Opt-out breast implant registry established
The Federal Government has agreed to establish an opt-out registry of breast implants in response to criticisms of the nation’s response to the Poly Implant Prothese implant scandal.
The Government has accepted virtually all the recommendations made by a Senate Committee critical of the handling of the PIP breast implant episode by the nation’s medicines and medical device watchdog, the Therapeutic Goods Administration.
The PIP scandal erupted in 2010 when a world-wide recall of the silicone breast implants was issued after French authorities discovered they had been manufactured using industrial-grade rather than medical-grade silicon, and warned they had an elevated rupture rate.
Concerns have been raised about the TGA failure to detect problems with the implants, with Independent Senator Nick Xenophon among those highly critical of what they say was a failure of the regulator to protect Australian patients.
According to a report by the medical director of United Kingdom’s National Health Service, Sir Bruce Keogh, PIP implants were up to six times more likely to fail than the alternatives within the first five years of implantation.
About 13,000 PIP implants were supplied in Australia between 1998 and 2010, and regulators have confirmed 451 incidents of rupture, and 22 unconfirmed, with most commonly occurring between four and seven years following implantation.
In its response to a Senate Committee inquiry into the handling of the PIP scandal, the Government accepted that the TGA needed to improve its performance, including increased vigilance and rigour in overseeing the supply and use of implantable medical devices, better communications with the public, and the establishment of a breast implant registry.
The Government said “the TGA will adopt a strong focus on improving its communication and engagement with the community”.
“The Government will ensure that the TGA focuses on the information needs of the community and other stakeholders to ensure that the right information is presented in a way that meets the varying needs of all stakeholders,” it said.
The Government also embraced a recommendation by the Committee that an opt-out Breast Implant Registry be established as a priority.
It allocated $5.1 million in the May Budget to establish and maintain two clinical registries – one for breast implants, the other for cardiac devices.
It said the money would cover the first two years of operation, until funding arrangements based on cost recovery from industry were put in place in 2015.
“The Government agrees that an opt-out approach will be adopted by the new breast implant register, in line with the recommendation of the Australian Commission on Safety and Quality in Health Care,” it said.
The Government also agreed to extend until 11 March 2015 the access of women with PIP implants to Medicare rebates for MRI scans to detect any leakages or abnormalities involving the implants.