CONSUMER health groups across Australia have called for a total ban on all pelvic mesh devices after the death of a Canadian mesh campaigner, and despite the objections of Australia’s medical device regulator.
In a joint media release on Tuesday the chief executives of groups in five states and the Australian Capital Territory said the Therapeutic Goods Administration had “unfinished business” after it announced a targeted ban of prolapse mesh and some incontinence sling devices on November 28, but stopped short of a total pelvic mesh ban.
The TGA announced a ban on all transvaginal – surgery through the vagina rather than the abdomen – prolapse mesh devices and a group of problematic sling devices, but said there was good evidence supporting “gold standard” midurethral mesh sling devices to treat urinary incontinence.
Consumer health groups argue the catastrophic injuries suffered by some women even with the “gold standard” mesh sling devices was not outweighed by benefits experienced by the majority.
The push for a total ban also follows evidence from individual doctors and doctors’ groups to a Senate inquiry on pelvic mesh which emphasised that low complication rates were obtained by skilled, experienced doctors, but complication rates can rise sharply with unskilled or inexperienced surgeons.
Royal Australian College of Obstetricians and Gynaecologists president Dr Stephen Robson told the inquiry there was “a need for a formal mechanism to ensure that training in new surgical techniques should be undertaken by experienced surgeons with an ongoing audit of the cases they do”.
“We have been recommending this, but we don’t have any actual power to enforce our recommendations,” Dr Robson said.
Health Consumers Queensland chief executive Melissa Fox said Australia’s consumer health groups were “concerned that the TGA’s decision still leaves those women who are being advised to undergo mesh surgery for incontinence at risk”.
“We are heartened that the TGA has finally acted to remove some mesh products from the register of approved devices. But this still leaves products available for despite evidence that these too have caused adverse outcomes.”
Health Issues Centre Victoria chief executive Danny Vadasz said the American drug and device regulator had identified 2874 reports of injury, death and malfunction of mesh implants over three years by 2010. Of these 1371 were associated with stress incontinence repairs, the majority using “gold standard” midurethral slings.
“Given the noted under-reporting of complications and a dearth of retrospective data, how could any woman make an informed decision about the risk of undergoing mesh surgery?” Mr Vadasz said.
The consumer health groups released the statement backing Australian women who called for a total ban on Monday after the death of well-known Canadian mesh campaigner Christina Lynn Brajcic, 42, the day after the TGA announced its targeted mesh and sling ban.
Mrs Brajcic died one month after emergency treatment for sepsis after chronic infections following mesh surgery using an incontinence sling device in 2013. A formal cause of death is yet to be determined.
In a statement on Monday the TGA said Mrs Brajcic’s death was tragic, but “we don’t know the circumstances surrounding it”.
There is “a different risk benefit profile” between midurethral slings for incontinence and the prolapse mesh devices banned in November, the TGA said.
“While there are obviously a number of Australian women who have had problems from the surgery, the total number of women operated on is extremely large,” it said.
The TGA conceded it did not know “exact numbers”.
“The weight of evidence thoroughly supports midurethral slings for stress incontinence. The TGA is not banning the midurethral slings and this position is constent with all overseas regulators,” a spokesperson for the TGA said.
The health groups called on the TGA to immediately establish a mesh user registry similar to the Australian Orthopaedic Association national joint replacement registry, and to undertake retrospective health checks of the many thousands of women who have had pelvic mesh implants since the late 1980s.
A registry “would ensure there is a central database of device types implanted by women and a way to track complications”, the health groups said.