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The Food and Drug Administration is issuing what it calls a "unique type of restriction" on sales of the permanent contraception device Essure, made by Bayer, to ensure that women considering its use have all available information about its risks and benefits.
"Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information," FDA Commissioner Scott Gottlieb said in a statement Monday. "This is simply unacceptable."
The move will restrict the sale of Essure to doctors and health-care facilities that provide a specific patient brochure detailing the risks of the device — those include perforation of the uterus and fallopian tubes, migration of the device to other parts of the body, pain and allergic reactions, the FDA said.
The checklist was added to the Essure label in November 2016, and now includes a subtitle "to emphasize the importance of this tool," Bayer said in a statement.
The patient must be given the opportunity to sign the document, and the physician implanting the device must sign it, the FDA said. The agency said Bayer is required to ensure health-care provider compliance, and said it will take action such as criminal and civil penalties for a failure to comply.
"Patients deserve the most accurate and comprehensive information to help them make their healthcare decisions, and Bayer has educated and continues to educate healthcare providers about the importance of appropriately counseling each patient on the benefits and risks of Essure," Bayer said, in a statement. "The FDA requested we update the label to emphasize this point."
The company said it will "continue to reinforce the use of the Checklist with healthcare providers and will inform them about this important label update." It noted the FDA "has repeatedly determined — after a rigorous review of the scientific evidence" that Essure "is a safe and effective medical device that benefits women by providing them with a valuable contraception option."
The FDA ordered Bayer to conduct a post-marketing study in February 2016 to provide a better idea of Essure's safety profile, and in November of that year required the company to add a boxed warning — its strongest — on the product label warning of safety issues. It says that since then, sales of Essure have declined 70 percent in the U.S. Bayer pulled the device from markets outside the U.S. in 2017, citing commercial reasons.
Essure is the only permanent contraception device on the market that doesn't require a surgical incision. The procedure entails the placement of flexible coils into the fallopian tubes where then, over about three months, tissue forms to create a barrier that can keep sperm from reaching eggs and preventing conception.