A DOCTOR who knocked back "lucrative" American offers to buy his pelvic mesh device in 2008 is accused of knowingly misleading health regulators nearly a decade later after women implanted with the device were left with serious and permanent injuries.
Dr Peter Petros is accused of giving misleading evidence to the NSW Health Care Complaints Commission on four matters, including retaining a significant financial stake in his Tissue Fixation System (TFS) pelvic mesh device after denying a financial interest, and failing to disclose nearly $2 million in loans to the device manufacturer, a tribunal was told on Monday.
Dr Petros is also accused of failing to fully disclose his financial interest in TFS to Sydney Private Hospital before a hospital medical committee in 2013 prioritised the device's use in surgery on more than 100 women patients where Dr Petros supervised another doctor.
The hospital's decision was "effectively a slam dunk the TFS was going to be used" in any surgery where Dr Petros supervised gynaecologist colleague Dr Richard Reid, who was found guilty of professional misconduct in September, 2018 after more than 20 years of serious complaints by women patients in Australia and America.
While Dr Petros told the hospital he invented the TFS, he did not disclose he retained the right to sell the device under a deed of agreement with Adelaide-based TFS Manufacturing, owned by former Newcastle Falcons basketballer Paul Zadow, the NSW Civil and Administrative Tribunal was told on Monday.
"Partial disclosure is just as misleading as no disclosure at all," barrister for the HCCC Christopher Mitchell told the tribunal at the end of a public hearing where Dr Petros denied misleading investigators, but made admissions where he conceded his financial stake in the device.
His continuing financial interest in TFS meant there was an incentive for him to help increase its use, including by making loans to the manufacturer, the tribunal was told.
Dr Petros was charged with multiple breaches of the national health practitioner law after a woman complained to the HCCC after she was implanted with TFS without her consent by Dr Reid at Sydney Private Hospital in 2013 and suffered serious and permanent injuries.
The woman's complaint to the HCCC in early 2014, which included asking why Dr Petros's name appeared on her hospital records and questions about his financial interest in the TFS device, prompted Dr Petros to direct his accountant to remove him as a beneficiary from a family trust, the tribunal was told.
The move allowed Dr Petros to respond that he no longer had a financial interest in the device, but it failed to acknowledge he did have a financial stake when the woman was implanted with TFS, Mr Mitchell said.
An earlier pelvic mesh invention by Dr Petros, the Intra Vaginal Sling (IVS) device, which was developed in Western Australia in the late 1980s after experimental surgery on 13 large dogs, was sold to American firm Tyco in 2001.
The IVS was approved by American regulators 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 IVS 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.
In early April Dr Petros gave evidence to the tribunal about receiving two "lucrative" offers by American companies in 2008 to purchase his TFS device, which was invented in the period after the IVS sale.
The TFS device was one of the first pelvic mesh devices in the world to be cancelled by Australian regulators in November, 2014 after TFS Manufacturing failed to substantiate safety and efficacy claims.
TFS surgery was restricted to Sydney Private Hospital by 2014 after a majority of Australian gynaecologists declined to accept Dr Petros's "integral theory" that underpinned both TFS and IVS devices.
The tribunal was told Dr Petros was under an even greater obligation to disclose his full financial interest in the TFS device to other doctors after it was cancelled, but during a period when it continued to be implanted in women at the hospital.
While Dr Petros did not have an obligation to disclose his financial interest to patients, he had an obligation to ensure surgeons who used the device after its cancellation advised patients.
Barrister Patrick Griffin, SC, for Dr Petros said his client's retirement was a consideration for the tribunal if it found him guilty of professional misconduct.
While deregistration is a penalty available following a professional misconduct finding, a reprimand "would be appropriate" because Dr Petros had already retired and the allegations against him were "at the mid to lower end of seriousness", Mr Griffin said.
The HCCC told the tribunal the allegations against Dr Petros were at the high end of objective seriousness.
Mr Griffin urged the tribunal to "think long and hard before reaching a conclusion" Dr Petros "set out to deliberately mislead, provide false information or knowingly cause the HCCC to be misled". The tribunal reserved its decision.