New Zealand is following Australia in ‘banning’ the supply of surgical mesh for pelvic prolapses and stress incontinence – a move that follows strong protests for many years from women who have suffered pain from mesh injuries.
Medsafe announced this afternoon that it is taking action to remove “from supply and effectively limit the use” of certain surgical mesh products used for urogynaecological indications.
“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,” said Medsafe in statement.
The Kiwi group, Mesh Down Under which had petition the Health Select Committee for a number of years over their concerns at the injuries and pain caused by the mesh, had earlier this month urged Medsafe to follow the Australian authority’s move.
Medsafe said it was using its powers under section 38 of the Medicines Act 1981 to require suppliers to provide safety information about their devices and had written to the four companies involved (see list below) requesting the information or confirmation that they would comply with the Australian requirements.
Medsafe said it understood that the companies 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. But, 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.
List of products affected:
Boston Scientific NZ Ltd
- Xenform Soft Tissue Repair Matrix
- Obtryx II
- Uphold Life
- Coloplast – 9 models
Endotherapeutics NZ Ltd
- TOA Sling
- TVA Sling
- Multi Purpose Sling
- BSC Mesh
- 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