Union, NJLast week U.S. Food and Drug Administration (FDA) officials seized all implantable devices from Shelhigh Inc. The seizure, which involved almost one million units, came after the FDA found "significant deficiencies" in how the devices were manufactured. The FDA is particularly concerned with the sterility of the implantable devices.
In making seizure, the FDA said all companies that manufacture medical devices must follow requirements that ensure the safety of all medical products. They noted that Shelhigh's violations included poorly constructed and maintained facilities, improper sterilization, failure to test properly for sterility, and improper extension of expiration dates on medical devices.
Last fall the FDA inspected the Shelhigh manufacturing facility and met with the company. At that time, the FDA reports, it warned Shelhigh about the violations and told Shelhigh to correct the problems. The FDA also says that Shelhigh was sent two warning letters about the violations
In its letter to physicians, the FDA noted that it is aware of published reports of premature failure associated with some of Shelhigh's medical devices. The FDA also issued an advisory to patients warning that the devices may have been contaminated and therefore may not function properly.
Products taken by the FDA include pediatric heart valves and conduits, surgical patches, annuloplasty rings, and arterial grafts and are used in surgical settings including open-heart surgery and soft tissue repair. Adults, children, and infants have all received Shelhigh devices. The FDA says that it does not yet know how many devices are contaminated.
The FDA warns that critically ill patients, pregnant women, children, and the elderly are at greatest risk of unexpected complications from contaminated devices. Patients who already have Shelhigh products implanted should be monitored for infections and proper device functioning during the lifetime of the device. Physicians have been urged to consider using other devices rather than using Shelhigh devices, which will not be distributed.
Patients who think they may have a Shelhigh device implanted should contact the doctor who performed the surgery. Those who do have the device implanted should contact their doctor immediately to discuss their options. Furthermore, patients who have the devices implanted and experience any signs of infection including fever, unusual pain, swelling, redness or warmth at the site of implant, or drainage or discharge from their incision should seek medical attention immediately.
If you or a loved one has had complications after having devices implanted, please contact a [Shelhigh Medical Devices] lawyer who will evaluate your claim at no charge.