FDA Turns Down Consumer Safety Group's Petition to Ban Transvaginal MeshJul 31, 2014
The U.S. Food and Drug Administration (FDA) has rejected a petition to ban transvaginal mesh implants, which have been fraught with safety concerns in recent years. The petition, which was filed in 2011, urged the agency to remove all transvaginal mesh implants from the market, recall any that were in distribution, and reclassify the devices as Class III, or high risk.
The FDA's May 1st reply was recently posted onto their website and took issue with the fact that Public Citizen used a petition to request the reclassification rather than the formal reclassification process. Even though the agency felt there was not enough evidence to ban all transvaginal mesh devices, they said that they would take additional actions to address some of the group's concerns.
Transvaginal mesh devices are supposed to treat women who suffer from stress urinary incontinence and pelvic organ prolapse by providing additional support to the pelvic walls and muscles. However, pelvic mesh has come under fire due to mounting reports of serious injuries and complications. One of the most serious complications is mesh erosion, where the mesh becomes embedded in tissue, causing severe pain and the often the need for multiple surgeries. Other adverse events include bleeding, pain during intercourse, organ damage and painful urination.
In June 2011, the FDA warned that complications associated with transvaginal mesh are “not rare”. Furthermore, there is little evidence to show that pelvic mesh is more effective than other methods of treating POP although it may have greater risks, the agency said.
The FDA has been criticized for approving transvaginal mesh and other controversial devices through a process called 510 (k), which only mandates that the new product is “substantially equivalent” to a previously approved device. Clinical testing is not required for these devices.
New draft proposals issued by the FDA in April seek to implement stricter regulations for transvaginal mesh. One of the agency's drafts proposed that the devices be reclassified as Class III. The other draft proposed that mesh go through premarket approval, a more rigorous process that would mandate clinical testing.
Michael Carome, director of Public Citizen's health research group and author of the petition, told Law360 that the group is pleased about the FDA's recent actions but is unimpressed with the timeline. “Obviously we were pleased that they were taking this step, but we know that this is a long overdue action, and we found it disturbing that it had taken so long.” he said.
Thousands of transvaginal mesh lawsuits have been filed in the United States against various manufacturers. In 2012, the FDA asked device makers to study organ damage and other complications associated with transvaginal mesh. In late April, Endo agreed to pay $830 million to settle transvaginal mesh claims.