Tuesday, February 7, 2012

Frenchwomen Worry About Suspect Breast Implants

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Rachel Rodriguez, a 35-year-old mother who sells shoes in this quiet city on France’s Atlantic coast, has stopped exercising. And, she said, she developed psoriasis on her scalp from anxiety and lost 24 pounds in a month.

“She is glued to the Internet, doesn’t sleep or enjoy life anymore,” said her husband, Jean-Marc, a security guard. “We’ve fallen into real paranoia.”

Ms. Rodriguez is one of the 30,000 Frenchwomen who were given the implants, which were filled with an industrial-grade silicone and are more likely to rupture or ooze than those made from surgical silicone. About 300,000 women across 65 countries received the implants.

The problems with the implants were first revealed in 2010, when the French government ordered their withdrawal from the market, though at the time it did not recommend their removal from those who already had them. But women with the implants got a fresh jolt in November news broke that a woman whose suspect implants had leaked had died of a rare form of lymphatic cancer.

While French health officials said the gel carried no known link to cancer, the news had many women here hurrying to have their implants removed, lest they rupture and spread a potentially toxic gel in their bodies.

?milie Germain, who received the faulty implants in 2009, said she had noticed several lumps in her breasts and often felt a burning sensation. But she was not sure what to make of it.

“I feel like I’m having symptoms that aren’t real,” she said. “It certainly comes from anxiety.”

In December, French health officials recommended that women have the implants removed as a preventive measure. The government has said that it will cover the cost, but that it will pay for new implants only for women who had them for reconstructive surgery after breast cancer.

“Many women who come to us can’t pay for new breasts,” said Muriel Ajello, who leads a group defending affected women. “Those people are our priority.”

The women primarily fear for their health. Even so, many also joined Ms. Ajello’s association to be recognized as victims and fight against the perception that they were somehow at fault for having had the surgery in the first place. They pointed out that many women have implants after a mastectomy, or after extensive breastfeeding that can shrink the breast, and not just for vanity.

“We aren’t bimbos,” Ms. Rodriguez said. “We aren’t psychologically weak people, either.”

Ms. Rodriguez and the others criticized health officials and surgeons for not immediately alerting them to the potential risks. Some women even said that their surgeons had been absent or on vacation since news of the scandal broke. Others held the government responsible for waiting more than a year after the offending gel was withdrawn from the market before taking preventive measures.

They often compare the implant scandal to the outrage in the 1990s over contaminated blood, when the news media discovered that France’s National Center of Blood Transfusion had knowingly distributed AIDS-contaminated blood products to hemophiliacs in 1985. That case brought criminal prosecutions.

“We found out the truth only 15 years after it happened,” Ms. Rodriguez said. “I fear that this is going to happen with the implants.”

Many surgeons have tried to calm fears, saying that there was no evidence that the gel was harmful. But women with the implants said that they knew very little about the product.

“There hasn’t been any reliable medical expertise about it,” Ms. Germain said of the gel, adding that her surgeon had on his desk the files of 200 women waiting to have their implants removed.

“There are many rumors, and sometimes nonsense,” said a surgeon who had given several women the implants. “What struck me most is that no one until recently asked us to keep the implants with us for further analysis,” he said. He agreed to speak only if his name was not used, because of the possibility of litigation over the issue.

Annie Mesnil, a 65-year-old graphic designer and mother of three, had her right breast removed after she received a diagnosis of breast cancer in 1999.

“I couldn’t imagine myself living with one of my breasts missing,” she said.

She happily accepted her surgeon’s suggestion to have implants and asked no questions. “He said they had satisfying results, and I trusted him.”

In March 2010, when she found out that the company had stopped its production of implants, she had a scan that showed nothing wrong. But because she had already suffered from heavy chemotherapy and wanted to take no chances, she picked another surgeon and had her implants removed in June.

But the implants had already leaked. “They had ruptures of more than 10 centimeters deep in different places,” said Dr. Benjamin Pulvermacker, the surgeon who operated on Ms. Mesnil. “The gel had leaked, and I had to clean up the entire space where the implant was placed.”

Ms. Mesnil said that she felt like she has had a sword of Damocles over her head for the past six months, anxious about the consequences of the leakage. “The gel can infiltrate the body tissues, and no one knows if we can take all of it out,” she said.

Ms. Rodriguez has been coping with the same feeling of helplessness. She is counting the days before she has her surgery on Jan. 25. This time, she said, her surgeon told her of a Web site where she could choose different varieties and brands of implants.

“I’ll pick ones made of physiological salt solution,” she said. “They are translucent, and you can easily see through them.”

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Health breast implants concerns over suspected French spread abroad

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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 modern associated with leaving them intact.

The British health authorities on Wednesday sought to calm the women's fears, saying that there was no evidence that the suspect implants, which were manufactured by Poly Implants Proth?se, 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 Association also tried Wednesday to "soothe anxiety. "The message here is not to panic," said a consultant plastic surgeon, Mr 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 implants 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 implants manufactured by the company to have died of cancer, although the statistical significance of that is unclear.

French prosecutors have said that Poly Implants Proth?se 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 into your body," said Laurent Lantieri, a plastic surgeon at a hospital near Paris.

H?l?ne 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 percent 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 trade-off 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 the women with the implants to undergo annual exams.

Sebasti?o 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 materials.

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.

Reporting was contributed by Ravi Somaiya from London; Simon Romero from S?o Paulo, Brazil; Gardiner Harris from Washington; and Jon Moriconi from Rio de Janeiro.

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