21 Jul, 2018FORTUNE.COM
Bayer said Friday that it would stop selling its Essure birth-control implant later this year following complaints from thousands of women that it led to serious health problems.
"This decision is based on a decline in U.S. sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable. Essure is the only FDA-approved non-incisional form of permanent birth control," Bayer said in a statement. “The safety and efficacy of Essure have not changed."
Introduced in 2002, the Essure implant consists of two coils made of polyester and a nickel alloy that are placed in the fallopian tubes and cause scar tissue that effectively blocks them. Several women have sued Bayer, claiming the Essure implant perforated the uterus or otherwise injured them.
In 2016, the FDA ordered Bayer to label Essure packages with warnings of such potential injuries as well as the risk of its traveling into the abdomen or pelvic cavity. In April, the agency moved further, restricting Essure sales to medical practices that agree to inform patients of the risks involved.
The FDA has received 27,000 reports of injuries related to Essure implants in the past 16 years. Some health officials have indicated the actual figure could be higher as potential side effects could include hair loss, tooth loss, chronic pain, and miscarriages.
"Thousands of women have reported serious complications from Essure, and there has been no unbiased long-term research to refute or confirm those reports," Diana Zuckerman, president of the National Center for Health Research, told the New York Times. "Both the FDA and the company are responsible for a situation where women could not make informed decisions."