FDA Requires “Black Box” Warning on Essure Label

February 29, 2016 — The FDA has ordered new safety studies and a “Black Box” warning about serious risks associated with Essure, a sterilization device made by Bayer.

The FDA has been reviewing the risks of Essure since September 2015. After a five-month review, the agency issued draft guidance that included warnings about serious complications, such as:

• Persistent pain
• Perforation of the uterus or fallopian tubes
• Device migration
• Abnormal bleeding
• Allergy or hypersensitivity reactions

However, the actions fell short of demands from lawmakers to ban Essure. U.S. 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 a permanent form of birth control for women. It is a matchstick-sized piece of plastic coated in irritating fibers and wrapped in metal coils. Essure is implanted into the fallopian tubes through the vagina, where it causes low-level inflammation and scarring that causes infertility.

Essure was marketed as an easy outpatient procedure for women who don’t want a hysterectomy. Instead, many were left with debilitating pain, bleeding, and other side effects. A study published in the British Medical Journal linked Essure to 10X increased risk of needing follow-up surgery compared to traditional “tube tying” sterilization.