ONE of Australia’s peak health regulators approved mesh devices for women’s prolapse surgery more than a decade ago despite no evidence of their safe use in prolapse cases, and clear warnings of the need for controlled trials on related mesh devices.
The Therapeutic Goods Administration 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 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 prolapse devices from 2002 was not “mature” and lacked “rigour” before the devices were released on the Australian market and used in prolapse surgery on an unknown number of women.
It was not until August 2014 that the TGA announced there was “little evidence to support the overall effectiveness of these surgical meshes as a class of products” and moved to deregister devices that could not provide clinical proof of safety and efficacy.
The TGA move was nearly three years after its American equivalent, the Food and Drug Administration (FDA), determined serious adverse events with prolapse mesh were “not rare”, and could be “life-altering” for some women.
More than 100,000 women in America and an unknown number in Australia, the United Kingdom and New Zealand have taken legal action against mesh prolapse device manufacturers in what is expected to become one of the largest medico-legal cases in history.
Prolapse occurs when women’s pelvic muscles and tissue are weakened, usually after pregnancy and birth, and symptoms can affect up to 50 per cent of women.
At the height of what has become known as the transvaginal mesh decade – where surgeons carried out prolapse surgery using mesh and accessing the pelvis via the vagina rather than more traditional abdominal surgery – more than 40 mesh devices were on the Australian market, and more than 60 in America.
In a letter to a patient advocate in December 2014 the TGA admitted early mesh device approvals were based on “clinical information considered to support the safety and performance of the device at that time”.
“The medical devices regulatory framework we have today is significantly more mature than it was at the time the (early mesh devices) were assessed,” the TGA’s principal medical advisor Dr Anthony Hobbs wrote.
“Consequently, the rigour of clinical evidence required to demonstrate the safety and performance of devices TGA requires today has also matured and TGA now has a higher expectation of what comprises adequate clinical data.”
Registration documents for some early mesh devices approved for the Australian market, and obtained under freedom of information legislation, show the TGA approved mesh devices for women’s prolapse surgery based on them being of the “same kind” as approved devices for women’s incontinence surgery.
This was despite some of the earliest prolapse meshes using anchors for the first time to secure mesh into women’s pelvic ligaments and other tissue, and the mesh device inventor describing it as a “next generation” device, an “advance” on existing incontinence devices and the product of “a new connective tissue theory for female incontinence”.
An Australian Safety and Efficacy Register of New Interventional Procedures report, which formed part of the registration material supplied to the TGA to support one of the earliest mesh device applications, noted “the published studies available were of the lowest level of evidence”.
In a statement last week the TGA said manufacturers were obliged to report any serious adverse events to the TGA but “reports from consumers and health professionals are voluntary”.