TGA bans vaginal mesh implants
The TGA has banned all transvaginal mesh products for use in pelvic organ prolapse surgery ahead of a Senate inquiry report into high rates of complications.
The regulator has announced the removal of eight mesh implants and mini-sling products from the Australian Register of Therapeutic Goods, saying it has reviewed the product information and has found that the evidence does not support their use in pelvic organ prolapse procedures.
“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,” its advisory statement says.
The TGA has also stated there is not enough evidence to support the safe use of mesh products as single incision mini-slings for the treatment of stress urinary incontinence.