Plaintiff Patricia B. of Illinois says she had a TVT transvaginal mesh device implanted in November 2006. She is now suing defendants Ethicon Inc. and its parent company Johnson & Johnson over her subsequent transvaginal mesh complications.

Patricia’s vaginal mesh lawsuit is part of a multidistrict litigation pending in the U.S. District Court for the Southern District of West Virginia. This vaginal mesh MDL is a consolidation of several individual vaginal mesh lawsuits against Ethicon, J&J, and over a dozen other defendants who manufactured transvaginal mesh or bladder sling devices.

About Vaginal Mesh

According to the master complaint for this MDL, transvaginal mesh products originated back in the 1970s, when surgeons began adapting mesh implants developed as hernia treatments for use to treat pelvic organ prolapse in women. These mesh implant techniques found application as treatments for POP and stress urinary incontinence.

In 1996, the FDA approved the first vaginal mesh product designed specifically to treat stress urinary incontinence. The first such product designed as a treatment for pelvic organ prolapse was approved in 2002.

Plaintiffs in the MDL generally allege that these transvaginal mesh products are defective for several reasons. They claim the polypropylene mesh used to make these products is biologically incompatible with the human body.

In some patients, the polypropylene triggers an immune response that degrades both the mesh and pelvic tissue, the complaints allege. One particular product, the Prolift+M, also uses a material called monocryl that allegedly aggravates this same immune response.

Vaginal mesh plaintiffs also allege that the insertion procedure is defective. Transvaginal mesh is designed to be inserted through the vagina, avoiding surgery. The plaintiffs of this vaginal mesh lawsuits claim that this transvaginal procedure spreads microorganisms and sometimes results in nerve damage or damage to other internal organs.

Vaginal Mesh Complications

Some of the most common vaginal mesh complications alleged by plaintiffs include the tendency for the mesh to deform while in place; the emission of a toxic substance created during the manufacturing process; damage to surrounding tissue caused by friction with the mesh; and development of scar tissue that can lead to mesh pain, mesh erosion, and device failure.

The plaintiffs cite action taken by the FDA in response to complaints received about vaginal mesh complications. In October 2008, the agency issued a Public Health Notification describing over 1,000 complaints related to pelvic mesh products. And in July 2011, the FDA issued a safety communication stating that based on a review of scientific literature from 1996 to 2011, repair of pelvic organ prolapse with transvaginal mesh does not improve symptoms or the patient’s qualify of life compared to traditional, non-mesh repair.

The plaintiffs say these communications from the FDA put the defendants like Ethicon and J&J on notice of the problems with their vaginal mesh products.

Vaginal Mesh Allegations

Plaintiffs allege the defendant manufacturers failed to conduct adequate clinical studies on their vaginal mesh devices before releasing them onto the market. They further claim the defendants deliberately misled patients and their physicians about the safety and effectiveness of these products.

According to the short-form complaint Patricia used, this transvaginal mesh MDL includes claims based on the following transvaginal mesh products:

• Prolift
• Prolift+M
• Gynemesh/Gynemesh PS
• Prosima
• TVT
• TVT-Obturator (TVT-O)
• TVT-SECUR (TVT-S)
• TVT-Exact
• TVT-Abbrevo

The MDL is not limited to these particular vaginal mesh products, however. Women who received transvaginal mesh implants other than those listed here may also have a valid claim.

The Vaginal Mesh MDL is In re: Ethicon Inc. Pelvic Repair System Products Liability Litigation, MDL No. 2327, U.S. District Court for the Southern District of West Virginia.