Nine types of surgical mesh have now been banned in New Zealand. Photo / 123RF
Nine types of surgical mesh have now been banned in New Zealand. Photo / 123RF
Nine surgical mesh products have been removed from supply in New Zealand after recent regulatory action by Medsafe to check the products' safety.
Medsafe decided to ban the supply of the mesh for operations such as pelvic organ prolapse and stress urinary incontinence after the Australian Therapeutic Goods Administration (TGA)reviewed surgical mesh for urogynaecological use, and took regulatory action.
In December 2017, Medsafe used the provisions in the Medicines Act 1981 to request safety information from four suppliers of surgical mesh products in New Zealand.
The companies included Boston Scientific NZ Ltd, Culpan Medical, Endotherapeutics NZ Ltd and Johnson & Johnson Medical NZ.
Medsafe group manager Chris James today said all four companies had responded and confirmed that all products removed from the Australian register are no longer supplied in New Zealand.
This means all surgical mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation will no longer be supplied, and one product, a single incision mini-sling for the treatment of stress urinary incontinence, is also no longer supplied in New Zealand.
This action does not affect the ongoing supply of surgical mesh products for other uses such as hernia repair or stress urinary incontinence.
Companies have also told TGA they have made its required changes to warnings in the instructions for use, or will when the wording has been agreed.
James said Medsafe would continue to work with the companies to make sure the changes are made in New Zealand as soon as possible.
"As with all medical devices, Medsafe continues to monitor the use of surgical mesh products. Information for surgeons and patients is published on the Medsafe website.
"Patients who are considered for surgery, where there is potential for the implantation of surgical mesh products, should be fully informed about the benefits and risks of treatment and informed consent obtained," he said.
List of affected products:
Boston Scientific NZ Ltd Solyx Uphold Life
Culpan Medical Coloplast – 9 models
Endotherapeutics NZ Ltd TOA Sling TVA Sling Multi Purpose Sling BSC Mesh EndoGYNious Ophira Minisling
