FDA May Classify Pelvic Implants as “High Risk” in New Rules Likely to Affect Transvaginal Mesh Lawsuit Allegations
Federal regulators have proposed new regulations likely to impact thousands of women whose transvaginal mesh lawsuit allegations note the potential for debilitating injuries to stem from their use, according to the Washington Post.
Under a proposal announced April 29th by the U.S. Food and Drug Administration (FDA), transvaginal mesh used to treat pelvic organ prolapse (POP) may be reclassified as “high risk” in light of their possible association with pain, bleeding, infection and other side effects. Manufacturers of these devices, which include Johnson & Johnson and its subsidiary, Ethicon, Boston Scientific, American Medical Systems and C.R. Bard, will be required to submit their products for pre-market safety testing and approval if the new rules go into effect.
Prompted by the FDA announcement were findings of an internal analysis that showed 10 percent of women experiencing mesh erosion within a year of implantation. More than half the women shown to have suffered this complication needed surgical intervention to remove the mesh, resulting in sometimes two or three additional procedures.
In a statement related to the proposed pelvic mesh regulations, a chief scientist for the FDA’s device center said, “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.”
According to the Post, the federal agency will take comments on the proposal for 90 days.
50,000 Cases Now Pending in Nationwide Transvaginal Mesh Lawsuit Litigation
Meanwhile, court documents show more than 50,000 transvaginal mesh lawsuits now filed by women in the U.S. Plaintiffs in these cases similarly accuse medical device manufacturers of failing to warn about side effects that may stem from use of their products, which they say were designed defectively given their association with side effects. Many of these claims are pending in separate federal multidistrict litigations in the U.S. District Court, Southern District of West Virginia and involve products marketed by Ethicon, C.R. Bard, Boston Scientific and American Medical Systems.
How to File a Transvaginal Mesh Lawsuit
To join the thousands of women who were allegedly injured as a result of transvaginal mesh, contact our Firm to find out if you are eligible to file a claim. Call our attorneys directly at (877) 779-1414.