Transvaginal Mesh Recall Urged by Consumer Group Public Citizen

The prominent consumer advocacy group Public Citizen is pushing the FDA to issue a recall for transvaginal mesh used to treat pelvic organ prolapse, citing data that suggests the bladder suspension surgery products carry a high risk of permanent injury while providing no significant benefits. 

In a petition filed with the FDA on Thursday, Public Citizen indicated that a transvaginal mesh recall should be issued to prevent the needless exposure of patients to a substantial risk of serious and life-altering complications.

The request comes a little more than a month after the FDA issued a warning about the risk of vaginal sling problems. However, Public Citizen indicates that the agency needs to do more than just warn about the transvaginal mesh dangers and the group is asking the FDA to remove the surgical mesh products from the market.

Transvaginal mesh products, which are sometimes referred to as a bladder sling or vaginal surgical mesh, are designed to support organs that have begun to fall in older women or women who have had children, to prevent them from pressing on the bladder and vagina.

The products are sold by a number of different companies, including Ethicon, C.R. Bard, American Medical Systems (AMS), Boston Scientific and others. They are made of non-absorbable synthetic material that is permanently implanted using small incisions as an alternative to other methods of treating pelvic organ prolapse.

Despite limited evidence to establish that the products provide any benefits over other treatment options, an estimated 75,000 women undergo surgical procedures to have transvaginal mesh implanted each year.

Thousands of reports of been filed with the FDA involving serious and potentially life-altering transvaginal mesh problems, including erosion of the mesh into the vagina, shrinkage of the mesh, infection, bleeding, organ perforation and other complications.

Public Citizen wants the FDA to recall transvaginal mesh from the market and require any future surgical mesh products designed to treat pelvic organ prolapse to be classified as class III medical devices, requiring them to undergo a rigorous premarket approval application (PMA).

Most, if not all, of the transvaginal mesh slings currently on the market went through the FDA’s expedited 510(k) accelerated approval process, which only requires that a product is substantially equivalent to a medical device already on the market in order to be sold in the U.S.

A number of women throughout the United States who have experienced problems are pursuing a transvaginal mesh lawsuit against the makers of the products to secure compensation for painful and often disfiguring injuries caused by the bladder slings.