We profile so many promising new gizmos and techniques hitting the market, you’ve got to figure, they can’t all work out, right? Here’s one that flamed out particularly soon — a reflux therapy called Enteryx, from Boston Scientific:
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 esophagus. It thickens into a permanent spongy lump which is supposed to help block acid from flowing from the stomach toward the throat.
Boston Scientific’s recall notice said 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.
The way Boston Scientific spins it, it sounds like the docs didn’t know what they were doing. But, according to a physician experienced in the ways of Enteryx, “It is quite difficult to control even in the best settings — even in experienced hands, when you inject, you cannot be absolutely certain where the Enteryx is injected.”
Hence, the voluntary recall (the fact that they were only attaining 1% of their expected market penetration may have also factored into the decision).
More from Boston Scientific…