New York, New York (PRWEB) 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. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization, the FDA said. The agency also noted that its review found that transvaginal POP repair with mesh does not offer any additional benefits over traditional non-mesh repair.
According to an FDA Executive Summary released on August 31, 2011, agency staff believes that “vaginal placement of surgical mesh for pelvic organ prolapse repair inherently introduces risks of complications that are unique to the mesh itself.” The Executive Summary proposed that transvaginal mesh products for POP repair be reclassified as Class III medical devices, and undergo the most stringent of testing prior to FDA market approval. Currently transvaginal mesh products are placed in Class II, which allows approval via 510(k) protocols if a device is shown to be "substantially equivalent" to another product already on the market. As such, 510(k) clearances do not require human clinical trials.
On September 8 and 9, 2011, the FDA's Obstetrics and Gynecology Devices Advisory Panel met to discuss the safety of transvaginal mesh devices in POP repair. Though no formal vote was taken, the majority of outside medical experts on the panel backed the FDA's proposal to reclassify transvaginal mesh devices as high risk. The majority also agreed that the FDA should require the manufacturers of transvaginal mesh devices currently on the market to conduct postmarketing studies to assess their safety and effectiveness in POP repair.
In light of the staggering number of serious complications reported among women who have received transvaginal mesh devices for POP repair, Parker Waichman Alonso LLP urges the FDA to implement its proposal to reclassify these devices as soon as possible. Parker Waichman Alonso LLP also calls on the FDA to order a recall of all transvaginal mesh devices currently being marketed for POP repair until their safety and effectiveness can be established.
Parker Waichman Alonso LLP continues to offer free lawsuit consultations to victims of transvaginal mesh. If you or a loved one experienced complications following POP surgery with transvaginal mesh, please visit the firm's transvaginal mesh injury page at http://www.yourlawyer.com.
Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding transvaginal mesh lawsuits and Parker Waichman Alonso LLP, please visit: http://www.yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman Alonso LLP