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France to pay for removal of risky breast implants

PARIS (AP) -- 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 (euro) 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.''

 

<한글기사>

프랑스, '발암성' 유방보형물 제거 권고



최근 발암성 논란에 휩싸인 프랑스제 가슴성형 보형물을 둘러싼 우려와 혼란이 확산하고 있다.

특히 프랑스와 영국 등 국가별로 문제의 보형물을 삽입한 여성들에게 어떻게 대 처해야 하는지 각기 다른 권고를 내놓으면서 논란이 커지고 있다. 

프랑스 정부는 지난 23일(현지시간) 자국 유방보형물 업체 `폴리 앵플랑 프로테 즈(PIP)'가 생산한 보형물의 발암 위험성은 뚜렷하게 확인된 바 없지만  비정상적으 로 파열되는 위험성은 확인됐다며 해당 여성들에게 보형물 제거를 권고했다.

그러면서 보형물 제거 수술에 드는 비용은 국가가 지불하겠다고 밝혔다.

반면 영국 보건부의 최고의료담당관인 샐리 데이비스는 "PIP의 보형물을 삽입한 여성들은 지나치게 걱정할 필요가 없다"며 "해당 제품이 암이나 파열 위험을 높인다 는 증거는 없다"고 말했다.

그는 "걱정이 되는 여성은 의사와 상의해야 한다"며 "보형물 제거 자체가  위험 을 초래할 수 있다"고 경고했다.

영국 미용성형외과의사연합회 관계자는 프랑스 정부의 조치는 "지나친 것이  아 니다"라며 옹호했고, 또다른 영국 성형외과의사는 각국 정부의 서로 다른 대응은 영 국 여성의 고충을 유발할 것이라고 지적했다.

독일 의학안전위원회도 PIP 보형물 삽입 여성들에게 검진할 것을 조언했지만 보 형물 제거까지는 권고하지 않았다.

브라질의 건강 감시단체는 PIP 보형물을 삽입한 모든 여성에게 검진을 촉구했고 , 호주의 보건 감시단체는 일부 사용자들이 보형물 파열을 신고했다고 밝혔다.

이러한 와중에 프랑스의 PIP 보형물사용자협회는 해당 보형물은 암을  제외하더 라도 다른 위험성도 있는데 프랑스 정부는 단순히 제거만을 지시했다고 비판하면서 향후 더욱 폭넓은 보상을 받기 위한 행동에 나설 것이라고 밝혔다.

현재 문제의 보형물로 수술을 받은 여성은 프랑스 3만명, 영국 3만∼4만명,  브 라질 2만5천, 호주 8천900명 등 전세계 65개국, 약 30만명에 이를 것으로 추정되고

있다.

하지만 PIP는 자사 보형물에 결함이 있다는 것은 인정하면서도 결함이 있는  것 이 자사 제품만은 아니라고 항변하고 있다. 

이러한 가운데 국제형사경찰기구(인터폴)은 문제의 보형물을 생산한 PIP의 최고

경영자(CEO) 장클로드 마스(72)를 지명수배했다.

인터폴은 코스타리카 당국이 생명·건강 관련 범죄 혐의로 그를 `적색수배'  명 단에 올렸다면서 홈페이지에 그의 사진을 올렸다. 그러나 구체적인 혐의에 대해선 밝히지 않았다.

적색수배는 체포영장이 발부된 피의자 등 중요 도피사범에 대한 인터폴의  수배 조치다.

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