AUSTRALIA’S peak medical device regulator could reclassify all pelvic mesh devices as high risk after a decision by the European Commission, and following damning inquiries and investigations in England, Scotland and other European centres.
The Australian move comes only three days before a Senate inquiry public hearing in Melbourne into how pelvic mesh devices were cleared for use in Australia and implanted in women without evidence of safety and efficacy, and nearly four years after the regulator, the Therapeutic Goods Administration, rejected a reclassification proposal.
In October, 2013 the TGA advised an internal working group which recommended making all mesh devices “high risk” that there was “insufficient evidence to support a change in classification”.
“The data isn’t robust enough to determine if there’s a significant problem with the actual devices or whether there are problems in particular patient groups or if the problems are as result of the manner in which the devices are being used in some circumstances,” said working group notes, obtained under freedom of information legislation.
In a statement on Monday the TGA said it was considering “up-classifying” all surgical mesh medical devices, including gynaecological mesh devices for incontinence and prolapse treatment, from IIb (medium to high risk) to class III (high risk).
The move would include stress urinary incontinence mesh devices regarded as “gold standard” by regulators, medical colleges and specialists’ groups. The TGA is also considering requiring device manufacturers to provide patient implant cards and consumer information for all implantable medical devices.
The working group minutes show the TGA rejected a patient card proposal, with a registry run by the TGA, after it was raised by the internal working group in October, 2013. The TGA said the move was “not possible as it is not within the TGA’s legislative bounds to establish (quasi) product registries”.
The working group was told the TGA’s American equivalent, the Food and Drug Administration, had mandated an active implantable device register 20 years earlier.
On Monday the TGA said the proposed moves follow an expert review of medical device regulations in September, 2016 which recommended the Australian regulatory medical device framework align itself with the European Commission.
The TGA has called on consumers and the health industry to comment on the proposals, with a deadline of August 25 when the Senate inquiry into mesh holds a second public hearing in Perth. The inquiry was called after a campaign by pelvic mesh survivors and the Newcastle Herald.