A so-called "black box" warning has been recommended for the device, which is "designed to call attention to serious or life-threatening risks" of the device including "persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions," according to an FDA statement.
Touted as the only form on non-surgical permanent birth control, implanted Essure coils are supposed to stay in the fallopian tubes, where they create a chronic infection causing scar tissue to form, effectively closing the tubes and rendering the woman sterile. The device was first manufactured by the group Conceptus and pre-approved by the FDA before hitting the markets in 2002. In June 2014, Conceptus was bought by Bayer, which has continued to manufacture and distribute Essure.
In addition to the "black box" warning, the FDA asked Bayer to include a "patient decision checklist" in Essure's packaging, "to ensure women receive and understand information regarding the benefits and risks of this type of device," and is accepting the public's input on the device for 60 days.
The FDA has also ordered Bayer to conduct a three-year clinical study in which they will follow 2,000 women who have been implanted with Essure, and compare them to women who've had different sterilization procedures. The FDA expects Bayer to submit a study protocol within 30 days and the company is required by law to begin the study within 15 months, CNN reports. If Bayer does not comply, the FDA can declare the device misbranded.
The Facebook page "Essure Problems" is over 27,000 members strong (up from 14,000 just last year) and serves as a place where the "E-sisters" women band together for support and protest the device. They tell their stories to women considering the device and provide the names and locations of doctors who won't dismiss women's Essure complaints.
"We have provided the FDA with enough relevant data to prove that Essure is unsafe," the group said in a statement following the FDA's latest announcement.