June 26, 2015 — The FDA has announced that it is reviewing the safety and effectiveness of Bayer’s permanent birth control implant Essure following more than 5,000 complaints involving serious injuries, chronic pain, pregnancies, and even deaths.
The FDA will hold a public meeting of the Obstetrics and Gynecology Devices Panel on September 24.
Essure is the only type of permanent birth control approved in the United States. It consists of a small metal coil that is inserted into a woman’s fallopian tubes. It has been on the market since 2002 and implanted in about 750,000 women.
Since then, the FDA has received 5,093 reports of complications. The most frequently-reported side effects include abdominal pain, heavier periods, headache, fatigue, and weight fluctuations.
Five fetal deaths occurred in women who became pregnant after Essure was placed. There were also four adult women who died from complications like infection, uterine perforation, air embolism, and suicide.
The agency warned:
“Problems have also been reported in clinical studies, and they are addressed in the Essure product information (labeling for physicians and patients). Other reports describe symptoms that are not included in the labeling, and were not observed in post-approval studies, or described in the clinical literature such as extreme fatigue, depression and weight gain.”
Public outcry regarding Essure went mainstream after Erin Brokovich, the famed environmental attorney who brought down a California water company, took up the cause and launched an online forum for women to share their stories about Essure.
When Essure was approved in 2002, it was given premarket approval, shielding it from lawsuits. Earlier this month, a judge decided whether to allow five lawsuits to move forward against Bayer on behalf of women who were injured.
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