Medsafe brings in surgical mesh restrictions

Medsafe has released a list of surgical mesh products that can no longer be supplied for transvaginal surgery. Photo / Getty

A long list of surgical mesh products can no longer be supplied in New Zealand for transvaginal surgeries after hundreds of patients were injured, some left in agony, following their operations.

Medsafe said it had made the decision to ban the supply of the mesh for operations such as pelvic organ prolapse and stress urinary incontinence following a similar move in Australia.

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

The use of the mesh has cost ACC at least $13 million in injury payouts in the past 12 years.

Most New Zealand suppliers have told Medsafe that by early next year they will limit supply so it cannot be used for those purposes.

The decision from Medsafe, New Zealand's medical regulatory body, follows a similar decision made last week in Australia.

The Medicines Act 1981 allows Medsafe 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.

Suppliers must either confirm they will comply with the requirements of the Therapeutic Goods Administration in Australia, or to supply information supporting continued use for these indications within the next 45 days.

All four companies said they intended to comply with the requirements by January 4 and have indicated they do not intend to push for continuing use of the mesh in transvaginal operations.

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Medsafe's spokesman said meanwhile suppliers could not knowingly provide the mesh for urogynaecological surgery.

"If there was a situation where a surgeon already had some of this product, discussed it with patient and got their informed consent, it could still be used," he said.

A surgeon or DHB could also purchase the mesh products from overseas although that was unlikely, he said.

"The steps Medsafe is taking are the strongest possible under the current law."

Associate Minister of Health Julie Anne Genter welcomed the move, saying it was an important step in restoring people's faith in the New Zealand medical system.

"Hundreds of women in New Zealand have seen their health and lives compromised because of surgical mesh, and I gladly welcome changes to restrict usage," Genter said.

"This will prevent further harm to women being caused by surgical mesh."

List of affected products

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