Surgical mesh is a medical device which has been used for more than three decades for hernia repair. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In 1996, the FDA cleared the first mesh product for use transvaginally to treat stress urinary continence, and in 2001 the agency cleared the first surgical mesh device for treatment of pelvic prolapse. Pelvic organ prolapse and stress urinary incontinence frequently occur in women after childbirth (allowing organs to prolapse and push against the vagina toward the outside). These devices were generally cleared by the FDA’s 510(k) process, which allows approval without substantive studies if a product is “substantially equivalent” to others already on the market.
In 2008, the FDA issued a public health notification on serious complications associated with surgical mesh placed transvaginally to treat pelvic organ prolapsed and stress urinary incontinence.
Research following the 2008 FDA notification confirmed the serious complications associated with these surgical mesh products. In an article published in the August 2010 issue of the Journal Obstetrics and Gynecology, researchers reported that scientists had to stop a transvaginal mesh clinical trial because women implanted with the mesh experienced too many complications; the trial was cut short in 2009 because 15 percent of the women implanted with the surgical mesh suffered vaginal mesh erosion within only a few months after implantation, a potentially serious complication. A 2011 study released by the Journal of Obstetrics and Gynecology Canada concluded that, “Until adequate effectiveness and safety evidence is available, the use of new [transvaginal mesh] devices for prolapse repair should be considered experimental and restricted to use in investigative trials.” Further research published in the New England Journal of Medicine in May 2011 also discusses the negative side effects associated with the use of surgical mesh as compared to the traditional treatment of sticking connective tissue in the vaginal wall back together (colporrhaphy), including bladder perforation, urinary incontinence, and the need for surgical repair.
In July 2011, after nearly 4,000 adverse events associated with the transvaginal mesh were reported to the FDA, the FDA warned patients and healthcare providers of a rise in “serious complications” associated with surgical mesh for transvaginal repair. The FDA has also stated that “it is not clear” that transvaginal mesh repair for pelvic organ prolapse is more effective than traditional non-mesh repair, and may expose patients to greater risk.
Approximately 600 law suits have been filed to date across the country against the manufacturers of the transvaginal mesh products due to serious injuries suffered by women who have had these products implanted. If you would like more information about transvaginal mesh, or would like to discuss your potential claim, please e-mail Marianne C. LeBlanc at firstname.lastname@example.org or call 617-542-1000.