Events

Recall of Essure Permanent Birth Control System(contraceptive device for hysteroscopic placement)

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-00825-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00825-1
  • 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
    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.
  • Action
    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.

Device

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

Manufacturer

Australasian Medical & Scientific Ltd