Essure Receives New Boxed Warning and Patient Decision Checklist

Following reports of pain and other adverse events, Essure, the permanently implanted birth control device for women from Bayer, now includes a new boxed warning and a Patient Decision Checklist.

Both of these additions are designed to support patient counseling, according to a statement from the US Food and Drug Administration (FDA). The new labeling changes will allow users to have a better understanding of the risks and benefits associated with Essure, as well as what to expect during and after implantation.

The boxed warning includes safety statements on potential adverse events or outcomes associated with the device and information about removal. The Patient Decision Checklist provides information about the device’s use, safety, and effectiveness outcomes.

Officials with Bayer revised the patient counseling and device removal sections of the labeling consistent with the FDA’s recently finalized guidance.

The FDA has received a growing number of reports of adverse effects associated with Essure in recent years. Commonly reported adverse events include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and hypersensitivity reactions. As a result, some patients have had their Essure surgically removed.

At the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee meeting in September 2015, FDA advisory committee members addressed patients’ experiences with Essure, as well as clinical opinions of the product.

Officials with Bayer were asked to conduct a postmarket surveillance study to learn more about Essure’s risks and benefits and following that study, FDA officials recommended the boxed warning and the Patient Decision Checklist.