Boston Scientific has recalled an injectable polymer used to treat acid reflux disease, citing physician errors that led to puncturing the esophagus.
The company made the announcement about Enteryx only on a section of its Web site aimed at doctors, the Wall Street Journal reported.
The company said the recall "is not related to the safety and effectiveness of the Enteryx product."
Paul Donovan, a spokesman for the company, told the Journal that 3,800 patients are using Enteryx, which is injected into the walls of the esophagus to keep acids from flowing up from the stomach. In 11 cases, doctors punctured the esophagus, causing complications and one death.
Donovan said that any complications have occurred within 21 days of injection. He said that after consulting the U.S. Food and Drug Administration had determined it should notify doctors that patients who had received Enteryx injections within 30 days should be monitored.
Boston Scientific received $5.5 million in sales from Enteryx last year.
© Copyright 2005 by United Press International
