The FDA and Boston Scientific have notified healthcare providers and patients about serious adverse events, including death, that have occurred in patients treated with Enteryx liquid chemical polymer, which is injected into the lower esophageal sphincter for treatment of gastroesophageal reflux disease.
Boston Scientific has issued a recall of all Enteryx procedure kits and Enteryx injector single packs from commercial distribution. According to the FDA, practitioners should stop injecting Enteryx immediately and follow the manufacturer's procedures for returning unused product.
The serious adverse events associated with Enteryx involve unrecognized transmural injections of Enteryx into structures surrounding the esophagus. Transmural injections can potentially result in death or serious injury. Some cases of transmural injections were not recognized at the time of the procedure or during immediate follow-up despite the use of fluoroscopy during the procedure.
The number of adverse events associated with transmural injection of Enteryx is not yet known. In addition, recent literature cites two cases in which serious mediastinal events suggestive of possible inflammatory reactions occurred even though proper procedure was followed.