The FDA & Boston Scientific notified health care professionals and patients about serious adverse events, including death, occurring in patients treated with the Enteryx device. On September 23, 2005, Boston Scientific ordered a recall of all Enteryx Procedure Kits and Enteryx Injector Single Packs from commercial distribution. Additionally, Boston Scientific Corp. recently suspended sales of it’s Enteryx Device after more than two dozen reports of problems. The notice was posted on the company’s Web site, during the week of September 19, 2005.
An estimated 3,800 patients have been treated with Enteryx device, which was approved in 2003 by the FDA. The company’s recall notice stated some doctors accidentally punctured the wall of the esophagus while injecting the substance, causing adverse events. Boston Scientific sold about $5.5 million worth of Enteryx kits in 2004.
Based upon reports filed with the FDA, patients suffered leakage, swelling
Based upon reports filed with the FDA, patients suffered leakage, swelling, and ulcers in the esophagus. One elderly patient died last year after a doctor accidentally hit the wall of the patients aorta, the body’s largest artery. Boston Scientific Corp. said the U.S. Food and Drug Administration is looking into reports of one death and six injuries linked to the use of its treatment for acid-reflux disease. Boston Scientific, said the FDA is looking into its Enteryx device, an injectable treatment for acid reflux, after the death of an elderly woman last month, three weeks after treatment. The agency will try to determine whether the death was linked to the device or to physician technique.
We’ve reported this to the FDA and we’re working cooperatively with them," said Paul Donovan, a Boston Scientific spokesman. FDA spokeswoman Kathleen Quinn confirmed the agency was reviewing the adverse events. The Enteryx treatment, which the company had identified as one of its top products in terms of sales growth potential involves the injection of a plastic substance into the esophagus to help protect patients from acid backing up from the stomach.
In July 2004, the company issued an alert to doctors about the product and is updating the product label. In the case of the patient who died, some of the polymer had been injected into the woman’s aorta, which ruptured, causing her to bleed to death.
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