AUSTRALIA’s peak health regulator cancelled an Australian-made mesh device implanted in thousands of women after the manufacturer failed to show how the benefits of mesh implants outweighed the risks, and questions about a “large discrepancy” in reported problems.
Former Australian champion basketballer and Newcastle Falcons player Paul Zadow is appealing the November 2014 cancellation after the Therapeutic Goods Administration (TGA) found his company, TFS Manufacturing, had failed to provide “sufficient evidence to establish the benefits to be gained from using this device”.
The Tissue Fixation System (TFS) was one of the first transvaginal mesh devices cancelled by the TGA following significant concerns in Australia and overseas about more than 60 different mesh devices, and mesh as a class of products. More than 13,000 TFS devices have been sold worldwide.
Details about the cancellation are made public for the first time after the cancellation report was obtained following a freedom of information application through the American Food and Drugs Administration (FDA).
The report adds to calls for a Senate inquiry into the registration of mesh devices in Australia by women implanted with one of more than 40 mesh devices, including the Tissue Fixation System device, available in Australia for a decade from 2005.
The cancellation review and report showed that nearly 10 years after the TGA registered the TFS device for use on the Australian market, the regulator had serious concerns about the reporting of adverse events experienced by women.
Mesh devices are used in women experiencing prolapse, or weakening of the pelvic muscles and ligaments, after pregnancy and childbirth.
TFS Manufacturing advised the TGA that between 2005 and May 2014 the company had had only two complaints, and one of those related to advertising. The TGA noted it was unclear if the complaints related to Australia, where 1938 devices were sold, or worldwide, but it raised “serious concerns”.
“This result is not consistent with the known complication rates associated with this type of device,” the TGA cancellation report said.
“This clear discrepancy between the expected complication rate and the rate presented by the (company) raises serious questions regarding the quality of the post market surveillance system utilised by the (company) and manufacturer.”
The TGA found TFS Manufacturing had failed to adequately address concerns about how it identified and managed risks including erosion of mesh devices in women, bleeding, voiding dysfunction, urinary retention and damage to the bladder and bowel during surgical procedures to implant the mesh devices.
The company had failed to provide adequate clinical evidence to meet TGA requirements for the device. The cancellation report noted one article referred to in a review of the clinical evidence related to an incontinence device specifically for males.
Mr Zadow did not respond to questions from the Newcastle Herald. In March Mr Zadow confirmed his company was seeking reinstatement of the TFS mesh device on the Australian Register of Therapeutic Goods and had an appeal before the Administrative Appeals Tribunal.
”While the review is in process, we cannot make any further comment about the TGA’s decision,” Mr Zadow said in March.
Australian Pelvic Mesh Support Group member Gai Thompson warned the TGA five years ago that mesh devices – including the Johnson and Johnson mesh device she received – had left women with permanent and serious complications.
The group will hold a rally in Canberra on May 25 and call for a Senate inquiry into the TGA’s registration of more than 40 mesh devices in Australia, and an investigation of how the TGA monitored their use.