Mesh device appeal against decision by Australia's peak health watchdog

A COMPANY run by former champion Australian basketballer and Newcastle Falcons player Paul Zadow sold more than 15,000 gynaecological devices without sufficient trials proving its claims, and based on “very poor” evidence, a tribunal has been told.

Mr Zadow’s Tissue Fixation System (TFS) was the first mesh product approved in Australia in 2006 for prolapse surgery in women after pregnancy complications, and one of the first of the controversial prolapse mesh devices in the world to be deregistered in 2014.

But an expert expressed concern about how the device remained on the Australian market for more than a decade, with continued sales of about 600 per year overseas, as Victorian Senator Derryn Hinch vowed to campaign for a Senate inquiry into how more than 40 prolapse mesh devices were approved in Australia after 2006 with little, or poor, evidence to back safety and efficacy.

Obstetrician and gynaecologist Dr Elizabeth Gallagher backed the Therapeutic Goods Administration’s deregistration of TFS, in a statement to the federal Administrative Appeals Tribunal in early February after Mr Zadow appealed the deregistration.

“I have concerns that after more than 10 years on the market in Australia, and over 15,707 devices sold worldwide, with continued sales of approximately 600 per annum, the evidence to support this device for the use of organ prolapse does not include any randomised controlled trials comparing either a vaginal mesh product or native tissue repair,” Dr Gallagher said.

“The clinical evidence to support the use of TFS to treat prolapse is very poor.”

Director: Former champion Australian basketballer and Newcastle Falcons player Paul Zadow is challenging the deregistration of his company's medical device for women's prolapse surgery.

Director: Former champion Australian basketballer and Newcastle Falcons player Paul Zadow is challenging the deregistration of his company's medical device for women's prolapse surgery.

Evidence supplied to the TGA backing the device’s re-registration consisted of “editorial letters, preliminary studies or descriptions of the surgical techniques”, which did not allow an independent assessor “to be confident in the way results and complications have been collected and assessed”, Dr Gallagher said.

In 2014 the Therapeutic Goods Administration ordered a large number of mesh device manufacturers to provide evidence and trials backing their claims of safety and efficacy after tens of thousands of women around the world, including in Australia, took legal action or complained of complications.

It deregistered TFS and two other mesh devices in August, 2014, only one week after concluding there was “little evidence to support the overall effectiveness of these surgical meshes as a class of products”.

But documents obtained in 2016 under freedom of information showed the country’s peak health regulator was given clear warnings of the need for controlled trials on related mesh devices.

The TGA was told in 2003 that there was “no peer-reviewed, good quality evidence available to determine the safety and efficacy” of incontinence mesh devices used to support registration of mesh for use in prolapse surgery.

“The safety and efficacy of the procedure cannot be determined at the present time due to an incomplete and poor quality evidence base. It is recommended that further research be conducted to establish safety and efficacy,” a report from the Australian Safety and Efficacy Register of New Interventional Procedures said in a document used to support an early prolapse mesh device application.

The news angered Port Stephens MP and health lawyer Kate Washington, who said the TGA was “tasked with protecting our community but in this instance of mesh devices for women’s prolapse they’ve entirely failed to do so”.

“It’s not like we’re talking a very long time ago. Had they done what they should have done back then and rigorously assessed the evidence put to them we wouldn’t be seeing the devastating impacts on women today.”

The TGA has admitted its assessment process for mesh devices from 2002 was not “mature” and lacked “rigour”. Devices developed and released on the market to treat women with incontinence, despite warnings to the TGA about the need for more trials, were later approved for use in prolapse surgery without evidence of efficacy.

Tissue Fixation System, patented by obstetrician Dr Peter Petros who sold the rights to Mr Zadow’s company TFS Manufacturing, is patented in 19 countries, the TFS website said. It does not state in how many countries the devices are actually sold. The website notes the device is not available in Australia.

In a preliminary hearing in early February before TFS’s appeal against the deregistration is heard later this year, Administrative Appeals Tribunal deputy president Katherine Bean rejected a TFS application to obtain the names of TGA internal evaluators who questioned the evidence base.

Ms Bean noted there was no inconsistency between the opinions of the TGA’s internal evaluators and other experts, including Dr Gallagher, who had each concluded the TFS device’s evidentiary material did not meet national standards.

The claim by TFS that it “easily matches results of other minislings and in many cases is found to be superior” was “not supported by the evidence presented”, the tribunal was told.

Ms Bean noted the first TGA evaluation report of TFS in April, 2010 querying “the adequacy of the training and the instructions for use provided for this device”.

Senator Derryn Hinch has supported a Senate inquiry into how mesh devices were approved in Australia, telling Federal Parliament their sale had led to “one of the greatest medical scandals and abuses of mothers in Australia’s history”.

“Once again the drug companies and the so-called watchdogs like the TGA are letting victims down,” Senator Hinch said in a speech after meeting with women who suffered serious complications after they were implanted with mesh devices.

The women – some from the Hunter – were then “treated like mushrooms: kept in the dark and fed bullshit by doctors, hospital administrators, the drug companies and even the TGA”, he said.

Senator Hinch’s office is collecting the details of women who have suffered mesh injuries after the Federal Government queried the extent of the mesh problem.

Mr Zadow’s Adelaide company’s website says the TFS mesh device is based on the “Integral Theory” – developed by Dr Petros – which “set the foundation for a new approach to treatment of female pelvic floor dysfunction”.

“With over 3 years of extensive patient data, these conditions can now be treated with the TFS, using a minimally invasive technique under direct vision, many in a day-care surgery environment,” the website said.

In an email in response to Newcastle Herald questions, Mr Zadow said experts put forward by the TGA and the federal Minister for Health had been “quoted selectively for the purpose of the Tribunal considering one procedural issue”.

“Without that context, the quoted material paints a misleading picture. There has been no finding that the material quoted in the decision is correct – it is not correct,” Mr Zadow said.

“In any event, the ultimate question for the Tribunal is whether TFS Manufacturing has demonstrated compliance with the Essential Principles defined in the relevant regulations. The material from Minister’s specialists is largely directed to a different question.

“TFS Manufacturing has put forward expert evidence and medical research to demonstrate that the TFS device meets the Essential Principles and, when used by skilled surgeons, is very effective in the treatment of a range of difficult to treat conditions.

“As the proceedings are ongoing, and we cannot refer in detail to the evidence provided by the parties, it would not be appropriate to comment further.”