All Mesh “High Risk” in Australia
Mesh Medical Device News Desk, October 30, 2017 ~ In a quiet but striking move, Australia’s drug and medical device regulator has strengthened the classification of pelvic mesh, increasing the likelihood it will not be used, especially as a first-line treatment.
If you were not paying attention you might not have noticed an announcement last Thursday, October 26.
All pelvic mesh devices in Australia are to be reclassified from moderate to “high risk” over the next 24 months.
The announcement was made on the Therapeutic Goods Administration (TGA) website (here), the Australian version of the U.S. Food and Drug Administration (FDA).
The reclassification will begin in December 2018, for the larger pelvic organ prolapse (POP) mesh, used to treat falling pelvic organs. That gives POP mesh manufacturers 14 months to make the change.
At the same time, the smaller “tape” or “slings” used to treat stress urinary incontinence (SUI) will be upgraded to high risk by December, 2020, a full 26 months away.
A three-year transition period to December 2021 is proposed to apply for other surgical mesh devices such as hernia mesh.
The TGA is part of the Australian Government Department Of Health and it regulates medicine, vitamins, med devices and blood products.
The change is significant.
After the dates above, mesh manufacturers must provide a “higher evidentiary requirement” before they are approved for sale. If they fail to, the devices cannot be marketed.
Patient cards for implantable medical devices will be required for all new urogynecological mesh devices from Dec 1, 2018. At that time, manufacturers of new permanently implantable devices will need to have a patient information leaflet in the TGA approved format.
The changes were approved by Health Minister Greg Hunt and follow an Australian Senate inquiry where women testified they felt like “guinea pigs” after their implants.
At the same time, the largest class action lawsuit in Australia is underway. Seven hundred women are suing Ethicon, a division of Johnson & Johnson, for defective mesh implants, both POP mesh and SUI mesh. The class action trial began in July and is expected to take six months. See MND story here.
“No woman that I know in the support group of more than 1000 women was told 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 has pushed for an Australian Senate report due in late November. She slammed the TGA for “quietly announcing” the changes on its website after her group’s sustained criticism.
The U.S. FDA still classifies SUI mesh as moderate risk or Class II, despite the fact that it is a permanent implant and the subject of thousands of defective product lawsuits filed in the U.S.