Surgical mesh problem lost on new Government

In one month, it will be illegal to use surgical mesh products to treat pelvic organ prolapse in Australia. In New Zealand, the Labour-led Government – which supported stricter mesh regulations during its opposition years – have yet to offer any real solutions to the problem. Teuila Fuatai reports.

Members of patient advocate group Mesh Down Under last week watched their counterparts across the Tasman celebrate a regulatory ban on transvaginal mesh products used for pelvic organ prolapse injury surgery.

It was a bitter-sweet victory for the 500-strong group. Changes in the Australian jursidiction, controlled by Therapeutic Goods Administration (TGA), are monitored closely by New Zealand’s Medsafe – which relies on information from overseas regulatory bodies like the TGA and the United States’ Food and Drug Administration to inform its own decision-making.

In response to the Australian announcement, Ministry of Health Medsafe spokesman Chris James said the agency had been aware of the TGA’s four-year review that had led to the product ban. It had also been “anticipating the outcome”, he said.

Despite this, and the litany of problems associated with surgical mesh products in New Zealand – which have cost at least $13 million in ACC injury claims over the past 12 years – James and others in charge remain hesitant about enforcing change.

“Medsafe has asked TGA for the detailed information on which it made its decisions and will carefully assess this,” James said.

“As the products available on either side of the Tasman can differ, Medsafe has been enquiring about the status in New Zealand with suppliers. This is ongoing.”

In response to the Australian announcement, Health Minister David Clark said he had requested to be briefed about the TGA ban from his officials.

Clark, who had promised during the election campaign to immediately begin work on a surgical mesh registry if elected to office, was asked by Newsroom whether he would call for a registry in light of ban.

Clark, who also told MDU before the election he would do just that “when the opportunity presents”, sent an old written statement in response to Newsroom’s question.

“Now that I’ve become Health Minister, I look forward to being briefed more fully by health officials about this issue and ways to better respond to it, alongside my colleague, ACC Minister Iain Lees-Galloway.

“I’m pleased that the Ministry held a positive meeting recently with people injured by surgical mesh. As an initial response, it has committed to looking at a cost-benefit analysis for a pelvic surgical mesh registry."

That meeting Clark referred to happened on October 20. Furthermore, the development of a national surgical mesh registry was proposed a year ago as part of a raft of health select committee recommendations following a two-year inquiry into surgical mesh products.

After a month of non-action following the October meeting, MDU wrote to Clark requesting he overlook the cost-benefit analysis due to the urgency of the situation.

MDU-co founder Carmel Berry, who presented before the health select committee in 2014, also recalled a previous statement made to the group from Clark regarding a registry:

"Hopefully we will be in government in September and then we can bypass campaigning and just set about fixing things,” Clark had said before the election.

“There has been no further progress in regards to the health select committee recommendations that we have been made aware of,” Berry said at the weekend.

“We have written to the Minister asking him to bypass the cost-benefit analysis and make funding available to get on with the job of creating a registry. All parties at that October 20 meeting supported the implementation of the registry except the Ministry of Health, which had cost concerns,” she said.

The Minister is yet to respond to MDU's letter and request. 

Berry also highlighted seemingly unnecessary delays from the Ministry – which has cited the need to consider an upcoming UK publication on further guidance of the gynaecological use of surgical mesh, due December 20.

“I have the NICE [National Institute for Health and Care Excellence] draft report and have offered it to the Ministry of Health,” Berry said.

“They just need to do this urgently and take action urgently - just as we have been urging them to do since 2014.”

Meanwhile, Helen Clark also weighed in on the issue – urging New Zealand to act on the recent TGA ban announcement, and on the UK NICE draft report.

“UK Health watchdog NICE is reported to be set to recommend banning of vaginal mesh operations for treating organ prolapse. Many women around world have suffered greatly from these. Hope NZ will follow suit,” she said in a tweet at the weekend. 

Another tweet read:

"UK health advocates call for ban on vaginal mesh implants to extend more widely to include a ban on implantation to treat incontinence. Hope NZ Govt will also act. NZers are among those badly injured by these "treatments".

The former Prime Minister tagged both David Clark and his associate health minister Jenny Salesa in the tweets.

Last week, the Government also came under fire for refusing to release a document with directives for new ministers, despite previously promising it would be made public. Labour had promised in its supply and confidence agreement with the Greens to “strengthen New Zealand’s democracy by increasing public participation, openness, and transparency around official information”.

Read more:

Government disappoints early on transparency

Aussies turn focus on NZ's surgical mesh problems

Surgical mesh: a decade of damage

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