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The FDA began an investigation last year into a possible link between implants and a very rare form of cancer, known as anaplastic large cell lymphoma. The agency said it had learned of about 60 cases of the disease worldwide among women with implants.
France’s Health Safety Agency has said the suspect PIP implants appear to be more rupture-prone than other types, but officials have not specified why.
French health authorities have said they don’t know enough about the health effects of the industrial-grade silicone in the faulty implants, and have recommended that women get them removed after the implants ruptured in more than 1,000 cases. The government has agreed to pay for the procedure.
Investigators in France say PIP sought to save money by using industrial silicone rather than the medical-grade variety.
Last week, French authorities filed preliminary charges against PIP’s founder, Jean-Claude Mas, who according to his lawyer is under investigation for “involuntary injury.” His company went into bankruptcy proceedings shortly after the government in 2010 pulled the implants from the market.
The scandal has left many women asking about the risks they may face, and doctors so far have limited answers.
“We don’t know, neither in Venezuela nor Latin America, what percentage of PIP implants rupture,” said Dr. Carlos Nieto, a surgeon and board member of the Venezuelan Society of Plastic and Reconstructive Surgery.
It’s also unclear how many women have had the implants removed so far.
In Argentina, about 300 women are negotiating with private clinics and a local distributor, Pro Estetica, demanding the defective implants be replaced for free, said attorney Virgina Luna, who represents the group.
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Gabriela Febres, a 30-year-old financial analyst in Caracas, has joined the legal case against Venezuelan distributors. She suspects she needs to have surgery soon because her right breast has been hurting for weeks.
“This affects you in so many ways: your job, your finances and your psychological state,” Febres said. “The uncertainty is the worst.”