TGA undertakes regulatory actions after urogynaecological surgical mesh implants review
Australia's medicine and medical devices regulator, the Therapeutic Goods Administration (TGA), has decided to remove a number of mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation from the Australian Register of Therapeutic Goods (ARTG).
Australia’s medicine and medical devices regulator, the Therapeutic Goods Administration (TGA), has decided to remove a number of 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 overall 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 a lack of adequate scientific evidence has been provided 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.
As a result, the TGA has taken a series of regulatory actions in relation to transvaginal mesh products and single incision mini-slings.
As a result, these products will also 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.
The TGA has now issued a range of cancellation notices and notices to impose conditions under the Therapeutic Goods Act 1989 to a number of sponsors in relation to their mesh and sling products.
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.
Devices which will remain included on the ARTG and available for legal supply in Australia for urogynaecological repair procedures, effective 4 January 2018, are listed in the TGA web posting.
Full information available on the TGA website.
Media contact: Kay McNiece, 0412 132 585