Private Healthcare Australia has called for the immediate removal of Transvaginal Mesh from the Australian Prostheses List and the ARTG (Australian Register of Therapeutic Goods).
PHA Chief Executive Dr Michael Armitage said media surrounding the current class action by Australian women against a major medical devices company, highlighted the horrendous impact the use of the transvaginal mesh had on women and their families.
Dr Armitage said PHA had expressed concerns about the availability of transvaginal mesh in Australia with the Department of Health, the Therapeutic Goods Administration and relevant Ministers, on numerous occasions.
“The U.S. Food and Drug Administration highlighted concerns on the “serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse” in July 2011, however, transvaginal mesh still appears on the ARTG and the Prostheses List nearly three years later.
“While some companies have ceased the manufacture of transvaginal mesh, the product is listed as available for use on the Prostheses List and the ARTG. This should be dealt with immediately.
“Private Health Australia is currently developing a series of safeguards or ‘Proposed Prostheses Arrangements’ which if adopted by Government, would lead to better health outcomes for consumers.
“These new arrangements will include measures to ensure the removal of devices where clinical evidence is not available and the introduction of clinical registries to identify underperformance,” said Dr Armitage.