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Editor: Bob Binstock, Attorney at Law
Profession: Defective Medical Device Attorney

Category: Hernia Patch Recalls

In three different product recalls that date back to 2005, C.R. Bard Inc. and its subsidiary Davol Inc. in association with the Food and Drug Administration had initiated voluntary recalls of the Kugel patch.

The manufacturer originally sent out the recall, urging doctors to stop using specific versions of the Kugel patch because a plastic component in the patch could possibly break leading to injuries to a patient's internal organs.

According to the FDA, the plastic component is called a "memory recoil ring", which opens the Kugel® patch but can break under the stress of placement of the large sized products in the intra-abdominal (inside the belly area) space.

Ring breakage can cause bowel rupture and/or recurring intestinal fistulae.

Under the Freedom of Information Act, the NY Times recently got documents that indicate the manufacturer of the patch did not accurately report the possible health risk and severity of complaints.

Since the initial 2005 recall, the FDA received over 80 injury reports and problems relating to the patch and in some cases even fatalities.