x Abu Dhabi, UAESaturday 22 July 2017

PIP chief defends faulty implants

Up to six managers face prosecution as businessman at the centre of storm of recalled silicone breast implants claims decision to reimburse patients is 'criminal'.

A photograph taken on January 17, 2001 shows the founder of the implant manufacturer Poly Implant Prothese (PIP) Jean-Claude Mas at the plant in La Seyne sur Mer, southern France.
A photograph taken on January 17, 2001 shows the founder of the implant manufacturer Poly Implant Prothese (PIP) Jean-Claude Mas at the plant in La Seyne sur Mer, southern France.

A French businessman whose company is blamed for an international health alert after making breast implants using unauthorised material has called government recommendations that women have them removed "criminal".

Jean-Claude Mas has broken a long silence in the past week to make brief French media appearances to defend the work of the company he founded, Poly Implant Prothèse (PIP).

His comments have provoked some outraged responses. Nora Berra, France's secretary of state for health, has condemned his statements as "scandalous and despicable".

PIP sold more than 300,000 silicone gel implants used in surgery on women in 65 countries before it was forced into liquidation after the French authorities ordered the product off the market in 2010. Prompted by reports from surgeons of an abnormally high number of implants rupturing, health safety officials found that PIP's manufacturing procedures did not conform to legal standards.

In December, the French government advised the 30,000 women who received PIP implants in France to have them removed because of concern that they were more liable than standard medical implants to rupture.

Mr Mas, 72, who was previously said by his lawyer to be avoiding comment in the interests of dignity and discretion, appears to have been driven by increasingly hostile public discussion to speak out.

On RTL radio, he accepted that his implants, manufactured with industrial-grade silicone gel because it's cheaper, had not been approved by regulators. But he was dismissive of claims that this had put women's health in jeopardy and said there was no medical or scientific reason to believe the gel was toxic.

Of the French health minister, Xavier Bertrand, Mr Mas was especially scathing: "This man has decided to reimburse patients even though there was no medical reason to do so … This decision is criminal."

He pointed out that countries such as Britain, Brazil and Argentina had not followed France's lead in advising women to have implants removed. In another interview, with the M6 television channel, he said it was common for chemical products to have a variety of uses.

His lawyer, Yves Haddad, said last month that of two gels used in the PIP manufacturing process, one was an approved product while the other, five times cheaper, was not.

Ms Berra told Agence France-Presse that Mr Mas's responses betrayed "extraordinary contempt" for women. "He arrogantly accepts he used industrial gel, that is to say non-medical, for reasons of business calculation, profitability, at the same time denying he was putting these women at risk."

A judicial source has told the Reuters news agency that up to six former PIP managers face prosecution later this year for fraud and deceptive business practices. The official did not identify Mr Mas by name but Ms Berra said he was pursuing a "strategy" of attack in an attempt to escape responsibility.

"Now he reinvents himself as an expert," she said. "So he knows better than the experts of the National Cancer Institute [INCa, a French government agency] about the consequences of adulterated gel.

"Experts brought together by INCa actually said there was no increased risk of cancer, but that there was a well-established risk of rupture arising from irritation by the gel of breast tissue."

PIP, based at La-Seyne-sur-mer on the Mediterranean coast, was once the world's third-largest maker of breast implants.

About 80 per cent of the company's implants were exported and campaigners say the health of women in several European countries, South America, Australia and elsewhere was endangered.

The scandal has led to bitter controversy in some countries, notably Britain, where the government says women who are concerned should consult their physicians but will pay only for the removal of implants fitted under the state's national health service.

PIP implants may not be the only defective ones on the market. Claude Nos, an oncologist at a French institute specialising in breast conditions, told Le Point magazine the possibility of problems with other makes could not be excluded. He noted that in the late 1990s, thousands of implants were removed in Britain because it was found some had been filled with a soy derivative. The British government concluded the implants presented some risk and the removals, totalling more than 10,000 worldwide, were carried out at the expense of a company that had acquired the rights to the product.

Meanwhile, for Mr Mas, there are signs of further trouble beyond the threat of criminal court proceedings in France. He is wanted in Costa Rica on a drink-driving charge.