Health ministry welcomes US ban on surgical mesh
The United States Food and Drug Administration (FDA) has ordered an immediate halt to the sale of surgical mesh products to treat pelvic organ prolapse.
The FDA said the action this week was taken as two remaining manufacturers of the product, Boston Scientific and Coloplast, had not been able to prove the products were safe to treat pelvic prolapse, which occurs when the uterus bulges through weakened tissue into the vagina.
Ministry of Health chief medical officer Dr Andrew Simpson welcomed the FDA decision.
Supplies of mesh products for pelvic organ prolapse to New Zealand stopped in December 2017 after the ministry required companies to supply additional safety information.
This came a month after Australia’s Therapeutic Goods Administration (TGA) cancelled approval of the products.
But other surgical mesh products for stress urinary incontinence, hernia and some plastic surgery remain available in the US, New Zealand and Australia.
While some doctors and patients say the products have successfully treated these conditions, others say they have caused agonising, life-long pain and disability.
The New York Times reported that seven medical device manufacturers, including Boston Scientific and Johnson & Johnson, were paying nearly $US8 billion ($NZ11.95 billion) in more than 100,000 lawsuits brought by women who have experienced severe complications associated with the devices.
New Zealanders cannot join these international lawsuits because in this country cover for injuries is provided by ACC.
The most recent ACC figures available showed there were 578 surgical mesh claims for pelvic organ prolapse procedures from July 2005 to June 2018. Of
‘‘Their inability to address this issue properly has resulted in hundreds of thousands of patients around the world being harmed. Sadly, they could have stopped this devastation sooner but it has been allowed to continue.’’ Charlotte Korte, patient advocate
those claims, 125 (22 per cent) were declined.
New Zealand requires no pre-market approval for medical devices, but manufacturers are required to list products on a Medsafe database prior to sale.
Simpson said a draft Therapeutic Products Bill would bring improved oversight of medical devices and would address existing gaps in the regulatory requirements.
Patient advocate Charlotte Korte said the FDA had known about surgical mesh complications since 2008. ‘‘Their inability to address this issue properly has resulted in hundreds of thousands of patients around the world being harmed. Sadly, they could have stopped this devastation sooner but it has been allowed to continue.’’
Those in New Zealand who had been implanted with a device to treat pelvic organ prolapse (POP) should have access to fully funded treatment and financial support, she said.
‘‘Now that the FDA have come out and said these devices are no longer safe to use, ACC should accept every single claim for a POP device because they were implanted with a product that isn’t safe.’’
The FDA and other regulatory bodies needed to look at stress urinary incontinence products as they were also causing severe injuries in some women, Korte said.
Most surgeons implanting surgical mesh for stress urinary incontinence in New Zealand could not fully remove the mesh devices if it later became necessary, she said.
‘‘When a patient is implanted [with mesh] they need to know that if something goes wrong they will be left permanently implanted and the surgeon may not be able to remove it themselves.’’
In September 2018, the Ministry of Health asked district health boards to ensure surgeons undertaking urogynaecological surgical mesh procedures met Australian guidelines.
Simpson said 24 surgeons at eight DHBs were sufficiently credentialed.
The other 12 DHBs had stopped offering the procedure either temporarily, while surgeons gained credentials, or permanently.
Korte said the requirements only applied to implanting surgical mesh and not removing it.