One trigger for the agency's review was a case involving Dr. Patrick McCarthy, a cardiac surgeon at Northwestern Memorial Hospital who implanted into patients a heart valve repair ring made by California-based Edwards Lifesciences. Two of the patients filed suit, claiming permanent injury. Both said they were unaware the heart ring was different from FDA-approved versions.
McCarthy invented the ring, shares royalties and is a paid consultant to the manufacturer.After the ring came under scrutiny from the U.S. Senate Finance Committee, the company asked the FDA to review the device, and the agency granted approval last year. By then, the ring had been implanted into 667 patients. Neither the company nor Northwestern would say how many of those patients were at Northwestern.
Northwestern contacted patients to reassure them the device was safe, and the company contacted hospitals and surgeons to offer an expert for questions. Neither the FDA nor the company has contacted patients to collect data on adverse outcomes.
By the end of June, about two dozen "adverse events" complaints about the device, known then as the Myxo ETlogix 5100 annuloplasty ring, were reported to a FDA database, including two possible deaths. Annuloplasty rings are medical devices used in the surgical repair of the heart's mitral valve.
Thursday, August 05, 2010
FDA proposes stricter rules on approving medical devices - chicagotribune.com
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