Issues with Vaginal Mesh
This surgical mesh, made of polypropylene, is used to treat pelvic organ prolapse or POP, an often painful condition that affects thousands of women annually. POP occurs when the connective tissue and muscles that surround and support the pelvic organs have grown weak or have stretched, often after childbirth.
Traditional surgery to treat POP uses a woman's own tissue to support the organs. When synthetic mesh is used, it is implanted transvaginally (through incisions and punctures made through the wall of the vagina) to reinforce tissues around the descended pelvic organ. It may be inserted using an anterior or posterior approach.
Surgical mesh is also used to treat urinary incontinence.
In July 2011, the FDA issued a safety warning noting that serious complications associated with transvaginal repair of POP are “not rare” and it is “not clear that transvaginal POP repair with mesh is any more effective than traditional repair [transvaginal surgery without mesh…] and may expose patients to greater risk.
The following month, the public interest and safety group Public Citizen called upon the FDA to recall non-absorbable transvaginal surgical mesh. Public Citizen stated that the non-absorbable mesh “offers no clinically significant benefits and has high rates of serious complications.
On September 8, 2011, a FDA advisory panel called for more clinical studies and tougher regulation of certain surgical mesh products used to treat POP. The FDA is proposing that mesh products that are inserted through the vagina be moved to the highest-risk, Class III FDA category of medical devices. This requires companies to conduct clinical trials on people and then submit an application seeking FDA approval, similar to the mechanism required for drugs.