The US Food & Drug Administration has placed additional restrictions on the sale and distribution of Essure, a controversial birth control implant that has been linked to hundreds of thousands of severe injuries across the world. On April 9, 2018, regulators at the FDA issued a new press release detailing safety measures designed “to protect women and to require that patients receive risk information.”

Healthcare providers are now required to disclose the device’s risks to patients before implantation. Doctors who fail to do so lose the right to purchase and use Essure implants, opening themselves (and device manufacturer Bayer) to civil and criminal liability.

FDA Puts “Unique” Restrictions On Essure

“Despite previous significant efforts to educate patients and doctors,” FDA reviewers write, the federal agency became “aware that some women were not being adequately informed of Essure’s risks before getting the device implanted.”

Doctor Filling Out Checklist

The FDA ordered Bayer to add a “black box warning” to all Essure materials in 2016, after receiving a wave of product complaints that described chronic pain, abnormal menstruation, autoimmune disorders and invasive hysterectomy procedures. The labeling change led to a 70% decline in sales, the FDA says. But apparently, those 2016 measures weren’t completely effective, so the FDA is now “requiring a unique type of restriction,” the agency wrote in its April 9 press announcement.

Checklist Mandatory For Implant Sales

The change in FDA policy doesn’t revise or update any of the agency’s previous statements on the safety or efficacy of Essure. Rather, the agency is expanding its role in ensuring that all women who consider Essure as a contraceptive option are fully-informed of the risks.

From here on out, Essure can only be sold by health care providers and medical facilities that provide prospective patients with a full view off the risks and benefits. It’s now a requirement according to federal regulation that doctors review with their patients the patient decision checklist, issued in 2016, that lists medical evidence on the device’s risks.

The checklist now includes a sub-title, “Acceptance of Risk and Informed Decision Acknowledgment,” to “emphasize the importance of this tool,” Bayer said in its own press release, published April 9.

Bayer Must Comply Immediately

“The patient must be given the opportunity to sign the acknowledgment,” the FDA writes, “and it must be signed by the physician implanting the device.” Only healthcare providers who comply with these regulations will be able to purchase and implant Essure in the future.

The responsibility and liability for complying with these regulations has been placed squarely on Bayer’s shoulders. “Bayer, the device manufacturer, is required to implement the restrictions immediately and ensure that the process going forward results in health care provider compliance with the sales restriction.”

Meanwhile, the FDA will review and approve Bayer’s plan for maintaining compliance. And if a doctor slips through, gaining access to Essure without discussing the severe risks with patients, Bayer will bear the brunt of the punishment. “The FDA plans to enforce these requirements and will take appropriate action for a failure to comply, including applicable criminal and civil penalties.”

“Informed Decisions About Risk”

“We’ve been closely evaluating new information on the use of Essure,” says Scott Gottlieb, M.D., current Commissioner of the FDA. “Based on our review of a growing body of evidence,” Gottlieb continues, “we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option.”

Bayer withdrew Essure from the global market in September 2017. In spite of plummeting sales numbers, the company decided to continue selling Essure in the United States until July 2018, when Bayer announced that Essure would be discontinued in North America as well. On December 31, 2018, Essure will no longer be available anywhere in the world.

Nearly 11,000 women have filed lawsuits against Bayer, accusing the company of releasing an unsafe medical device without providing sufficient warnings. Their claims are currently working through the court system.