The FDA says plastic mesh used to repair pelvic collapse should be reclassified as a “high risk” medical device. For years women who have received the implant have been reporting pain, bleeding, and infections.
Why Should Pelvic Mesh Safety be of Concern?
The agency discovered that women getting the mesh have more complications then women who undergo traditional surgery with stitches.
According to an FDA analysis, the agency found that 10 percent of women experienced mesh erosion within 12 months, which means the mesh had worn away through the vaginal wall into the surrounding tissue or organs.
This resulted in more than half of these women requiring follow-up surgery to remove the mesh, which in some cases took two or more procedures.
Initially, the mesh products were pitched to doctors as a high-tech improvement over traditional surgeries however, the FDA found no evidence that they improved safety outcomes.
The FDA proposal does not apply to mesh products used to treat incontinence, hernia and other conditions not related to women’s health.
Guidelines For The FDA Proposal To Re-Classify Device As “High-Risk”
The first pelvic mesh products for woman received fast approval from the FDA because they were deemed similar to the mesh used to treat hernias.
At that time the FDA classified all pelvic meshes as a “moderate-risk” device, not subject to the rigorous testing of high-risk implants.
However, under the new proposal companies will now have to submit clinical data establishing their devices’ safety for pelvic collapse before gaining FDA approval.
Injuries caused by the mesh for pelvic collapse are the subject of more than 22,000 personal injury lawsuits against leading manufacturer Johnson & Johnson.
Women who are suing allege that J&J was aware of the risks but did not warn the public.