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Boston Scientific Enteryx Device
Boston Scientific Enteryx Device
The FDA & Boston Scientific notified health care professionals and patients about serious adverse events, including death, occurring in patients treated with the Enteryx device. On September 23, 2005, Boston Scientific ordered a recall of all Enteryx Procedure Kits and Enteryx Injector Single Packs from commercial distribution. Additionally, Boston Scientific Corp. recently suspended sales of it's Enteryx Device after more than two dozen reports of problems. The notice was posted on the company's Web site, during the week of September 19, 2005.An estimated 3,800 patients have been treated with Enteryx device, which was approved in 2003 by the FDA. The company's recall notice stated some doctors accidentally punctured the wall of the esophagus while injecting the substance, causing adverse events. Boston Scientific sold about $5.5 million worth of Enteryx kits in 2004.
Based upon reports filed with the FDA, patients suffered leakage, swelling, and ulcers in the esophagus. One elderly patient died last year after a doctor accidentally hit the wall of the patients aorta, the body's largest artery. Boston Scientific Corp. said the U.S. Food and Drug Administration is looking into reports of one death and six injuries linked to the use of its treatment for acid-reflux disease. Boston Scientific, said the FDA is looking into its Enteryx device, an injectable treatment for acid reflux, after the death of an elderly woman last month, three weeks after treatment. The agency will try to determine whether the death was linked to the device or to physician technique.
We've reported this to the FDA and we're working cooperatively with them," said Paul Donovan, a Boston Scientific spokesman. FDA spokeswoman Kathleen Quinn confirmed the agency was reviewing the adverse events. The Enteryx treatment, which the company had identified as one of its top products in terms of sales growth potential involves the injection of a plastic substance into the esophagus to help protect patients from acid backing up from the stomach.
In July 2004, the company issued an alert to doctors about the product and is updating the product label. In the case of the patient who died, some of the polymer had been injected into the woman's aorta, which ruptured, causing her to bleed to death.
If you or a loved one suffered injuries from a Boston Scientific Enteryx device, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.
Boston Scientific Enteryx DeviceRSS Feed
FDA Warns of Potentially Fatal Complications from Improper Injection Procedures with ENTERYX
Oct 18, 2005 | www.newsinferno.com
Reports that serious patient injuries and death can be caused by improper injection procedures, Boston Scientific Corporation has recalled all ENTERYX® Procedure Kits and ENTERYX® Single Pack Injectors. Prescribed for gastroesophageal reflux disease (GERD), ENTERYX® is injected by a physician into the inside muscle wall of the patient’s esophagus.The liquid then thickens into a sponge-like substance helping to block stomach acids and prevent them from entering the...
Boston Scientific ENTERYX Procedure Kits and Injector Single Packs Recalled
Oct 17, 2005 | www.pharmalive.com
The FDA and Boston Scientific notified healthcare professionals and patients about serious adverse events, including death, occurring in patients treated with ENTERYX, a liquid chemical polymer which is intended to be injected into the lower esophageal sphincter for treatment of gastroesophageal reflux disease. The serious adverse events involve unrecognized transmural injections of ENTERYX(r) into structures surrounding the esophagus. On September 23, 2005, Boston Scientific issued a recall of...
Boston Scientific Suspends Enteryx Sales
Sep 28, 2005 | AP
Boston Scientific Corp. has suspended sales of a treatment for acid reflux disease after more than two dozen reports of problems.The company says it considers its Enteryx injection kit safe, but some patients have been harmed because doctors used it incorrectly.About 3,800 patients have been treated with Enteryx, which was approved in 2003 by theFood and Drug Administration. The treatment is a liquid polymer injected directly into the walls of esophagus. It thickens into a permanent spongy lump...
FDA Reviews Boston Scientific Acid Reflux Device After Death
Aug 15, 2004 | AP
The Food and Drug Administration is reviewing the death last month of an elderly woman after she was treated with a Boston Scientific Corp. device for acid reflux disease.The FDA is also looking at injuries in six other patients treated with the Enteryx device.The review comes as Boston Scientific grapples with a month-old recall of its lucrative drug-coated heart stent.Nearly 100,000 Taxus and Express 2 model stents have been recalled since July 2 because of a manufacturing defect.In the...
Boston Scientific Enteryx Device
Quick Facts
Boston Scientific Enteryx Device Reference Guide
Date Approved
April 2003
Manufacturer
Boston Scientific Corp.
Status
Recall September 23, 2005 Approved Uses
Acid-Reflux Disease
GERD
Complications
Death
Serious injuries
Related Topics
Defective Medical Devices
April 2003
Manufacturer
Boston Scientific Corp.
Status
Recall September 23, 2005 Approved Uses
Acid-Reflux Disease
GERD
Complications
Death
Serious injuries
Related Topics
Defective Medical Devices
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