Doctors often use surgical mesh to strengthen the hernia repair and reduce the rate of recurrence. Surgical mesh refers to a medical device used to provide additional support to weakened or damaged tissue. Hernia mesh repair using a synthetic mesh is a common surgery. Synthetic mesh is made of man-made materials, such as polyprolylene, ePTFE, composite mesh, or polyester fibers. Several companies make many products used for hernia repair surgery.
The Bard Composix Kugel Mesh hernia repair patch, manufactured by Davol Inc. (a subsidiary of C.R. Bard, Inc.) is a medical device approved for hernia repair surgeries. The device comprises a plastic “memory recoil ring” surrounding two mesh layers. It is folded and inserted through a small incision in the abdomen. The memory recoil ring causes the mesh patch to spring open and lay flat once the device is in place.
When the company introduced larger versions of the patch in 2002, problems with the mesh material and memory recoil ring were introduced. This led to FDA warnings, alerts, recall notices, and hundreds of lawsuits over patient injuries and fatalities.
Thousands of actions were filed against Bard. In 2011, the manufacturers came to a settlement agreement with many plaintiffs for $184 million.
Twenty-four women sued the manufacturers of hernia mesh products claiming they suffered serious injuries from defects with the mesh. The lawsuit was filed on September 27, 2013 in the Eastern District of Texas, Sherman Division.
The women were implanted with the mesh products to repair hernias. The women allege injuries from the mesh ranging from pain, infections, abscesses, bowel obstructions, sepsis and chronic intestinal fistulae.
The lawsuit alleged claims against the mesh manufactures for negligence for the design, development, manufacture, testing, packaging, promotion, marketing, distribution, and labeling of the products. The mesh products involved include the Composix Kugel Hernia Patch, the Composix E/X Hernia Patch, the Composix L/P Hernia Patch and the Ventralex Hernia Patch.
Also, in August 2013, Rosemary S. Roberts sued C.R. Bard for injuries she suffered from the hernia mesh implanted in her in 2004. According to her lawsuit, she received the Bard Composix Mesh and Ventralex Hernia Patch. Roberts experienced physical pain and suffering and has permanent and substantial physical injuries and deformity. She had multiple surgeries and is expected to undergo more. She has lost income, significant medical costs and a loss of the enjoyment of life.
