The Therapeutic Goods Administration (TGA) of Australia has issued an alert concerning urogynaecological surgical mesh implants.
The TGA has 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).
This follows a review by the TGA of the latest published international studies and an examination of the clinical evidence for each product included in the ARTG and supplied in Australia. Based on this new information, and since the publication by the TGA of the Results of review into urogynaecological surgical mesh implants, 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 TGA also considers that there is a lack of adequate scientific evidence before the TGA 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 are outweighed by their benefits. These products will be removed from the ARTG. It should be noted that mini-slings are different devices to mid-urethral slings, which are not being removed from the ARTG.
Since the review commenced in 2013, 45 devices have been removed from urogynaecological use by the TGA – 43 cancelled from the ARTG and a further two have been limited to non-urogynaecological procedures. Additional devices have been removed from the ARTG by sponsors of the device, due to commercial reasons.
For details, please refer to the TGA website:
https://www.tga.gov.au/alert/tga-actions-after-review-urogynaecological-surgical-mesh-implants
Posted on 30 November 2017