New Zealand has become the first major country to effectively ban vaginal mesh implants in response to safety concerns over the surgery.
The country’s Ministry of Health announced on Monday that it had written to leading mesh suppliers asking them to stop marketing the products from January – or prove that their products are safe.
Ministry of Health spokesman, Stewart Jessamine, told a New Zealand radio station: “We’re always cautious about the use of the word ‘ban’, but effectively the companies are agreeing no longer to sell these products … in New Zealand from the 4th of January.”
The move goes considerably further than recent announcements in other countries, such as Australia and the UK, which only restrict the use of pelvic mesh operations for organ prolapse. In New Zealand, the use of mesh implants to treat urinary incontinence, which accounts for the vast majority of mesh operations, will also be effectively banned, according to an announcement posted on the government website.
The decision has been applauded by campaigners, many of whom argue that the potential complications of mesh surgery, which include chronic pain and implants cutting through the vagina, are unacceptable. However, doctors expressed concern at the far-reaching nature of the ban.
It is now widely accepted that vaginal mesh should not be routinely offered for prolapse, where the pelvic organs bulge into the vagina. But many doctors maintain that mesh surgery to treat stress urinary incontinence can have advantages over traditional surgery and believe that these procedures should continue to be offered.
“This makes New Zealand the only country in the world to have banned all of these procedures and will leave women without effective surgical options for these debilitating conditions,” said Giovanni Losco, a urologist in Christchurch and spokesman for the Urological Society of Australia and New Zealand.
Carl Heneghan, professor of evidence-based medicine at the University of Oxford, says the medical profession needs to acknowledge that there have been major failings in regulation and act to address the issue. If they don’t then other regulators may also react with outright bans.
“[New Zealand] is basically saying ‘we can’t guarantee patient safety’,” he added.
Jessamine said that the decision had been taken after reviewing data on mesh safety provided in November by the Australian government, which had been carrying out its own inquiry into the use of pelvic implants. “We’ve reviewed that data and come to the opinion that the data is sound and we now believe the risks of the use of these products in the pelvis for prolapse and stress incontinence far outweighs the benefits,” he said.
“We’ve got an ability within our legislation to limit the use of those products, to discourage and ultimately remove those products from the market,” he added.
Owen Smith, a shadow cabinet minister, who chairs the all-party parliamentary group on surgical mesh implants, described the announcement as “hugely significant”. “It’s the first major country to effectively ban mesh for all pelvic operations. It’s precisely what we’ve been calling for in the UK.”