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Surgical mesh products banned for transvaginal surgeries

Surgical mesh products banned for transvaginal surgeries

Medsafe has banned the use of numerous surgical mesh products for transvaginal surgeries in New Zealand.

It’s followed Australia’s lead and effectively limited the supply of mesh for the repair of pelvic organ prolapse and stress urinary incontinence. The UK has taken the same action.

Medsafe has written to four companies: Boston Scientific NZ Ltd, Culpan Medical, Endotherapeutics NZ Ltd and Johnson & Johnson Medical NZ Ltd, requesting they comply with the Australian requirements.

They all pledged to do so 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.

Hundreds of people in this country have been injured following transvaginal operations using the mesh – and it’s cost ACC at least $13 million in injury payouts in the past 12 years.

Continence NZ applauds Medsafe’s move.

“This is a welcome decision, too long coming, as the FDA first put out a warning about this in 2008,” says Continence NZ awareness educator and longtime continence nurse Janet Thackray.

 

“Thousands of women worldwide have experienced chronic pelvic infections, severe pain, and migration of the mesh into surrounding organs, sexual intercourse becomes impossible with the resulting destruction of relationships and quality of life.”

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