FDA TELLS DOCTORS TO STOP USING BOSTON SCIENTIFIC'S ENTERYX

The FDA is warning physicians to immediately stop using Boston Scientific's injectable polymer Enteryx, which is used to treat gastroesophageal reflux disease, because of the risk of serious adverse events including death.

In an Oct. 14 "Dear Healthcare Practitioner" letter, the FDA said the serious adverse events associated with Enteryx involve unrecognized transmural injections of the product into structures surrounding the esophagus. The Enteryx procedure involves injecting a patented liquid polymer into the lower esophageal sphincter that solidifies into a sponge-like permanent implant.

Transmural injections can potentially result in death or serious injury, the FDA said. Signs and symptoms of transmural injection may include chest pain, flu-like symptoms and pneumonia. Some cases of transmural injection were not recognized at the time of the procedure or during immediate follow-up, the agency said. "At this time, it is not possible to provide accurate estimates of the number of adverse events associated with transmural injection of Enteryx, or to describe all of the possible outcomes," the FDA said.

Boston Scientific recently issued a recall of all Enteryx Procedure Kits and Enteryx Injector Single Packs from commercial distribution. The company cited "adverse events" resulting from growing reports of incidents that indicate some physicians are experiencing procedural difficulties with the device as the reason for the recall.

"There have been a limited number of injections through the wall of the esophagus (transmural) that were undetected at the time of the procedure and resulted in adverse events," the company said. "Boston Scientific considers the possibility of an undetected transmural injection an unacceptable risk and has elected to recall these products," the firm said at the time.