Wednesday, 6 December 2017
Questions without Notice: Additional Answers
I refer to a question asked of me yesterday by Senator Hinch in my capacity as Minister representing the Minister for Health. I would like to add to the response that I provided to Senator Hinch during question time yesterday regarding transvaginal mesh. The Therapeutic Goods Administration, TGA, has been monitoring this situation closely since 2008 and did reviews in 2010 and 2013. The most recent review was completed on 28 November 2017. The TGA has in place an established adverse events reporting system, and the TGA has continued to encourage doctors and patients to report adverse events involving gynaecological mesh. It is mandatory for manufacturers to report adverse findings to the TGA.
At the time of the calling of the Senate inquiry, the TGA had received about 250 adverse event reports from the use of gynaecological meshes in the context of about 150,000 devices having been implanted in Australia. The Senate inquiry did play a role in stimulating additional reports from affected women. However, the recent decision of the TGA was not directly in response to the Senate inquiry, which is still underway and has not yet made any recommendations. Rather, a decision was made to remove from the Australian Register of Therapeutic Goods transvaginal mesh products, whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation and single-incision mini slings for stress urinary incontinence. This decision 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 Australian Register of Therapeutic Goods and supplied in Australia.