Essure is a birth control device that is marketed as a form of permanent birth control with no surgery required. Instead of going under the knife, which tubal ligation requires, Essure is inserted during an outpatient procedure in which a doctor inserts it by catheter. No anesthesia or incision is required. The device is made up of metal coils that are placed inside the fallopian tubes; over a three month period, scar tissue develops around the coils which blocks conception.
Essure has been on the market since 2002, but there has been a recent surge in complaints. The U.S. Food and Drug Administration has reportedly received almost 1,000 adverse event reports – 500 of those came in 2013. In addition to FDA reports, thousands of women are discussing its debilitating side effects and mysterious health issues they believe are linked to the device through online support groups. Some have even gone to drastic measures to remove the coils, including undergoing hysterectomy.
Some of the common issues reported by women include:
- Menstrual irregularities
- Weight fluctuation
- Device migration
Because Essure is meant to remain permanently in the body, some doctors are said to be reluctant to remove it without proof that it’s the device that is responsible for the problems the woman is experiencing. Removal is said to be technically challenging, particularly after it’s been in place over three months.
FDA reviewing evidence
After re-examining results of safety studies presented by the manufacturer as well as Internet testimonials and complaint reports, the FDA stated that “no conclusive evidence” can be found to link the device to symptoms like weight change, depression and extreme fatigue. The agency admits there is evidence of complications, but that the overall results don’t demonstrate new safety issues or increased incidence of problems that were already known.
Some women’s health advocates disagree with the statement that adverse events are rare, and well-known activist Erin Brockovich is also lending support to the cause. She believes the manufacturer is at fault for not completing a full study and the FDA is also at fault for not enforcing it. When the agency approved the device it was given “preemption status” which means that if a woman is injured by it she cannot sue the manufacturer.