Bayer will no longer distribute or sell the Essure permanent birth control device in the United States after December 31, 2018, the company said Friday.
Essure, the only non-surgical permanent form of birth control for women marketed in the US, is inserted into the fallopian tubes, where scar tissue will form and build a barrier to block sperm from reaching — and fertilizing — a woman’s eggs.
US Food and Drug Administration Commissioner Dr. Scott Gottlieb said in a statement Friday the company’s decision follows the FDA’s patient safety action in April when the agency ordered sales and distribution of Essure be restricted.
“The device has been associated with serious risks including persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen,” according to Gottlieb.
The April action was a “unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device’s safety and effectiveness,” according to Gottlieb.
Dr. Yesmean Wahdan, an OB-GYN at Bayer US Medical Affairs, Women’s Healthcare, said in a video statement to the press posted online Friday that the company “made a business decision to discontinue sales and distribution because of a decline in sales.”
Courtney Mallon, a spokeswoman for Bayer, said the “voluntary discontinuation” is not indicative of safety issues and added that the company is “working closely with the FDA and have planned a slow wind-down process to ensure patients and providers are appropriately supported.”
The FDA estimates Essure has been used by more than 750,000 patients worldwide since it was first approved by the agency on November 4, 2002. At the time of the approval, Essure was manufactured and marketed by Conceptus, Incorporated, a company Bayer acquired in June 2013.
From 2002 through 2017, the patient problems most frequently reported to the FDA were pain/abdominal pain (21,215), heavier menses/menstrual irregularities (9,846), headache (7,231), fatigue (5,842) and weight fluctuations (4,970).