Essure

Essure System for Permanent Birth Control (Essure) is a non-hormonal birth control system used to permanently prevent pregnancy in women. It is considered a less invasive procedure than surgical alternatives. Bayer, its manufacturer, claims Essure is 99.3 percent effective in preventing pregnancy. However, some patients implanted with Essure have reported life-changing adverse side effects, including perforation of the uterus and/or fallopian tubes, persistent pain, feeling the inserts, and allergic reactions.  Some instances of death have also been reported. Many women are calling for the device to be banned, and the device has been subject to a Food and Drug Administration (FDA) investigation. Between FDA approval of Essure in November 2002 and December 2016, the FDA has received thousands of adverse reports about the device, mostly from women who had received the implants.

14,919 cases of adverse side effects have been reported to the FDA, ranging in severity. The FDA conducted an investigation and mandated that Bayer include a black box warning relating to the side effects, as well as carry out a further study of patients who have the device. The FDA has reported 30 cases of deaths in women who had the device.

Bayer claims that women with a history of pain are more likely to be at risk for pain related to Essure. The device is not indicated for women who have had their tubes tied, have had an abortion, have recently delivered a baby, have had a recent infection, or are undergoing immunosuppressive treatments, including treatments for cancer.

After 14,000 adverse reports (including allegations of clinical trial data being falsified) and a letter from three congresswomen to the FDA commissioner, the FDA conducted a panel review of the device in 2015.

The panel mandated that Bayer:

1. Conduct a postmarket surveillance study to gather more data about the device’s benefits and risks. This study was approved in September 2016 and the interim results are to be made available on the Essure Postmarket Surveillance Study page. However, of the 2,800 women required for the study, only 136 patients had been enrolled by October 19, 2017. The FDA considers this to be adequate progress.
2. Include a black box warning on the device that includes safety statements to better communicate to patients and providers of the significant side effects and complications of the device, and information about the potential need for removal.
3. Provide a Decision Checklist with key terms about the device, its use, and safety and effectiveness outcomes, which the patient should be aware of as they consider permanent birth control options.

The FDA concluded in their review panel that the data had not been falsified and that over 94 percent of women who have the device reported being satisfied with it. The FDA stated that Essure’s improved labeling sufficiently and appropriately informs women of the risks associated with the device, but that they would continue to monitor the studies.