Paris:
Health officials in at least a half-dozen countries are grappling with the intense anxiety of tens of thousands of women who received breast implants that were made in France with substandard silicone - and that have been rupturing at unusually high rates.
It is unclear whether there are health risks posed by the substandard silicone used in the implants, and the French government is expected to decide soon whether to require as many as 30,000 women in France to have their implants removed.
If the government mandates the removals, it will also pay for the procedures, though not for replacements. Regulators will have to weigh whether the known risks associated with removing the implants outweigh the uncertain risks and anxieties associated with leaving them intact.
The British health authorities on Wednesday sought to calm women's fears, saying that there was no evidence that the suspect implants, which were manufactured by Poly Implant Prothese, a company known as PIP, had caused cancer. They urged women who had received them to take any concerns to their surgeons, but they also said, "There is currently no evidence to support routine removal" of the implants.
Britain's surgical associations also tried Wednesday to soothe anxiety. "The message here is not to panic," said a consultant plastic surgeon, Douglas McGeorge, who spoke for the British Association of Aesthetic Plastic Surgeons.
Silicone implants have had a contentious history, with the United States imposing a 14-year moratorium on their use that ended in 2006, after years of lawsuits contending that they had caused cancer. None of PIP's implants appear to have been sold in the United States.
The Institute of Medicine and the Food and Drug Administration eventually determined that there was no evidence that silicone implants were harmful.
Concerns over the silicone in the suspect implants began to build last year, when PIP was shut down and prosecutors began investigating the company for possible fraud. The French authorities said the implants had been rupturing at a rate double the industry average, the French media reported.
But the concerns over the company's implants caught the attention of European health officials after a woman whose implant had ruptured died last month from a rare cancer called anaplastic large-cell lymphoma.
The French media reported that she was the eighth woman with an implant manufactured by the company to have died of cancer, although the statistical significance of that is unclear.
French prosecutors have said that Poly Implant Prothese substituted a cheap, industrial-grade silicone for medical-grade silicone that is the industry standard. The French authorities have said the substandard product causes inflammation to body tissues when implants are compromised. But so far, they have emphasized, there is no evidence linking it to cancer.
"In case of rupture, you'd have a dangerous quantity of silicone in your body," said Laurent Lantieri, a plastic surgeon at a hospital near Paris.
Helene Guillois, 29, a nutrition student who lives in northern France, said she had the company's devices implanted seven years ago.
"I'm worried, because of the possible damage this could cause," Ms. Guillois said. "No one is really capable of saying what will be the effects. Maybe we'll see in 10 years or so. Like all the big French medical scandals."
Breast implants, which are essentially small silicone rubber bags filled with a material, typically silicone or a saline solution, are used after breast cancer surgery or simply for cosmetic purposes.
More than 1,000 of the estimated 30,000 French women fitted with the devices have experienced ruptures or leakage. Tens of thousands more in other countries have had the company's devices implanted, because PIP exported 80 per cent of its products, many of them to Britain, Spain and Latin America.
More than 40,000 British women are estimated to have received the company's implants.
The implants were also used in Brazil, Argentina, Chile, Colombia and Venezuela. In Brazil, the National Agency of Sanitary Vigilance prohibited the importation and use of the implants in April 2010, after concerns about their safety emerged in France.
Chile's Public Health Institute asked the estimated 1,000 or so women thought to have implants from the French company to contact their doctors so the implants could be removed if ruptures occurred. Otherwise, Chilean officials asked women with the implants to undergo annual exams.
Sebastiao Guerra, the director of the Brazilian Society of Plastic Surgery, said, "We do not have significant reports of either ruptures or rejections or even cancer associated with those PIP implants, and we don't know why there is this difference with respect to the French news."
Prosecutors in Marseille have been investigating the company for possible fraud and reckless endangerment. They say it cut costs over the last decade by using an industrial silicone gel that was not approved for medical use and that cost a fraction of the medical-grade material.
Several hundred thousand of the implants had been manufactured by the time issues were raised early last year about their quality.
Yves Haddad, a lawyer for the company's founder and chairman, Jean-Claude Mas, said there was no evidence that the product, "even if it was unapproved, is dangerous for health."
