WOMEN victims of pelvic mesh surgery are investigating legal action against not only device manufacturers and surgeons, but state health departments and Australian regulators they hold responsible for failing to protect them.
The Western Australian Health Department is already a focus, said solicitor Adrian Barakat of AJB Stevens Lawyers in Sydney, after women alleged a cover-up of mesh device surgical trials in WA public and private hospitals.
This followed Newcastle Herald articles revealing two senior Western Australian doctors released research papers from 2005 about surgical trials in Western Australian public and private hospitals using a pelvic mesh device invented by one of the doctors, and a secret settlement in 2013 paid by WA Health to a woman implanted with the device in a public hospital in 2003.
Although the research papers stated the trials had ethics committee approvals, WA Health said it could not locate records of ethics approvals for trials of the device.
“The majority of the cases we have at the moment are in Western Australia so that’s our focus, but we have a large number of clients and they’re from all over the country. We’re definitely looking at health departments in each state,” Mr Barakat said.
The Herald has also revealed research papers citing ethics approval of a surgical trial using the device at a Victorian public hospital. Victoria’s new health care watchdog launched an investigation in June after Health Minister Jill Hennessy was told there was no record of the trial, ethics approval or hospital credentialing of the device inventor who assisted with surgery on some of the women.
The majority of the cases we have at the moment are in Western Australia so that’s our focus, but we have a large number of clients and they’re from all over the country. We’re definitely looking at health departments in each state.Lawyer Adrian Barakat on pelvic mesh device legal action
Mr Barakat said his firm had engaged a senior barrister to advise how Australia’s drug and device watchdog, the Therapeutic Goods Administration, could be sued after multiple pelvic mesh devices were registered for use more than a decade ago with little or no evidence of safety and efficacy.
“Somebody needs to find a way to make the TGA accountable. We really think that’s one of the most important ways forward,” Mr Barakat said.
The TGA’s role in the pelvic mesh scandal led University of Canberra academics Dr Wendy Bonython and associate professor Bruce Arnold to call for a complete overhaul of the regulator, in a submission to a Senate inquiry on pelvic mesh devices.
They argued there were legislated indemnity provisions that protected the TGA from being sued for negligent performance of its regulatory functions, which was “problematic because it removes any incentive towards carefulness”.
More than 1350 Australian women are now registered in legal class actions against major mesh manufacturers Johnson & Johnson and American Medical Systems, with an unknown number of individual settlements after legal suits by women against doctors who implanted the devices.
Mr Barakat said his firm, which has successfully litigated child sexual abuse cases against institutions, would run individual cases against device manufacturers, doctors and regulators, rather than class actions.
“We’re looking at the women individually because they’ve all suffered immensely, in different ways. I’ve got women who have had to give up their businesses and jobs. Most of them have suffered in terms of their marriages. Some have lost their marriages because of this. Most of them can’t have intercourse.”
Women implanted with Intra Vaginal Sling (IVS) and Tissue Fixation System (TFS) devices have engaged the firm, along with others considering action against American Medical Systems, Boston Scientific and Johnson & Johnson.
WA Health did not respond to questions about the 2013 secret settlement or how public hospitals responded to complications experienced by women during an early pelvic mesh trial.