VICTORIA’S new public health watchdog will investigate allegations two doctors – including a former University of Newcastle associate professor being monitored by the NSW Medical Council – assisted a Victorian specialist during pelvic mesh device surgery on women without a major Melbourne public hospital’s knowledge.
Victorian health minister Jill Hennessy has directed Safer Care Victoria to prioritise an investigation into surgery on women at the Northern Hospital in 2009, 2010 and 2013 after evidence two doctors, including former Newcastle University doctor Richard Reid, assisted a Northern Hospital gynaecologist without the hospital’s knowledge or approval, using a pelvic mesh device for prolapse that was one of the first in the world to be cancelled in 2014.
The investigation will include how a research paper by Northern Hospital gynaecologist Dr Max Haverfield about the mesh device – the Australian-invented and manufactured Tissue Fixation System (TFS) – was published in 2015 saying a trial involving 40 women had “Northern Hospital/Northern Health ethics committee” approval, after the hospital said it had no record of the trial or ethics committee approval.
“These are very serious and concerning allegations, which we have referred to Safer Care Victoria for investigation as a matter of priority,” a spokesperson for Ms Hennessy said.
These are very serious and concerning allegations, which we have referred to Safer Care Victoria for investigation as a matter of priority.- Victorian Health Minister Jill Hennessy
The investigation will include allegations TFS inventor and then director of TFS Manufacturing, Dr Peter Petros, assisted Dr Haverfield on two occasions in January and March 2010, without the knowledge or approval of Northern Health.
It will also investigate allegations former University of Newcastle associate professor Richard Reid assisted Dr Haverfield perform TFS surgery on women on two occasions in May and June 2013 without the knowledge or approval of Northern Health, and while being monitored by the NSW Medical Council after complaints from women linked to pelvic mesh surgery.
The investigation will include whether Dr Reid was being trained to use the TFS device at the Melbourne hospital, after Dr Haverfield in 2014 advised a NSW tribunal that in June 2013 he trained Dr Reid in “pelvic floor construction involving TFS and had several surgical sessions with him until he was competent and comfortable operating with a surgical assistant”.
Doctors performing surgery at Northern Health are required to be credentialed and to hold an appointment, the health service said.
It was not able to identify “any documentation or other evidence” to suggest Dr Petros and Dr Reid were in Northern Hospital operating theatres “with the knowledge or approval of Northern Health”, the health service said in a statement.
Theatre records showing Dr Petros and Dr Reid assisted Dr Haverfield in 2010 and 2013 were not located until after an “extensive review” by Northern Health following questions by a member of the public to the health service in 2016 about the TFS research paper, published in the journal Pelviperineology.
In the research paper Dr Haverfield concluded TFS procedures were “minimally invasive, safe and effective” based on a trial of 40 women at Northern Hospital between December, 2009 and July, 2010.
The research paper was published after the TFS device was cancelled by Australia’s Therapeutic Goods Administration in November, 2014, because of lack of evidence of its safety and efficacy, and while the Adelaide-based TFS Manufacturing was preparing an appeal against the decision.
In a statement Northern Health said Dr Haverfield was a visiting gynaecologist at Northern Health until 2014.
“Northern Health does not have any record of its human research ethics committee having granted approval to Dr Haverfield to conduct the research studies described,” a spokesperson for the health service said.
“Each surgery performed is fully documented in individual clinical records relating to that patient and such records include details of the consent obtained for surgery.”
Ms Hennessy referred the matter to Safer Care Victoria after questions from the Newcastle Herald.
Safer Care Victoria was established after a damning report into the Victorian hospital system in October, 2016 following a cluster of baby deaths at a Bacchus Marsh hospital.
Safer Care Victoria acting chief executive Ann Maree Keenan said the new public health watchdog was leading Victoria’s response to complaints by thousands of Australian women about pelvic mesh devices for incontinence and prolapse complications after childbirth, which have prompted a Senate inquiry into how they were cleared for use in Australia.
“Safer Care Victoria is working with Northern Health to investigate the matters that have been referred to the agency by the Minister,” Ms Keenan said.
NSW Health said Dr Reid in 2013 was not required to advise the NSW Medical Council where he was working, but conditions on his registration included that he keep a log book recording “each surgical procedure that he performs”, and forward a copy to the Medical Council every three months.
“There is no record held by the Medical Council of NSW of Dr Reid advising the Council that he was assisting with any surgery in Victoria in 2013,” a NSW Health spokesperson said.
NSW Health Minister Brad Hazzard said it was “very concerning that a doctor in NSW can go to Victoria and the conditions and pre-existing concerns not be necessarily noted and acted upon”.
In May NSW Greens MP David Shoebridge raised questions in NSW Parliament about Dr Petros, Dr Reid and Dr Haverfield and the Northern Hospital.
Dr Haverfield advised there would be no comment after written questions from the Herald.
Dr Petros and Dr Reid did not respond to questions.
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