Potentially dangerous breast implants made by a now-defunct French company were sold to about 1,000 Dutch women under a different name, a Dutch health official said Monday, broadening a scandal that could already affect some 300,000 women worldwide.
Dutch health authority spokeswoman Diane Bouhuijs said a Dutch company had bought implants made by France's Poly Implant Prothese, which went bankrupt in 2010 after French health authorities shut its doors and is now under investigation, and sold them in the Netherlands rebranded as M-implants.
We estimate that some 1,000 women in the Netherlands have those implants. We have advised them to consult their physician, Bouhuijs said.
She declined to disclose the name of the Dutch company.
The rebranding of PIP implants potentially expands the scope of the health controversy in which PIP, once the third-largest maker of breast implants in the world, stands accused of using industrial-grade instead of medical-grade silicone in some of its prostheses. They were sold in a number of European and Latin America countries.
The company's founder, Jean-Claude Mas, was able to charge lower prices for the implants using the non-approved silicone.
Health authorities have cited no evidence of increased cancer risk due to the PIP implants but have said they have higher rates of rupture that could cause inflammation and irritation.
While the French government has urged the 30,000 women in France with PIP implants to have them removed, other countries including Britain and Brazil say that women should visit their surgeons for checks.
Health spokeswoman Bouhuijs did not say how long M-implants were sold in the Netherlands before they were banned in March 2010, along with PIP-labelled implants, as in France.
In early 2010 Dutch authorities launched an investigation into breast implants which is still going on, Bouhuijs said.
France's drug and medical device regulator, AFSSAPS, was closed Monday due to the holidays, so Reuters was unable to ascertain whether health authorities knew about the M-implants.
SICK IN SOUTHERN FRANCE
Mas's lawyer Yves Haddad told Reuters Monday that his 72-year-old client is in poor health but ready to respond to any court summoning.
No one has been charged in the case, but sources say a Marseilles court could soon announce fraud charges against four to six ex-PIP employees. An investigation into involuntary homicide is going on, following the death from cancer in 2010 of a woman who had PIP implants.
Haddad denied that Mas was in hiding, reiterating that he was still in southern France's Var region.
He's currently in very bad health because he has just undergone a difficult surgery that prevents him from walking, Haddad said.
The news that Mas had recently been operated on was confirmed by a second source, who cited a vascular problem.
He is worried by the importance this matter is taking on. He is angry at those who pointlessly add to people's suffering,
Haddad denied reports that Mas was a former butcher, saying that before founding PIP in 1991 he worked for more than 15 years as a medical sales representative for Bristol Myers.
PIP AT FOREFRONT
French plastic surgeon Patrick Perichaud, who implanted over 600 women with prostheses made by PIP between 2001 and 2009, defended the devices, saying their rupture rates were no higher than other makers' products.
Perichaud told Reuters PIP was at the forefront of breast implant technology in the past two decades. Whereas other implant makers made saline prostheses that had to be filled once inside the breast, PIP introduced a pre-filled version, he said.
In 2001, after a 10-year ban of silicone implants was lifted in France, PIP was the first to make asymmetrically shaped implants whose look was more natural than competitors', he said.
This made for very natural-looking breasts, and allowed me to put the prostheses in front of the muscle and not behind it, like we had to do often before, said Perichaud, who is based in the southern city of Toulon.
The cost of the implants was 610 euros ($800). He said the patients bought the implants directly from PIP and that he as a surgeon did not get any financial incentive to steer clients toward the company.
The current breast implant health scare was more psychological than scientific he said, adding that no concrete link had been made between PIP implants and cancer.
Breast cancer affects one in ten women, even one in eight, so if 30,000 patients received PIP implants, statistically that would make 3000 cancers, he said.
Since the start of the PIP scandal in 2010, Perichaud has re-operated on 148 women to remove the implants at issue.
(Additional reporting by Alexandria Sage and Sophie Louet; writing Alexandria Sage; editing by Geert De Clercq)