Oct 19 2005
Doctors in the United States have been instructed by the U.S. Food and Drug Administration to stop using Enteryx, a device used to treat acid-reflux disease.
The device, manufactured by Boston Scientific was recalled by the company last month.
The FDA say doctors should immediately stop injecting Enteryx, due to serious adverse effects, including death, occurring in patients treated with the liquid chemical polymer, used for gastroesophageal reflux disease.
According to the FDA web site, Enteryx is intended to be injected into the lower esophageal sphincter where it polymerizes into a spongy material that cannot be removed.
The FDA says that Boston Scientific issued a recall of its Enteryx procedure kits and its Enteryx injector single packs on Sept. 23.
It appears that while some problems with the device related to how it was injected, not all injuries were the result of user technique.
Apparently one reported death was due to the injection of Enteryx into the wall of the aorta and two cases of possible inflammatory reactions occurred even when proper procedures were followed.
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