September 14, 2011
Parker Waichman Alonso LLP commends the U.S. Food & Drug Administration’s (FDA) proposal that transvaginal mesh devices used in the surgical repair of pelvic organ prolapse (POP) be reclassified as Class III medical devices, the agency's highest-risk category. This reclassification would make transvaginal mesh devices for POP repair ineligible for the FDA's less-stringent 510(k) approval protocols, and require that they be subjected to human clinical trials in order to gain FDA approval. The FDA proposal would also require the makers of transvaginal mesh devices currently on the market to conduct postmarket studies to assess their safety and effectiveness in POP repair.
Transvaginal mesh manufacturers, including American Medical Systems, C.R. Bard, and Johnson & Johnson, have been named in hundreds of lawsuits filed by women who claim to have suffered painful and debilitating complications following implantation of the devices to repair POP. In a safety communication released on July 13, 2011, the FDA reported that between 2008 and 2010, it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair. According to the agency, the most frequently reported complications included mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2011/9/prweb8796909.htm