Bayer will end the sale of its embattled Essure permanent contraception outside the United States, but its decision is based on commercial, not safety reasons, the company announced earlier this week.
Marketed as a nonsurgical alternative to tubal ligation, Essure is a small, flexible metal coil that fits into each fallopian tube through the cervix and uterus. The ensuing inflammation and scarring permanently seal each tube within 3 months.
The US Food and Drug Administration (FDA) still views Essure's benefits as outweighing its drawbacks. However, in November 2016, the FDA added a boxed warning to its label that points to the risk of the device perforating organs, migrating within a woman's body, triggering allergic reactions, and causing pain.
As of July 13, some 5700 women in the United States who've used Essure have sued Bayer, alleging that they were injured by the device, according to a recent company financial report. Public Citizen, a consumer watchdog group, wants Essure banned here.
The birth control device has run an international regulatory gauntlet. Brazil stopped Essure sales temporarily and recalled distributed products in February ― for administrative reasons, according to Bayer. European Union nations suspended sales of Essure for 3 months this year over a licensing issue, which led a few countries to issue a recall as well.
In an email to Medscape Medical News, Bayer spokesperson Courtney Mallon said that the company "made a commercial decision this spring to discontinue the distribution of Essure outside of the US where there is not as much patient interest in permanent birth control.
"The decision is unrelated to product safety or efficacy," Mallon said. "More than a decade of science and real-world clinical experience support the safety and efficacy of Essure. Bayer's decision does not impact the sale or marketing of the product in the United States, where there continues to be demand despite the recent inaccurate and biased reporting."
Michael Carome, MD, director of Public Citizen's healthcare division, told Medscape Medical News that his group encourages Bayer to halt Essure sales in the United States as it's doing elsewhere. The device was approved, Dr Carome said, without adequate testing for safety.
Follow Robert Lowes on Twitter @LowesRobert
Medscape Medical News © 2017
Cite this: Sales of Essure Contraceptive Halted Outside of US - Medscape - Sep 21, 2017.