Background: Surgical mesh is a woven fabric used as part of surgical procedures to repair, reinforce and strengthen weakened tissues. It is used during different types of surgeries, including, among other procedures, hernias, chest wall reconstructions, and slings for stress urinary incontinence.

Transvaginal mesh is used in the transvaginal repair of a condition called pelvic organ prolapse (POP), or to surgically treat stress urinary incontinence (SUI). Pelvic organ prolapse is a condition that occurs when one of the pelvic organs such as the bladder, uterus, bowel or rectum, drops from the normal position and pushes against the wall of the vagina. This happens when the muscles and connective tissues holding the organs in place are stressed and weakened over time. When treating pelvic organ prolapse, physicians often permanently implant the mesh in order to hold pelvic organs in place. When treating stress urinary incontinence (SUI), physicians often use the mesh to support the urethra or neck of the urinary bladder.

The United Stated Food and Drug Administration (FDA) has approved transvaginal mesh kits from manufacturers such as American Medical Systems, Ethicon, Inc. and C. R. Bard, Inc. The first surgical mesh kit for use in SUI was approved by FDA in 1996, and the first surgical mesh kit for use in POP was approved by the FDA in 2002.

Complications of Transvaginal Mesh: The following complications have been reported as a result of transvaginal pelvic organ prolapse (POP) procedure:

• Mesh erosion – exposure, extrusion and/or protrusion of the mesh
• Pelvic pain
• Infection
• Bleeding
• Urinary leakage
• Pain during sexual intercourse
• Recurrence of prolapse
• Organ perforation

On July 13, 2011, the FDA issued an updated safety communication to all U.S. medical providers and patients regarding a risk of serious complications resulting from the placement of transvaginal mesh to treat pelvic organ prolapse (POP).

The communication noted that even though there was an increased risk of these serious complications, there was no corresponding clinical evidence of greater benefit, such as an improved quality of life. Furthermore, the FDA reported that these complications were not rare. This was a significant change from the FDA’s prior communications on this topic in 2008 and signals growing alarm over the rate of side effects from the use of surgical mesh for this purpose. From 2008 to 2010 alone, the FDA received 2,874 adverse event reports documenting complications arising due to surgical mesh devices used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). There has not yet been any type of recall associated with the placement of transvaginal mesh to treat pelvic organ prolapse (POP).

If you or a loved one has experienced any of the above complications after undergoing transvaginal placement of mesh, you should visit your healthcare provider immediately. If a visit to your healthcare provider is warranted, you also owe it to yourself to speak to an experienced pharmaceutical and medical product liability attorney to see if you have a case and to discuss the possibility of bringing a lawsuit to recover for your damages and injuries. The attorney will be able to ascertain if you have a claim for which a lawsuit can be pursued and whether the case and lawsuit can be brought to a successful settlement, verdict, award or other recovery. The experienced lawyer will also be able to advise you on any deadlines for bringing your legal claim for damages. Please contact the law firm of Ashcraft and Gerel, LLP to discuss your lawsuit with an experienced medical product liability lawyer in our Drug and Medical Product Liability Litigation Department.

The lawyers at Ashcraft and Gerel, LLP have been leaders in pursuing medical product liability lawsuits involving unsafe drugs, implants, and medical devices for over 50 years. Our attorneys have successfully brought about verdicts, settlements, awards or other recoveries in lawsuits on behalf of clients who have been injured by Fen-Phen, Rezulin, Propulsid, Gadolinium, Ortho Evra, Vioxx, Phenylpropanolamine (PPA), and many other drugs and medical devices. Although some of these claims and lawsuits resulted in class action settlements, class actions are not the only way these cases are handled. The courts have devised methods to deal with mass torts so that each lawsuit can benefit from information and evidence gathered in other lawsuits nationwide and yet be handled on an individual basis.

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