February 29, 2016 — Bayer has been ordered to conduct new clinical trials and update the label on Essure to include a “Black Box” warning about severe, debilitating side effects.
The FDA also required a new clinical trial to determine the risks for particular women. The agency will also require a Patient Decision Checklist to help make sure women understand the risks and benefits of Essure.
Essure is a permanent sterilization device that was marketed as an quick outpatient procedure with a fast recovery time. Instead, thousands of women were injured by debilitating side effects, such as:
- Persistent pain
- Perforation of the uterus or fallopian tubes
- Device migration
- Abnormal bleeding
- Allergy or hypersensitivity reactions
The FDA resisted demands to ban Essure because it is the only non-surgical sterilization device on the market. Congressman Mike Fitzpatrick issued this statement:
“It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market.”
Essure is inserted through the vagina into the fallopian tubes, where it causes low-level inflammation and irritation. After a few months, scar tissue grows around the metal coils and blocks the fallopian tubes. Unfortunately, a recent study published in the British Medical Journal linked Essure with a 10X increased risk of follow-up surgery compared to traditional “tube tying” sterilization surgery.