June 26, 2015 — After receiving over 5,000 complaints involving Bayer’s permanent birth control coil Essure, the FDA announced that it will launch a safety investigation.
The FDA’s Obstetrics and Gynecology Devices Panel will meet on September 24 to discuss the “safety and effectiveness” of Essure. The spring-like metal coil is implanted though a woman’s uterus into the fallopian tubes, where it blocks fertilization.
Unfortunately, the FDA has received 5,093 reports of side effects, including five fetal deaths in women who became pregnant and four women who died from complications like infection, uterine perforation, air embolism, and suicide.
The most commonly-reported adverse events include:
- Abdominal pain
- Heavier periods
- Headache
- Fatigue
- Weight fluctuations
The FDA warns:
“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 against Essure has been growing for many years. Erin Brokovich, an attorney who made her name fighting against water pollution, launched an online forum for women to share stories about injuries caused by Essure.
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