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Worldwide Implant Recall

by Breast.com
​What began as series of silicone breast implant failures in France and the UK just over a year ago has now become a worldwide health scare as women in more than 65 countries now face reports that they might have implants that could rupture and leak a questionable type of silicone gel.
 
Silicone gel breast implants manufactured by now bankrupt French company Poly Implant Prothese (PIP) were given to tens of thousands of women in the last decade, mainly in South America and Western Europe. In March of 2010, PIP was shut down and its product was banned in France after it was revealed the firm used an unapproved type of silicone gel that caused high implant rupture rates. By December of 2011 several hundred British women had filed a court action after more than half of them experienced ruptures in their PIP breast implants, and later that same month France's health ministry told women with PIP implants to get them removed to prevent ruptures.
 
Mr. Jean-Claude Mas, head of PIP throughout the 90’s, is now being sought under an international arrest warrant in conjunction with charges that his company used industrial-grade silicone that had not received any approvals by French health authorities in its implants. Now, new reports have recently emerged that PIP had knowingly been manufacturing adulterated products for more than a decade, and although Mr. Mas’ whereabouts are presently unknown, he did speak through his lawyer Yves Haddad, who said that Mr. Mas admits using a silicone product that never received approval and was in violation of health regulations.
 
When asked why PIP would employ unapproved industrial-grade silicone gel in its implants, Haddad said that there was a more expensive high-end PIP implant product available for upscale clients, but added that because economic objectives dictated that management should try to get the best costs, there was a basic product for most women and there was a high-end product using high-quality gel for rich clients. That PIP claimed the industrial-grade silicone implants were “just as effective, but five times cheaper” than the more expensive grade implants is small comfort to the thousands of women around the world who now must worry about their own risks of implant failures.
 
There have been different reactions to the problem so far, with the French government stepping up and paying for some French 30,000 women to have their PIP implants removed for free. In Britain, women have been advised to visit their physicians and in Belgium, health authorities advise removal if problems are suspected. Finland and Italy recommended monitoring and Dutch health authorities advise women with PIP implants to see their doctors. In Latin America, Brazilian officials recommended women with PIP implants should get them tested, and in Venezuela, the government has announced that nation’s public health service will remove the French-made implants for free.
 
Because the U.S. Food and Drug Administration issued warnings about serious quality control violations involving several of PIP’s early implants back as early as 2000, the defective implants were never sold here in the United States and few if any, American women have implants made by PIP unless they got them while traveling outside of the U.S. Any woman who suspects she may have breast implants made by PIP, or is unclear what brand of implant she does have, should obviously consult with her physician or surgeon as soon as possible.


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