to doctors and implanted in patients.

Possible Side Effects of Surgical Mesh

Transvaginal mesh devices like C.R. Bard’s Bard Avaulta Mesh have been heavily marketed by manufacturers over the past decade as a safe and effective treatment for women suffering from pelvic organ prolapse (POP) and stress urinary incontinence (SUI). However, serious concerns about these medical devices have surfaced in recent years, as women across the country have reported experiencing severe and debilitating injuries due to alleged vaginal mesh complications, including mesh erosion into the vagina, infections, and damage to internal organs.

FDA Reports of Vaginal Mesh Injuries

The FDA first issued warnings about the potential health risks of surgical mesh in October 2008, citing hundreds of reports of women suffering serious complications following transvaginal mesh surgery. In July 2011, the FDA notified consumers and the medical community that it had received thousands of adverse event reports linked to surgical mesh, and noted that it saw no benefit from vaginal mesh when used to treat pelvic organ prolapse. The most recent FDA action prior to this new proposal came in January 2012, when the agency ordered surgical mesh makers to start planning new studies examining the complication rates of transvaginal mesh procedures.

Transvaginal Mesh Not Adequately Tested

Transvaginal mesh devices are currently approved via the FDA’s controversial 510k approval process – a fast-track program that allows manufacturers to introduce medical devices without extensive testing if they are proven to be “substantially equivalent” to a product already on the market. “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,” said the FDA’s deputy director of science, Dr. William Maisel. “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.”

Contact an Experienced Vaginal Mesh Lawyer Today

More than 50,000 women are currently pursuing product liability lawsuits against the makers of allegedly defective transvaginal mesh devices, after suffering complications that resulted in serious and long-lasting injuries. All of the vaginal mesh lawsuits involve similar allegations that the makers of these medical devices knew or should have known about the health risks associated with transvaginal mesh. If you believe you have been harmed by side effects of surgical mesh, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by dangerous medical devices, and can put you in touch with an attorney who has experience handling transvaginal mesh cases.

Posted Under: Bard Avaulta Mesh, FDA - Food and Drug Administration, Medical Products, News, Transvaginal Mesh
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