FDA to add bold warning to Essure contraceptive device

Federal health regulators plan to add new warnings to Essure, a much-debated contraceptive implant that has been subject to thousands of complaints from women reporting chronic pain, bleeding and other problems.

The Food and Drug Administration says it will also require manufacturer Bayer to study the risks of the metallic device for various groups of women.

Essure has been sold for more than a decade and is frequently pitched to women as the only non-surgical option for permanent birth control. Bayer estimates 750,000 women have received the device since 2002.

But since 2013, the Food and Drug Administration has received thousands of reports of problems with the device. Many women have said problems including and bleeding were so severe they required surgery to remove the device.

© 2016 The Associated Press. All rights reserved.

Citation: FDA to add bold warning to Essure contraceptive device (2016, February 29) retrieved 28 March 2024 from https://medicalxpress.com/news/2016-02-fda-bold-essure-contraceptive-device.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.

Explore further

FDA aims to publish Essure safety review in February

1 shares

Feedback to editors