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17 Dec 2013

The man at the centre of a worldwide scare over the safety of breast implants has been jailed for fraud.

Founder of infamous breast implant manufacturer Poly Implant Prothese (PIP), Jean-Claude Mas, has been convicted of fraud and sentenced to four years imprisonment by a French court, which also imposed a lifetime ban from working in medical services or running a company.

The conviction of the 74-year-old brings to an end criminal proceedings sparked by revelations in 2010 that PIP implants were being manufactured using industrial-grade silicone.

The discovery prompted a global safety alert, including in Australia, where health authorities imposed an immediate ban on the use of PIP implants amid fears rupture could leak toxic substances into the body.

Around 300,000 women worldwide have PIP implants, including an estimated 13,000 in Australia. In its latest update, the Therapeutic Goods Administration has confirmed 490 cases where PIP implants have ruptured, and a further 24 instances of unconfirmed ruptures.

Plans for a class action by Australian women against the company’s local distributor were abandoned after it was revealed it had only limited product liability insurance.

During a month-long trial in Marseille earlier this year, former PIP executives admitted using substandard silicon, but Mas denied the implants posed any additional health risk.

The former travelling salesman founded PIP in 1991 and developed into the world’s third largest supplier of implants, news agency AFP has reported.
But his operations came under scrutiny in 2010 when surgeons reported an unusual number of ruptures involving his products. Subsequent investigations by French authorities found the company was saving costs by using industrial-grade silicon in 75 per cent of its implants.

The revelation prompted a worldwide ban on the product, including in Australia.

A series of safety reviews and reports has confirmed that PIP implants were more likely to rupture than those of other suppliers, but health authorities have recommended that they not be removed unless a leak is confirmed.

In October, a high-level European scientific committee found that there was no convincing reason for PIP breast implants to be removed unless they had ruptured.
In a conclusion that brought to an end a string of inquiries and reports on the implants, 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.

“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”.

A separate report a report by the medical director of United Kingdom’s National Health Service, Sir Bruce Keogh, earlier this year found there was no evidence they caused cell damage or genetic mutations.

According to the British study, PIP implants were “significantly more likely” to rupture or leak than other brands.

But the NHS medical director said the idea that PIP implants could slowly leak silicon and other substances into the body over years without being detected was not supported by the evidence.

The British report also sought to allay concerns that any material that leached into the body from a ruptured PIP implant could cause cancer or other serious illnesses.

“PIP implants are not associated with a higher risk of breast cancer or other forms of cancer than other breast implants,” it said, adding that, “standard toxicological tests carried out in the UK, France and Australia showed no evidence of cytotoxicity (damage to cells) or genotoxicity (genetic mutations)”.

Adrian Rollins

Published: 17 Dec 2013