JACKSONVILLE, Fla. – The U.S. Food and Drug Administration issued an order Monday to restrict the sale and distribution of the Essure contraception device over concern women may not be receiving adequate risk information.
The FDA said it's decision comes after it became aware some women were not making informed decisions before making the decision to get the Essure device implanted.
In addition, the FDA is imposing new requirements to provide patients with adequate information about the safety and effectiveness of the device.
New Essure labeling, which is now legally required when the product is offered to a patient, restricts the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risk and benefits of Essure.
The patient brochure, titled in part "Patient-Doctor Discussion Checklist" must now be reviewed with a doctor. The patient must be given the opportunity to sign the acknowledgement, and it must be signed by the physician implanting the device.
The FDA will review and monitor Bayer’s plan to ensure the company complies with the restriction. It plans to enforce these requirements and will take action for a failure to comply, including applicable criminal and civil penalties.