Boston Scientific ENTERYX Procedure Kits and Injector Single Packs .
via FDA Safety I nformation Alerts:
For those who haven’t consider endoscopic procdedures for the treatment of GERD, well, at least, you shouldn’t think in Enteryx treatment.
FDA and Boston Scientific notified healthcare professionals and patients about serious adverse events, including death, occurring in patients treated with ENTERYX, a liquid chemical polymer which is intended to be injected into the lower esophageal sphincter for treatment of gastroesophageal reflux disease. The serious adverse events involve unrecognized transmural injections of ENTERYX into structures surrounding the esophagus. On September 23, 2005, Boston Scientific issued a recall of all ENTERYX Procedure Kits and ENTERYX Injector Single Packs from commercial distribution. Physicians should stop injecting ENTERYX immediately and follow the manufacturer’s procedures for returning unused product. FDA also provided recommendations on avoiding future occurrences and advice for patients.
Last month, Aggravated Doc Surg has made an excellent review of this treatments and recalls.
Regards,
Jon Mikel Iñarritu, M.D.