In March 2006, the Food and Drug Administration announced a Class I medical device recall for the Bard Composix Kugel mesh patch due to potential catastrophic failure. This followed a 2005 warning the patch may be defective.
Type in “hernia patch” in a search window and pages of legal websites appear. For some attorneys, this has become a main practice area.
Thousands had the Bard patch implanted after surgery to repair ventral hernias caused by the thinning or stretching of scar tissue. The patch is placed just behind the hernia. Its memory recoil spring permits the patch to be folded before insertion into a small incision. Once placed inside, the patch springs open and lays flat in one dimension.
The device’s problem is its memory recoil ring that opens the patch and can break if oversized products are placed in the intra-abdominal space. If the patch breaks, bowel perforations can occur while chronic intestinal fistulae (abnormal connections or passageways between intestines and other organs) can manifest.
Productsthathurt.com reports that bacteremia (presence of bacteria in the bloodstream), sepsis, multi-organ failure or shock may result from a defective Bard patch.
A Class I Medical Device Recall is the highest recall the FDA can issue for a supposed defective medical device. Such was the case with the Bard patch.
At the time of the recall, patients who had received a Bard patch were advised to seek immediate medical attention if they experienced persistent abdominal pain, fever or tenderness at the implant site potentially related to ring breakage.
Davol, manufacturer of the Bard patch, did not accurately report the severity of complaints' about its’ device to the FDA, said the New York Times.
Medscape.com reminds patients they may contact Bard at 1-800-FOR-BARD (1-800-367-2273) or at bard.helpline@crbard.com. Physicians may contact Bard’s medical services and support division at 1-800-227-3357 or medical.services@crbard.com. Additional information is available at davol.com/HTMLFiles/hernia/recall.htm
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