FDA restricts sales of implanted birth control device - WECT TV6-WECT.com:News, weather & sports Wilmington, NC

(RNN) – The U.S. Food and Drug Administration announced Monday that it’s restricting sales and distribution of Essure, an implanted birth control device for women.

The FDA said the order is meant “to ensure that all women considering use of the permanent contraception device are provided with adequate risk information so that they can make informed decisions.”

Essure, which basically consists of two flexible coils inserted into the fallopian tubes, is the only implanted birth control device for women that doesn’t require a surgical incision.

FDA employees recently became aware that some women “were not being adequately informed of Essure’s risks before getting the device implanted.”

Those risks include perforation of the uterus and/or fallopian tubes, persistent pain, allergic reactions, and “migration of inserts to the abdominal or pelvic cavity,” which are “adverse events” the FDA said some women have experienced with Essure.

Other women have reported headaches, fatigue, weight changes, hair loss and depression, though it’s unclear whether those symptoms were related to the device.

“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” said FDA Commissioner Scott Gottlieb, M.D, in a written statement. “We take the concerns of all women affected by Essure very seriously."

CNN reports that thousands of women have filed complaints with the FDA about the device since it went on the market in 2002. Those complaints have included unintended pregnancies, severe pain and bleeding.

Copyright 2018 Raycom News Network. All rights reserved.