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Intact PIP implants given qualified all-clear

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A high-level European scientific committee has found that there is no convincing reason for PIP breast implants to be removed unless they have ruptured.

In a conclusion that brings to end a string of inquiries and reports on the implants, which were subject to a worldwide recall after it was discovered they were being manufactured using substandard silicone, the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks found that there was no “convincing medical, toxicological or other data to justify removal of intact PIP implants as a precautionary approach”.

The Therapeutic Goods Administration said the finding was in line with its own assessment and, while it would continue to monitor failure rates of the implant, it was not planning any further investigations.

According to figures collected by the TGA, there were 490 confirmed ruptures of PIP implants, and a further 24 unconfirmed ruptures, as of 10 October.

The regulator said it had been found that PIP implants had higher concentrations of several cyclic siloxanes than other silicone breast implants, but they were non-toxic and were not shown to be an irritant.

“Neither implant rupture, nor local inflammation, has been found to be associated with breast cancer or anaplastic large cell lymphoma,” the TGA said. “While there are differences in rupture rates, there is no reliable evidence that ruptured PIP implants create a greater health risk than a ruptured silicone implant from another manufacturer.”

Nonetheless, the regulator “strongly advised” that where rupture occurred, the implant be removed, adding that widespread concern regarding undetected ruptures meant “there is a need for women with PIP breast implants to seek regular clinical examinations”.

Adrian Rollins