News Tagged ‘food and drug administration

History of hernia patch raises questions on implant recalls

How do makers of implanted medical devices react when one of their products starts breaking?

One answer can be found in the case of a repair device made by a subsidiary of C. R. Bard Inc. In late 2005, the company sent out a , urging doctors to stop using some versions of the product because a plastic component could break and cut through a patient’s internal organs and tissue.

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Kugel Mesh patients not out of the woods yet

Rockville, MD: Just because the Kugel Mesh Patch was recalled over a year ago does not mean that adverse event reports regarding the hernia patch are no longer being submitted to the U.S. Food and Drug Administration (FDA). In fact, the FDA received numerous reports in August of serious problems with the , some of them life-threatening incidents.

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