AMERICAN regulators have banned a problem group of pelvic mesh devices nearly 18 years after they appeared on the market, and as the Australian doctor who invented one of the first of the US-approved problem devices faces professional misconduct proceedings in NSW.
The American Food and Drug Administration (FDA) has ordered all remaining manufacturers to immediately stop selling and distributing prolapse mesh devices because of safety and efficacy concerns, and after billions of dollars in damages claims by thousands of women in America, Australia, the United Kingdom and Europe.
The ban comes 18 years after the FDA approved an Australian-invented mesh device to treat prolapse, a complication after childbirth, only months after Australian reviewers in February, 2001 found no "good quality evidence to determine the safety and efficacy" of the device procedure.
The American approval allowed multiple prolapse device kits on the global market without clinical trials over the following decade under the FDA's controversial device approval system, including at least one Johnson & Johnson device cited in a class action by 1000 Australian women against the company.
Mesh devices implanted transvaginally (via the vagina) were marketed in American from 2001 as quicker and with less complications than traditional abdominal surgery. In 2010 alone 75,000 American women were implanted with transvaginal prolapse mesh devices, while more than 200,000 were implanted with transvaginal incontinence mesh devices.
A Senate inquiry in 2017 was told about 150,000 prolapse and incontinence devices have been sold in Australia.
Injured women, health consumer advocates and some doctors say the FDA ban, 18 months after Australia's regulator, the Therapeutic Goods Administration, took similar action, is an indictment on national health systems that allowed the devices to be approved without good evidence of safety and efficacy.
"It's a case of too little, far too late by regulators. What's left is a generation of devastated women implanted with prolapse mesh devices where there was little to no evidence of safe use from the start," said leading Australian health consumer advocate Danny Vadasz.
"The mesh scandal is an indictment on health systems around the world, including in Australia, and those responsible are still not being held fully accountable."
The recent FDA banning order is the toughest yet by the American regulator which issued a first warning about prolapse and incontinence mesh devices in 2008. By 2011 the FDA warned that serious adverse events from pelvic mesh surgery were not rare and included the deaths of some women.
Australia's regulator banned the first prolapse mesh devices in 2014. It cancelled all transvaginal prolapse mesh devices in 2017 after acknowledging evidence supporting their use was poor, and after some women experienced catastrophic injuries.
Mid-urethral mesh slings to treat incontinence can still be supplied in Australia after studies supporting their use. In 2018 Johnson & Johnson withdrew its mid-urethral slings from Australia, including devices backed by randomised controlled trials that were regarded as "gold standard" slings.
An FDA spokeswoman confirmed Australian gynaecologist Peter Petros' Intra Vaginal Sling (IVS) was one of the first transvaginal mesh devices approved for use in America to treat prolapse after it was sold to US device manufacturer Tyco in 2001.
The IVS was developed and implanted in women in Western Australia from the late 1980s after Dr Petros tested the device on 13 large dogs, and after it was "exclusively marketed" by the WA branch of the Australian Medical Association as a "medical design breakthrough" before its sale to Tyco.
In 2017 the then AMA president Michael Gannon said promotion of the IVS, despite reports of serious complications in women from as early as 1989, was "a long way from our proudest hour".
Western Australian pelvic mesh patient advocate Caz Chisholm, who campaigned for a Senate inquiry into the mesh scandal, repeated her call for a judicial inquiry into how mesh devices continued to be implanted in WA health facilities for years despite reports of serious concerns.
"It is imperative that Australia gets to the root cause of this worldwide mesh destruction and holds those responsible to account," Ms Chisholm said.
"It is infuriating that it takes all the energy of a small group of women who constantly fight for the majority of the injured, and we all burn out from the stress, the frustration and the endless accounts of ruined lives."
In early April NSW health investigators alleged before the NSW Civil and Administrative Tribunal that Dr Petros gave "misleading and untruthful information" for two years from 2014 about the financial benefit he received from a second pelvic mesh device he developed, the Tissue Fixation System (TFS) device.
Dr Petros is facing professional misconduct proceedings after a woman implanted with the TFS device at Ashfield's Sydney Private Hospital, without her consent, suffered severe and permanent injuries.
Dr Petros developed the TFS device in the early 2000s after selling the IVS device to Tyco. The TFS device was registered for use in Australia from 2006.
The tribunal was told Dr Petros admitted two of the charges against him - that he had a financial interest in the TFS device between 2009 and July 7, 2014 as a beneficiary of the family trust that owned the company that held the intellectual property in the device.
The tribunal heard evidence Dr Petros disclosed his invention of the device and "continuing involvement" with it in 2013 to a Sydney Private Hospital medical advisory committee made up of surgeons and hospital executives.
The tribunal was told women were implanted with TFS at the hospital in 2013 and 2014, some without their knowledge or consent.
In 2013 Dr Petros was required to supervise a colleague, former University of Newcastle associate professor Richard Reid, during surgery at the hospital while Dr Reid was under conditions imposed by the NSW Medical Council.
Sydney Private Hospital's medical advisory committee required Dr Petros to supervise Dr Reid for three months after Dr Reid was suspended following a surgical emergency involving a woman patient.
The tribunal was told a condition of Dr Reid's reinstatement was that he "adopt... the Tissue Fixation System (TFS) for his pelvic floor surgical cases" after his suspension was lifted.
The TFS device was cancelled by the TGA in November, 2014, less than 18 months after the hospital committee directed its use by Dr Reid.
In September, 2018 the NSW Civil and Administrative Tribunal found Dr Reid guilty of professional misconduct following complaints by 17 women patients, many after TFS surgery at Sydney Private Hospital. The tribunal criticised Dr Reid for exhibiting "zeal" for Dr Petros' theories that were practised by only a few gynaecologists in Australia. The tribunal said it would have deregistered Dr Reid but he retired before the professional misconduct decision.
An appeal against the cancellation of the TFS device by Adelaide-based TFS Manufacturing, headed by former Australian and Newcastle basketballer Paul Zadow, failed in December.
Dr Petros denied receiving a financial interest from nearly $2 million in loans his family trust company made to TFS Manufacturing. The family trust company was paid no fees or royalties and interest on the loans accrued but was not paid.
The tribunal hearing into professional misconduct allegations against Dr Petros will resume in May.
Lawyer Adrian Barakat, from AJB Stevens Lawyers, representing IVS and TFS women patients, said the FDA ban was significant but "we're disappointed it took so long for this to happen and for women's voices to be heard".
Women had initiated civil action against Dr Petros, other doctors who used the devices and hospitals in different Australian states where surgery was carried out, and others were considering a class action against the devices, Mr Barakat said.
"The only remedy available to the women to achieve some justice is the civil remedy," Mr Barakat said.