Agents seized all implantable medical devices made by the company. According to the FDA, these products "were manufactured under conditions that may have contaminated the devices."
"Shelhigh's violations include: manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed; failing to adequately monitor critical manufacturing environments for possible microbial contamination; failing to properly test products for sterility and fever-causing contaminants; and failing to scientifically support product expiration dates," reads an FDA press release.
Shelhigh's product line includes pediatric heart valves, surgical patches, annuloplasty rings (which are used to help repair heart valves), etc. The company has loudly contested the charges against them. In an April 22 press release, Shelhigh officials announced their intention to challenge the product seizure in Federal Court.
"I am deeply disappointed by the FDA decision which was made after the full cooperation of Shelhigh during an intensive 10 week inspection of our facility by the FDA," stated Shelhigh founder and Chief Scientific Officer, Dr. Shlomo Gabbay, in the release. "During this inspection Shelhigh fully addressed all observations raised by FDA personnel, repeatedly requested corrections of statements made by the FDA in their site report and also repeatedly requested meetings with the FDA to discuss any outstanding issues as well as concerns which arose during the 10 week inspection, and these meetings were also refused by the FDA."
This is not the first time that Shelhigh—which received FDA approval to sell their implantable medical devices in 1997—has been under federal scrutiny. The Food and Drug Administration sent warning letters to the company in 2000 and 2005, citing many of the same concerns that led to the product seizure. FDA inspectors toured the Shelhigh manufacturing facility in the fall of 2006.
The FDA urges patients who might have been implanted with a Shelhigh device to contact their doctor or the physician who performed surgery on them. Patients can also phone the FDA's Division of Small Manufacturers, International and Consumer Assistance at 1-800-638-2041.
Fever, unusual pain or swelling in the area of an implant or discharge from the incision are possible signs that the implant has caused infection. Critically ill patients, children and people with compromised immune systems are at the greatest risk from using these devices, added the FDA.Shelhigh officials accuse the federal government of baseless fear mongering.
"It is unfortunate that the FDA is stopping Shelhigh from shipping our life-saving products," said Dr. Gabbay in the company press release. "I remain hopeful that the FDA will quickly resolve whatever internal issues they have which have led to their baffling seizure decision."