WASHINGTON -- Physicians who want to implant the controversial Essure sterilization device are now required to provide an FDA-approved to patients, which includes a consent form, the .
Essure, a flexible coil inserted through the vagina into the fallopian tubes that prompts obstructive tissue growth, is intended to be a minimally invasive option for permanent sterilization. However, numerous reports of adverse events, including procedural complications, need for second procedures, chronic pain, and device failure -- i.e., patients became pregnant -- prompted the agency to begin re-examining Essure in 2015. Essure was first approved in 2002.
Last September, the product's current owner, Bayer AG, said it would in all worldwide markets, except the U.S., saying the decision was for commercial reasons, not because of safety problems. In fact, a favorable benefit-risk balance.
In the announcement Monday, the FDA did not provide any new evaluation of Essure's basic benefit-risk profile. 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."
"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," said FDA Commissioner Scott Gottlieb, MD, in the agency's statement.
The required brochure includes comparative information on various other contraception methods -- IUDs; hormonal pills, patches, and implants; male condoms; female barrier devices; and the so-called rhythm method. It also includes a checklist of possible adverse effects that patients must individually initial, indicating that the physician had explained them.
Further action may await completion of a in 2016. Final results are expected in 2023.