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Medsafe introduces surgical mesh restrictions

Medsafe introduces surgical mesh restrictions

Medsafe is taking action in New Zealand to remove from supply and effectively limit the use of certain surgical mesh products used for urogynaecological indications.

Medsafe has already contacted suppliers in New Zealand and most of them have already indicated by early next year that they will be taking the same steps here to limit supply, as they are in Australia.

As a consequence of the Australian TGA (Therapeutic Goods Administration) review of surgical mesh for urogynaecological use, and subsequent regulatory action, there is cause for Medsafe to question the safety of certain devices.

Medsafe is using powers under the Medicines Act 1981 to require suppliers to provide safety information about their devices.

Under section 38, Medsafe has written to four companies: Boston Scientific NZ Ltd, Culpan Medical, Endotherapeutics NZ Ltd and Johnson & Johnson Medical NZ Ltd requesting safety information or confirmation that the companies will comply with the Australian requirements.

Medsafe understands from its communications with these companies that they intend to comply with the requirements by 4 January 2018.

As in Australia, surgical mesh will still be able to be used for other surgical conditions such as hernia repair in New Zealand.

As is also the case in Australia, Medsafe’s response is effectively a limit on the supply of mesh for the repair of pelvic organ prolapse and stress urinary incontinence rather than a limit on use of surgical mesh for other types of surgery.



Background
Section 38 of the Medicines Act 1981 permits the Director-General of Health to request safety information from a supplier should there be reason to believe that a medical device is unsafe.

List of products affected
Boston Scientific NZ Ltd
Xenform Soft Tissue Repair Matrix
Advantage
Lynx
Obtryx
Obtryx II
Solyx
Uphold Life
Upsylon
Culpan Medical
Coloplast – 9 models

Endotherapeutics NZ Ltd
TOA Sling
TVA Sling
Multi Purpose Sling
BSC Mesh
EndoGYNious
Ophira Minisling
Johnson & Johnson Medical NZ Ltd
GYNEMESH PS soft mesh
Gynecare TVT Device
Gynecare TVT W/Abdominal
Gynecare TVT Obturator
TVT Abbrevo
TVT Exact Retropubic system

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