On May 1, 2014, the U.S. Food and Drug Administration announced a proposed rule to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. This proposed rule change acknowledges that there is insufficient evidence on the safety of mesh products for POP repair and would require any transvaginal mesh to undergo premarket approval to ensure the mesh's safety and effectiveness before it can be marketed and implanted in women. This classification change would remove mesh products for POP from the much maligned 510K process, which does not require premarket approval. In making this significant announcement, the FDA identified numerous risks with the use of transvaginal mesh for POP repair, including mesh exposure and extrusion, vaginal scarring, pelvic pain, shrinking and tightening of the mesh, incontinence and infections such as pelvic abscesses. Comments on the proposed rule changes are due by July 30, 2014. Needless to say, the mesh manufacturers and their lobbyists are certainly expected to fight this proposed change.
SUGARMAN principals Marianne LeBlanc and David McCormack continue to represent clients who have been implanted with defective or recalled transvaginal mesh products. If you believe you may be suffering from adverse medical complications as a result of a defective or recalled transvaginal mesh product, fill out a Contact Form, call Marianne LeBlanc or David McCormack at 617-542-1000 or e-mail Marianne LeBlanc or David McCormack.