FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Restricts Distribution of Essure to Establish Additional Safeguards

April 13, 2018
A A

The FDA ordered a restriction on marketing and distribution of Bayer’s permanent birth control device Essure amid fears that patients were not given enough risk information to make informed decisions about the product.

Some patients implanted with Essure reported adverse events such as perforation of the uterus and/or fallopian tubes, persistent pain or suspected hypersensitivity or allergic reactions. In addition, some reported hair loss, depression and mood changes, among other side effects, the agency said.

The agency implemented a unique restriction by limiting the sale and distribution of the device in order to require additional information that adequately assures patients of the device’s safety.

The agency stated that after reviewing evidence and information about the device’s use, it felt that “this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” FDA Commissioner Scott Gottlieb said.

 

Editor’s Note: This article has been updated with a correction since first published.

 

View today's stories