In November 2016, Bayer, the manufacturer of the permanent birth control tubal implant system (Essure), revised the Essure product labeling in accordance with a US Food and Drug Administration (FDA) guidance document.1 The FDA developed its labeling guidance based on its examination of an increasing number of reported adverse events associated with the system’s use (such as persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions) and its evaluation of a trade complaint regarding allegations initially made in a Citizen Petition.
Changes to the new FDA-approved labeling for Essure include:
- the addition of a boxed warning listing adverse events that have been reported either in clinical studies or through postmarket surveillance (see Box)
- updated Instructions for Use document for clinicians and Patient Information Booklet, which contain additional information on safety (contraindications, warnings, and precautions), clinical data, and instructions2,3
- a Patient-Doctor Discussion Checklist (included within the Patient Information Booklet), designed to support appropriate patient counseling, facilitate the patient’s understanding of birth control options, and explain the benefits and risks associated with the device and what to expect during and after the implantation procedure.3
How will these labeling changes impact clinicians and patients? OBG Managementasked Linda Bradley, MD, Professor of Surgery and Vice Chair of Obstetrics and Gynecology at the Women’s Health Institute, Cleveland Clinic, Cleveland, Ohio, to share her expertise with readers.
1. Essure permanent birth control (Bayer) Instructions for use. http://www.hcp.essure-us.com/assets/pdf/Link%20Essure%20IFU.pdf. Accessed January 5, 2017.