- German drugmaker Bayer AG will halt sales of its Essure contraceptive implant in countries outside of the U.S., citing commercial reasons and a lack of demand in a statement posted to its French website Monday.
- Bayer said the decision was unrelated to the product's efficacy or safety and would not impact sale of the device in the United States.
- Approved in 2002, Essure has been the subject of thousands of consumer complaints related to pain and device migration, spurring the Food and Drug Administration to review the device's benefit/risk profile. The regulator concluded last year the device remained appropriate for a majority of women, but added a boxed warning label and mandated Bayer conduct a post-marketing surveillance study.
Practically, Bayer's decision means it will not seek renewal of its Conformité Européene (CE) mark for Essure, a requirement of selling a medical device in the E.U., Liechtenstein, Iceland and Norway.
"Bayer made a commercial decision this spring to discontinue the distribution of Essure outside of the U.S. where there is not as much patient interest in permanent birth control," the company said in an emailed statement.
Essure is a form of permanent birth control involving the implantation of flexible coils into a woman's fallopian tubes.
The company stands behind the device, emphasizing its positive risk/benefit profile. The FDA has agreed, although it notes the potential risk of serious complications such as persistent pain, bleeding or perforation of the uterus due to device migration.
According to an annual report for 2016, more than 3,000 lawsuits have been filed against Bayer related to Essure.