More Women Seek Legal Recourse for Transvaginal Mesh InjuriesSep 16, 2011 | Parker Waichman LLP
The U.S. Food & Drug Administration's (FDA) recent safety alert for transvaginal mesh devices has sparked a surge in inquiries to personal injury lawyers, according to a report from Bloomberg News. Attorneys report that they are receiving an "amazing number of calls" from women who allegedly suffered transvaginal mesh complications following surgery to repair pelvic organ prolapse (POP).
According to Bloomberg, about 300,000 women in the U.S. had POP surgeries last year, including more than 70,000 who received transvaginal mesh. Women who have inquired about filing transvaginal mesh lawsuits complain that complications have left them unable to work, exercise, or enjoy sex.
At least 600 transvaginal mesh lawsuits are currently pending across the country, though none have gone to trial yet. Johnson & Johnson, which Bloomberg says is a global leader in mesh, has been named in roughly 270 complaints. American Medical Systems, C.R. Bard and Boston Scientific have also been named in transvaginal mesh lawsuits.
In July, the FDA said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.
Transvaginal mesh devices were approved for POP surgery under the FDA's 510(k) approval process. This clearance protocol is reserved for "moderate risk" devices that are substantially equivalent to devices that have already been brought to market. 510(k) clearances do not require that medical devices undergo clinical trials involving humans be conducted before they are approved.
Last month, FDA staff proposed that such devices be moved to the agency's high -risk medical device category, which does not allow 510(k) clearances. Under the FDA proposal, transvaginal mesh devices already on the market would be allowed to remain, but manufacturers would have to conduct studies to asses their safety and effectiveness. Just last week, an FDA panel of outside experts backed both proposals. While the agency is not required to follow the advice of its advisory panels, it does so in most cases.