FDA Restricts Sale and Distribution of Bayer's Essure Device

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Patients must also receive a brochure and sign risk acknowledgment.

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The US Food and Drug Administration (FDA) issued an order to restrict the sale and distribution of Bayer’s Essure device to guarantee that all women contemplating the use of the permanent contraception device are provided with adequate risk information.

As of recent, the FDA has become aware that women were not adequately informed of Essure’s risks before receiving implantation of the device, despite past significant efforts to educate patients and doctors about the risk associated.

“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,” Scott Gottlieb, MD, FDA Commissioner, said in a statement. “We take the concerns of all women affected by Essure very seriously.”

The FDA is mandating a unique type of restriction on the device to restrict the sale and distribution, imposing additional requirements needed to provide a reasonable assurance of its safety and effectiveness.

In February 2016, the FDA ordered Bayer to conduct a post-market (522) study to better evaluate the safety profile of the device when used in the real world, then in November 2016, the agency required Bayer to add a boxed warning to the product labeling stating information about adverse effects associated with the device. Additionally, the FDA required a more comprehensive patient decision checklist to provide women considering Essure information about the benefits and risk of the device.

The new labeling, which will now be legally required when the product is offered to patients, restricts the sale and distribution of the device, except to health care providers and facilities that provide information about the risks and benefits.

The patient brochure, “Patient-Doctor Discussion Checklist-Acceptance of Risk and Informed Decision Acknowledgement,” must be reviewed with the prospective patient to ensure the patient understands the information about Essure implantation. Patients must be allowed the opportunity to sign the acknowledgment and it must also be signed by the physician implanting the device.

“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 added. “That is simply unacceptable. Every single woman receiving this device should fully understand the associated risk.”

Essure is the only permanent implanted birth control device that does not require surgical incision. The process involves the insertion of flexible coils through the cervix and vagina into the fallopian tubes. Over about 3 months, scar tissue forms around the inserts and creates a barrier to prevent conception.

Some patients implanted with Essure experience adverse effects including perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain and suspected allergic or hypersensitivity reactions.

Additionally, women have reported headache, fatigue, weight changes, hair loss and mood changes like depression, however, it’s unknown whether these are related to Essure.

Bayer is required to implement the restrictions immediately and must ensure the process going forward results in health care provider compliance with the sales restriction. The FDA will review and monitor the company’s plan and will enforce the requirements. Failure to comply with the FDA’s decision will result in appropriate action, including applicable criminal and civil penalties.

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