Mesh devices ‘high risk’ in new regime

Written by admin on 28/09/2019 Categories: 广州桑拿

Action: Australian Pelvic Mesh Support Group members outraged by the Australian Therapeutic Goods Administration’s years of mesh device approvals.
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AUSTRALIA’S peak drug and medical device regulator will require stronger evidence from pelvic mesh manufacturers afterlegal action by women and a Senate inquiry that has exposed the lack of evidence before mesh devices were approved for use more than a decade ago.

All pelvic mesh devices on the Australian market will be classified high risk, denoting a high level of potential harm, and women will receive patient cards with details of their pelvic mesh devices, the Therapeutic Goods Administration announced in a statement on its website on October 26.

From December, 2018 all new pelvic mesh devices will have to meet “higher evidentiary requirements”, and the small number of devices for incontinence and prolapse that remain on the Australian market will be upgraded to high risk and required to meet the new standards by December, 2020.

The changes, approved by Health Minister Greg Hunt, follow a 2011 Parliamentary inquiry which questioned whether the TGA’s emphasis on post-approval monitoring could lead to devices being “trialled unofficially” on patients.

Women implanted with pelvic mesh devices for incontinence and prolapse after childbirth have told a Senate inquiry they felt like “guinea pigs” after revelations about the lack of evidence supporting the use of many pelvic mesh devices before they were first used in Australia from the late 1980s.

Australian Pelvic Mesh Support Group founder Caz Chisholm, who successfully pushed for theSenate inquiry that is due to report in late November, said mesh devices had always been classified at least medium to high risk, but the issue was about what women were told.

“No woman that I know in the support group of more than 1000 womenwastold by her surgeon that her device was high risk, or medium to high risk,” Ms Chisholm said.

“Once these devices are re-classified, are specialists going to tell women the device they are about to be implanted with is high risk? I don’t think so.”

Ms Chisholm slammed the TGA for “quietly announcing” the changes on its website after her group’s sustained criticism.

The Herald, Newcastle

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