AN Australian Department of Health monitoring group repeatedly issued safety warnings about pelvic mesh devices from as early as 2004 without response from regulatory bodies because of a “fragmented” health system that continues to place patients at risk, a Senate inquiry has been told.
Health technology assessment bodies in 2008 recommended that pelvic mesh devices to treat prolapse in women should be “archived” after four annual “horizon scanning” reports warned of the lack of evidence supporting their safe use.
But fragmentation of Australia’s health system and lack of communication and transparency left some Department of Health groups issuing warnings without being aware devices were already being implanted in Australian women, while others failed to act despite being “in a position to call out or review” pelvic mesh procedures, Sydney academic and medical device analyst Dr Sally Wortley has told a Senate inquiry into pelvic mesh.
In a damning submission Dr Wortley said that by 2007, after a British National Health Service review raised serious concerns about prolapse pelvic mesh devices, they should have been referred to Australia’s Medical Services Advisory Committee for safety, efficacy and cost-effectiveness assessment, but weren’t.
A committee assessment in 2007 or 2008 might have recommended against public funding of pelvic mesh devices, or “at the very least” have recommended a separate Medicare Benefits Schedule number which would have allowed regulators to track the number of devices implanted and more accurately estimate complication rates, Dr Wortley said.
Instead an unknown number of prolapse pelvic mesh devices – estimated at up to 40,000 – were implanted in Australian women and subsidised by Australian taxpayers for nearly a decade until medical devices regulator, the Australian Therapeutic Goods Administration, cancelled the first prolapse devices in November, 2014. It took further action to remove all prolapse devices from the market over the following three years.
Dr Wortley told the inquiry a fragmented health system with separate federal and state health technology assessment processes, and hospitals left with the power to determine whether a new procedure or technology should be used, “is placing patients at risk”.
Dr Wortley said it was possible that prolapse mesh devices were not assessed by the Medical Services Advisory Committee in 2007 because of a misunderstanding about whether an assessment was “within the remit” of another assessment body.
“The issues around (pelvic) mesh implants illustrate the problems within the Australian health technology assessment system at the time ,and to some extent the problems that continue to be present,” Dr Wortley said.
“These problems included lack of communication and fragmentation across the agencies involved in the regulation and assessment of new technologies and procedures as well as a lack of transparency and rigorous methods for the pre‐market and assessment of safety for devices and prostheses.”
While problems have been repeatedly identified in reports – including a 2009 report that recommended greater “rigour” in the assessment of higher risk medical devices – recommendations are not implemented, she said.
During a final public hearing on Tuesday before the Senate Community Affairs References Committee inquiry into pelvic mesh devices, Therapeutic Goods Administration national manager John Skerritt said Australia had been “ahead of the pack” in responding to mesh.
“While the issue with meshes is a tremendous problem for those affected, and I’ve indicated we’ve had a few learnings from it, I am proud – if I can use that word – that we’ve actually moved faster, and some would argue further, than the major regulators globally. It has been a fairly nimble response,” Mr Skerritt said.
The Therapeutic Goods Administration has been contacted for comment.
Dr Wortley Sally is a Sydney University academic who has worked as an analyst assessing health technologies for the Australian and UK governments. Her research interest is in public engagement and health technology assessment.
The Senate report on pelvic mesh devices is due for release on February 14.