Events

Recall of Coloplast urogynaecological surgical mesh Aris Kit, Altis System, Restorelle YRestorelle Y-XLRestorelle LRestorelle MRestorelle XLRestorelle DirectFix PosteriorRestorelle DirectFix Anterior

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Coloplast Pty 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-2015-RN-00748-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-09-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00748-1
  • 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
    The tga carried out a clinical review of urogynaecological surgical mesh implants and found that, while there may be a benefit in certain patients there is little evidence to support the overall effectiveness of these surgical meshes as a class of products.The findings from the review have highlighted the importance of:- appropriate patient selection;- surgeon experience; and- the need for fully informed patient consent.Following the tga's review coloplast pty ltd has made significant and substantive updates to the instructions for use (ifu) for the referenced products. additional contraindications, warnings, and precautions have been added to present the most comprehensive and up to date information available.
  • Action
    Coloplast is issuing a notification to inform hospitals and healthcare professionals of changes to the Instructions for Use (IFU) for their range of urogynaecological meshes.. These changes have been made following the TGA’s clinical review of urogynaecological meshes and include additional information on adverse events, warnings and contra-indications. This action has been closed-out on 12/08/2016.

Device

Coloplast urogynaecological surgical mesh Aris Kit, Altis System, Restorelle YRestorelle Y-XLRest...
  • Model / Serial
    Coloplast urogynaecological surgical meshAris KitARTG Number: 157074Altis SystemARTG Number: 190173Restorelle YRestorelle Y-XLRestorelle LRestorelle MRestorelle XLRestorelle DirectFix PosteriorRestorelle DirectFix AnteriorARTG Number: 190172
  • Manufacturer
    Coloplast Pty Ltd

Manufacturer

Coloplast Pty Ltd