FDA Warns of Transvaginal Mesh Device’s Serious Health Dangers

The Food and Drug Administration (FDA) yesterday issued a warning that urges patients and their doctors to consider alternative treatments to use of surgical mesh in certain transvaginal procedures.

Transvaginal mesh (TVM) is a medical device used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) – both condition which may develop following childbirth and pregnancy.

The FDA is meeting to consider a potential ban on the mesh, and reports that it was prompted to issue the warning since receiving 3,875 injury reports associated with the mesh, including three related fatalities.

The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion occurs in at least ten percent of women who have received the implants and can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.

Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.

Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.

Sheller, P.C. currently is investigating possible claims related to complications resulting from erosion and contraction of TVMs. If you or someone you know has had surgery involving TVM and has begun experiencing any of the symptoms or problems described above, call 1-800-883-2299.