Pharmaceutical giant Bayer announced in a press release that the company is voluntarily discontinuing sales of its Essure birth control device at the end of 2018, citing business reasons.
The Essure System offered women an option for permanent birth control. It is the only FDA-approved, non-incisional form of permanent birth control.
News of the recall comes ahead of a Netflix documentary called The Bleeding Edge, which highlights health problems caused by devices like Essure.
Bayer states that the recall is due to declining sales and that the Essure business “is no longer sustainable.”
In the press release, the company stood behind its product, writing: “The benefit-risk profile of Essure has not changed, and we continue to stand behind the product’s safety and efficacy, which are demonstrated by an extensive body of research undertaken by Bayer and independent medical researchers, involving more than 200,000 women over the past two decades.”
Bayer maintains that the discontinuation of sales is strictly a business decision and not due to safety or efficacy concerns.
“Women who currently have Essure in place may continue to confidently rely on the device, and Bayer will continue to support women with Essure and their healthcare providers,” the company said in its statement.
Bayer had been facing increased pressure from women who claim to have experienced severe side effects from Essure. More than 16,000 women have filed lawsuits, according to the company’s annual report.
The FDA restricted sales of Essure to medical facilities in 2018. Doctors were required to use a specific checklist that informed patients of the many potential side effects of the device. The move came after the FDA in 2016 required the company to add a black box warning to its label. The FDA also required Bayer to continue postmarket surveillance of Essure’s safety and effectiveness.
Between 2002 and 2017, the FDA received more than 27,000 adverse event reports related to the contraceptive device.