FDA Approves Important Labeling Changes for Essure Birth Control Device

In continuing effort to advise patients and physicians regarding permanent birth control options, the Food and Drug Administration (FDA) recently approved labeling changes for the Essure birth control device.

Bayer, the manufacture of Essure, will make label and packaging changes for the product, including a boxed warning and patient decision checklist to help patients receive and understand the benefits and risks of the device.

The boxed warning includes safety statements to clearly communicate significant side effects or adverse outcomes associated with Essure and information about the potential need for removal. The patient decision checklist highlights key risk and benefit information. Physicians are encouraged to review the checklist with their patients and co-sign it after the discussion.  

Essure is a permanently implanted birth control device consisting of flexible, metal coils. To implant Essure, the flexible coils are inserted into the fallopian tubes. In about three months, tissue forms around the inserts, blocking sperm from reaching the eggs and preventing pregnancy. Essure is not immediately effective, and users must use another form of birth control for at least three months after the device is implanted.

These labeling changes come after some Essure users reported serious complications, including:

  • perforation of the fallopian tubes and/or uterus;
  • inserts traveling to the abdomen or pelvic cavity;
  • persistent pain lasting weeks or months after the procedure;
  • change in menstrual cycles (bleeding patterns);
  • symptoms similar to those of allergic reactions; and
  • symptoms similar to those in autoimmune diseases, such as joint pain and fatigue.

The FDA encourages health care providers to thoroughly discuss Essure and alternate available birth control methods with their patients, including the benefits and risks. The addition of the patient decision checklist can be used to facilitate these important discussions.

More information is found at the FDA website

Previous Article
Risk alert — Phishing emails sent as official OCR communication

The Office of Civil Rights is alerting physician practices and other HIPAA-covered entities about phishing ...

Next Article
Authentication — A vulnerability in your practice?

Under the ever-present threat of an attack by cyber criminals, health care entities are taking a closer loo...

Telemedicine in Texas: Risks, Rewards, and Where We Go Next [CME webinar]

Learn More