Lieff Cabraser represents over 300 women in the United States who have suffered serious complications and injuries arising from transvaginal mesh. As of spring 2018, we are in all phases of litigation and settlement on these cases. Lieff Cabraser has been recognized by U.S. News, Best Lawyers, and the National Law Journal as one of the top plaintiffs’ law firms in the nation.
Attorney Wendy Fleishman Provides an Update on Transvaginal Mesh Risks & Injuries
Transvaginal Mesh Complications and Side Effects
Trans vaginal mesh, also known as pelvic mesh or bladder sling, is used to treat pelvic organ prolapse (“POP”) and stress urinary incontinence (SUI).
Between 2005 and 2010, nearly 4,000 injuries were reported to the U.S. Food and Drug Administration (FDA) in connection with transvaginal/pelvic mesh devices.In the past three years, the FDA has received over 1,500 reports of complications arising from surgical mesh devices used to repair POP, and over 650 As of early 2015, more than 70,000 patients have filed lawsuits as a result of their alleging injuries from transvaginal mesh. During this time, there were seven reported deaths associated with POP repairs, three of which were related to the mesh placement procedure.
In July 2011, the FDA issued a safety alert stating that serious complications associated with surgical mesh for the repair of POP are not rare. The FDA reported that “it is not clear” that the use of surgical pelvic mesh to repair POP is more effective than traditional procedures that do not use surgical pelvic mesh. In September 2011, an FDA advisory panel recommended that mesh for POP be reclassified from a “moderate risk” to a “high-risk” medical device.
In 2011, the public interest safety group Public Citizen called upon the FDA to recall non-absorbable synthetic transvaginal surgical mesh. Public Citizen noted that the non-absorbable meshes “should be recalled because they offer no significant benefits but expose patients to serious risks and the potential for permanent, life-altering harm.”
The mesh products are made by several companies including American Medical Systems, C.R. Bard Inc., Boston Scientific Corp. and Johnson & Johnson.
The most common complications and side effects of plastic surgical mesh devices may include:
- Chronic vaginal drainage
- Erosion of the vaginal tissue
- Feeling as though something is protruding from the vagina
- Lower back pain
- Mesh trim or removal in doctor’s office
- One or more surgeries to repair or remove mesh
- Pain during intercourse
- Perforations of the bowel, bladder or blood vessels
- Pressure or feeling of “fullness” in the lower abdomen
- Urinary problems
- Vaginal bleeding
- Vaginal infections
- Vaginal pain not related to intercourse
- Vaginal scarring