FDA Panel to Reevaluate Essure Birth Control Method

Medical experts will meet on Thursday to take a closer look at problems reported with the birth control implant Essure, including chronic pain, bleeding, headaches, and allergic reactions.

On September 24, the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee of the Food and Drug Administration (FDA) will meet to discuss the risks and benefits of Bayer HealthCare’s Essure birth control system, US News reports.

Essure was granted FDA approval in November 2002 and is marketed as the only permanent birth control method that does not require surgery. According to Bayer HealthCare Pharmaceuticals’ online materials, the implant procedure can be done in a doctor’s office and takes about 10 minutes to perform. The procedure does not require hospitalization, incisions, or the recovery time of surgical sterilization.

Essure consists of small nickel-titanium coils that are inserted through the vagina into the woman’s fallopian tubes. The coils cause scar tissue to form in the fallopian tubes, eventually blocking the tubes and preventing pregnancy. Three months after the procedure, the woman has a follow-up X-ray using dye to confirm that the tubes are fully blocked. Once blockage is confirmed, the method is considered 99.83 percent effective, National Public Radio (NPR) reports.

Essure has been in use for 13 years, but the FDA has recently received numerous complaints of injuries and side effects from women implanted with the device. Some studies suggest problems with Essure are relatively rare, but thousands of women have attributed health problems to the implant. Among the health effects are unintended pregnancies and ectopic pregnancies. Ectopic pregnancy, where the embryo implants somewhere other than the uterus, can be life threatening. Women have also experienced migration of the device from the fallopian tubes, organ perforation, chronic pain, and allergic reaction to the nickel in the coils. Though the method is considered permanent, akin to surgical sterilization, some women have had the coils removed to alleviate the unwanted effects. NPR reported that a Facebook group formed for Essure users drew posts from more than 18,000 women who have experienced symptoms they attributed to Essure,

The FDA panel will seek expert scientific and clinical opinion on the risks and benefits of Essure, including comments and written testimony from women implanted with the device. The committee will evaluate scientific evidence about the safety and effectiveness of Essure, and will provide recommendations to the FDA about appropriate use of the device, product labeling, and the potential need for additional post-market clinical studies.

The panel meeting will be held at the FDA’s campus in Silver Spring, Maryland and will be open to the public. The FDA collected written and electronic submissions that will be given to the panel for consideration in its deliberations.

This entry was posted in Defective Medical Devices, Essure. Bookmark the permalink.


© 2005-2018 Parker Waichman LLP ®. All Rights Reserved.