NEARLY one in two women insured by nib for pelvic mesh surgery have required readmission to hospital because of complications, the health insurer said in a submission to the Senate inquiry into pelvic mesh devices.
Of 138 women who have had mesh implants for incontinence or prolapse repair between 2011 and March this year, 60 were readmitted to hospital for further treatment, nib executive for benefits and provider relations, Dr Justin Vaughan, said in the submission released on Tuesday before a first public hearing in Melbourne on August 3, and Perth in August 25.
Complications range from “mechanical failure and other issues affecting nearby organs through to infection”, Dr Vaughan said.
The nib figures, while conceded by Dr Vaughan as providing a “limited window on the issue”, directly challenge public statements by Australian regulators, doctors’ organisations, medical colleges and manufacturers that complication rates – particularly for incontinence devices – are low.
They also clash with figures by Australia’s peak device regulator, the Therapeutic Goods Administration, showing only 99 Australian women had adverse events after mesh surgery between 2012 and 2016.
In an internal document in 2013 the TGA conceded it only received between 10 and 20 per cent of adverse event reports, in a system that relies on mesh device manufacturers as the only mandatory reporters of complications.
No manufacturer has been prosecuted for failing to report a mesh device adverse event to the TGA, despite thousands of Australian women reporting serious complications, and penalties of up to $180,000 and a 12-month jail term.
nib chief executive Mark Fitzgibbon on Wednesday said the pelvic mesh scandal exposes fundamental weaknesses in the Australian health industry, including a lack of transparency about doctors’ skills and histories that leaves patients at risk in a system “still back in the 19th century”.
Change comes when patients start reporting poor experiences. Sadly, typically, it takes controversies before there’s change.nib chief executive Mark Fitzgibbon.
nib paid out $1.6 million in benefits to 138 women implanted with pelvic mesh devices for incontinence and prolapse between 2011 and March this year, and an additional $330,000 to treat 60 of the women readmitted to hospital after complications.
The health insurer’s Dr Justin Vaughan labelled the TGA figure an “under-reporting of the issue if nib customer incidence is used as a measure”, in a submission to the mesh inquiry calling for a clinical registry for any at-risk prosthetic devices in Australia to “enable more accurate assessment and risk management”.
“Other prostheses have been identified as causing significant injuries to patients, for example the metal on metal hip replacements, and where there is a risk there has been a clinical registry to provide ongoing monitoring,” Dr Vaughan said.
In the case of pelvic mesh devices the TGA continues to rely on manufacturers reporting adverse events, in addition to doctors and patients voluntarily reporting, despite an internal TGA report in 2013 acknowledging doctors had a low level of awareness of the adverse events reporting system.
In an interview on Wednesday nib chief executive Mark Fitzgibbon said the mesh scandal highlighted the need for patients to have much greater access to information about the health practitioners treating them, and the trust relationship between doctor and patient needed to be brought into the 21st century.
“Change comes when patients start reporting poor experiences. Sadly, typically, it takes controversies before there’s change,” Mr Fitzgibbon said.
Information on the clinical performance of doctors is missing and where there is information it’s not transparent, he said.
A doctor’s history of complaints, investigations and legal actions and settlements was also largely beyond the public and health insurers, including nib which established the website Whitecoat in 2011 to provide opportunities for patients to give feedback about their health experiences.
“If some doctor has been sued, we’d never know that,” he said.
“We want to provide patients with a large amount of patient feedback. We also do patient outcome measures where we go back to them 6-12 months after treatment and ask how they’re going,” Mr Fitzgibbon said.
Very few (if any) hospitals or specialist doctors make their rates of complications publicly available. This means that women rarely have access to full information about the surgery and the ramifications.Australian College of Midwives chief executive Ann Kinnear.
“Had more women known about the negative outcomes other women had experienced from mesh surgery they would have been more informed about the possible consequences.
“Most patients put their faith in GPs and specialists to do the right thing, and they rely on the fact their providers are certified by Medicare. But there’s no information from other patients about their experiences with doctors, and this is the vacuum Whitecoat’s trying to fill.”
Mr Fitzgibbon’s call for greater transparency in the health system was backed by a submission to the Senate inquiry from Australian College of Midwives chief executive officer Ann Kinnear, who said “very few (if any) hospitals or specialist doctors make their rates of complications publicly available”.
“This means that women rarely have access to full information about the surgery and the ramifications. In addition, very few specialist doctors provide information about their own level of skill and training with this specific procedure,” Ms Kinnear said.
The college has called on the Senate inquiry to recommend specialist doctors should be required to publish their skill and training with pelvic mesh procedures, and public and private hospitals should be required to publish their complication rates.
The nib submission – the only submission by a health insurer made available on the Senate inquiry’s website – reveals the large sums paid by insurers and Australia’s health system for pelvic mesh devices over the past 15 years.
Insurers are required to pay about $800 per device in benefits once they are cleared for use by the Therapeutic Goods Administration, nib’s Dr Justin Vaughan said.
More than 100 mesh devices were cleared for use in Australia over the past 15 years, with more than 15,000 of just one device – the now cancelled Tissue Fixation System (TFS) device developed by Australian Dr Peter Petros – sold in that time.
The nib figures do not give a breakdown of whether the complication rates relate to mesh devices for incontinence – including Johnson & Johnson TVT devices repeatedly described as “gold standard” by some doctors and groups, and the subject of a Federal Court class action – or transvaginal polypropylene mesh devices, which the Royal Australian and New Zealand College of Obstetricians and Gynaecologists said are “not recommended as the first line treatment of any vaginal prolapse”.