The Kugel Mesh Patch has been linked to BOWEL PERFORATIONS.
The Kugel Mesh Hernia Patch is constructed with a spring-like recoil ring that opens the patch after insertion. But the recoil ring's design was defective, and has caused serious and painful injuries to thousands who have suffered bowel perforations, chronic enteric fistulae and infections.The injuries caused by the patch have required most patients to undergo additional painful surgeries. Many victims will not completely recover from their injuries, even after followup surgeries.
Thousands still carry the Kugel Mesh Hernia Patch, and the device could fail at any time. Persons with a patch should seek medical attention if they experience unexplained fever, persistent abdominal pain or tenderness at the incision site. These could be a sign that the patch's defective recoil ring has broken. Only immediate attention can prevent more serious health consequences.
The first Kugel Mesh Hernia Patch recall was issued in 2005 and has been expanded several times to include more sizes of the patch. Many patients received the patch long after Davol received the first reports of patch failure. Those who received the patch are left with few alternatives other than to wait to see if their patch malfunctions.
The Kugel Mesh Hernia Patch's manufacturer, Davol, had received its first complaints in 2002. Davol did nothing when it started receiving reports of recoil ring failures, and claims that number of incidents did not warrant public notification. In 2005, Davol received ten reports of recoil ring breakage over a three-month period. Still, Davol did not take responsibility for its device and blamed doctors for implanting the device improperly. Davol simply started work on new instructions for implanting the patch, and offered training sessions for some physicians. The Kugel Mesh Hernia Patch remained on the market.
It wasn't until 2005 that Davol admitted that the Kugel Mesh Hernia Patch was defective. In December, the company conducted studies that concluded that a failure in the ring weld on the device, and not doctor error, were responsible for the injuries. Davol issued a recall of its X-Large patch, but by then this dangerous device had been implanted in thousands of unsuspecting patients.
The FDA inspected the Davol company headquarters in Cranston, Rhode Island in early 2007, following the first patch recall, and afterward issued a scathing warning letter to Davol. The FDA issues warning letters when an inspection finds serious problems in the methods, facilities and controls used in the manufacture, storage, packing or installation of a company's products. The warning letter states that the Davol facility lacked procedures to handle everything from complaint investigation to the determination of actual recall actions. The FDA said that the lack of these procedures where directly to blame for Davol's delays in dealing with the patch's problems.
In January 2008, the Federal Court charged with hearing all claims related to the Kugel Mesh Hernia Patch ruled the proceedings would be expanded to include claims against any of Davol Inc's defective mesh patches, even those that were not involved in the original recall.