Using what it called “a unique type of restriction,” the FDA said providers must first review a brochure with patients that lists Essure's risks. The patient then must be given the opportunity to sign the document, and the physician implanting the device will be required to sign it.
The agency said Bayer, which manufactures the device, will be responsible for implementing the restrictions immediately and for ensuring that providers comply. And the agency said it will take appropriate action against Bayer, including imposing criminal and civil penalties, if the company does not follow through.
FDA Commissioner Scott Gottlieb said in a statement that the agency was making the checklist mandatory because some women were not being adequately informed of Essure's risks “despite previous efforts to alert women to the potential complications ... That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”
Essure is a permanent birth-control device. In a procedure that takes about 10 minutes, doctors insert two sets of tiny coils through the vagina and cervix and into a woman's fallopian tubes, which carry eggs from the ovaries to the uterus. Over a period of about three months, scar tissue is supposed to form around the inserts, creating a barrier that keeps sperm from reaching the eggs.
Bayer is facing a raft of lawsuits from patients who say they have experienced complications related to the product, including perforation of the uterus or fallopian tubes, persistent pain and allergic reactions. Some women have also reported headache, fatigue, weight loss and depression, but whether those symptoms are linked to Essure “is unknown,” the FDA said Monday.
In 2016, as a result of rising numbers of complaints about the device, the FDA directed Bayer to conduct a new safety study and to add a “black box” to the label, the strongest type of warning. It also directed Bayer to add a more comprehensive patient-decision checklist to the label that doctors could use to discuss all relevant risks with patients. The latest FDA action made such discussions mandatory.
Agency officials said Monday that they would continue to evaluate new information about the device and “regulatory options” that balance risks and benefits. Essure sales have fallen about 70 percent in the United States since the FDA's 2016 actions, officials said.
Bayer announced last fall that it would stop selling the device outside the United States — for commercial reasons, it said, not safety reasons. Some experts expect the company to stop selling Essure in this country, as well.
Earlier this year, Gottlieb met with critics of the device, including women who manage the Essure Problems Facebook group, which has 36,000 members. The critics told Gottlieb that many women who joined the Facebook group after the black-box warning was added said they had not been told about it, according to BuzzFeed.
On Monday, the administrators of the Essure Problems group praised the FDA action. “While it does not take Essure off the shelves, it certainly holds Bayer accountable to train doctors on the true risks of this device and mandates that doctors must share the black-box warning and patient checklist with women considering Essure,” the statement said. “This is the first step the FDA has taken that actually benefits women over industry, and we are overjoyed to see that the Commissioner listened to our concerns.”
A company statement said that “patients deserve the most accurate and comprehensive information to help them make their health-care decisions, and Bayer has educated and continues to educate health-care providers about the importance of appropriately counseling each patient on the benefits and risks of Essure.” The statement also said the FDA “has repeatedly determined — after a rigorous review of the scientific evidence” — that Essure is a “safe and effective medical device.”