NEWCASTLE, Australia — A company run by a former champion Australian basketballer sold more than 15,000 gynecological devices without sufficient trials proving its claims, and based on “very poor” evidence, a tribunal has been told.
Paul 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 de-registered in 2014, according to the Newcastle Herald.
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 gynecologist Dr. Elizabeth Gallagher backed the Therapeutic Goods Administration’s de-registration of TFS, in a statement to the federal Administrative Appeals Tribunal in early February after Zadow appealed the de-registration.
“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 randomized controlled trials comparing either a vaginal mesh product or native tissue repair,” Gallagher said.
“The clinical evidence to support the use of TFS to treat prolapse is very poor.”
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 de-registered 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.
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