The FDA has announced that it will take several actions regarding Essure, an implantable permanent female sterilization device, according to a press release.
The agency has called for additional study of Essure as well as the inclusion of a boxed warning to inform both patients and doctors.
“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,” William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the 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 may cause serious complications in some women, including "persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions,” according to the FDA.
In its draft guidance, the agency looks to improve patient and physician understanding of risks associated with devices like Essure. It will be included in the product labeling and a patient decision checklist. The FDA has also called for comments from the public, industry and other stakeholders regarding the draft guidance. Comments will be accepted for 60 days.
Additionally, the FDA will require a warning on the box of the product that details adverse events associated with the devices, their insertion and their removal.
Bayer, the company that manufactures Essure, must "conduct a new postmarket surveillance study designed to provide important information about the risks of the device in a real-world environment," according to the FDA. The company will develop and conduct a study to assess the risks associated with Essure compared with laparoscopic tubal ligation.
"This includes the rates of complications including unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the Essure device," the FDA stated. "The study will also evaluate how much these complications affect a patient’s quality of life. Additionally, it will collect information to identify reasons for why some patients don’t have a confirmation test to ensure that Essure has been properly placed 3 months after insertion. 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."