Essure Birth Control
On July 20, 2018, Essure manufacturer, Bayer AG, announced that it was pulling Essure off the U.S. market by the end of 2018. This announcement followed a series of earlier actions taken by the FDA to address the reports of serious complications associated with Essure use and the filing of more than 16,000 lawsuits by women alleging injury caused by Essure. In 2017, Bayer discontinued the sale of Essure in all countries outside of the United States.
WHAT IS ESSURE?
Essure is a minimally invasive permanent birth control procedure for women. It is a type of tubal sterilization. A soft, flexible insert is placed into each fallopian tube. The Essure insert is made of materials that include polyester fibers, nickel, titanium, platinum, silver-tin and stainless steel. Over three months after insertion, a barrier forms around the inserts. This barrier, which is made of scar tissue, helps keep sperm from reaching the eggs so pregnancy cannot occur.
Essure was approved by the FDA in 2002. The device was developed by Conceptues Inc., a subsidiary of Bayer AG. More than 750,000 women and their doctors have chosen Essure for permanent birth control.
Reports of severe complications following the Essure procedure include:
- Additional surgeries, including hysterectomy to remove the device and repair internal organs
- Autoimmune response to the device, including fatigue, rashes, hair loss, and weight gain
- Migration of the device or a device component
- Perforation or tear of pelvic organs, including uterus or colon
- Severe migraines and allergic reactions to the device or device components.
- Fetal Death
- Life-threatening Ectopic Pregnancy
FDA RECENT ACTION
- September 2015: The FDA convened a panel of experts to get their input on how we should investigate patient complaints that included abdominal pain, abnormal uterine bleeding, and device migration.
- February 2016: The FDA ordered Bayer to conduct a postmarket (522) study to better evaluate the safety profile of the device when used in the real world. The agency announced that it intended to require labeling changes to help patients better understand the potential risks of the device.
- October 2016: The FDA issued the final guidance, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” and in November 2016, the FDA approved updated labeling for Essure consistent with the guidance that added a boxed warning and a Patient Decision Checklist.
- February 2018: FDA officials met with women implanted with Essure and patient advocates to listen to their concerns and experiences with the device.
- March 2018: The FDA reported on a rise in new medical device reports submitted to the agency’s public database in 2017 with more than 90 percent of the reports involving potential device removal.
- April 2018: In order to address concerns that not every patient was receiving adequate risk information, the FDA restricted the sale and distribution of the Essure device.