Once again, Bard Medical – the company that brought defective products to the health care market that include the Avulta pelvic mesh (among several other models) and the Vena TechTM LP IVC filter – is facing lawsuits over yet another device that has been injuring and killing patients.
The latest product in this grim parade is the KugelTM Hernia Patch , which has been used to repair painful and potentially fatal tears in the abdominal wall muscles. Unfortunately, like so many medical devices, this “treatment” has been causing more problems than it has solved.
The hernia mesh patch at the center of this latest round of litigation against the New Jersey-based company was designed, manufactured and marketed by Davol, a Bard subsidiary since 1980. The Kugel Mesh was intended for the repair of two types of hernia.
One of these is the ventral, or “incisional” hernia, which occurs when there is a tear in the muscles of the abdominal wall. These tend to happen at sites where a patient has had a surgical incision in the past (hence the name). The other type is the inguinal hernia, which occurs in the groin region and can be the result of heavy lifting done incorrectly.
The Kugel Mesh won FDA approval in 1996. This device is made with two layers of monofilament polypropylene plastic (used in the manufacture of numerous consumer products ranging from food grade containers to carpet). This double layer forms a pocket, surrounded by a “memory recoil” ring that holds the device open and allows it to retain its shape. When the device is first implanted at the hernia site, it is folded. Once the device is in place, the memory recall ring causes it to spring back into its original shape, covering the injury and holding everything together during the healing process.
Problems started about six years later, in 2002, after Davol introduced two larger Kugel Mesh models. Shortly thereafter, the FDA began receiving reports that the device was fracturing, resulting in serious injuries that include bowel obstruction and perforation, and an abnormal connection between the intestine and the skin, known as a fistula. All of these can result in dangerous infections.
At first, the manufacturer blamed these incidents on physician error. Eventually, however, Davol carried out its own tests on the Kugel Mesh. These tests revealed that device failure consistently occurred at the spot where the ends of the memory recoil ring was welded together. An initial recall was issued in December of 2005, but plaintiffs allege that Devol was aware of the problems long before that point.
It isn’t the first time C.R. Bard has run afoul of the law. In 1993, the company pleaded guilty to 391 criminal charges involving defective catheters that had been illegally modified and sold without regulatory approval. Three company executives were convicted and jailed on charges of fraud and conspiracy, and Bard wound up paying $61 million in fines and penalties. More recently, the company has been called to account over pelvic meshes and IVC filters.
The latest fiasco with Kugel Meshes clearly demonstrates that C.R. Bard is a repeat offender. Unfortunately, because Bard is a “corporate” person and not a natural human, there is no way to jail it and make sure it doesn’t harm anyone else.