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TGA’s mesh ban welcomed but needs to go further

doctor-checks-record

Mesh victims and participants in the Shine Lawyers Johnson & Johnson mesh class action 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:

ARTG Sponsor Manufacturer Brand/Product Name Regulatory and other Action
174878 Boston Scientific Pty Ltd TEI Biosciences Inc Xenform Tissue Repair Matrix Condition 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.
150342 Boston Scientific Pty Ltd Boston Scientific Corporation Upsylon Y-Mesh Kit Conditions 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.
104326 Boston Scientific Pty Ltd Boston Scientific Corporation Advantage Range Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling, effective 11 August 2017.
104326 Boston Scientific Pty Ltd Boston Scientific Corporation Lynx Range Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling, effective 11 August 2017.
104326 Boston Scientific Pty Ltd Boston Scientific Corporation Obtryx Range Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling, effective 11 August 2017.
190172 Coloplast Pty Ltd Coloplast AS Restorelle Range Condition 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.
157074 Coloplast Pty Ltd Abiss Aris mesh Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.
160738 Coloplast Pty Ltd Coloplast AS Aris kit with Aris mesh Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.
160738 Coloplast Pty Ltd Coloplast AS Supris kit with Aris mesh Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.
99193 Johnson & Johnson Medical Pty Ltd Ethicon SARL Switzerland Gynecare TVT W/Abdominal Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.
99193 Johnson & Johnson Medical Pty Ltd Ethicon SARL Switzerland Gynecare TVT Device Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.
99193 Johnson & Johnson Medical Pty Ltd Ethicon SARL Switzerland Gynecare TVT Obturator Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.
99193 Johnson & Johnson Medical Pty Ltd Ethicon SARL Switzerland TVT Exact Retropubic system Condition of inclusion imposed: additional precautions must be included in Instructions for Use and labelling for the device, effective 11 August 2017.
99193 Johnson & Johnson Medical Pty Ltd Ethicon SARL Switzerland TVT ABBREVO Condition 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

For more information on any of the mentioned products or the Johnson & Johnson class action, get in touch with Shine Lawyers’ class action department today.

Related information:

Written by Shine Lawyers on . Last modified: December 11, 2017.

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