Surgical mesh patients 'totally failed' by health system, gynaecologist says
Pressure is mounting on the Government to take action on surgical mesh complications to protect patients and compensate victims.
Labour, the Greens and New Zealand First want a register of surgical mesh complications set up immediately and an assurance those affected will be covered by ACC.
Auckland woman Alison Lee, 38, said mesh surgery for stress incontinence had robbed her of a once happy, healthy life.
"If I knew then what I know now there's no way in hell I would have gone down that road, I would have just put up with it."
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Wellington gynaecologist Dr Hanifa Koya said every part of the health system has failed surgical mesh patients and they should be able to sue those responsible.
Koya had used mesh for patients with urinary incontinence for over 20 years and had removed mesh from over 50 patients.
"I wish we would realise that the ACC and Health and Disability Commission (HDC) system may work in some situations, but in this situation it has totally failed patients."
She said ethics committees should be re-established in major hospitals to oversee surgeons.
"Individual doctors are trying to do the procedures, they are not reporting, they are not well informed and so I think the patient is the most adversely affected."
She was shocked by the lack of informed consent and oversight of surgeons, especially as the evidence of potential for complications was very clear, she said.
"This needs to stop because there are women whose lives are really ruined."
Medsafe general manager Chris James said there was no pre-market assessment or approval process for medical devices, including surgical mesh.
Sponsors for a medical device can register a product themselves on the Medsafe database and begin sales within 30 days.
A device sponsor could be challenged if the Director-General of Health believed it was unsafe, James said.
Medsafe was unable to say if any devices had been recalled as a result of a challenge.
An overhaul of the Medicines Act was planned for 2018 and would include more comprehensive regulation of all therapeutic goods, including mesh devices.
Mesh Down Under support group founders Charlotte Korte and Carmel Berry said treatment injury claims decided by ACC and reported to Medsafe had not all been made public.
The number of accepted mesh treatment injury claims had doubled in the past three years, with a total 301 made, figures from ACC showed.
James said the lack of reporting by Medsafe was due to a problem identifying information in the ACC reports, but resolving any missing information was a "priority".
New Zealand First health spokeswoman Barbara Stewart said she had not seen "any action" and did not believe people were being properly informed about the potential side effects of surgical mesh.
Labour health spokesman David Clark said the Government lacked the political will to take action.
"It feels like there's been a failure of leadership over a long time."
Green MP Julie Anne Genter said it was "unbelievable" Medsafe did not have an approval process for medical devices "being put inside of people in New Zealand" and called for a moratorium on devices associated with complications.
"It is just not good enough for experimental surgical mesh to be causing agony for women and for the Government to just shrug their shoulders."
A spokeswoman for Health Minister Jonathan Coleman said he was "seeking advice from officials on the issue".