WOMEN victims of Australia’s pelvic mesh scandal say a Senate report released last week has not gone far enough to hold regulators, health bureaucracies, doctors and doctors’ groups accountable.
Peak health consumer groups across the country have called for a new inquiry into Australia’s device regulator, the Therapeutic Goods Administration (TGA), after the Senate report said criticism of the lag between mesh complaints and regulatory responses was justified.
The consumer groups have backed women’s groups that say the Senate report’s recommendations and findings could have gone further.
“The TGA is culpable for a shocking lag in regulatory response to emerging evidence of complications relating to mesh implanted through the vagina,” said Australian Pelvic Mesh Support Group spokesperson Linda Schultz.
The support group, representing mesh-injured women from across the country, said the Senate report acknowledged the significant financial impacts of failed mesh surgery, including many women forced to stop work, suffering marriage breakdowns and losing their homes. But it gave no specific solutions, the group said.
The committee can find no reasonable justification for the dismissive and disrespectful treatment many women have experienced from trusted medical professionals.Senate inquiry report into pelvic mesh device scandal
“There are a few glimmers of hope for mesh-injured women in the report, but the wording used in the recommendations is so weak that it could, if not followed up by robust policy change, give Australian health authorities, specialists and primary carers permission to carry on as usual,” said Ms Schultz.
The Senate report recommended broad reforms across the health system, including mandatory reporting of adverse events by doctors, a national registry for all high risk implantable devices, a more comprehensive monitoring scheme for devices approved for use in Australia, an audit of all mesh devices implanted and establishment of specialist medical units for mesh victims.
It also recommended a review of doctors’ relationships with device manufacturers “to prevent the payment of inducements” to doctors and teaching hospitals.
The Senate committee was concerned that it is not possible to accurately identify the number of women who have received mesh implants after evidence that Medicare item numbers do not distinguish mesh surgery from other incontinence and prolapse surgery.
“The committee considers that an understanding of the true scale of the risk posed by mesh devices, or any implantable medical device, is fundamental to tailoring an effective regulatory response,” the report said.
Pelvic mesh inquiry chair Senator Rachel Siewert said she was “deeply concerned” that in 2015-16 there were 17,599 prolapse services funded under Medicare and 5339 services for incontinence, but the committee could not determine how many were for mesh implants rather than surgery without mesh.
The figures showed that prolapse surgery was funded at more than three times the rate of incontinence surgery, despite strong evidence and warnings from Australian and American regulators by 2015-16 that mesh implants for prolapse had significantly higher complication rates than incontinence “sling” meshes.
Senator Siewert said it was a concern that lack of data meant the figures could not be examined to see if doctors were implanting the problem prolapse meshes at a much higher rate than incontinence slings despite the warnings.
The Senate inquiry committee said it was “deeply concerned” by women’s accounts of how some doctors treated them.
“They present the medical profession in a very poor light. The committee can find no reasonable justification for the dismissive and disrespectful treatment many women have experienced from trusted medical professionals,” the Senate report concluded.
Ms Schultz said mesh-injured women faced “chronic gender discrimination, ignorance, complacency and abusive treatment” from doctors and others in the health system.
Peak health consumer group spokesperson Melissa Fox said a key question for governments was why it had taken a decade since the TGA first reviewed the safety of pelvic mesh devices, and the need for women to lobby for a Senate inquiry, to “shine a light on this issue”.
“We call on the federal, state and territory governments to hold a separate inquiry into the responsibilities, operations and funding of the TGA, with special emphasis on its failure to provide timely warnings,” Ms Fox said.
The inquiry needed to include investigating why state and federal health service complaints processes failed to identify a pattern of mesh failure, despite many women repeatedly complaining for years, she said.
The peak health consumer groups said they were disappointed the Senate committee had not recommended suspension of all mesh until data confirms their safety and efficacy.
“These devices will continue to be implanted in women in hospitals across Australia tomorrow, and not one more woman should be unwittingly subjected to this high-stakes surgical intervention until we can be assured of their safety,” Ms Fox said.
The peak health groups have backed mesh-injured women who say the need for long-term, compassionate, specialist support units across the country has to be a priority for governments.
While different states have established some services, the report acknowledged they may be “inadequate” after the committee was advised initial consultation had been confined to doctors and doctors’s groups.
The report recommended governments provide services after speaking with mesh-injured women about their needs. The recommendation was backed by the mesh support groups.
“We strongly welcome the recommendation that mesh-injured women are involved in the co-design of all specialist mesh clinics and insist that it happen,” said Ms Schultz on behalf of the mesh support groups.
“Women will not regain trust in the health system if these clinics do not treat them holistically and with empathy. It also requires full disclosure of the level of experience, and interests, of the clinicians treating patients.”