An Australian Clinical Investigator promoted a controversial investigational device (vaginal mesh device known as Tissue Fixation System) that left Australian women with serious and permanent injuries to their bowels and sexual organs. Consequently, in 2014, the national medical device watchdog cancelled its registration for use in Australia. Now Peter Petros, the gynecologist behind the development and use of the mesh to fix uterus prolapse, has registered the product for clinical trials in an Austrian hospital.
The NSW Civil and Administrative Tribunal found Dr. Petros guilty of professional misconduct over his involvement with the surgeries in Australia.
What is the controversial device?
Tissue Fixation System (TFS)
What is the Trial Status in Australia?
Dr. Petros reported that the clinical trial for TFS had been withdrawn from the Australian New Zealand Clinical Trials Registry (ANZCTR) for “logistical reasons.”
What Actions have Authorities taken?
Earlier this year the NSW Civil and Administrative Tribunal case, the Health Care Complaints Commission (HCCC) alleged that Dr. Petros had surgically implanted the TFS device in 108 patients between 2013 and 2015 and failed to disclose that he and his family had an interest in the product.
Continual Problems in Australia
Apparently, although the Therapeutic Goods Administration (TGA) in Australia cancelled the device’s registration back in November 2014, the product was still being used in some surgeries at the Sydney Private Hospital. Dr. Petros told the hearing he purportedly didn’t care to inform patients that it had been removed from the register raising real ethical problems.
Other Investigators to Watch
Dr. Petros had supervised Dr. Richard Reid, who was separately found guilty of professional misconduct in September, 2018, inset a pelvic mesh device. The patient of Dr. Reid suffered severe bleeding and was transferred in critical condition to St. George Public Hospital accompanied by Dr. Petros. The HCCC alleged that they did not notify the staff at the emergency department what specific procedure the patient had and did not mention that the TFS device was used.
What was the Australian Tribunal Finding Against Dr. Petros?
They found Dr. Petros acted improperly, unethically, and that his behavior around the disclosure of his financial ties to the product had been “clearly misleading.” They ruled to cancel the registration of the trial for two years but he had already retired.
What is the New Clinical Trial?
The Sydney Morning Herald reports that Dr. Petros has shown up in association with an Austrian clinical trial. The study offers a keyhole surgery at Feldkirch Hospital in Australia to insert the TFS in 30 women suffering uterine prolapse, with surgery performed by Professor Burghard Abendstein.
What has been the Austrian’s responses to the Australian Inquiry?
Nothing. The Austrians—Professor Abendstein nor the hospital have responded to requests to discuss Dr. Petros and the incidents in Australia.
Investigator Watch: Be careful with these Researchers