Implantable medical devices seized in New Jersey because of sterility scare - http://www.komotv.com/news/health/7082141.htmlU.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 sterility.
The seizure from Shelhigh Inc. was expected to net an estimated one million parts and finished products. The FDA said it found significant problems in the company's manufacturing processes.
The federal officials seized all implantable medical devices from the company, saying the problems could compromise their safety and effectiveness, including the sterility of the implants. The products include pediatric heart valves and conduits, or tube-like devices for blood flow, 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 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.
