IN 2003 two doctors – Newcastle’s “grand old man” of obstetrics and gynaecology, Dr Alan Hewson, and his Brisbane colleague, Dr Chris Maher – wrote a paper sounding the alarm about a pelvic mesh procedure after treating women with serious complications following mesh surgery.
The procedures “cannot be recommended”, they wrote.
Two years later Dr Hewson and Dr Maher co-wrote another paper with colleagues in Germany and Switzerland, based on severe mesh complications seen in women in the three countries, including women as young as 35 unable to have sex, with chronic infections not responding to antibiotics, mesh tape eroding into their vaginas, discharges, bleeding and extreme, disabling pain.
The paper highlighted the lack of published data on the safety and efficacy of intravaginal slingplasty techniques and the mesh developed by Tyco in its IVS Tunneller. The doctors repeated that “these procedures cannot be recommended” and should be used in “controlled clinical trials only”.
For the next decade Dr Maher, who became an Associate Professor and one of Australia’s leading experts on pelvic prolapse surgery in women, continued to sound the alarm as mesh device manufacturers aggressively marketed them, regulators continued clearing devices for use without new evidence, and doctors’ professional organisations and teaching colleges remained largely silent.
Associate Professor Maher was the target of heavy criticism from some sections of his profession, said Dr Hewson, 89, and now retired.
“He was the honest guy, the whistleblower, saying: ‘Come on guys, we shouldn’t be doing this’,” said Dr Hewson.
The clearance of transvaginal mesh – where mesh tape is implanted in women via the vagina rather than abdominal surgery to treat incontinence and prolapse complications after childbirth – was “one of the real scandals of the past decades”, Dr Hewson said.
He was the honest guy, the whistleblower, saying: ‘Come on guys, we shouldn’t be doing this’.
“The (American) Food and Drug Administration made an awful mess of it. They should have been more careful about letting these devices on the market but the horse has bolted, sadly.
“The (Australian) Therapeutic Goods Administration, they have got something to answer for. The government regulator made errors. There was enough evidence there 10-15 years ago to pull the shutters down on mesh devices.
“A lot of the patients did not give valid informed consent. They did not know what they were getting.”
Dr Hewson said he warned Hunter specialists of his concerns about mesh and that he did not use it.
In a 2013 submission to the New Zealand Parliament which was considering an inquiry into how mesh devices were cleared for use in New Zealand, Associate Professor Maher strongly criticised pelvic floor specialists, regulators, medical colleges and professional organisations.
Pelvic floor clinicians had “failed to demand a satisfactory level of evidence regarding the safety and efficacy of a product prior to its utilization”, which he described as a “completely unsatisfactory scenario”.
Gynaecologists “appeared very receptive” to mesh and “many were surprised” to later find devices were cleared for use in America and Australia without premarket demonstrations of safety and efficacy, he said.
In America alone in 2010 doctors implanted an estimated 75,000 devices.
In Australia just one company, the Adelaide firm TFS Manufacturing owned by former national champion basketballer and Newcastle Falcons player Paul Zadow, sold more than 15,700 devices from 2006. More than 60 mesh devices for prolapse surgery were cleared for use in Australia from 2002.
In November, 2014 TFS became one of the first mesh devices in the world to be deregistered.
An appeal by TFS Manufacturing against the deregistration is being heard in the federal Administrative Appeals Tribunal. In a recent decision before a full hearing later this year, the tribunal was told the TFS device was cleared for use in Australian women based on “very poor” evidence.
Between 2002 and 2011 – when the American Food and Drug Administration finally issued a warning that complications with mesh devices were “not rare” - it was “manufacturers and their paid key opinion leaders” who “aggressively marketed” the devices, and taught the theory and surgical techniques, Associate Professor Maher said.
Elected educational and representative bodies were largely silent on this issue until the 2011 safety notifications.
“Elected educational and representative bodies were largely silent on this issue until the 2011 safety notifications.”
The only medical colleges to provide guidance on transvaginal mesh devices until the 2011 FDA warning were the Royal Australian and New Zealand College of Obstetrics and Gynaecology in 2009, and its Canadian counterpart in 2011, he said.
The International Urogynaecology Association (IUA) and the American Urogynaecology Society (AUGS) did not issue any guidance before 2011. In his paper Associate Professor Maher said members of the IUA declared links with mesh manufacturers in statements after 2011, and at least three declared they received royalty payments from mesh manufacturers.
The professional organisations also accept sponsorship from drug and device manufacturers.
It was women and their lawyers who forced regulators to act on mesh by finally demanding clinical evidence of safety and efficacy – in Australia from August, 2014, Associate Professor Maher said.
“The overwhelming group that has influenced clinician behaviour relating to transvaginal mesh are the litigation lawyers and advertising undertaken to the general community,” he said.
In his 2013 paper he heavily criticised the FDA for clearing a mesh device in 2001, modified from an Australian mesh delivery device, that had no “predicate case” – or similar device with associated evidence – to rely on to approve its use for prolapse surgery.
The FDA’s finding that “any differences in the devices do not raise new questions of safety and efficacy” was “factually incorrect”, he said.
The device with its faulty clearing for prolapse became the predicate case for multiple subsequent prolapse mesh device clearances in America, and later Australia, he said.
He recommended substantial changes in regulatory approvals for devices, an “arm’s length” relationship between manufacturers and doctors, and requiring college directors to be free of any conflicts of interest.
“It is vital that we review the events that allowed the women we are trained to serve to be exposed to unknown risk during the surgical treatment of pelvic organ prolapse,” he said.