The FDA has seized all implantable medical devices from Shelhigh, Inc.. These devices were used in many types of surgeries, including open heart surgery, neurosurgery and abdominal, pelvic and thoracic surgery.
The recalled Shelhigh implants are a danger due to deficiencies in the manufacturing process that may compromise sterility and cause infection leading to serious injury or death. Critically ill, pediatric, and geriatric patients – and those with poorly functioning immune systems – are particularly at risk.
According to the Shelhigh website, “The Shelhigh proprietary No-React® Tissue Detoxification process has revolutionized the biological tissue and valve marketplace. Our No-React process effectively resists infection…”
Obviously, that is an inaccurate statement.
Shelhigh products include a range of biological tissues and valves, in the Aortic, Mitral and Pulmonic categories, including tricuspid, semi-stented, and stentless valves, valve repair systems, annuloplasty rings, pulmonic valve systems, valved conduits and tissue patches.
Doctors should stop using the recalled Shelhigh devices immediately, and screen patients who have received ANY Shelhigh implant for infections, and ensure that the device is functioning properly
Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information. If indeed they were given a Shelhigh implantable device, they should see the doctor immediately and get checked for infections, and to ensure that the device is properly working.