Vaginal mesh implants have been banned in Australia after more than 700 women who were left in horrific pain, launched a class action lawsuit.
The medical watchdog found the risks of vaginal mesh implants far outweighed the benefits of the product, which was used to treat pelvic prolapse and urinary incontinence.
Hundreds of Australian women claimed the mesh left them with debilitating, chronic pain and left them unable to have sex again.
Hundreds of Australian women claimed the mesh left them with debilitating, chronic pain and left them unable to have sex again
The Therapeutic Goods Administration decided this week to remove transvaginal mesh for the sole purpose of pelvic prolapse and single incision mini-slings from the Australian Register of Therapeutic Goods (ARTG) as a result of a review of the latest international studies.
The review was conducted following dozens of complaints by women across Australia, saying the implants had left them with chronic, debilitating pain and unable to have sex.
‘Based on this new information, and since the publication by the TGA of the Results of review into urogynaecological surgical mesh implants, the TGA is of the belief that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse do not outweigh the risks these products pose to patients,’ a TGA statement said.
‘The TGA also considers that there is a lack of adequate scientific evidence before the TGA for it to be satisfied that the risks to patients associated with the use of mesh products as single incision mini-slings for the treatment of stress urinary incontinence are outweighed by their benefits.’
The bans take effect from January 4.
(L to R) Members of the class action against Johnson & Johnson, Gai Thompson, lawyer Rebecca Jancauskas and Joanne Maninon, address the media outside the Federal Court in Sydney on Tuesday, July 4
(L to R) Members of the class action against Johnson & Johnson, Gai Thompson, Joanne Maninon and Carina Anderson, arrive to address the media outside the Federal Court
A Senate inquiry into transvaginal mesh products was launched in February after Senator Derryn Hinch labelled their use in Australia as one of the country’s worst health scandals. The findings of the inquiry are due to be handed down in early 2018.
The ruling of a class action launched in August by more than 700 Australians against manufacturer Johnson & Johnson is also expected to be handed down by the federal court next year.
Hundreds of women launched a class action in the federal court earlier this year.
The women claimed to have suffered horrific and chronic pain from the implants.
Rebecca Jancauskas from Shine Lawyers said ‘many now live in excruciating pain, suffering terrible side effects that impact all aspects of their lives’.
Carina Anderson, is a member of the class action against Johnson & Johnson
‘I’ve had so much bad health since that operation. There are days that i can’t get out of bed and there are days that i try to do things and i just can’t,’ Louise King (pictured) said
‘This class action is about righting the wrong against these women, who will suffer pain and complications for the rest of their lives,’ Ms Jancauskas said.
Speaking to Daily Mail Australia in July, Louise King said the vaginal mesh left her with debilitating chronic pain.
What is a vaginal mesh implant?
The mesh is fashioned from a plastic called polypropylene
It’s designed to help the pelvic floor muscles keep internal organs in place
‘I’ve had so much bad health since that operation. There are days that i can’t get out of bed and there are days that i try to do things and i just can’t,’ she said.
Ms King said she was given ‘no choice’ but to have the mesh implant when she suffered a vaginal prolapse in 2006.
‘I was told this was the only option,’ she said.
Ms King also said she was unable to have sex with her husband after the operation.
‘Before he even entered me i was screaming, it was agonising,’ she said.
‘We tried a few times but he became really scared to touch me. He got to a point where he couldn’t touch me.’
Ms King said she was given ‘no choice’ but to have the mesh implant when she suffered a vaginal prolapse in 2006 – she said she was never able to have sex with her husband again