AN Australian prolapse mesh manufacturing company, headed by a former Newcastle and Australian representative basketballer, substantially modified its device twice without advising regulators in Australia and the United States.
South Australian-based TFS Manufacturing modified its Tissue Fixation System device in 2009 and 2010 within five years of being registered on the Australian and American markets for use in surgery for women with prolapse, where pelvic muscles are weakened, usually after pregnancy.
TFS Manufacturing’s sole director, former Newcastle Falcons basketball player Paul Zadow, confirmed the modifications in a letter to the US Food and Drug Administration (FDA) in May, 2014, after the regulator deemed the modified TFS device “not approvable” following reviews of more than 60 prolapse mesh devices on the market.
“We modified the product several times in 2009 and 2010. We did not believe that any of the changes required a new (application), so we documented the changes in our files,” Mr Zadow wrote.
In 2014 a patient advocate asked Australia’s medical device regulator, the Therapeutic Goods Administration (TGA), to investigate the modified device because changes to the mesh, and anchors used to secure the mesh to women’s ligaments and tissue, meant it was substantially different to the originally approved device.
The TFS device and more than 40 other mesh devices were registered in Australia based on being the “same kind” of device as mesh devices for incontinence surgery.
They were approved despite no evidence of use in prolapse surgery, and warnings of the need for clinical trials for incontinence mesh that had already been registered.
Mr Zadow did not respond to questions about the modifications, but in a statement last week he said the company withdrew its mesh device from the American market for commercial reasons. The TFS device was deregistered in Australia in November 2014. The company’s appeal against that decision is ongoing.
In January the FDA reclassified all prolapse mesh products as high risk.