Essure: FDA Restricts Sale & Distribution

The permanent contraception device, Essure, was just recently given strict orders by the U.S. Food and Drug Administration that limits the sale and distribution of the device and requires additional safeguards for potential consumers.

The permanent birth control, marketed by Bayer Healthcare, has been under the microscope for years after thousands upon thousands of problems were reported. In 2015 the FDA convened a panel to assess the risks of Essure. An article published in the New England Journal of Medicine in October 2015 stated that Essure problems might have been “detected sooner or avoided altogether” if more thorough and pre and post-market evaluations had taken place. It suggested the Essure risk information should have been disseminated in a “more timely and transparent way.”

Now the FDA is cracking down even more on 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. “We take the concerns of all women affected by Essure very seriously. I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”

New labeling will be legally required for Essure and the sale and distribution of it is restricted solely to health care providers and facilities that provide patient brochure outlining potential risks. Patients will be asked to sign an acceptance of risk statement.

It is estimated some 750,000 women in the U.S. have been implanted with Essure with sales topping $47 Billion in 2014. However, since the FDA ordered Bayer to add a boxed warning to Essure and include a patient decision checklist, there has been about a 70% drop in sales.