Australia Pulls Ethicon TVT Mesh Devices from the Market

TVT graphic www.kup.at

Mesh Medical Device News Desk, January 23, 2018 ~ Last November the Australian government announced that the larger pelvic meshes to treat pelvic organ prolapse (POP) would be taken off the market because the risks outweighed the benefits.

Now in another setback to mesh makers, Johnson & Johnson's Ethicon TVT mesh devices can no longer be sold in that country because it failed to update its warnings. However, many other pelvic meshes remain on the market in Australia.

Johnson & Johnson has been forced to withdraw all of its TVT mesh devices from the Australian market after it failed to update its warning label by a government imposed deadline.

The Australian Therapeutics Good Administration (TGA) ordered all transvaginal mesh makers to update instruction to include all known complications by January 17, 2018.

While Boston Scientific and Coloplast met the deadline, J&J did not.

Complications include mesh erosion, groin pain, bladder and vaginal perforation, severe chronic pain and infection, painful sex, nerve pain, need for repeat surgeries, need for mesh removal, among other complications. Mesh makers have been accused by plaintiffs’ lawyers of underplaying complications, omitting complications, and failing to fully inform doctors about potential adverse events.

Abbrevo from Ethicon brochure

J&J and its Ethicon division did not meet the January deadline therefore TGA deregistered the entire line of Gynecare TVT products including mid-urethral vaginal slings to treat stress urinary incontinence (SUI).

Those that can no longer be imported include:

Johnson & Johnson – TVT Abbrevo, TVT Exact Retropubic system, Gynecare TVT-Obturator, Gynecare TVT device, and Gynecare TVT w. Abdominal.

The Guardian newspaper did not confirm whether or not those products that remain on hospital shelves can still be used.

*New Add* The Gynecare products listed above are all still sold in the U.S. The TGA does not address are Artisyn Y-Shaped mesh and Gynecare PS, which are also still sold and marketed in the U.S.

REACTION

The president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, Professor Steve Robson said J&J products were probably the most used to treat SUI, reports The Guardian.

He is quoted as saying “In fact, I think it’s regrettable it won’t be available for a while, but there are other similar products.” Dr. Robson said mid-urethral tapes are an appropriate treatment for SUI and are “very safe.”

Mini-slings are not being removed from the Australian Register of Therapeutic Goods (ARTG), just mid-urethral slings.

Since 2013, 45 devices have been removed from urogynecological use by the TGA. Additional devices have been removed by the mesh maker.

At the present time, a product liability lawsuit involving 700 Australian women is wrapping up in Sydney. Closing arguments are reportedly set to begin next week by the Shine Lawyers.

Buzzfeed quotes Professor Christopher Maher who estimates more than 200,000 mesh implant surgeries have been performed in Australia.

MET THE DEADLINE

Advantage Fit sling

At the same time, some mesh makers did meet the deadline. They include:

Boston Scientific devices:

1. Advantage Single Handle Kit (UPN M0068502000);
2. Advantage Fit – single (UPN M0068502110);
3. Advantage Fit - 5 pack (UPN M0068502111);
4. Lynx Suprapubic Mid-Urethral Sling Sys. (UPN M0068503000);
5. Lynx Suprapubic Sling Syst 5-Pack (UPN M0068503001);
6. Obtryx Curved Single System Device (UPN M0068504000);
7. Obtryx Halo Single System Device (UPN M0068505000);
8. Obtryx Halo System 5-Pack (UPN M0068505001);
9. Obtryx II, Halo, Single unit (UPN M0068505110); and
10. Obtryx II, Halo, 5 pack (UPN M0068505111).

Coloplast devices:

1. Aris (UR3010);
2. Aris kit with Aris mesh (UR3105); and
3. Supris kit with Aris mesh (519562)

Last November, Australia’s TGA announced it planned to remove transvaginal mesh products to treat pelvic organ prolapse (POP). TGA felt the benefits of using transvaginal mesh products to treat POP did not outweigh the risks.

Devices that remain on the market include the Boston Scientific Xenform Tissue Repair Matrix, Upsylon Y-Mesh Kit, (neither to be implanted transvaginally). Boston Scientific Advantage Range, Lynx Range, Obtryx Range had to undergo updated precautions added to the label.

Coloplast Restorelle Range may not be implanted transvaginally. Coloplast Aris, Aris kit with Aris mesh, Supris kit with Aris mesh, could only stay on the market with updated information.

In June 2012, J&J withdrew four Gynecare pelvic mesh products in the U.S. including Prolift, Prolift +M, TVT Secur and Prosima. ###