TGA Should Fast-track Changes for Transvaginal Mesh

In our recent submission to the Therapeutic Goods Administration (TGA) on the up-classification of surgical mesh and patient implant cards, Painaustralia has called for the TGA to consider fast-tracking up-classification of transvaginal mesh from Class IIb to Class III.

The more than 700 women who have joined the class action against manufacturers of pelvic mesh implants allege implants have left them with catastrophic injuries as well as chronic pain. 

As many as 30% of the 100,000 women who have received the implants are now suffering complications, while 65% of respondents to a survey conducted by the Health Issues Centre say they are now living with severe, debilitating or unendurable chronic pain.

The TGA proposal would allow more than three years for transitional arrangements to be put in place, during which time there is a high risk of ongoing damage to the health of Australian women and related impacts on families, the community and our economy.

Painaustralia has also asked that the requirement for patient information should relate to pre-procedure not just post-procedure, that this information be provided to consumers directly (rather than indirectly through a website) and that the requirement for information also be fast-tracked rather than delayed by three years.

Given the high incidence of persistent post-surgical pain, we believe patient implant cards should include information about best-practice multidisciplinary pain management and where to find help and support for chronic pain.

Painaustralia has also offered to act as a dissemination point for information related to transvaginal mesh and potential risks.