Fears Grow Over Faulty French-Made Breast Implants

Jan 5, 2012
Originally published on January 5, 2012 4:27 pm

A scandal involving French-made breast implants continues to widen.

The implants contain industrial-grade silicone that causes abnormally high rupture rates, according to critics. They have been sold in many countries in Europe and beyond, though not in the United States. Now, the French government has opened a criminal investigation into the company.

French television showed footage on Thursday of investigators and a judge searching the factory of the Poly Implant Prothese company, or PIP, in southern France.

The probe could potentially lead to charges of involuntary homicide against the firm. PIP was shut down and its products banned in 2010.

By this point, an estimated 400,000 women worldwide had received the PIP implants. Christian Marinetti was one of the first plastic surgeons to notice a problem with them.

"We began informing health authorities about the high rupture rate as early as 2007. And in 2008 and 2009, we kept contacting them. It was clear there was a serious problem with these implants," Marinetti says.

Both French and German health authorities are now under fire for not taking action sooner. A German company provided the industrial silicone, and it has just come to light that another German company paid by PIP was in charge of inspecting the implants. French Health Minister Xavier Bertrand says investigators will get to the bottom of it.

He wants to know at what point the companies were alerted about the problems, and what controls were in place. He says it's clear the implants were substandard.

A Death Spreads Fears

Fears over the implants spread globally last month after a French woman with ruptured implants died of cancer. French health authorities advised 30,000 French women to have their PIP implants removed. The French state has offered to bear the cost of the removals, which could come to more than $75 million.

Murielle Agelo, 37, has never had a problem with her implants, but says she will get them removed.

"As soon as they tell you the implants are fragile, it radically changes the way you live. You buckle your seat belt differently, carry your groceries and children in another way, you're worried about doing sports, and you're always stressed by any sort of changes," she says.

PIP implants' low price made them popular, especially in Britain, where an estimated 50,000 women got them. Catherine Kydd received PIP implants in 2004. In 2009 she found out one had ruptured. Though she had them removed, silicone had already leaked into her lymph nodes.

"If I was told that I was going to have industrial silicone put in me, then I would never have had it done, as would none of the 50,000 women," she says. "If that's what you knew you were going to get, you wouldn't sign the dotted line, would you?"

The British government is taking a more cautious approach than the French. It has not yet recommended the mass removal of the implants. Perhaps fearing the costs of such an operation, Britain's health secretary, Andrew Lansley, is urging private clinics to take some responsibility, calling it an ethical and moral obligation.

"My expectation is that the private sector, as the providers of these implants, they should give women access to information, to specialist advice, to scanning, and if necessary, to follow-up and remedial treatment," Lansley says.

But many clinics, including those that provide breast reconstruction for cancer patients, say they bought the PIP implants in good faith and will go out of business if made to bear the full costs of removal.

The Czech government on Thursday recommended women wearing PIP implants have them removed. And Friday, some 200 Venezuelan women say they will join a French lawsuit against the company.

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Transcript

ROBERT SIEGEL, HOST:

A scandal is intensifying over faulty French-made breast implants. Hundreds of thousands of women may have the implants, which are said to be defective because they contain industrial-grade silicone. They've been sold in many countries in Europe and beyond, but not in the United States.

NPR's Eleanor Beardsley reports that the French government has opened a criminal investigation into the company responsible.

(SOUNDBITE OF A NEWS CLIP)

UNIDENTIFIED WOMAN: (Speaking foreign language)

ELEANOR BEARDSLEY, BYLINE: Today, French television showed footage of investigators and a judge searching the factory of the Poly Implant Prothese Company, or PIP, in southern France. The probe could eventually lead to charges of involuntary homicide against the firm.

PIP was shut down and its products banned in 2010, after it was revealed that the industrial-grade silicone gel caused abnormally high rupture rates. But it was already too late for the estimated 400,000 women worldwide who now have PIP implants.

Christian Marinetti was one of the first plastic surgeons to notice a problem with them.

CHRISTIAN MARINETTI: (Through Translator) We began informing health authorities about the high rupture rates as early as 2007. And in 2008 and '09, we kept contacting them. It was clear there was a serious problem with these implants.

BEARDSLEY: Both French and German health authorities are now under fire for not taking action sooner. A German company provided the industrial silicone and it has just come to light that another German company paid by PIP was in charge of inspecting the implants.

French Health Minister Xavier Bertrand says investigators will get to the bottom of it.

XAVIER BERNARD: (Speaking foreign language).

BEARDSLEY: At what point were people alerted about these problems, asked Bertrand. How were the controls done? It's clear these implants were substandard, so why didn't we know this earlier?

Fears over the implants spread globally last month after a French woman with ruptured implants died of cancer. French health authorities advised 30,000 French women to have their PIP implants removed. The French state has offered to bear the cost of the removals, which could come to more than $75 million.

Thirty-seven-year-old Murielle Agelo has never had a problem with her implants, but says she will get them removed.

MURIELLE AGELO: (Through Translator) As soon as they tell you the implants are fragile, it radically changes the way you live. You buckle your seatbelt differently, carry your groceries and children in another way. You're worried about doing sports and you're always stressed about any sorts of changes.

BEARDSLEY: Because of PIP implants' low price, they were popular, especially in Britain, where an estimated 50,000 women got them. Catherine Kydd received PIP implants in 2004. In 2009, she found out one had ruptured. Though she had them removed, silicone had already leaked into her lymph nodes.

CATHERINE KYDD: If I was told that I was going to have industrial silicone put in me, then I would never have had it done, as would none of the 50,000 women. If that's what you knew you were going to get, you wouldn't sign the dotted line, would you?

BEARDSLEY: The British government is taking a more cautious approach than the French. It has not yet recommended the mass removal of the implants. Perhaps fearing the cost of such an operation, Britain's health secretary, Andrew Lansley, is urging private clinics to take some responsibility, calling it an ethical and moral obligation.

ANDREW LANSLEY: My expectation is that the private sector, as the providers of these implants - they should give women access to information, to specialists' advice, to scanning and, if necessary, to follow up on remedial treatment.

BEARDSLEY: But many clinics, including those that provide breast reconstruction for cancer patients, say they bought the PIP implants in good faith and will go out of business if made to bear the full costs of removal.

Today, the Czech government recommended women wearing PIP implants have them removed. And tomorrow, some 200 Venezuelan women say they will join a French lawsuit against the company.

Eleanor Beardsley, NPR News, Paris. Transcript provided by NPR, Copyright NPR.