The FDA announced that it is limiting the sale and distribution of the birth control device Essure, stating that not enough women are aware of the risk for adverse events linked to using the device.
“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,” FDA Commissioner Scott Gottlieb, MD, said in a press release.
“Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information,” Gottlieb continued. “That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”
The release stated that effective immediately, the sale and distribution of the device will be restricted to health care providers and facilities that provide patients with a brochure titled “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement.”
According to the agency, providers must review this material with the prospective patient to ensure the patient comprehends the benefits, risks and other information about Essure. The patient must be allowed the chance to sign the acknowledgment, and it must be signed by the physician implanting the device.
“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,” the release stated. “The FDA will review and monitor Bayer’s plan to ensure the company complies with the restriction. The FDA plans to enforce these requirements and will take appropriate action for a failure to comply, including applicable criminal and civil penalties.”
The FDA also stated that some women who have received Essure have reported allergic and hypersensitivity reactions, depression, fatigue, hair loss, inserts moving to the abdominal or pelvic cavity, ongoing pain, perforation of fallopian tubes and/or uterus and weight changes. The agency indicated that Essure’s role in these symptoms is currently unknown.
Nearly 18 months ago, the FDA required Bayer to add a boxed warning to the product labeling stating information about adverse events linked to the device, “including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions.” The agency also mandated that a more extensive patient decision checklist be added to the product’s labeling.
In a separate press release, Bayer said its labelling changes have been approved by the FDA, and that despite the warning, Essure remains safe.
“The label now states that the sale and distribution of Essure is restricted to health care providers who counsel patients according to the approved label. The benefit/risk profile of Essure has not changed and remains positive,” the company stated. “As the FDA has repeatedly determined — after a rigorous review of the scientific evidence — Essure, the only nonincisional 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.”
Disclosure: Gottlieb reports no relevant financial disclosures.