Shine Lawyers Logo
1800 618 851
Shine Lawyers | A doctor checks records | Shine Lawyers

TGA's mesh ban welcomed but needs to go further


Mesh victims and participants in the Shine Lawyers mesh class actions have welcomed news that the Therapeutic Goods Administration (TGA) will ban the use of vaginal mesh implants for pelvic prolapse in Australia after finding that the risks outweigh the benefits.

The TGA announced the decision following a review of clinical evidence and complaints from dozens of Australian women, who said the device had caused them to suffer severe complications.

"The TGA has today decided to remove transvaginal mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation from the Australian Register of Therapeutic Goods (ARTG)," a statement from the TGA said.

"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," said a TGA spokeswoman.

Grays Point woman Gai Thompson received a mesh implant in 2008 and has since suffered life-changing complications.

Six years ago, Mrs Thompson warned the TGA of a looming disaster involving the mesh devices and in the years following has campaigned for a formal inquiry into the matter.

Mrs Thompson, a group member in Shine Lawyers' Johnson & Johnson mesh class action, has welcomed the news and says the ban vindicated the concerns impacted women had raised about the vaginal mesh implants.

"For so many years we've been told there's nothing wrong with us, that symptoms are either in our head or it's not because of the mesh. This has come about because of all the women who have come forward to shine a light on what’s happening," she said.

Mrs Thompson is calling for a total ban on all mesh implants still damaging women.

“This is wonderful news but we want all mesh banned. Even as we speak, women are still being implanted and will continue to be until the cancellation takes effect. Women’s lives will still be ruined by it.”

The banned mesh devices can only be sold until January 4, 2018. The TGA has imposed increased labelling requirements for those products that remain on the ARTG. These products are listed in the table below:

ARTGSponsorManufacturerBrand/Product NameRegulatory and other Action
174878Boston Scientific Pty LtdTEI Biosciences IncXenform Tissue Repair MatrixCondition of inclusion imposed: Instructions for Use and labelling include 'This device is not intended for any pelvic organ prolapse repair via a transvaginal approach', effective 11 July 2017.
150342Boston Scientific Pty LtdBoston Scientific CorporationUpsylon Y-Mesh KitConditions of inclusion imposed: not to be implanted transvaginally. The Instructions for Use, labelling and promotional documentation must be amended to include this information, effective 4 January 2018.
104326Boston Scientific Pty LtdBoston Scientific CorporationAdvantage RangeCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling, effective 11 August 2017.
104326Boston Scientific Pty LtdBoston Scientific CorporationLynx RangeCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling, effective 11 August 2017.
104326Boston Scientific Pty LtdBoston Scientific CorporationObtryx RangeCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling, effective 11 August 2017.
190172Coloplast Pty LtdColoplast ASRestorelle RangeCondition of inclusion imposed: not to be implanted transvaginally. Instruction for Use, labelling and promotional documentation must be amended to include this information, effective 4 January 2018.
157074Coloplast Pty LtdAbissAris meshCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.
160738Coloplast Pty LtdColoplast ASAris kit with Aris meshCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.
160738Coloplast Pty LtdColoplast ASSupris kit with Aris meshCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.
99193Johnson & Johnson Medical Pty LtdEthicon SARL SwitzerlandGynecare TVT W/AbdominalCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.
99193Johnson & Johnson Medical Pty LtdEthicon SARL SwitzerlandGynecare TVT DeviceCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.
99193Johnson & Johnson Medical Pty LtdEthicon SARL SwitzerlandGynecare TVT ObturatorCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.
99193Johnson & Johnson Medical Pty LtdEthicon SARL SwitzerlandTVT Exact Retropubic systemCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.
99193Johnson & Johnson Medical Pty LtdEthicon SARL SwitzerlandTVT ABBREVOCondition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.

Shine Lawyers - Get in touch

Shine Lawyers is representing recipients of mesh implants in two class actions against manufacturers listed above: Johnson & Johnson / Ethicon and Boston Scientific. A third action is underway for recipients of faulty mesh implants made by American Medical Systems. For more information or to register for the class actions, visit our Johnson & Johnson / Ethicon Class Action page, Boston Scientific Class Action page or our American Medical Systems Class Action page. You can contact our Mesh Class Action team online or on 1800 884 139.

Related information:

Written by Shine Lawyers. Last modified: March 20, 2021.

Enquire Now

If required, we gather more details or documents later in the process.
0/2000

Join the discussion