Published: Wed, April 11, 2018
Medical | By Marta Holmes

FDA restricts sale, distribution of Essure contraceptive device

FDA restricts sale, distribution of Essure contraceptive device

MONDAY, April 9, 2018 (HealthDay News) - To help curb complications tied to the permanent contraceptive implant Essure, the U.S. Food and Drug Administration on Monday slapped new restrictions on the sale of the device. It said the decision to require the new patient-consent form for the procedure was based on evidence "that some women were not being adequately informed of Essure's risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device". It issued an order restricting the sale and distribution of Essure to healthcare providers and facilities that provide information to patients about the risks and benefits of the device.

Two years ago, Essure got the FDA's strongest warning label.

"Bayer has educated and continues to educate healthcare providers about the importance of appropriately counseling each patient on the benefits and risks of Essure", Bayer spokesperson Courtney Mallon said in a statement.

So, the agency said it has made a decision to "impose additional requirements needed to provide a reasonable assurance of its safety and effectiveness". Flexible coils are inserted through the vagina and cervix and into the fallopian tubes, which carry eggs from the ovaries to the uterus. The FDA originally approved the product in 2002. Although Essure sales have decreased by ~70%, the FDA believes that some women are still not being informed about the established risks of Essure prior to implantation.

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Other women have reported headaches, fatigue, weight changes, hair loss and depression, though it's unclear whether those symptoms were related to the device.

Essure is the only permanent implanted birth control device that does not require surgical incision. Patients must be allowed the opportunity to sign the acknowledgment and it must also be signed by the physician implanting the device. The updated patient brochure, which includes the new "Acceptance of Risk and Informed Decision Acknowledgement", must be reviewed with the patient to ensure that she understands the information regarding Essure.

Bayer is required to implement the FDA's restrictions immediately. The FDA says failure to comply will lead to applicable criminal and civil penalties.

Still, one expert in women's health said the FDA move can only be helpful to women. The agency is now monitoring the company's progress. The agency noted that most of the new reports came from attorneys representing patients suing Bayer.

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At a meeting this February between FDA chief Scott Gottlieb and representatives from a Facebook group representing 36,000 current and former Essure patients, the women provided survey data from the group showing that of the 476 women who had joined since the black box warning was added, only 8 claimed their doctors had told them about the safety issues.

Angie Marie Firmalino, a co-founder of the group, emailed that members were "excited" to read about the FDA action.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

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