Davol Inc., the manufacturer of the Composix Kugel mesh patch , issued the first hernia patch recall in December 2005 after problems were detected with the “memory-recoil ring” which surrounds the device.

This ring allows the hernia patch to be folded in half during surgery and then springs back into place when the device is placed at the spot of a hernia.

In many cases, however, the memory recoil ring broke after it was implanted, which can lead to serious hernia patch side effects, including bowel perforation, bowel obstruction and chronic enteric fistulas (abnormal connections between two sections of the intestines).

Because of this risk of complications after hernia repair surgery, Davol issued the first hernia patch recall for the extra-large oval version of the Kugel mesh patch.

When breaks in the memory-recoil ring were found in patients who were implanted with the oval version of the hernia patch, Davol issued a Kugel mesh recall in March 2006 for this model as well. A third hernia patch recall was issued in January 2007 for some lot numbers of the large circle and large oval versions of the Kugel patch.

Which versions of the Composix Kugel mesh patch were recalled by Davol Inc.?

Since the first hernia patch recall was issued, the Food and Drug Administration has received reports of at least 80 injuries for patients who experienced problems with their Kugel patches, including several fatalities.

The FDA has criticized Davol for its slow response time in issuing the Kugel mesh recall . The agency says that the company began receiving a high number of reports of injuries from patients who had received the larger versions Kugel patch soon after they were released in 2002, but did not issue a hernia patch recall until three years later.

FDA inspectors visited Davol’s headquarters soon after the first recall was issued and found problems in the system the company used to track complaints related to the Kugel mesh patch.

As a result, the agency says, Davol underreported the severity of the hernia patch side effects suffered by Kugel mesh patients.

Several patients who were injured after using the Kugel mesh patch have filed hernia patch lawsuits against Davol, alleging that the company was aware of problems with the design of some Kugel mesh patches but delayed in issuing the first hernia patch recall.

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