The U.S. Food and Drug Administration announced Monday it is restricting the sales and distribution of the controversial Essure birth control device. An “overjoyed” patient advocacy group says this may be “the final nail in Essure’s coffin.”
The agency will now allow the device to be distributed only through providers and facilities that provide information about the risks and benefits of the permanent contraceptive device through a brochure titled Patient Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement.
The patient must be allowed to sign the acknowledgement, which also must be signed by the physician who implants the device.
The FDA describes the requirement as a “unique type of restriction.”
Sales of Essure have declined about 70 percent in the U.S. since February 2016 when the FDA ordered a post-market study of Bayer’s device. In that time, the agency also ordered a black box warning – the most serious kind – and a patient decision checklist to the label. The device is currently available only in the U.S.
In response to the FDA’s announcement, Bayer issued a statement asserting, “The benefit/risk profile of Essure has not changed and remains positive.”
“Choosing a birth control method is a very important and personal decision,” the company said. “Bayer is deeply committed to providing women with safe and effective healthcare options that meet their individual needs, and is dedicated to ensuring the continued safe, effective and appropriate use of Essure as an important option for permanent contraception. As the FDA has repeatedly determined – after a rigorous review of the scientific evidence – Essure, the only non-incisional option available for those who seek permanent birth control, is a safe and effective medical device that benefits women by providing them with a valuable contraception option.”
FDA Commissioner Scott Gottlieb met in February with members of the Essure Problems group and other advocates. Women told Gottlieb their experiences with Essure, including bleeding, chronic pain, punctured organs, autoimmune issues and allergic reactions to the nickel-based device.
The group issued a statement Monday saying that they told Gottlieb at that meeting that even after the FDA’s earlier guidance, nearly 95 percent of patients were not getting the recommended warnings.
While the FDA’s action on Monday “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 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 and will only permit the sale to physicians and facilities that provide the specific required warnings,” the group added. “We are also pleased that the FDA will require that the labeling must specify the specific training or experience practitioners need in order to implant the device.”
Angie Firmalino, one of the administrators of the Essure Problems Facebook support group, was personally gratified by the announcement.
“For me, I feel like this is the first time we’ve truly been heard, and action has been taken to benefit the safety of women,” she told Drugwatch in a message. “I’m honestly shocked by the FDAs action, but in a good way! It’s been a long seven year uphill battle, but I feel like we are cresting the mountain and about to see victory!!!”
About 750,000 women have used the device to prevent pregnancy. The device looks like a small spring. It is inserted into the fallopian tubes, allowing scar tissue to build around the coils and block the tubes.
Dr. Hooman Noorchashm, an advocate for women’s health, welcomed Monday’s announcement as a sign that Gottlieb, who was appointed by President Trump to head the agency last year, is taking these matters seriously.
“It’s a very important press release from the FDA,” he said. “It really highlights the fact that the commissioner of the FDA himself, Dr. Gottlieb, has taken an active role in looking at this issue.”
The FDA’s announcement “demonstrates that this particular commissioner has not been asleep at the wheel,” he said. Noorchashm also congratulated the patients who fought for years for restrictions.
In September, Bayer announced it was removing Essure from every market outside the United States. The company denied the decision was related to safety concerns.
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