CONSUMER NEWS    RECALLS    COMPLAINT FORM    SCAM ALERTS  


Complain about a product or service

Small Claims Guide | Class Actions | Lemon Law | FAQ | Resources | Newsletters | Spanish
Automotive    Education    Electronics    Family    Finance    Health    Homeowners    Shopping    Travel   
NEWS   Latest |  Archives |  Auto |  Cells, etc. |  Computers |  Financial |  Health |  Homeowners |  Parents |  Privacy |  Scams |  Seniors |  Travel

Acid Reflux Treatment Recalled After Injuries and One Death





September 28, 2005
Boston Scientific Corp. said it is recalling Enteryx, an endoscopic product used to treat acid-reflux disease, because of what it called doctor errors that have harmed several patients and killed at least one.

The company said is the recall is "not related to the safety and effectiveness of the Enteryx product when properly implanted." Enteryx is an injectable polymer used to fill the walls of the esophagus; it is supposed to block acid from flowing upward from the stomach.

In 11 cases, doctors accidentally punctured the wall of the esophagus while doing the procedure, causing serious complications including one death.

The recall was initially reported the The Wall Street Journal. It is posted on an obscure section of the company's Web site aimed at doctors.

"This action is being initiated based on the procedural injection technique and is not related to the safety and effectiveness of the Enteryx product when properly implanted. The Company has not found any evidence of complications resulting from long-term implantation of Enteryx," the company statement said.

Boston Scientific said it has informed the FDA of its actions and is notifying doctors and hospitals directly.

"The company has been collecting and analyzing a growing body of data that indicates procedural injection technique is critical to achieving clinically acceptable results. There have been a limited number of injections through the wall of the esophagus that were undetected at the time of the procedure and resulted in adverse events," the company said.



Report Your Experience
If you've had a bad experience -- or a good one -- with a consumer product or service, we'd like to hear about it. All complaints are reviewed by class action attorneys and are considered for publication on our site. Knowledge is power! Help spread the word. File your consumer report now.


Consumer News

July 5 2008

Recent Recalls & Safety Alerts

Print, mail, etc.




FREE CONSUMER NEWSLETTERS

The Daily Consumer
Afternoons M-F

Sign up now!


Consumer News & Alerts
Every Sunday

Sign up now!


Knowledge is free.
Knowledge is power.



Back to the top |

Advertisement


Home | Rogues Gallery | Good Guys | Complaint Form | News | Recalls | Search | Video | FAQ |
Consumer Resources | Small Claims Guide | Lemon Law | Newsletter | Contact Us
Advertise With Us | Testimonials | Newsroom | RSS Feeds | Radio | Job Postings




Terms of Use Your use of this site constitutes acceptance of the Terms of Use

Advertisements on this site are placed and controlled by outside advertising networks. ConsumerAffairs.com does not evaluate or endorse the products and services advertised. See the FAQ for more information.

Company Response Welcome If complaints about your company appear on our site, we welcome your response. Please see the Response Form for more information.

For more information, see the FAQ and privacy policy. The information on this Web site is general in nature and is not intended as a substitute for competent legal advice.  ConsumerAffairs.com Inc. makes no representation as to the accuracy of the information herein provided and assumes no liability for any damages or loss arising from the use thereof. 

Copyright © 2003-2008 ConsumerAffairs.com Inc.  All Rights Reserved.