By Nishant Mohan
Bayer AG will stop selling its Essure birth-control device in the U.S. after this year due to declining sales, the company said Friday.
Bayer said the sales decline resulted from fewer women favoring permanent contraception over other options, as well as from "inaccurate and misleading publicity."
The U.S. is the only remaining market where the German pharmaceutical and chemicals company sells Essure. The company said in a statement it sold Essure in a total of 21 countries, but ended sales of the implant in all countries but the U.S. last year on a "lack of interest in the product."
"Our decision to discontinue sales is for business reasons, and not for any safety or efficacy concerns about Essure," the company said in a statement.
In April, the U.S. Food and Drug Administration tightened restrictions on the sale and distribution of the birth-control implant, requiring both patients and health-care providers to sign an acceptance-of-risk form.
That move followed an FDA decision in 2016 requiring Bayer to add a prominent warning to call attention to serious risks associated with the device, after studies linked it to pain and other health issues among women.
In April the FDA said since adding the warnings, Essure sales have declined about 70% in the U.S.
The company said it planned to continue enrolling Essure patients in a postmarket study and would work closely with the FDA to ensure appropriate follow-up.
Bayer said Essure, which gained FDA approval in 2002, is the only FDA-approved nonsurgical form of permanent birth control.
--Stephen Nakrosis contributed to this article.
Write to Nishant Mohan at [email protected]