FDA petitioned to stop sales of essure implant

FDA petitioned to stop sales of essure implant
(HealthDay)—Bayer's contraceptive implant Essure can cause serious complications and should be taken off the market, says a citizen's petition filed with the U.S. Food and Drug Administration.

The FDA approved Essure about 13 years ago after a review process that was fast-tracked because the device was the first alternative to surgical sterilization for women who did not want more children and offered patients a quick recovery, The New York Times reported.

However, since approving Essure, the FDA has received more than 4,000 reports of serious complications, including severe back and pelvic pain, coils that pierced the fallopian tubes and lodged in other organs, and heavy prolonged menstrual periods, The Times reported.

Thousands of women who say they were seriously injured by the implant want the FDA to take Essure off the market and to issue a public warning about its complications. Both the FDA and Bayer say the device's benefits outweigh the risks, The Times reported.


Explore further

Bayer to pay $1.1B for California firm Conceptus

More information: Health Highlights: May 4, 2015
More Information

Copyright © 2015 HealthDay. All rights reserved.

Citation: FDA petitioned to stop sales of essure implant (2015, May 5) retrieved 24 January 2019 from https://medicalxpress.com/news/2015-05-fda-petitioned-sales-essure-implant.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
54 shares

Feedback to editors

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more