Mesh standards raised

New Zealand hospitals will need to guarantee their surgeons have specialist credentials to perform controversial transvaginal mesh procedures, the Ministry of Health says.

In a letter to district health boards (DHBs) and surgical colleges yesterday, director general of health Dr Ashley Bloomfield asked that surgeons be required to have specific specialist qualifications and experience in either urology or gynaecology, and a minimum of 10 procedures every year.

Patient advocates have been calling for protections from surgical mesh harm for the past decade after thousands of women worldwide suffered life-changing complications such as severe pain, mesh erosion, infection and nerve damage. Some say these changes, based on Australian standards, do not go far enough.

In the letter, DHBs were asked to ‘‘ensure rigorous informed consent processes that include understanding of the associated risks’’.

‘‘If you are not satisfied that your services or surgeons meet these standards, surgeries involving surgical mesh should not take place,’’ Bloomfield’s letter said.

Surgical mesh is used to treat pelvic organ prolapse, stress urinary incontinence and hernias.

An August Medsafe update showed 627 adverse-event reports were received for stress urinary incontinence and pelvic organ prolapse procedures with transvaginal mesh. In the same period, 394 adverse event reports for hernia procedures were lodged.

Acting associate health minister James Shaw said too many women had experienced harm.

DHBs were to stop using surgical mesh in urogynaecological surgery unless they could guarantee surgical standards and ‘‘robust’’ informed consent processes were being met, he said.

The ministry action comes two and a half months after the British government ordered an immediate suspension on the use vaginal mesh implants to treat child birth complications in NHS hospitals after a review.

Review chairwoman Julia Cumberlege said she had been appalled by the scale of ‘‘tragic stories’’ from women and their families. ‘‘Their bravery and dignity in speaking out is deeply moving, and their sadness, anger, pain and frustration at what has happened to them and others has been compelling. We had to act now.’’

Advocate Charlotte Korte, of Mesh Down Under, said she was disappointed the Government had not followed Britain by suspending the use of mesh until better protections were in place.

‘‘The Ministry of Health has no way of mandating or enforcing this. There are way too many loopholes.’’

Korte, who last week won this year’s Women of Influence public policy award, said more than half of mesh surgeries were performed in private hospitals, which fell outside DHB control. ‘‘How many more of these patients will have to have their lives ruined before the surgeons and the Government actually wake up? What’s it going to take?’’

Urological Society of Australia and New Zealand (USANZ) president-elect and Christchurch urologist Stephen Mark said the society supported the Government actions.

‘‘We do not support a ban on mesh at the moment and are very happy to be compliant with the recommendations from the [Australian] guidelines – essentially that experienced and qualified surgeons continue to use mesh in stress incontinence, that an appropriate informed consent process needs to be present and documented and a local registry needs to be established.’’ Mark said he knew of six to eight urologists who met the Australian standards, but some may not perform a minimum of 10 procedures a year.

He expected the number of mesh procedures for stress urinary incontinence and associated complications to reduce further as a result of tougher requirements. ‘‘We want to minimise harm, but maintain access to appropriate treatment.’’

Under existing legislation, the ministry has no authority to make DHBs implement the new criteria. A planned overhaul of the Therapeutic Products Act, in which the issue could be addressed, had failed to materialise. A draft was originally due last year.

The proposed bill was expected to be released for public consultation later this year, a Ministry of Health spokesman said.