The 2005 hernia mesh recall of the Kugel mesh patch continues to affect patients throughout the United States. In 2005, the FDA acted on years of reports that the Kugel patch was causing serious injuries to hernia patients citing that the hard plastic ring had a tendency to break, and that the sharp edges of the ring could and did puncture organs of patients.
The Kugel hernia patch was first developed by manufacturer C.R. Bard and its subsidiary, Davol, Inc. After gaining FDA approval in 1996, the patch was used routinely to repair abdominal hernias during surgery.
Initially, the manufacturer of the mesh patch believed the problems were caused by surgeon errors, however investigators discovered later that the breakage was due to the manufacturer’s design error. An FDA report revealed later that the manufacturer did not track patient complaints diligently, and as a result, may not have been aware of the degree of the problem.
Hernia Mesh Complications
In 2002, the manufacturer of the Kugel patch, C.R. Bard, and its subsidiary, Davol, began to hear about hernia mesh complications. Doctors were reporting that the hard plastic ring was breaking after it was implanted in patients. As a result, patients were subject to two serious conditions: bowel perforations and chronic fistulas.
When the hard ring broke, it could poke a hole in one of the soft internal organs. A hole in the stomach, gall bladder or intestine could cause food material to leak into the abdominal cavity, leading to infection.
Chronic fistulas were another serious potential side effect. Repeated infections and inflammations could create a tunnel effect and cause abnormal connections between sections of the intestine. With bowel perforations and fistulas, surgical repair is necessary.
Hernia Mesh Lawsuit
Although the recall has been issued, many patients still have the original Kugel mesh patch. The manufacturer has recommended that the patch remain in place unless it is presenting problems. For these patients, this means they must live with a potentially defective device that at any moment could lead to a medical emergency.
Concerned with this, as well as the knowledge that the manufacturer may not have been diligent in tracking and reporting patient complaints, numerous patients have filed a Kugel hernia mesh lawsuit to seek legal reparations for their suffering.
If you have had hernia surgery and believe you may the recalled hernia patch, contact us for a free consultation. There is never any cost to speak to us regarding your legal options.
