| Recall Action Instructions |
A summary of changes to the labelling includes:
1. The addition of a Boxed Warning listing information on the Essure Confirmation test, reported adverse events (either from clinical studies or post market surveillance), and situations where device removal may be indicated;
2. Additional information in the IFU. This includes a new section on patient counselling, & revisions to sections discussing safety, clinical studies, instructions for use & patient management; and
3. Introduction of a PIB including a Checklist. This is intended to be reviewed by the physician & patient to facilitate the patient's understanding of birth control options, benefits & potential risks associated with the use of Essure, as well as what to expect during and after the procedure.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |