NSW Health is investigating how a male pelvic mesh company representative was in a private hospital operating theatre during a woman’s intimate pelvic mesh surgery, without her knowledge or approval.
The investigation, initiated on Friday after Newcastle Herald questions to Health Minister Brad Hazzard, is the second investigation launched by state health authorities in a week involving surgery by former University of Newcastle associate professor of gynaecology, Richard Reid.
They are in addition to a NSW Health Care Complaints Commission investigation of Dr Reid that will be heard by the NSW Civil and Administrative Tribunal in December, and at least five civil suits by women patients involving pelvic mesh surgery by him.
The Sydney Private Hospital investigation will include how NSW Health initially did not pursue a complaint in 2015 after incorrectly advising the woman patient that the man’s company was a member of a professional association, the Medical Technology Association of Australia (MTAA), which bound him by its code of conduct.
When the information was independently checked the MTAA said the company was not a member.
“NSW Health takes the concerns raised by the Newcastle Herald very seriously. The matter is being actively investigated,” a spokesperson said on Friday.
The woman was implanted with the Australian-manufactured Tissue Fixation System (TFS) pelvic mesh device at Sydney Private Hospital by Dr Reid and device inventor Dr Peter Petros, only weeks after Dr Reid is alleged to have assisted with TFS surgery at Victoria’s Northern Hospital in June, 2013, without the public hospital’s knowledge or approval.
The woman had multiple subsequent surgeries at the hospital after serious complications.
NSW Health takes the concerns raised by the Newcastle Herald very seriously. The matter is being actively investigated.NSW Health spokesperson
After a complaint about the male company representative in the operating theatre, NSW Health advised he was not from Adelaide-based TFS Manufacturing, but from another pelvic mesh device company.
“The hospital director of the Sydney Private Hospital has advised that medical representatives are permitted admittance to the operating theatre at the discretion of the theatre manager in consultation with the surgeon. They are present to provide technical advice to the surgeon,” NSW Health’s private health care unit wrote in June, 2015.
The unit named the mesh device company and gave the incorrect advice that “all representatives from this company are members of the MTAA and are bound by their code of conduct”.
A NSW tribunal has heard evidence Northern Hospital gynaecologist Dr Max Haverfield trained Dr Reid in TFS surgery only weeks before the woman’s surgery.
Victoria’s new public hospital watchdog, Safer Care Victoria, is investigating allegations Dr Petros and Dr Reid assisted Dr Haverfield with TFS surgery at the hospital in 2010 and 2013 respectively, without the hospital’s knowledge or approval. It is investigating a separate allegation that Dr Haverfield conducted a TFS trial on 40 women at the hospital, without the hospital’s knowledge.
Safer Care Victoria is also investigating how a research paper on the trial was published by Dr Haverfield in 2015 saying the TFS trial had Northern Hospital ethics committee approval, when the hospital could find no record of such an approval.
The investigation followed Herald questions about the Northern Hospital surgery to Victorian Health Minister Jill Hennessy.
The investigations are in addition to a Senate inquiry into how the controversial pelvic – or transvaginal - mesh devices for prolapse surgery were cleared for use in Australia from 2003/04 without evidence of safety and efficacy. Prolapse surgery in women generally follows complications from childbirth.
The Senate inquiry was established after Victorian Senator Derryn Hinch compared transvaginal mesh devices with the drug Thalidomide, and told Federal Parliament mesh was “one of the greatest medical scandals and abuses of mothers in Australia’s history”.
A landmark Australian legal class action by 450 women implanted with just one company’s pelvic mesh devices, Johnson & Johnson, will start on Tuesday. It is estimated to run for six months.
Dr Reid did not respond to questions.
Sydney Private Hospital did not respond to questions. Correspondence seen by the Herald shows the hospital changed some procedures after the NSW Health inquiries, including requiring company representatives to sign a code of conduct on entering an operating theatre and wear identifying theatre clothing. Patients are also advised in writing that “it may be necessary to have a medical representative present during my surgery to provide technical support”.