Public Citizen: Recall Synthetic Surgical Mesh
AUGUST 25, 2011 – Synthetic surgical mesh is implanted into women for the treatment of pelvic organ prolapse and incontinence and now Public Citizen is calling for a ban citing the needless exposure of patients to serious, life-altering complications.
Synthetic mesh used for pelvic surgeries, and hernia repair in men, is made of a petroleum-based plastic that is non-absorbable. In a petition sent to the U.S. Food and Drug Administration, Public Citizen said the risks outweigh the benefits. The consumer advocacy group was joined by co-petitioners from Washington University in St. Louis and the Mayo Clinic in Rochester, Minn.
POP stands for pelvic organ prolapse where the pelvic organs descent into the vagina largely due to the weakness in the connective tissue of the pelvic floor and the muscles around the pelvic organs. Surgery can be done transvaginally (through the vagina) or abdominally or laparoscopically.
Alternatives to synthetic mesh involve sutures, non-surgical interventions or a biologic mesh.
With about 300,000 procedures performed annually for POP and stress urinary incontinence (SUI), Public Citizen estimates about 67,500 are done with non-absorbable synthetic mesh, resulting in a high complication rate and in many cases, multiple surgeries. Removing the mesh once it has eroded and migrated within the body can prove difficult if not impossible. As a result, many women live their lives in extreme pain and immobility.
Public Citizen calls for a ban in the marketing of all synthetic non-absorbable mesh specifically those used in transvaginal repair of POP and orders the manufacturers to recall them. In the future any synthetic mesh should be classified as the most high-risk or Class III medical device and be subjected to stringent post market approval involving clinical studies before being cleared for marketing as it currently is under the 510(k) process.
“Surgical mesh in POP treatment procedures needlessly exposes patients to a wide array of serious risks, many of which can permanently alter women’s quality of life,” said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group. “Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately.”
The petition follows a July 13 FDA safety announcement (here) saying that complications are “not rare” and have resulted in thousands of complications. From 2008 to 2010, the FDA received almost 3,000 reports of complications associated with surgical mesh used for POP and SUI repair including pain, mesh erosion, exposed mesh through the vagina and infection. #
Dr. Lewis Wall- Washington University
Dr. Daniel Elliott – Mayo Clinic