Essure Permanent Birth Control System(contraceptive device for hysteroscopic placement) 의 리콜

Recall

RC-2017-RN-00825-1

Class II

2017-07-20

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00825-1

Australasian medical & scientific ltd (amsl) is issuing revised essure instructions for use (ifu) and introduced a patient information brochure (pib) that includes a patient-doctor discussion checklist.

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.