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France Govt. to pay for removal of risky breast implants
Reported, January 4, 2012
France took a costly and unprecedented leap Friday in offering to
pay for 30,000 women to have their breast implants removed because of
mounting fears the products could rupture and leak cheap,
industrial-grade silicone into the body.
Tens of thousands of other women elsewhere in Europe and in South
America have the same French-made implants, but authorities there have
so far refused to follow suit. The silicone-gel implants in question are
not sold in the U.S.
Over the past week, the safety fears have created a public furor over
something usually kept private, even in France. Women, some whose own
families didn't know they had their breasts enlarged, marched on Paris
to demand more attention to worries about what might be happening inside
them. Images of leaky, blubbery implants and women having mammograms
have been splashed on French TV.
More than 1,000 ruptures pushed Health Minister Xavier Bertrand to
recommend that the estimated 30,000 women in France with the implants
get them removed at the state's expense.
Bertrand insisted the removals would be "preventive" and not urgent, and
French health authorities said they had found nothing to link the
implants to nine cases of cancer in women. The death last month of a
woman who had the implants and developed a rare cancer — anaplastic
large-cell lymphoma — had catalyzed worries.
The implants, made by the now-defunct French company Poly Implant
Prothese, were pulled from the market last year in countries around
Europe and South America where they had been sold. The company's website
said it exported to more than 60 countries and was one of the world's
leading implant makers.
International police agency Interpol put PIP's former director,
Jean-Claude Mas, on its most-wanted list, based on a warrant from Costa
Rica for crimes involving "life and health." Interpol's website carries
a photo of the 72-year-old Mas but no details about his alleged crimes
or link to Costa Rica. Mas' lawyer could not be reached for comment
Friday.
France's health safety agency says the PIP implants appear to be more
rupture-prone than other types. Also, investigators say PIP used
industrial silicone instead of the medical variety to save money.
However, the medical risks posed by industrial silicone are unclear.
The financial burden of the French government's decision falls on the
state health care system, which estimated the removals could cost €60
million ($78 million) at a time when the country is teetering on the
brink of another recession and struggling with debt.
In recommending removal, the government noted the risks associated with
major surgery and general anesthesia.
Because of those risks, many women may decide against removal. The
government said those women should be examined every six months.
After the French decision, Britain's Medicines and Healthcare Products
Regulatory Agency announced that it doesn't see enough proof of cancer
or an excessive risk of rupture to recommend women in Britain have the
implants removed. Up to 40,000 women in Britain may have had the
implants, even more than in France.
Britain's chief medical officer, Sally Davies, said women "should not be
unduly worried."
"While we respect the French government's decision, no other country is
taking similar steps because we currently have no evidence to support
it," she said.
The president of Brazil's Plastic Surgeons Association, Jose Horacio
Aboudib, said it would be premature to have women remove the implants if
they are not having any problems. About 25,000 women in Brazil received
PIP implants.
"There is always a risk associated with surgery, and there is a cost. In
France, the government is paying for it. Here it's not considered a
public health risk, so the patient would have to pay for it," he said.
Medical authorities in Argentina and Venezuela recommended closer
monitoring of women who have the implants.
In the U.S., concerns about silicone gel implants in general led to a
14-year ban on their use, in favor of saline-filled implants. Silicone
implants were brought back to the market in the U.S. in 2006 after
research ruled out links to cancer, lupus and some other concerns.
In France, one reason for the alarm was the uncertainty over the
ingredients of the silicone used and the risk to internal organs. Also,
while all breast implants can burst, especially as they get older,
"these implants have a particular fragility" and appear to pose risks of
rupture earlier in their life spans than other implants, said
Jean-Claude Ghislain of the French health agency AFSSAPS.
France's state health care system normally pays for implants for medical
reasons, such as after a mastectomy, but not for cosmetic implants.
About 80 percent of those with the PIP implants had them for aesthetic
reasons.
Annie Mesnil, who had a PIP implant to replace a breast removed after
cancer in 1999, said she was relieved that the Health Ministry "accepts
the idea that there is a potential danger." But she added: "It's not
enough. They will pay for the removal of the implants, but they will not
pay for the replacements."
After the PIP product was recalled last year, a mammogram and ultrasound
did not reveal any problems with Mesnil's implant. But Mesnil, 62, had
it removed anyway, at her own expense, out of fear.
When her surgeon took it out and studied it, "he discovered it had
already burst," she said. "I don't know what's spilled inside my body."
The state health care system only reimburses about 230 euros for implant
removal operations, but public hospitals that provide the service for
that low fee are rare and overbooked. Most plastic surgeons in France
are private practitioners who can charge five to 10 times more than that
for a removal. Some plastic surgeons have agreed to lower their fees
under government pressure.
Chantal Guerin, a 46-year-old accountant and mother of three, had her
left breast removed after cancer and had PIP implants put in both
breasts. In 2010, she developed cancer in her right breast.
"One cannot directly incriminate the implant, since there is no
scientific proof," she said in an interview. "But we have the right to
ask ourselves a lot of questions, because there is a great amount of
physical pain involved."
Credits:Jill Lawless in London, Juliana Barbassa in Rio de Janeiro,
Barry Hatton in Lisbon, Ian James in Venezuela, Deborah Gouffran and
Ingrid Rousseau in Paris contributed to this report. The Associated
Press. Check out at:
http://www.msnbc.msn.com/id/45778822/ns/health-womens_health/t/france-pay-removal-risky-breast-implants/#.TwBxNdTVWg4
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