Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Australasian Medical & Scientific Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01125-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01125-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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

Device

Essure Permanent Birth Control(Australasian Medical & Scientific Ltd - ESSURE System - Contracept...
  • Model / Serial
    Essure Permanent Birth Control(Australasian Medical & Scientific Ltd - ESSURE System - Contraceptive, tubal occlusion, Insert)Catalogue Number/Order Code: ESS305All Batch NumbersARTG number 174123
  • Manufacturer
    Australasian Medical & Scientific Ltd

Manufacturer

Australasian Medical & Scientific Ltd