Boston Scientific Corp. has suspended sales of a treatment for acid reflux disease after more than two dozen reports of problems.
The company said that it considered its Enteryx injection kit safe but that some patients had been harmed because doctors administered it incorrectly.
About 3,800 patients have been treated with Enteryx, which was approved in 2003 by the Food and Drug Administration. 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 stomach acid from flowing toward the throat.
Boston Scientific’s recall notice said some doctors accidentally allowed the injection needle to go all the way through the wall of the esophagus, causing “adverse events.”
The notice was posted on Boston Scientific’s website last week.
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.
The Enteryx device was touted as one of the company’s promising new products and analysts initially projected several hundred million dollars in annual revenue. But the procedure has been dogged by safety questions and uncertainty about whether insurers would pay for it.
Dr. Ram Chuttani, chief of endoscopy at Beth Israel Deaconess Medical Center, said his hospital had performed 40 to 50 Enteryx procedures. He called the process “very demanding” technically.
“It is quite difficult to control even in the best settings,” Chuttani said. “Even in experienced hands, when you inject, you cannot be absolutely certain where the Enteryx is injected.”