FDA Panel Recommends Vaginal Mesh Studies and Reclassification
On September 8, 2011, the U.S. Food and Drug Administration (“FDA”) Obstetrics and Gynecology Devices advisory panel met to discuss transvaginal mesh products which are often used to treat those with pelvic organ prolapse (POP).
The panel met in response to an FDA recommendation, issued on July 12, 2011, that found “clear risks associated with transvaginal placement of mesh to treat POP.” In 2010, there were 75,000 transvaginal implantations of mesh to treat POP in the United States.
Complications Linked to Transvaginal Mesh After Pelvic Organ Prolapse Surgery
The FDA press release stated that “The most frequently reported complications from surgical mesh used to repair POP include mesh becoming exposed or protruding out of the vaginal tissue (erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems. Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh.”
The Obstetrics and Gynecology Devices advisory panel met to address this issue.
The mesh products that are currently on the market were approved by the FDA’s 510(k) expedited approval process that does not require significant pre-market testing. (This topic was recently discussed at length in another entry: The FDA Medical Device Fasttrack Approval Process Draws New Fire.) After discussion as to the lack of rigorous clinical testing, the advisory panel has indicated it would support reclassifying mesh products intended to be used for POP repair as those that cannot use the fasttrack process.
If you or a loved one has experienced complications with transvaginal mesh, please click here to learn more about the Brandi Law Firm Transvaginal Mesh Attorneys.