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Editor: Bob Binstock, Attorney at Law
Profession: Defective Medical Device Attorney

Category: Hernia Patch Recalls

The Bard Composix Kugel Mesh Patch was originally designed by Dr. Robert Kugel as a way to repair ventral (incisional) hernias, which are caused by the stretching or thinning of scar tissue formed after surgery. While older hernia repair methods may require several weeks of patient recovery time, the Bard Composix Kugal Mesh Patch was created to minimize recovery time and pain, typically allowing patients to return to normal activities soon after surgery. Since the Bard Composix Kugel Patch was first manufactured in 2001, thousands of Americans have been implanted with it. The patch, which is positioned behind the hernia injury through an incision, is held open by a 'memory recoil ring' that allows it to be folded for insertion then spring open and lay flat once it is in place. The 'memory recoil ring' is designed to keep the patch closed until after it has been inserted in the body. Then, the primary purpose of the patch is to stop the hernia from breaking through weakened tissue walls, specifically in instances when stomach muscles are very fragile. In recent years, defects in the Bard Composix Kugel Patch's 'memory recoil rings' have been the source of several injuries and lawsuits, as well as product recalls.

In March 2006, the Food and Drug Administration (F.D.A.) declared an updated Class I Medical Device Recall for the Bard Composix Kugel Mesh Patch due to the probability of potentially catastrophic failure of the device. A Class I Medical Device Recall is the most serious recall the F.D.A can declare for a defective medical device and is used only in cases where a device presents an actual danger to the health and safety of the public. This particular recall follows a 2005 F.D.A. warning that the Bard Composix Kugel Patch may be potentially defective. Usually such defects are only detected after someone is injured from the side effects of the product. In this case, the Bard Composix Kugel Mesh Patch was recalled because its plastic 'memory recoil ring', which opens the patch after it has been inserted into the intra-abdominal space, can break when increased pressure is placed on it from certain surgical placement methods. According to the F.DA., a malfunction of this type can lead to infections, chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs), abdominal pain, and/or bowel perforations (rupture).

As of this F.D.A. recall date, the manufacturer of the Bard Composix Kugel Mesh Patch received 24 reports of defective rings with this product. The F.D.A is recommending that individuals who were implanted with Bard Composix Kugel Mesh Patches on the recall list seek immediate medical care if they experience unusual symptoms, including unexplained abdominal pain, tenderness at implant site, fever, painful lumps, frequent abdominal pain, and any other abnormal symptoms. In addition, several law firms are offering free and confidential evaluations to those who were implanted with one of these defective medical devises.