Consumer advocacy group Public Citizen petitioned the U.S. Food and Drug Administration (FDA) on Aug. 25, 2011, to ban the sale of all non-absorbable surgical mesh products used to transvaginally repair pelvic organ prolapse (POP).

In the petition of Public Citizen, the FDA is requested to immediately ban the sale of all non-absorbable surgical mesh used for transvaginal repair of POP and to order all non-absorbable mesh manufacturers to recall the transvaginal mesh products designed for POP repairs. The petition also urges the FDA to require all such products be reclassified as a class III device. This reclassification would require the manufacturers to go through prospective clinical trials proving the transvaginal mesh would be safe and effective.

Advocacy groups have said these mesh devices were no more beneficial in POP surgery than surgery without using the mesh. Transvaginal mesh products have had high rates of complications which can often require additional surgery. In some instances, the surgeries were unsuccessful and can result in “life-altering harm” to transvaginal mesh product patients.

Lawsuits have been filed regarding the potentially defective transvaginal pelvic mesh products. Currently, vaginal mesh products are manufactured by several companies, including Ethicon / Gynecare /Johnson & Johnson and C.R.Bard, Inc.

The FDA in October 2008 issued warnings to doctors, saying transvaginal placement of surgical mesh products had triggered more than 1,000 adverse event reports for such products. The transvaginal pelvic mesh products are manufactured by at least nine different companies. The most frequent complications noted by the FDA reports included erosion, infection, pain, urinary problems, and recurrence of prolapse and / or incontinence, bowel, bladder, and blood vessel perforation during insertion.