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TGA removes transvaginal mesh products from Australian Register

30 November 2017


Media Release

1 December 2017

Therapeutic Goods Australia (TGA) has recently announced the removal of transvaginal mesh products used solely to treat pelvic organ prolapse from the Australian Register of Therapeutic Goods (ARTG).
 
An alert was issued by the TGA stating that the benefits of using transvaginal mesh products in the treatment of pelvic organ prolapse did not outweigh the risks these products posed to patients. Similarly, single incision mini-slings have also been removed from the ARTG due to a lack of adequate scientific evidence to show that the benefits outweigh the risk.
 
RANZCOG President, Professor Steve Robson, has said “We understand the reasons that have prompted this decision by the TGA.”
 
It has become clear that the evidence underpinning the safety and usefulness of mesh used for prolapse is of questionable value. RANZCOG takes on board the decision made by the TGA as the regulatory body for Australian implants. Until such time that the evidence of scientific studies provides a more persuasive argument in favour of mesh kits in the treatment of vaginal prolapse, RANZCOG supports this cautious approach.
 
“The health and wellbeing of women is absolutely paramount. There is an urgent need for good-quality research to guide us on the appropriate use of mesh for prolapse.”
 
The TGA has made it clear that mini-slings are different devices to mid-uretheral slings, and these are not being removed from the ARTG.
 



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