French breast implant maker denounces 'untruths' in scandal
The founder of the French breast implant maker at the centre of a global health scare said Thursday much of the information emerging in the scandal was untrue but refused further comment.
In a statement, Jean-Claude Mas denounced the "impressive number of untruths" that had emerged but said he would refrain from making other public comments because of a judicial investigation.
Following complaints from hundreds of women, investigators in southern France have opened a probe into sub-standard silicone used in implants made by Mas's now-defunct Poly Implant Prothese (PIP).
A litany of accusations against PIP has triggered a worldwide scare, with several countries including France now advising thousands of women to have the implants surgically removed.
In the statement Mas, 72, denied he was in hiding and said he was keeping silent "first out of respect and out of a sense of decency in regards to the concerns of the patients involved, and also due to the existence of ongoing (court) proceedings".
"The impressive number of untruths, of nonsense and of aberrations are also leading Mr. Mas to abstain from comment," the statement said.
"Mr. Jean-Claude Mas intends to reserve his statements for judicial authorities when he receives a summons, which to this day has not arrived," it said.
Mas told police in October he knew the silicone used by his firm was "not approved but I did it (changing the composition) knowingly because PIP gel was cheaper and as far as the price-performance ratio is concerned it was cheaper and of better quality," he said according to minutes seen by AFP.
"I always knew" that the product was non-standard, he added.
He said that as early as 1993, two years after he created his company, he "gave orders to hide the truth" from German technical inspection board Tuev, years before the suspect implants were marketed.
Around 300,000 women in 65 countries are believed to have PIP implants. An unknown proportion are made with sub-standard gel which the firm, once the world's third-largest silicone implant producer, used to cut its costs.
PIP was shut down and its products banned in 2010 after it was revealed to have been using a silicone gel that caused abnormally high rupture rates.
Fears over its implants spread globally last month after French health authorities advised 30,000 women to have their PIP implants removed because of the increased risk of rupture.
Officials have also said that cancer, including 16 cases of breast cancer, had been detected in 20 French women with the implants, but have insisted there is no proven link with the disease.
Earlier Thursday French Health Minister Xavier Bertrand said Europe should impose stricter controls on medical devices in the wake of the scandal.
"For medical devices, we need other rules," he told French television channel LCI.
"A simple label is not enough," he said. "I want to see changes in European regulation because unlike with medicine, which must be authorised to be put on the market, there are no (such regulations) with medical devices.
"There needs to be a sales authorisation, firstly for products that have a potential health risk," Bertrand said, calling also for a toughening of testing procedures.
Le Parisien newspaper reported Thursday that PIP also made products for men, including buttock, testicular and pectoral implants.
It quoted a PIP employee as saying that most of these implants went abroad, particularly to Latin America.
Meanwhile France's Centres for the Fight Against Cancer (CLCC) said in a statement it had used PIP as a supplier and given its implants to about 3,300 women. It said the women had been contacted and advised to see their doctors about the implants.
And Czech health authorities intend to recommend that up to 2,000 Czech women who received now-banned French breast implants have them removed, public broadcaster Czech Television reported Thursday.
"The health ministry will issue a recommendation Friday to the women who have these implants to have them removed," Czech TV reported following a meeting of health ministry officials, doctors and health insurers.
The Czech pharmaceuticals market watchdog SUKL said it had registered no "undesirable events" linked to the faulty PIP brand implants as yet.
© 2012 AFP