After years of controversy, Bayer has announced that it will no longer sell the Essure birth control implant in the United States.
The company had already stopped marketing Essure in Europe, Canada, South America, South Africa, and the United Kingdom.
Essure was brought to market in 2002 by Conceptus, Inc., a company that was acquired by Bayer in 2013.
Essure, which consists of two coils made of a titanium and nickel alloy, was designed for permanent implantation in the fallopian tubes, which is done via the vagina during a procedure that lasts about 10 minutes. Over the next 3 months, the coils promote a reaction that causes scar tissue to form and block the tubes, permanently preventing sperm from fertilizing any eggs released by the ovaries.
Though Essure is intended to be a permanent method of birth control, its FDA approval was only based on short-term studies.
More than 16,000 women nationwide have filed Essure lawsuits for serious complications they claim were caused by the implants, including pain, bleeding, allergic reactions, uterine perforations, and device migration.
Over the past 16 years, the FDA has received nearly 27,000 adverse event reports involving Essure, though some experts believe the true number could be higher, as most injuries stemming from drugs and devices are never reported to the agency.
Those complaints prompted the FDA to order Bayer to add a black-box warning – its most serious safety alert – to the Essure label in 2016. The company was also ordered to conduct a 2,000-patient study to assess the safety and effectiveness of Essure.
In April, the FDA placed “unique” restrictions on Essure which limited its sale to doctors who could guarantee that women were informed of its risks.
On Friday – the same day Bayer announced the end of Essure sales in the United States – the FDA disclosed that the company had been unable to enroll enough new patients for the mandated study.
While more than 750,000 women worldwide have received the Essure contaceptive coils, demand for the implants has dropped 70% since the FDA ordered the black box warning in 2016.
Bayer continues to insist that Essure is safe and maintains that its decision to end sales was driven by commercial concerns.
“Bayer has made a business decision to voluntarily discontinue sales and distribution of the Essure® System for Permanent Birth Control in the United States after December 31, 2018,” the company said in a July 20th press release. “This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable. Essure is the only FDA-approved non-incisional form of permanent birth control.”