| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00120-1 |
| Product Name/Description |
Boston Scientific Urogynaecological Surgical Meshes
Advantage/Advantage Fit, Transvaginal Sling, Lynx, Suprapubic Sling, Obtryx, Transobturator Sling (Curved/Halo), Obtryx II with PrecisionBlue Design, Solyx SIS, Single Incision Sling
ARTG 104326
Uphold LITE Vaginal Support with Capio SLIM Pinnacle LITE Pelvic Floor Repair Kit, Posterior with Capio SLIM, Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device
ARTG 150342
XenformTM Soft Tissue Repair Matrix
ARTG 174878 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
The TGA carried out a clinical review of urogynaecological surgical mesh implants which have highlighted the importance of:
- appropriate patient selection;
- surgeon experience; and
- the need for fully informed patient consent.
Boston Scientific (BSC) has made important updates to the Directions for Use (DFU) for the meshes. These updates are based on BSC’s review, as well as input from the TGA. Contraindications, precautions, and adverse events have been updated to present the most comprehensive and up to date information available. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The DFU for all Boston Scientific's surgical meshes were reviewed and updated to ensure consistency and alignment of language across the product lines. The customer letter identifies what amendments have to made to the DFU. This action has been closed-out on 27/01/2017. |
| Contact Information |
02 8063 8144 - Boston Scientific |