29 November 2017

TGA slaps ban on transvaginal mesh products

TGA Women

The TGA has removed transvaginal mesh products used solely to treat pelvic organ prolapse from the Australian Register of Therapeutic Goods.

The decision followed a review of international studies and an examination of the clinical evidence for each product included in the register and supplied in Australia.

“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,” the authority said in a statement.

In total, eight mesh implants and mini-sling products are to be removed from the register, to come into effect from 4 January.

The TGA said there was a lack of adequate scientific evidence 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 were outweighed by their benefits.

A number of other vaginal mesh kits and transvaginal tape products will remain on the register but will contain warnings that they should not to be used for transvaginal pelvic organ prolapse repair.

The decision comes ahead of a Senate report due in February investigating the rate of complications involving the vaginal devices.

More than 700 women in Australia are taking part in a class action against manufacturer Johnson & Johnson for damages allegedly caused by its vaginal mesh implants.

Those damages allegedly include life-changing pain and side-effects such as loss of sexual function.

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Max Kamien
Max Kamien
1 year 1 month ago

Was on a tribunal 12 years ago where an early advocate of transvaginal ‘mesh’ for stress incontinence and prolapse was sued by a patient whose sex life was now destroyed as well as being in constant pain. 12 years is a long time to finally make a decision that should have been made 12 years ago.