French implants firm was criticised by US inspectors in 2000
January 3rd, 2012 // 1:21 pm @ jmpickett
American health officials warned the manufacturer at the centre of the breast implant scare that its products were “adulterated” and substandard 11 years ago, it has emerged.
Investigators from the Food and Drug Administration wrote to the company in 2000 after inspecting its plant in the south of France. The development triggered questions over why the French health authorities did not act sooner. About 300,000 women worldwide are believed to have been given implants made by Poly Implant Prothese (PIP).
The problem identified by FDA inspectors a decade ago related to saline breast implants, not the silicone implants at the centre of the latest health scare. However, both products were made at the same plant inspected by the FDA.
After nine French women with the PIP implants – made of cheaper industrial as opposed to medical-grade silicone – were found to have a rare form of cancer, and following suggestions the implants were prone to rupture, the French authorities advised 30,000 French women on Friday to have them removed.
It said the move was “precautionary” as opposed to “urgent”.
Other countries, including Britain, where about 40,000 women are believed to have PIP implants, say there is no evidence the implants are a health risk but have advised women to see their surgeon for checks.
The implants were also sold widely in South America. On Tuesday night, Venezuela announced it would offer free removal for any woman who had them. The country’s health minister, Eugenia Sader, said patients could go for a check-up and have the implants removed if they wished, but she stressed that they would not be replaced by a different type.
The FDA inspectors visited the PIP plant at La Seyne sur Mer, in south-east France, in May 2000 to inspect its “saline pre-filled mammary implants”. At the end of the visit inspectors made 483 observations.
A month later, on 22 June, the FDA sent an extremely critical “warning” letter to the company’s founder, Jean-Claude Mas, saying the inspection revealed that “these devices are adulterated … and that the methods used in, or the facilities or controls used for, manufacturing, packing, storage or installation are not in conformance with good manufacturing practice”.
It said the company had not properly tested the implants or carried out risk analysis, and that procedures for analysing defective prostheses, complaints or returned implants were “non-existent or inadequate”.
It accused PIP of failing to report complaints to the FDA, saying more than 100 complaints about the saline implants had been reported in France between January 1997 and 2000 and at least 20 from other countries.
The letter, available on the FDA website (pdf), concludes that it “is not intended to be an all-inclusive list of deficiencies at your facility” and “you must promptly initiate permanent corrective actions”.
After receiving a faxed response to its observations, the FDA replied that because of the serious nature of the violations it would be holding all PIP implants imported to the US. PIP did not sell its silicone implants in America at the time because such implants were subject to a general ban due to safety concerns.
The letter was made public in 2000, but the French health authority AFSSAPS said it had not been informed of the warning’s existence. “We were not a priori informed,” said a spokeswoman. “This is not surprising in cases where there is no obligation to inform us. The information was put online on the FDA’s internet site, but to be honest there are thousands of those notices every day.”
On Monday Mas’s lawyer, Yves Haddad, told Reuters the 72-year-old was recovering from surgery and was in poor health. But he said Mas was ready to respond to a court summons.
“He is worried by the importance this matter is taking on and he is angry at those who pointlessly add to people’s suffering,” Haddad said. He revealed that his client was taken into police custody twice, in November 2010 and then in October 2011, as part of investigations into the implants.
PIP shut down in 2010 after accusations it was cutting corners in the manufacture of its implants.
By the numbers
PIP was the third largest manufacturer of breast implants in the world. At the height of its business it employed 116 people, had a turnover of nearly €10m (£8m) a year, and manufactured 100,000 implants a year. More than 80% of its products were exported to more than 65 countries, many of them in South America, but also China, Iran, Turkey and the United Arab Emirates, according to French officials.
• Israel estimates 850 women in the country have PIP implants – 5% of those who have undergone reconstructive or cosmetic surgery – and has set up a hotline for women to call.
• In Holland there are reports that 1,000 women received PIP implants sold under a different name. A Dutch company was reported to have bought the implants and rebranded them as M-Implants.
• In Italy, government officials say 4,300 Italian women have PIP implants, but the Italian Association of Consumers says the real figure could be “tens of thousands”.
• In China, there are reports that PIP implants named Bao Libei in Chinese have been used for some years.
• Forty thousand breast augmentations are performed every year in Venezuela and plastic surgery is widespread. Around 84% of implants come from French companies. The number of those with PIP implants has not been officially announced.
• Brazil banned imports of PIP implants last year but around 25,000 women are believed to have them.
• In Colombia, an estimated 15,000 women are thought to be carrying the PIP implants.
