BOSTON SCIENTIFIC SUSPENDS SALES OF ACID REFLUX KIT
Boston Scientific has suspended sales of the acid reflux disease treatment Enteryx after more than two-dozen reports of problems because of incorrect use of Enteryx injection kits.
The company's recall notice says that some doctors accidentally punctured the wall of the esophagus while injecting the substance, causing "adverse events." According to reports filed with the FDA, patients have suffered leakage, swelling and ulcers in the esophagus. An elderly patient died last year after a doctor accidentally hit the wall of the patient's aorta, the body's largest artery.
About 3,800 patients have been treated with Enteryx, which was approved in 2003 by the FDA. The treatment is a liquid polymer injected directly into the walls of the esophagus. It thickens into a permanent spongy lump that is supposed to help block acid from flowing from the stomach toward the throat.