After releasing warnings about “rare” complications from vaginal mesh implants in October 2008, the U.S. Food and Drug Administration now warns of serious dangers associated with the medical device. The agency’s July 2011 update was released after a rise in complications connected with prolapse repair.
Complaints from women include erosion through the vagina (allowing the device to protrude), pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems. Other reported issues include recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems.
The latest warning from the FDA only applies to surgical mesh implants for prolapse. However, the agency is investigating possible problems with use for urinary incontinence.
“Complications have become so prevalent that the FDA has called for a September meeting with outside experts to make recommendations regarding the safety and effectiveness of transvaginal surgical mesh,” said Ricky Bagolie, an attorney with Bagolie Friedman Injury Lawyers who reviews and handles cases involving the implants.
If you had POP surgery and have experienced complications, your pain is shared by many other women. From Jan. 1, 2008 to Dec. 31, 2010, the FDA received 2,874 reports of complications associated with surgical mesh devices, with 1,503 reports related to POP repairs and 1,371 related to SUI repairs.
Research by the FDA also revealed:
- There’s no evidence that transvaginal repair with mesh provides any added benefit over traditional surgery without mesh.
- Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery (in which the pelvic floor is repositioned and tightened using stitches).
A single brand of mesh has not been linked to complications from transvaginal mesh implants. Pelvic mesh manufacturers include Johnson & Johnson, Boston Scientific, C.R. Bard and American Medical Systems.