MEAG Media Gallery

Media Release

Tuesday, 7 February 2012, 18:00 hours

Senate Inquiry into TGA's handling of Poly Implant Prothèse (PIP) French Breast Implants

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Australia's Therapeutic Goods Administration (TGA) has recommended against routine removal of these implants on the basis of no internal TGA evidence of an increased rate of rupture.

Why did the TGA rely on a spontaneous system of reporting (non mandatory)?

Why did the TGA exclude the more comprehensive international figures on rupture?

International studies show that the rupture rate is higher than acceptable standards.

Why is the TGA refusing to acknowledge the more comprehensive international evidence on this when coming to a decision that sees them not following the international view?

Professor John McNEIL, from the School of Public Health at Melbourne's Monash University, describes the TGA's PIP breast implant reporting system to be flimsy, as it was not based on a mandatory reporting mechanism and therefore an inadequate tool to measure rupture rates. The TGA's decision to rely only on its own reporting methods, and its refusal to include international evidence of rupture rates needs to be examined.

Why did the TGA ban PIP breast implants for use in Australia in 2010?
What evidence exactly, did the TGA use to make this judgment?
Was it international evidence?

In stark contrast to this 2010 directive, the TGA has to date asserted that PIP implants are safe to remain in recipients.

Why is it that in 2010 the TGA recalled all non-implanted PIP devices, as they were deemed unsafe, yet these very same implants are now being endorsed by the TGA as safe enough to remain inside Australian PIP recipients. This contradiction needs to be examined.

In early 2011, French health officials discovered that the industrial grade silicone in the PIP implants failed intradermal irritation tests in rats, giving rise to fears that the implants caused inflammation in women's tissue, which is often a precursor to cancer.

Why did the TGA ignore the French warning for some 12 months?
Why does the TGA feel that its need to repeat these tests before alerting recipients to the danger?

On 5 February 2012 the TGA announced that it would begin a new batch of tests on PIP breast implants that were the subject of a national safety recall in April 2010.

What has the TGA been doing for the last 22 months in regards to testing the implants that the TGA recalled?

The full circumstances surrounding the sudden resignation of national manger of the TGA, Dr Rohan HAMMETT, on Friday 23 December 2011 warrants investigation. This is necessary given that the timing of Dr Hammett’s resignation coincided with the French Government recommending that women in France seek removal of PIP breast implants immediately. Given the gravity of the French Government's course of action, it is appropriate that all unanswered questions regarding PIP implants, including Dr Hammett's role in the handling of the crisis, be examined.

For more information or comment please contact:

Lorraine Long

info@medicalerroraustralia.com | www.medicalerroraustralia.com