FDA on Monday issued an order that limits the sale and distribution of Bayer's implanted birth control device Essure to health care providers that give women information about the risks and benefits of the device.
The order comes amid an FDA investigation into thousands of adverse event reports concerning Essure.
FDA approved Essure—a nickel-titanium coil inserted into the fallopian tubes in a 15-minute procedure to prevent pregnancy—in 2002. Bayer acquired Essure in 2013 and has since faced several lawsuits and received more than 5,000 reports of complications related to the implant, including abdominal pain, abnormal uterine bleeding, and device migration.
Since the device's approval, FDA has required updates to Essure's labeling, including risk disclosures for a chance of pregnancy after implantation and for chronic pain, as well as a warning to women with sensitivity to nickel. FDA in 2016 released final guidance requiring a "black box" warning for certain permanent contraceptive implants, including Essure. FDA also asked Bayer to conduct a post-market study to evaluate the device's safety.
FDA Commissioner Scott Gottlieb last month announced that FDA is investigating thousands of new adverse event reports concerning Essure, noting that the agency in 2017 received nearly 12,000 adverse event reports for Essure. According to Gottlieb, 90% of the reports cited complications involving potential device removal.
FDA orders Bayer to restrict Essure distribution, sales
According to FDA, U.S. sales of Essure have declined by about 70% since Bayer added the required black box warning to the devices' label. However, FDA said some women continue to be unaware of the risks associated with Essure, despite a number of efforts to educate patients and physicians about the device's risks. Gottlieb said, "We've been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option."
As such, FDA has ordered Bayer to immediately update Essure's labeling. The new labeling prohibits Bayer from selling or distributing Essure to health care providers and facilities that do not give women information about the device's risks and benefits. Under the order, health care providers that obtain Essure will be required to review a patient brochure, called "Patient-Doctor Discussion Checklist–Acceptance of Risk and Informed Decision Acknowledgement," with patients to ensure they understand the risks and benefits of Essure. The order mandates that both patients and physicians sign the brochure to acknowledge that the device's risk and benefits have been explained.
The order requires Bayer to implement the restrictions immediately and to develop a plan to ensure health care providers comply with the order's requirements. FDA said it will review and monitor how Bayer ensures compliance and will take appropriate enforcement actions, such as criminal and civil penalties, if affected parties fail to comply with the new requirements.
Further, Terri Cornelison, assistant director for the health of women in FDA's Center for Devices and Radiological Health, said FDA will continue monitoring Essure. "While some women may continue to choose Essure as their birth control option based on current information, as new information becomes available, FDA will continue to keep the public informed of the agency's evaluation and findings, and consider regulatory options that appropriately balance benefits and risks for Essure."
Bayer on Monday said the company has issued a revised label for Essure that emphasizes health care providers must discuss the device's risks with patients. Bayer said, "Patients deserve the most accurate and comprehensive information to help them make their health care decisions, and Bayer has educated and continues to educate health care providers about the importance of appropriately counseling each patient on the benefits and risks of Essure." Bayer added that FDA "has repeatedly determined—after a rigorous review of the scientific evidence"—that Essure is a "safe and effective medical device."
Separately, Holly Ennis, a lawyer representing women who are suing Bayer over Essure, said, "One of our … large concerns is that women who got Essure had no idea there was a warning on the device, or a doctor-patient discussion checklist."
According to the Associated Press, patient advocates have raised concerns over whether the new requirements will benefit patients' health. For instance, Diana Zuckerman, president of the National Center for Health Research, expressed concerns that about whether the patient brochure would be too long or too technical to be accessible to patients (Gever, MedPage Today, 4/9; AP/Modern Healthcare, 4/9; McGinley, "To Your Health," Washington Post, 4/9; Kaplan, New York Times, 4/9; FDA release, 4/9).
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