Bayer Stops Sales of Essure in U.S.

July 24, 2018 — Bayer will stop all sales of Essure implants at the end of the year, making the U.S. the last country where the controversial device was still sold.

Bayer stands by the safety and effectiveness of Essure, and claims that pulling it off the market in the U.S. was a “business decision” based on a 40% drop in sales.

Bayer stopped selling Essure in all countries except the U.S. last year, after several international health agencies issued safety warnings.

In the U.S., over 16,000 lawsuits have been filed by women who were injured by Essure. Thousands of women have reported severe side effects, or complained that they were not warned of the potential risks.

The FDA approved Essure in 2002 as the only non-surgical sterilization device on the market. The agency refused to recall Essure and consistently claimed that the benefits outweighed the risks.

Even so, the FDA added a “Black Box” warning to the label of Essure and took the unusual step of drafting a 3-page checklist outlining the potential risks. In April, the FDA limited sales of Essure to doctors who agreed to go over the checklist with patients before implanting Essure.

The potential side effects include changes in menstrual bleeding, pregnancy, permanent pain, perforation and migration of the device, allergic or hypersensitivity reactions, or immune-type reactions. If complications occur, surgery to remove Essure is often necessary.