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Breast Implant Scandal Shows Regulators in Dark on Risk

Long before the latest global breast implant scare, American health officials were toying with the idea of building a registry that would track patients with implants.

The registry would give a better idea of the number of complications over time, such as rupture or infection.

But to this day, none exists for the world's largest healthcare market, which often serves as a global model for regulatory practice. Some individual countries in Europe have made their own attempts but with only limited success, and there is no continent-wide registry.

In the wake of the current scandal surrounding France's Poly Implant Prothese (PIP), which used industrial grade silicone instead of medical grade silicone in implants placed surgically in some 300,000 women worldwide, advocates for a registry are again pushing the idea.

The French government has advised the 30,000 women in France who bought the implants to have them removed and governments in several other countries, such as Britain and Brazil, have asked women to visit their doctors for checks.

"If we had had registries, we would have known years ago if it's true that PIP implants break sooner," said Diana Zuckerman, president of the National Research Center for Women & Families. "We would have known if Mentor ones break sooner or later than Allergan's," she said, referring to the two largest makers of breast implants.

There were almost 400,000 breast enlargement or reconstruction procedures in the United States in 2010, according to the American Society of Plastic Surgeons. That includes silicone and saline implants.

The U.S. Food and Drug Administration has relied on company-funded efforts to track the safety of implants since allowing the silicone versions back on the market in 2006. It had banned silicone implants in 1992 after some U.S. women said the devices leaked and made them chronically ill.
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