ONE of Australia’s leading obstetricians and gynaecologists landed a damning indictment on his own profession and the health system in 2013 in a paper titled “The Transvaginal Mesh Decade”.
Associate Professor Chris Maher blamed regulators in America and Australia for clearing transvaginal mesh devices for use in women without original clinical evidence supporting safety and efficacy. The devices are used where women experience prolapse and incontinence problems after childbirth, and are implanted via the vagina.
The American Food and Drug Administration (FDA) made several serious mistakes in clearing a device, the IVS Tunneller, in 2001 for use in women with prolapse, Dr Maher said. The American system, which allows other devices to be “cleared” for use based on being “substantially the same” as earlier devices, supported a proliferation of prolapse mesh devices for the next 10 years or more. The results for many women have been devastating.
Products were “aggressively marketed” by manufacturers after the FDA clearance. More disturbing is that bodies traditionally associated with the training of doctors, such as their own medical colleges, were “largely silent” during the “transvaginal mesh decade”, Dr Maher said.
Instead the theory and surgical techniques of transvaginal mesh surgery was left to the manufacturers of the products and their paid key opinion leaders.
A Newcastle Herald investigation has uncovered disturbing gaps in Australia’s health regulatory systems, including an adverse event reporting process that relies on manufacturers to report complications and injuries to patients, and doctors who “do not have a strong awareness of Australia’s adverse event reporting systems”.
Australia’s Therapeutic Goods Administration (TGA) is not even able to give a percentage of women who have suffered adverse events after mesh surgery because, as it conceded in a report in 2013, there is “no way” to determine the total number of devices used to make comparisons to find complication rates.
The Australian Pelvic Mesh Support Group successfully lobbied Victorian Senator Derryn Hinch for a Senate inquiry into the scandal in Australia. It is taking submissions until May 31, with public hearings mid-year and a report expected in November. Serious questions need answers.