Aussie mesh verdict: blueprint for NZ
A Kiwi woman who spent $40,000 to have a United States surgeon remove her surgical mesh says New Zealand should follow the just-released recommendations from an Australian Senate inquiry.
Renate Schutte, 50, had a TVTO mid-urethral sling implanted to treat stress urinary incontinence in 2012. She developed severe burning pain in her groin and down her legs last August.
When Missouri surgeon Dr Dionysios Veronikis removed it, the pain disappeared ‘‘almost instantaneously’’.
Schutte considered herself fortunate to have been able to afford the treatment. ‘‘There are so many people who can’t do that, they haven’t got any ACC cover, they have no private insurance and they are falling through the gaps, they’ve got nothing.’’
Schutte has followed the progress of the Australian Senate inquiry into transvaginal mesh implants since it started in February last year. It released its report on Wednesday.
She said the recommendations were ‘‘fantastic’’ and she urged the New Zealand Government to consider them seriously.
‘‘The Australians have basically done the work for us. The evidence is there, it’s irrefutable, they just need to carry on and do it.’’
The inquiry report included 13 recommendations including mandatory reporting of adverse events by medical practitioners; a registry for medical devices; improved informed consent processes; and that transvaginal mesh implantation be undertaken only with fully informed consent and as a last resort.
Senators heard harrowing stories and received more than 500 written submissions.
Women shared experiences of debilitating pain, physical limitations, social isolation and financial and emotional stress following surgery with mesh to treat stress urinary incontinence or pelvic organ prolapse.
Submissions came from women who had positive experiences with mesh surgery and doctors and medical colleges supporting the use of mesh to treat incontinence and prolapse. The senate committee report acknowledged the successful outcomes many women treated with mesh experienced, but reprimanded those in the medical community who used this to downplay the experience of a minority of women suffering extreme adverse events.
‘‘The committee considers that it is of no consolation to women who have lost so much to be told that they are part of a very small minority.’’
Instead the inquiry wanted ‘‘greater focus ... on understanding why some women experience positive life-changing outcomes and others experience catastrophe.’’
Of about 150,000 Australian women implanted with a mesh device, an unknown number experienced complications as there was no single source of information, the committee found.
Under-reporting of adverse events was concerning and led to a recommendation to make it mandatory for medical practitioners.
The committee was concerned about the influence mesh suppliers had on surgeons, including financial inducements to use specific products.
‘‘In particular, evidence that medical practitioners have proposed transvaginal mesh products as a ‘quick fix’ or preventative option for minor symptoms ... or been overenthusiastic in their embrace of this new technology is troubling.’’ It recommended relevant agencies review systems to ‘‘support consistent, high ethical standards, with specific emphasis on systems in place to prevent the payment of inducements to medical professionals and teaching hospitals’’.
Associate Minister of Health Julie Anne Genter said New Zealand’s regulatory system had not been adequate to protect patients, and was ‘‘long overdue for an update’’. A Therapeutic Devices Bill introduced this year would ‘‘ensure that this regulatory failure does not happen again’’.
‘‘I agree with the senate inquiry that surgical mesh should only be used as a last resort, and want New Zealand women to have easier access to better quality information about the risks,’’ Genter said.
Senior New Zealand members of the UroGynaecological Society of Australasia said they supported the senate committee’s recommendations but were concerned about the statement that all mesh devices should be used as a last resort.
Limiting use of the midurethral sling, which had a good safety record for incontinence treatment, would be a backward step for the one in three New Zealand women who suffer from incontinence as it would force doctors to ‘‘revert to more traditional, riskier surgical methods’’, they said.
The Royal Australian and New Zealand College of Gynaecologists said the senate report highlighted that ‘‘more needs to be done to protect the safety of women’’ and committed to ‘‘implement governance arrangements’’ for transvaginal mesh procedures.
‘‘It was very clear in the report that women who have experienced adverse complications as a result of a mesh implant have endured long-term pain and reduced quality of life. The college is not dismissive of these accounts and is profoundly sympathetic to all women who have had this experience,’’ president Professor Steve Robson said.