The Food and Drug Administration issued guidance Monday for the labeling of permanent sterilization devices including Essure, a device made by Bayer that has led to dozens of lawsuits and thousands of reports from women who say the tiny nickel coils, implanted in their fallopian tubes, caused them serious harm.
The guidance, not legally enforceable, contains nonbinding recommendations representing the FDA's “current thinking” on a subject—in this case, per the title of the guidance, "Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization." The FDA recommended, as it did in the draft version issued in March, that a boxed warning and patient decision checklist be included in labeling these devices, and it “intends” to require such labeling in premarket approval applications for future devices and for application supplements of devices already on the market.
The only such device currently on the market is Essure, Deborah Kotz, an FDA spokeswoman, confirmed.
It's not clear when those requirements will go into effect. The FDA also did not confirm or deny whether application supplements for current devices exist, or comment on their status. But the FDA said the enhanced labeling will help patients become better informed.
“The agency strongly encourages healthcare providers to use the Patient Decision Checklist in discussions with patients considering Essure,” Kotz said. “The FDA is working with professional medical societies, patient advocacy groups and women's health organizations to ensure that risk information about these devices is disseminated to patients considering Essure or other sterilization options,” she added.
In September 2015, the FDA's panel on obstetrics and gynecology devices met to discuss adverse outcomes associated with Essure. That meeting led the FDA to conclude that some women were “not receiving or understanding information” about the risks and benefits of devices like Essure, the guidance noted.
Essure's maker, Bayer, said in a statement Monday that it would make changes to reflect the new guidance. “We anticipate that in accordance with the final guidance, the Essure Instructions for Use (IFU) and Patient Information Brochure (PIB) will be revised to include a boxed warning and a patient-doctor discussion checklist designed to support appropriate patient counseling,” Bayer said.
The labeling guidance's draft version, published in March, received public comments from 1,358 organizations and individuals, many of whom identified themselves as women harmed by Essure.
Some worried that a black box warning would be insufficient to protect women, while others slammed the FDA for failing to protect the public and for being too soft on Bayer, a multinational German company that in 2015 raked in more than $50 billion in sales.
Bayer, too, commented on the draft guidance from March. In a three-paragraph letter, Todd Paporello, Bayer's vice president and head of North American regulatory affairs for pharmaceuticals and consumer health, maintained that Essure is “an appropriate option for the majority of women,” and that for Bayer, “patient safety is our greatest priority.”
Since Nov. 4, 2002, when the FDA approved Essure, nearly 10,000 reports related to the device have accumulated in the FDA's Manufacturer and User Facility Device Experience database. Among them were injuries like organ perforation, device migration and irregular periods.
An FDA office is also investigating allegations of misconduct by Bayer during clinical trials of Essure, including claims that medical records were altered to improve patients' reported experiences.
Meanwhile, patients alleging Essure harmed them have filed lawsuits in state and federal courts all over the country. In California, plaintiffs were handed a minor, pretrial victory at the end of September when a state judge granted a motion to coordinate 55 cases against the pharmaceutical company.