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product_liability enteryxBoston Scientific Corporation voluntarily recalled Enteryx on September 23, 2005. The FDA originally approved Enteryx in April 2003 for the treatment of gastrointestinal reflux disease (GERD). Boston Scientific claims the Enteryx recall was due to “procedural injection technique” concerns. Enteryx was, however, linked to one death, about a dozen cases of serious injury, and other serious side effects by the time it was finally taken off the market.
Enteryx was a device that was permanently implanted. It was injected with the help of an endoscope under anesthesia. This product, made of a polymer material, was injected into the esophagus to strengthen the lower esophageal sphincter (LES) muscle. This would prevent acids from the stomach from flowing into the esophagus. Enteryx was intended to provide long-term relief from the symptoms of GERD which including heartburn and burning pain in the chest and/or throat. The highly technical Enteryx procedure required skill and precision to correctly execute and avoid causing serious injuries to the patient.
When performed correctly, the Enteryx procedure had a high rate of success. It was, however, never without risks. The common side effects of Enteryx included chest pain, trouble swallowing, fever, sore throat, nausea, bloating, vomiting, belching, gas, and an unpleasant body odor. While these side effects were troublesome to many, Enteryx posed risks that were much more serious.
In July 2004, Boston Scientific sent a safety advisory warning to healthcare professionals and the FDA about serious and possibly fatal Enteryx risks. The company reported the death of an older woman who died from a hemorrhage three weeks after suffering a punctured esophageal wall during an Enteryx procedure. The autopsy in this Enteryx death showed the patient suffered from a fistula, or an abnormal pathway between her esophagus and aorta created by the Enteryx procedure.
The Enteryx procedure posed the risk of bleeding, open esophageal sores, holes in the esophageal walls, fistula, infection, and inflammation of the chest cavity. There have been at least a dozen patients who have suffered from a punctured esophageal wall from Enteryx. While Boston Scientific informed healthcare providers about these risks, they failed to adequately protect consumers from these serious Enteryx side effects.
At the time, no long-term adverse Enteryx side effects were known. If you are concerned about Enteryx risks, you may want to talk to your health care provider in greater detail. If you or a loved one has suffered serious injury because of Enteryx, please contact us to speak with a qualified and experienced attorney who can evaluate your case at no cost to determine your legal rights. You may be eligible to seek compensation for your losses and suffering.