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Boston Scientific Corporation has voluntarily removed Enteryx from the market in September 2005. Enteryx is device that is permanently implanted by injection. It was designed to relieve the symptoms of gastrointestinal reflux disease (GERD). Since FDA approval of this treatment in April 2003, at least one patient died and a dozen injured by life threatening Enteryx side effects.
Boston Scientific first warned of serious Enteryx side effects in July 2004, after the first death from Enteryx side effects.
An elderly woman who received Enteryx died three weeks after the procedure due to hemorrhage and other complications. During her Enteryx procedure, the needle penetrated the esophageal wall creating a fistula (abnormal pathway) between her esophagus and her aorta. A hemorrhage caused by this Enteryx side effect was established as the cause of this patient''s death.
At least 11 additional patients who underwent the Enteryx procedure had reportedly suffered from punctured organs by the time this product was pulled from the market. Due to these serious Enteryx side effects, many experts believe that more should have been done to anticipate these problems before the treatment was made available and to more promptly recall the product when the risks of Enteryx side effects were discovered. Instead, this potentially dangerous product was allowed to remain on the market for over two years.
In addition to these Enteryx side effects, this treatment also posed the risk of serious injuries like bleeding, open esophageal sores, infection and inflammation of the chest cavity, and other serious Enteryx side effects. There are also numerous common Enteryx side effects that were discovered before this product was even approved. For example, 90 percent of all patients experienced significant chest and/or breastbone pain during the first two weeks following the procedure or longer. Other common Enteryx side effects include trouble swallowing, fever, sore throat, nausea, and more.
When Boston Scientific recalled Enteryx, they attributed the recall to concerns about “the procedural injection technique” and the possibility of an undetected transmural injection, a life-threatening Enteryx side effect. The company maintained, however, that the safety and effectiveness of Enteryx was not a concern.
Those who received Enteryx before the recall may wish to speak with their medical practitioner about Enteryx side effects. Boston Scientific states that no long-term Enteryx side effects have been discovered. If you or a loved one has been injured by Enteryx side effects, you may wish to confer with a qualified enteryx attorney to learn more about seeking compensation for damages caused by Enteryx side effects.
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