Boston Scientific Enteryx Device
The Boston Scientific Corp. is the world's leading medical device company, and in addition to it's sales , it also leads in the world for medical device recalls. The Enteryx device is an acid reflux disease treatment that is injected into the esophagus of a patient. More specifically, it was designed to treat gastrointestinal reflux disease, or GERD. Administered by injecting a plastic substance into the esophagus of the patient, the treatment aims to help protect the patient from the possible reflux of stomach acid into his throat. Entreryx is a chemical intended to be used in the esophageal sphincter, however, once it is injected it can not be removed.
Unbeknown to the FDA, the adverse side effects could result in serious injury or death. The Enteryx device is now also being investigated by the FDA, after dozens of people filed claims reporting problems. It was stated in the recall notice that some doctors inadvertently pierced the esophageal wall during the injection of the substance, causing unpleasant events. In 2004, an estimated $5.5 million worth of the Enteryx kits were sold by the company.
Even for successful Enteryx procedures, the side effects included nausea, gas, fever, chest pain, difficulty swallowing, bloating, and vomiting. While for many people, these side effects may seem extremely unpleasant, the potential for more serious risks were right around the corner. As with all surgical procedures, a certain level of risk is involved, however fatality is a one that no one expects from a faulty medical device. Some of the potential health risks of the procedure itself were bleeding, open esophageal sores, holes in the esophageal walls, infection, inflammation, and fistula. A long list for a small procedure.
There are approximately 3,800 patients who underwent treatment with the use of the Enteryx device, which was approved by the FDA in 2003. According to the reports that were filed with FDA, the events that occurred because of the treatment of the Enteryx device included patients suffering from inflammation, infection, bleeding, fistula, esophageal swelling, leakage and ulcers. There was even an elderly patient who died after a doctor inadvertently hit the wall of her aorta, the largest artery in the body.
If you trusted your medial staff to insert the Enteryx device into your esophageal sphincter, you should be monitored for the dangerous side effects. In addition, you may need to undergo several tests to rule out transmural injections, such as chest x-rays, barium swallows, or a CT scan. Also, if you experience any type of chest pain, go to an emergency room immediately. Be sure to continue follow-up appointments with your physician.
It should be evident to you now that this medical procedure may cause you some future complications that may require continued medical attention. Your medical bills can add up quickly, and at a time in your life when you are dealing with the emotional turmoil, financial stress may be too much to handle.
If you have sustained injuries because of a Boston Scientific Enteryx Device treatment, then you should contact a lawyer as soon as possible. There are statutes of limitations in every state that will only allow you to file a personal injury claim for a given period of time. A victim of personal injury due to a defective medical product is only given two years after the injury to file a claim against the responsible party. Failure to do this will result in the victim not being able to get compensation for his pain and suffering, so it is best to get an experienced defective medical device lawyer now.
