Essure Permanent Birth Control(Australasian Medical & Scientific Ltd - ESSURE System - Contraceptive, tubal occlusion, Insert) 의 리콜

Recall

RC-2017-RN-01125-1

Class II

2017-08-28

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01125-1

Amsl is advising that all lots of essure are being removed due to a temporary suspension of the european ec certificate during the european certificate renewal process. further, post-market information suggests that some patients may not be fully informed of possible device & procedure related complications, including changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of the device, allergy/hypersensitivity, or immune-type reactions.

AMSL is requesting customers: 1. Inspect stock and quarantine all Essure kits and then email or call AMSL to arrange for the affected stock to be recovered. This information is required to reconcile this process. 2. If any of the recalled stock could have been possibly transferred from your hospital to another, please immediately let that hospital know of the recall action. It would be appreciated if you would then telephone AMSL so contact can be made with the hospital supplied from your hospital. A summary of changes to the labelling includes: - 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. - The IFU has also been updated with additional information. This includes a new section on patient counselling in addition to revisions in the sections discussing safety, clinical studies, instructions for use and patient management. - 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. For more information, please see https://www.tga.gov.au/alert/essure-contraceptive-device