FDA turned up the heat Monday on Bayer to make sure women who are considering the implantable contraceptive device are adequately informed of its risks.
Now, patients must be given the opportunity to sign an acceptance of risk and informed decision acknowledgment, and the same "patient-doctor discussion checklist" must be signed by the physician implanting the device. The agency said Bayer will be required to implement the restrictions immediately and ensure that the process going forward results in healthcare provider compliance with the sales restriction. FDA said it will review and monitor the company's plan to ensure it complies with the restriction, and the agency threatened to take "appropriate action for failure to comply, including applicable criminal and civil penalties."
FDA added a boxed warning to Essure in 2016 and ordered Bayer to run a new postmarket surveillance study on the device, as well as provide a patient decision checklist to ensure that women considering the permanent birth control option were fully informed of the procedure's risks and benefits. It seems some women, however, never received that information before having the Essure implanted.
"Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information," said FDA Commissioner Scott Gottlieb, MD. "That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”
Essure is the only permanently implanted birth control device for women on the market that does not require a surgical incision. In the procedure, a healthcare provider inserts flexible coils through the vagina and cervix and into the fallopian tubes. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier intended to keep sperm from reaching the eggs, thus preventing conception.
Last month Gottlieb reported that the agency received nearly 12,000 medical device reports for Essure in 2017, the majority of which were received just in the last quarter of the year. It is still unclear, however, if these latest reports stemmed from new concerns or if they had been reported in a prior safety filing. Most of the newer reports stemmed from cases made available by plaintiff attorneys as part of litigation against Bayer.
Some of the adverse events that Essure patients have experienced after getting the device implanted include perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. Women have also reported headache, fatigue, weight changes, hair loss, and mood changes, such as depression, but FDA said it is not known whether these symptoms are related to Essure.
The Essure Problems patient advocacy group, which has been fighting for years to get the controversial birth control device off the market, said its administrators and online support group members were excited to read FDA's announcement restricting the sale and distribution of Essure in the United States.
"This is a unique restriction, and it will help resolve the issue we brought up with Commissioner Gottlieb, that almost 95% of women implanted after the FDA's guidance was issued were not getting the new warnings about Essure," the group said in a statement emailed to MD+DI.
The group said it had collected the data and presented it to Gottlieb in February.
"The new Essure labeling will now be legally required when this product is offered to a patient," Essure Problems said in the statement. "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 group, informally known as the E-Sisters, were not previously impressed by FDA's reaction to their complaints.
"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 and will only permit the sale to physicians and facilities that provide the specifically required warnings."
FDA noted that since it ordered Bayer to conduct a post-market study and to add a boxed warning and the patient decision checklist to the labeling, U.S. sales of Essure has dropped about 70%. The agency initially approved the device in 2002.
Bayer has not yet responded to MD+DI's request for comment on this story. The story will be updated if and when the company responds.