Retiro De Equipo (Recall) de ESSURE PERMANENT BIRTH CONTROL SYSTEM

Recall

48250

II

2017-01-19

Canada

HC

The purpose of this communication is to provide the updated labeling for essure. this notice does not include a stock recovery or any physical changes to product currently in use or on the market. labeling changes include revised essure instructions for use (ifu) and a patient information brochure (pib) that includes a patient-doctor discussion checklist (checklist). a summary of changes to the labeling includes: 1-the addition of a boxed warning listing information on the essure confirmation test adverse events that have been reported either in clinical studies or through post market surveillance and situations where device removal may be indicated. 2-the ifu has also been updated with additional information. this includes a new section on patient counseling in addition to revisions in the sections discussing safety clinical studies instructions for use and patient management. 3-the introduction of a pib including a checklist. the pib along with the checklist is intended to be reviewed by the physician and patient to facilitate the patient's understanding of birth control options benefits and potential risks associated with the use of essure as well as what to expect during and after the essure procedure.