Shelhigh hits low

            ROCKVILLE , MD - MedWatch, the Safety Information and Adverse Event Reporting Program of the U.S. Food and Drug Administration (FDA), disclosed FDA seized all implantable medical devices from Shelhigh Inc. after finding significant deficiencies in manufacturing processes. The tissue-based devices are used in surgical settings, including open heart surgery in adults, children, and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic, and thoracic surgery. Deficiencies may compromise safety and effectiveness of the products, particularly their sterility. Critically ill, pediatric, and immuno-compromised patients may be at greatest risk from the these devices. Physicians should use other devices and monitor patients with any Shelhigh implants for infections and proper device functioning over the expected lifetime of the device. Patients who think they received a Shelhigh device in surgery should contact their doctor for information. Healthcare professionals and consumers are urged to read the Preliminary Public Health Notification and Advice for Patients at www.fda.gov/medwatch/safety/2007/safety07.htm#Shelhigh.