A Florida woman has filed a Bard Kugel patch lawsuit against the makers of her hernia mesh device claiming it was defective and unsuitable for use.

Plaintiff Cynthia T., a resident of Florida, has filed her Bard Kugel patch lawsuit against Davol Inc., the manufacturer of the Bard Kugel patch hernia mesh device. According to Cynthia’s Bard Kugel patch lawsuit, Davol manufactures the Composix Kugel patch and Ventralex hernia mesh.

Davol’s primary focus is on products in key surgical specialties, including hernia repair, hemostasis, orthopedics, and laparoscopy.

Cynthia was forced to undergo hernia mesh repair surgery in 2006 with the Bard Kugel patch. She claims that at the time of the surgery, she was not made aware that there might be severe complications with the device.

Several years later, in 2015, Cynthia underwent abdominal surgery to repair a failed Bard Kugel patch. Allegedly, she suffered from an intense inflammatory response because of the Bard Kugel patch, along with contraction, degradation of the device and a broken or buckling PET ring. The device, according to her Bard Kugel patch lawsuit, was curled and adherent to several loops of bowel.

She claims that she has suffered and will continue to suffer mental anguish and physical pain. She has also incurred medical bills as a result of the Bard Kugel patch complications.

The Bard Kugel Patch

The Bard Kugel patch was approved in the early 2000s for use as a hernia mesh product through a fast track 501k FDA process. The design of the Bard Kugel patch includes heavyweight polypropylene mesh (2 layers) on one side. On the other side, the Bard Kugel patch has expanded polytetrafluoroethylene or ePTFE. The PTFE side is supposed to prevent adhesions between the device and the body and to protect the body’s tissues.

There is also an overlap memory ring made of polyethylene terephthalate that is used during implantation. However, this ring remains with the mesh after implantation. According to Cynthia’s Bard Kugel patch lawsuit, when the body heals, “the abdominal wall tissue grows into the polypropylene side of the mesh and scar formation occurs, which is supposed to strengthen the repair.” These mesh devices are the only ones that contain a ringed component that is permanent.

The Bard Kugel patch mesh device is considered heavyweight, and Cynthia believes that the manufacturers knew or should have known that the mechanical stability of the heavyweight material was “too high and significantly exceeded physiological values of the abdominal wall.”

Additionally, Cynthia says, the greater foreign body load in the Bard Kugel patch stimulates an inflammatory response or fibrotic response that can result in greater scar formation, decreased graft compliance, decreased abdominal wall compliance, decreased tissue incorporation, graft shrinkage, pain, increased risk of infection and failure of the device.

The greater the inflammatory response, the greater the possibility of contraction and hernia recurrence. The PET ring may also suffer and break if there is an inflammatory response, Cynthia says.

Cynthia’s Bard Kugel Patch Lawsuit is Case No. 3:18-cv-00927-MMH-JRK in the United States District Court for the Middle District of Florida.