The Food and Drug Administration (FDA) has announced label changes for Bayer HealthCare’s Essure permanent birth control system in accordance to the recently finalized guidance on “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.”
The labeling now includes a new Boxed Warning and a Patient Decision Checklist, which are intended to support patient counseling, acknowledgement of benefits and risks associated with Essure, and what to expect during and after the Essure procedure.
The Boxed Warning includes safety information to state significant side effects or adverse outcomes associated with Essure and information about the potential need for removal.
The Patient Decision Checklist contains important data about the device, its use, and safety and efficacy outcomes. The Company also included important changes to the patient counseling and device removal sections of the Essure labeling to offer additional guidance to physicians.
Clinicians are recommended to discuss with patients available sterilization and birth control options, along with their risks and benefits. Moreover, the Decision Checklist can serve to help guide these discussions and make sure that patients understand the benefits and risks
The FDA reiterated how some women may be at risk for serious complications, including persistent pain, perforation of the uterus or fallopian tubes, abnormal bleeding, allergy or hypersensitivity reactions. The FDA reviewed Advisory panel recommendations, comments submitted to the public docket, and additional medical literature and adverse event reports. After its review, the Agency had requested the Company to conduct a post-market surveillance study to gather more data about Essure’s benefits and risks.
For more information visit FDA.gov.