After significant reported complications, the FDA issued an advisory on July 13, 2011, about surgical mesh implanted in women to strengthen vaginal tissue to repair a common type of pelvic organ prolapsed (POP). Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. Vaginal mesh, which is also referred to as a bladder sling, hammock or pelvic mesh, is a surgical product that is commonly implanted into the vaginal area to prevent pelvic organ prolapse (POP).
In October 2008, the FDA had advised of potentially serious complications related to the use of transvaginal mesh, however the FDA stated these were rare occurrences.
Recently on July 13, 2011 the FDA issued an updated warning notating serious complications with the use of transvaginal mesh, however specifically stating these complications are not rare. Furthermore, the FDA stated that a review of studies and other literature appeared to show little to no health benefits related to the use of transvaginal mesh.
The FDA’s Advisory stated, in part, the following:
Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern. The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.
The use of these products can lead to the following:
- Multiple surgeries to remove the mesh which may result in permanent injuries
- Vaginal Pain
- Urinary problems
- Erosion of the mesh into the vagina
- Pelvic Pain
- Hardening of the vaginal mesh
- Injury to nearby organs
The companies involved, with each marketing one or many types of mesh/slings, could include the following:
- American Medical Systems (AMS)
- Boston Scientific
- Johnson & Johnson (Ethicon)
- Caldera Medical
- Cook Medical
- Tyco Healthcare
The attorneys at Hollis Wright are currently investigating claims involving women who have had complication resulting from the use of Transvaginal Mesh. Contact Hollis Wright today for a free case evaluation.