The Marseille prosecutor's office declined to comment.
It is unclear whether there are health risks posed by the substandard silicone used in the implants, and the French government is expected to decide soon whether to require as many as 30,000 women in France to have their implants removed.
If the government mandates the removals, it will also pay for the procedures, though not for replacements. Regulators will have to weigh whether the known risks associated with removing the implants outweigh the uncertain risks and anxieties associated with leaving them intact.
The British health authorities on Wednesday sought to calm women's fears, saying that there was no evidence that the suspect implants, which were manufactured by Poly Implant Prothese, a company known as PIP, had caused cancer. They urged women who had received them to take any concerns to their surgeons, but they also said, "There is currently no evidence to support routine removal" of the implants.
Britain's surgical associations also tried Wednesday to soothe anxiety. "The message here is not to panic," said a consultant plastic surgeon, Douglas McGeorge, who spoke for the British Association of Aesthetic Plastic Surgeons.
Silicone implants have had a contentious history, with the United States imposing a 14-year moratorium on their use that ended in 2006, after years of lawsuits contending that they had caused cancer. None of PIP's implants appear to have been sold in the United States.
The Institute of Medicine and the Food and Drug Administration eventually determined that there was no evidence that silicone implants were harmful.
Concerns over the silicone in the suspect implants began to build last year, when PIP was shut down and prosecutors began investigating the company for possible fraud. The French authorities said the implants had been rupturing at a rate double the industry average, the French media reported.
But the concerns over the company's implants caught the attention of European health officials after a woman whose implant had ruptured died last month from a rare cancer called anaplastic large-cell lymphoma.
The French media reported that she was the eighth woman with an implant manufactured by the company to have died of cancer, although the statistical significance of that is unclear.
French prosecutors have said that Poly Implant Prothese substituted a cheap, industrial-grade silicone for medical-grade silicone that is the industry standard. The French authorities have said the substandard product causes inflammation to body tissues when implants are compromised. But so far, they have emphasized, there is no evidence linking it to cancer.
"In case of rupture, you'd have a dangerous quantity of silicone in your body," said Laurent Lantieri, a plastic surgeon at a hospital near Paris.
Helene Guillois, 29, a nutrition student who lives in northern France, said she had the company's devices implanted seven years ago.
"I'm worried, because of the possible damage this could cause," Ms. Guillois said. "No one is really capable of saying what will be the effects. Maybe we'll see in 10 years or so. Like all the big French medical scandals."
Breast implants, which are essentially small silicone rubber bags filled with a material, typically silicone or a saline solution, are used after breast cancer surgery or simply for cosmetic purposes.
More than 1,000 of the estimated 30,000 French women fitted with the devices have experienced ruptures or leakage. Tens of thousands more in other countries have had the company's devices implanted, because PIP exported 80 per cent of its products, many of them to Britain, Spain and Latin America.
More than 40,000 British women are estimated to have received the company's implants.
The implants were also used in Brazil, Argentina, Chile, Colombia and Venezuela. In Brazil, the National Agency of Sanitary Vigilance prohibited the importation and use of the implants in April 2010, after concerns about their safety emerged in France.
Chile's Public Health Institute asked the estimated 1,000 or so women thought to have implants from the French company to contact their doctors so the implants could be removed if ruptures occurred. Otherwise, Chilean officials asked women with the implants to undergo annual exams.
Sebastiao Guerra, the director of the Brazilian Society of Plastic Surgery, said, "We do not have significant reports of either ruptures or rejections or even cancer associated with those PIP implants, and we don't know why there is this difference with respect to the French news."
Prosecutors in Marseille have been investigating the company for possible fraud and reckless endangerment. They say it cut costs over the last decade by using an industrial silicone gel that was not approved for medical use and that cost a fraction of the medical-grade material.
Several hundred thousand of the implants had been manufactured by the time issues were raised early last year about their quality.
Yves Haddad, a lawyer for the company's founder and chairman, Jean-Claude Mas, said there was no evidence that the product, "even if it was unapproved, is dangerous for health."
The Marseille prosecutor's office declined to comment.
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