FDA to Take Closer Look into Essure's Risks

To better understand the risks of Essure, a permanent method of birth control, the FDA has called for a new mandatory clinical study to look at its risks.

Essure involves the insertion of flexible coils through the cervix and vagina into the fallopian tubes. Over a 3-month span, scar tissue forms and creates a barrier, thereby preventing sperm from reaching the eggs. Pharmacists can remind patients that they need to take alternative forms of birth control during this 3-month period while the scar tissue forms.

Essure may be a suitable option for the majority of women who desire permanent birth control, but some women may be at risk for serious complications, including persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding, and allergy or hypersensitivity reactions.

The FDA expects to require changes to the product labeling, including a boxed warning on adverse events related to the insertion and removal procedures.

The FDA also envisions using a patient decision checklist to ensure women understand the risks of using such a device. This checklist would emphasize the importance of a “confirmation” test 3 months after the device is implanted to make sure Essure has been properly placed and scar tissue has formed.

In addition, the FDA has issued a draft guidance so that the public can comment on the language included in the warnings.

“The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them,” said William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, in a press release. “They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications.”

Essure’s manufacturer, Bayer, will also be required to conduct a new postmarket surveillance study to provide information about “the risks of the device in a real-world environment.”

The study must provide data to help the FDA better understand the risks of using Essure and compare them with laparoscopic tubal ligation. The FDA also seeks more information on the rates of complications, including unplanned pregnancy, pelvic pain, and other symptoms, and surgical removal.

In addition, the study must collect information about why some patients are not taking a confirmation test to make sure Essure has been properly inserted.

“The FDA will use the results of this study to determine what, if any, further actions related to Essure are needed to protect public health,” the FDA wrote in a press release.