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Kugel Patch News

Kugel patients who used non-recalled patch can file lawsuits, court says

January 25, 2008
A Federal court ruling has allowed patients who used a Composix Kugel mesh patch not listed in the hernia patch recall to go forward with their Kugel mesh lawsuits against Davol Inc., the manufacturer of the device. The ruling also transferred all federal Kugel patch lawsuits to a single federal court.
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FDA says Davol waited too long to issue hernia patch recall

March 23, 2007
Davol, Inc., the manufacturer of the Composix Kugel mesh patch, kept the device on the market long after it learned of several injuries linked with the hernia patch, including at least one fatality, a Food and Drug Administration safety report has concluded. The FDA documents also say that Davol underreported the number of device-related complaints it received from doctors about injuries stemming from the Kugel mesh hernia patch.
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NYT article criticizes Davol’s response in hernia patch recall

March 15, 2007
An article in the New York Times has criticized the response of Davol, Inc. (a subsidiary of C.R. Bard, Inc.) to injuries suffered by patients using its Composix Kugel mesh hernia patch. The article alleges that Bard executives knew about reports of injuries among Kugel patients but were slow to issue a hernia patch recall.
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Hernia patch lawsuit filed in Rhode Island

January 11, 2007
A lawsuit filed in Rhode Island against Davol Inc., maker of the Composix Kugel mesh patch, alleges that it failed after being implanted. This caused the hernia patient to suffer severe pain; bowel dissection surgery was performed to remove the patch.
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Injuries lead to recall of Kugel mesh patch

January 09, 2007
Rhode Island-based Davol Inc., in conjunction with the Food and Drug Administration, has recalled certain versions of its Composix Kugel mesh hernia patches following reports of serious injuries. The Kugel mesh patch was recalled because of a tendency for the “memory-recoil” ring to break, causing bowel perforations and chronic intestinal fistulas—abnormal connections between the intestines and other organs. The company has suggested that improper surgical placement techniques may put too much stress on the ring, causing it to fracture.
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