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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00748-1
Product Name/Description Coloplast urogynaecological surgical mesh

Aris Kit
ARTG Number: 157074

Altis System
ARTG Number: 190173

Restorelle Y
Restorelle Y-XL
Restorelle L
Restorelle M
Restorelle XL
Restorelle DirectFix Posterior
Restorelle DirectFix Anterior
ARTG Number: 190172
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 2/09/2015
Responsible Entity Coloplast Pty Ltd
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.
Contact Information 03 9541 1111 - Coloplast