Bayer To Stop Selling Essure Birth-Control Implant That Has Been Linked To Severe Injuries
Bayer cited a decrease in demand and said the decision was not related to the safety of the device or the thousands of lawsuits that have been filed against the company.
The New York Times:
Bayer Will Stop Selling The Troubled Essure Birth Control Implants
Bayer announced on Friday that it would discontinue sales of its Essure birth control implant by the end of the year, bowing to a lengthy campaign by health advocates and thousands of women to get the device off the market. The implant has had a troubled history. It has been the subject of an estimated 16,000 lawsuits or claims filed by women who reported severe injuries, including perforation of the uterus and the fallopian tubes. Several deaths, including of a few infants, have also been attributed to the device or to complications from it. (Kaplan, 7/20)
The Associated Press:
Bayer To Stop Sales Of Birth Control Device Tied To Injuries
The German company had billed the device as the only non-surgery sterilization method for women. As complaints mounted and demand slipped, it stopped Essure sales in Canada, Europe, South America, South Africa and the United Kingdom. The U.S. Food and Drug Administration has placed multiple restrictions on the device following patient reports of pain, bleeding, allergic reactions and cases where the implant punctured the uterus or shifted out of place. (7/20)
The Wall Street Journal:
Bayer To Stop Selling Essure In U.S.
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. (Mohan, 7/20)