The U.S. Food and Drug Administration issued an order yesterday to restrict the sale and distribution of the permanent contraception device, Essure, due to the revelation that not all women were being informed of its risks prior to getting it implanted.
The restriction will limit the sale and distribution of Essure to only health care providers who make sure to use the FDA-approved "Patient-Doctor Discussion Checklist -- Acceptance of Risk and Informed Decision Acknowledgement".
Doctors and healthcare facilities must agree to review this checklist with patients and have them sign it before implanting the Essure device in order to sell and distribute the product.
This safety measure has been put into place by the FDA in order to ensure that the medical device meets standards for a reasonable assurance of safety and effectiveness.
"We take the concerns of all women affected by Essure very seriously...Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren't receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks," stated FDA Commissioner Scott Gottlieb, M.D.
Bayer, the manufacturer of the device, must also include the following new labeling on the device:
- The following statement: "The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer."
- Bayer's Patient-Doctor Discussion Checklist -- Acceptance of Risk and Informed Decision Acknowledgement, which is part of the patient information booklet, and has key items about the device, its use, and safety and effectiveness outcomes, which the patient should be aware of as they consider permanent birth control options.
Bayer has been instructed to implement the restrictions immediately, ensuring that health care providers comply with the sales restriction. According to the FDA, failure to comply may include criminal and civil penalties.
Essure, which is the only permanent birth control device on the market that is not surgically implanted in women, has caused some cases of adverse events including persistent pain, allergic or hypersensitivity reactions, perforation of the uterus and/or fallopian tubes, and migration of inserts to the abdominal or pelvic cavity.
"Ensuring informed decision making is just one important step in our ongoing efforts to monitor this device. We remain committed to carefully and thoroughly considering all new data and evidence and will continue to work with patients affected by this device as part of our process," said Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA's Center for Devices and Radiological Health.
Read the FDA News Release here.