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Enteryx Injection May Result in Serious Injury or Death
On October 14, 2005, the Food and Drug Administration (FDA) recalled Boston Scientific's Enteryx Procedure Kits and Enteryx Injector Single Packs. The recall followed reports of serious adverse effects, including death, in patients treated with Enteryx.
Enteryx is used in the treatment of Gastroesphageal Reflux Disease (GERD). It comes in the form of a liquid chemical polymer, which is inserted into the walls of the esophagus by a doctor. Once injected, it takes the form of a spongy material and cannot be removed.
The FDA reports that transmural injections can potentially result in death or serious injury. Transmural injections occur when Enteryx is injected incorrectly, misses the intended destination and passes through the walls of the esophagus into internal organs or the blood stream. This mistake may cause blockage of the blood vessels and is not always detected immediately by the doctor.
Signs of transmural injection include:
- Chest or stomach pain
- Flu-like or respiratory symptoms (fever, cough, shortness of breath)
Additionally, the FDA reports that not all adverse effects are due to transmural injections. There are at least 2 cases in which inflammatory reactions occurred in patients who had followed proper technique.
The FDA reports that problems may occur up to 7 weeks following the injection.
If you or your loved one has suffered an Enteryx injury, contact us today. Submit the form to the right and we’ll let you know if you have a case and if we can represent you.