Senate asked to probe TGA advice on breast implants

INDEPENDENT federal senator Nick Xenophon plans to move for a Senate committee to investigate the Therapeutic Goods Administration's handling of problems with substandard breast implants.

Senator Xenophon says he will move in the Senate on Wednesday for the Community Affairs Committee to reconvene its hearing on the TGA.

"Clearly there are very serious questions as to whether the actions of the TGA were appropriate and timely," he said on Sunday.

"Potentially there are 4500 women in Australia with these implants."

Between 300,000 and 400,000 women in 65 countries are believed to have implants made with substandard silicon gel by the French company Poly Implant Prothèse (PIP).

The TGA has recommended against routine removal of these implants on the basis that there is no evidence of an increased rupture rate.

However, a number of other countries, including France and Germany, have officially advised women to have the implants removed.

Senator Xenophon said the Community Affairs Committee conducted an inquiry into the TGA last year.

"Given what has now emerged about PIP implants.... there are many unanswered questions in terms of whether the TGA's actions were timely or appropriate," he said.

In a statement released on Friday last week, the TGA defended its regulation and monitoring of the PIP implants in Australia, which it stated included rigorous pre-and post-market assessments by both the TGA and a nominated European based ‘notified body’ that continued to advise the TGA on whether PIP was continuing to meet required standards.

“In April 2010, acting on updated advice from French regulatory authorities, the TGA took prompt regulatory action to ensure that unimplanted PIP breast implants were withdrawn from the Australian market,” the TGA statement said.

“On 6 April 2010, as part of the recall information, the TGA published advice on its website that patients with PIP silicone gel implants who have concerns should contact their treating breast implant physician for advice and follow-up.”

The TGA said it was continuing to conduct tests on available samples of PIP implants, including some that had been surgically removed, and had recently commissioned intradermal irritation tests on PIP breast implants.

As of 2 February the TGA had received 123 confirmed reports of ruptured PIP implants and 14 unconfirmed reports, which it was continuing to investigate.