"Doctors should monitor patients with a Shelhigh implant for infections and proper functioning. Patients who think they may have received a Shelhigh device during surgery should contact their doctors for more information."
All inplantable medical devices have been seized by U.S. marshals and FDA investigators from Shelhigh Inc. today. It is estimated to be 1 million parts and finished products.
This following multiple warnings to the company from the FDA.
The facility was inspected and found to have a
poorly constructed and poorly maintained clean room, where sterilized devices are meant to be further processed.
These are tissue based devices including
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.
That are made from cow and pig tissues.
The FDA has gotten multiple reports of infections and other issues with these products.
Many surgeries have used the devices. Such as open-heart surgery, and the repair of soft tissue during neurosurgery and abdominal, pelvic and thoracic surgeries.
So if you or a loved one has gone through any of these procedures you should check with your doctors to see what types of materials were used.
As a precautionary measure. It's better to be safe than sorry.
The FDA has been warning this company since 2005.