Essure Contraceptive Gets Black Box Warning

Santa Clara, CABayer’s Essure, a permanent birth control system, now includes a black box warning as mandated by the US Food and Drug Administration (FDA). In a statement released earlier this week, the FDA stated that a Patient Decision Checklist will also be included in the Essure packing, in an effort to support women in making an informed decision about using this controversial and allegedly harmful form of birth control.

The boxed warning includes safety statements to clearly communicate significant side effects or adverse outcomes associated with the Essure contraceptive device and information about the potential need for removal.

Hailed as the next generation of contraception, Essure consists of implantable coils that are permanently inserted via a catheter into a woman’s fallopian tubes, to prevent pregnancy. It has been on the market since 2002.

Thousands of women across the US have had the coils implanted, and subsequently joined support groups on social media to discuss the side effects and medical problems they believe are caused by the device. The most common side effects include pain, hemorrhaging, headaches, menstrual irregularities, weight fluctuation, device migration and suspected nickel allergy. Some women have reportedly had a hysterectomy or other procedures to remove coils.

Bayer has revised the physician instructions for use and patient labeling consistent with FDA’s recently finalized guidance: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.

The Patient Decision Checklist provides key information about the device, its use, and safety and effectiveness outcomes. Bayer also incorporates important modifications to the patient counseling and device removal sections of the labeling to provide physicians with additional guidance in these critical areas.