News | April 17, 2007

FDA Seizes Shelhigh Implantables, Cautions Doctors to Monitor Patients for Infection

April 18, 2007 — Associated Press reports that on Tuesday U.S. marshals and FDA investigators began seizing heart valves and other implantable medical devices made from cow and pig tissue by a New Jersey company because of concerns about their sterility.

The FDA said it had found significant problems in the manufacturing processes at Shelhigh Inc., Union, NJ. It was estimated that one million animal parts and finished products were taken from Shelhigh Inc., Union, NJ, according to spokeswoman Heidi Rebello.

The seized products include pediatric heart valves and conduits, as well as surgical patches, arterial grafts and annuloplasty rings used to help repair heart valves.

The seizure followed an inspection of the company by the FDA last fall. The agency also warned Shelhigh about the problems during meetings and in two warning letters, sent in 2000 and 2005. The earlier letter cited multiple reports of infections and other problems with some of Shelhigh's products.

The tissue-based devices are used in many surgeries, including open-heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery, the FDA said. Critically ill patients, pediatric patients and patients with weakened immune systems may be at greatest risk from the use of these devices, it added.

The FDA recommended doctors consider using alternative devices. Also, doctors should monitor patients with a Shelhigh implant for infections and proper functioning.

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