Since it was approved in 2002, “permanent contraceptive” device Essure has been the subject of thousands of complaints from women who have had the device implanted. Complaints about the device range from headaches to hair loss, brain fog, heavy bleeding, abdominal pain, perforation of the uterus, and even pregnancy and miscarriage. Marketed as a less invasive alternative to surgical sterilization, the device consists of two small coils that are inserted in fallopian tubes through the vagina. The coils cause the growth of scar tissue that prevents sperm from fertilizing eggs.
Between Essure’s introduction and 2017, the Food and Drug Administration has received more than 26,000 reports on Essure. Though some of the reports are duplicates and others were submitted by Essure’s manufacturer Bayer, the FDA notes that patient-submitted reports are consistent on the “nature and severity” of Essure’s side effects.
The initial reports led the FDA to issue a “black box” warning on the device in 2016. The new labeling informed women of the risks of Essure, many of which were not reported following initial clinical trials; those include ectopic pregnancy, abdominal pain, and pelvic inflammatory disease. Patients were also given an FDA-approved booklet produced by Bayer further outlining risks and side-effects. (In addition to death, the booklet lists “regret” as a potential side effect.)
Though the sale of Essure fell roughly 70 percent, many advocates, including the over 35,000 women who have joined Essure Problems, a group for women who have “suffered side effects which may be attributed to Essure,” argued that the black box warning wasn’t enough to address the potentially serious side effects of the implant. In February, FDA Commissioner Scott Gottlieb met with a group women concerned that the 2016 warning attached to Essure wasn’t effective. While some of those women were concerned that patients weren’t being explicitly told about risks and injuries, other asked that the device be entirely removed from the market.
In response, the FDA announced on Monday that had placed further restrictions on Essure, but said that the device will remain on the market. According to the new regulations, the sale and distribution of Essure will be limited to healthcare providers who agree to review a brochure—called the Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement—with patients. Only women who read and sign the brochure will be able to receive Essure. The brochure must also be signed by the woman’s doctor.
“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” Gottlieb said in a statement. “Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks,” he added.
The news met with a mixed response from members of the Essure Problems digital community, some of whom argued that Essure must be removed from the market entirely. “While it doesn’t take Essure off the shelves, it certainly holds Bayer accountable,” the group said in a statement.