California Woman Claims Injuries from C.R. Bard Composix Mesh

Shay Morrigan | November 14th, 2012

A California woman filed a pelvic mesh lawsuit on October 30, 2012. The case is proceeding in the U.S. District Court for the Central District of California.

According to her vaginal mesh lawyer, the plaintiff suffered serious injuries after being implanted with a mesh product made by C. R. Bard and its subsidiary, Davol, Inc. The plaintiff seeks in excess of $75,000 in damages.

Pelvic mesh lawsuit describes problems with Composix mesh

As outlined in the pelvic mesh lawsuit, the plaintiff was implanted with the Bard Composix E/X Mesh Hernia Patch on May 1, 2007. The Bard Composix mesh for hernia repair was introduced in 1997. It was the first hernia repair prosthesis that combined two biomaterials—the Bard polypropylene mesh and the expanded polytetrafluoroethylene (ePTFE)—into one product. The edge of the mesh is heat sealed, resulting in two different sides.

However, as early as 2000, the FDA received reports concerning problems with the Composix mesh. These included bowel adhesions, obstructions, constipation, and findings of the patches being crumbled or delaminated. In December 2005, Davol issued a Class I recall for several lots of the Composix Kugel Mesh Patch, noting the device could cause a serious risk to the health of patients.

Reports of complications with the Composix E/X Mesh Patch also started in 2000, with patients making similar complaints of adhesions and obstructions, chronic abdominal pain, and separation of the layers of the patch.

Vaginal mesh lawyer details facts of the case

After the plaintiff underwent surgery in 2007, she started to experience weakness, fatigue and severe pain, as well as problems digesting food and limitations in mobility.

On October 14, 2011, the plaintiff had to go through a second surgery to remove the mesh product. She claims that there are several defects in the Bard Composix Mesh, including its tendency to react to human tissue, harbor infections, migrate, abrade and become embedded into tissue. All of these problems can lead to additional surgeries, which can cause further injuries such as damage to other organs and tissues.

The plaintiff alleges that the defendants were aware of problems with their product before she purchased it, and failed to provide adequate warnings about the potential risks. Her vaginal mesh lawyer claims that before the plaintiff was injured, the defendants were “on notice” of numerous bodily injuries caused by the vaginal mesh, and knew or should have known that the product caused an unreasonably high rate of erosion, infection, extrusion, perforation, chronic pain, and abscesses.

No vaginal mesh class action lawsuit to date

In 2011, the FDA issued a safety communication stating that transvaginal mesh complications were not rare, and that mesh devices may be no more effective in resolving symptoms like pelvic organ prolapse than more traditional treatment and surgical methods. That warning triggered many injured women to file individual complaints related to vaginal mesh, but there is currently no pending vaginal mesh class action lawsuit.

Numerous vaginal mesh cases have been centralized in MDL proceedings in West Virginia and New Jersey. Multidistrict litigation consolidates multiple lawsuits involving similar claims filed by individuals, as opposed to a class action suit, where a large number of plaintiffs band together in a single lawsuit.

The plaintiff in this case brings counts of defective design and manufacture, negligence, and breach of warranties.