Leaders of Essure Problems group met with FDA commissioner Scott Gottlieb in late February 2018. As a result, on April 9th, 2018, the FDA finally issued an order restricting the sale and distribution of Essure to ensure that all women contemplating use of the sterilization device are provided adequate risk information concerning the potential risks. The new, legally-required Essure labeling restricts the sale and distribution of the device to only health care providers and facilities who provide the mandated information to patients about the risk and benefits of the device, signed by both the patient and the physician. The FDA will enforce these requirements and will take appropriate actions, including civil and criminal penalties if necessary.
The members of Essure Problems are hopeful these new unique restrictions will lead to a decline in sales—and the demise of Essure all together, as it is not likely many physicians will want to endure the risks of purchasing Essure now that they they can be held accountable if women do not receive complete and appropriate informed consent.