(RxWiki News) By the end of this year, Essure, a permanent birth control device approved by the US Food and Drug Administration (FDA) in 2002, will no longer be produced and sold in the United States.
Device maker Bayer has announced its plan to stop making and selling Essure by Dec. 31, 2018. The company cited a decrease in sales as its reason for discontinuing the product.
In an effort to make women more aware of the risks tied to this product, the FDA placed a restriction on the sale and distribution of Essure in April of this year.
Essure is a permanent birth control device that is not intended to be removed. It is not surgically inserted — a health care professional inserts it into the fallopian tubes through the vagina and cervix.
The device consists of flexible coils. After about three months, tissue growth around the coils serves to block the path of sperm to eggs, preventing conception.
After approving Essure, the FDA looked into reports of adverse events tied to the device. These events included allergic reactions, relocation of the device in the body, pain, puncturing of the uterus and fallopian tubes, abnormal bleeding and failure of the device to prevent pregnancy.
Some women opted to have the device surgically removed. These incidents prompted the FDA in April of this year to restrict sales to only health care providers who used an FDA-approved checklist that the patient reviewed and agreed to. The agency also mandated certain changes in the labeling of the product.
Bayer said it will continue to honor the sales and distribution restrictions until the end of the year, when it will stop making Essure.
The FDA still believes the benefits of Essure outweigh the risks, and this position has not changed in light of Bayer’s announcement. The FDA advises women who have the Essure implant to discuss any medical questions they have with their health care providers.