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Allergan says its breast implants still safe

23 Dec 2011 20:18

Source: reuters // Reuters

(Adds details from FDA, consumer group)

By Anna Yukhananov

Dec 23 (Reuters) - Medical device maker Allergan Inc sought to reassure patients that its breast implants are safe after fears spread about similar products made by a French firm.

Allergan, which makes silicone gel-filled breast implants, said on Friday its products are not part of the investigation into such implants from Poly Implant Prothese (PIP).

The PIP implants appear to have an unusually high rupture rate, prompting the French government on Friday to recommend that tens of thousands of women have them removed by their surgeons as a precautionary measure.. The British government said removal was unnecessary, and could carry its own risks.

As many as 300,000 women worldwide may have received PIP's gel products before the company went bust in 2010, after its implants were ordered off the market.

The Food and Drug Administration said PIP never made products for the U.S. market, but women should report problems with any type of implant to the FDA.

"We do want to hear from women if they are having complications with their implants," said FDA spokeswoman Erica Jefferson. What happened in France "is an example of why tracking implant safety problems is so important."

Breast implant safety has been under the spotlight in the United States this year, with U.S. health regulators warning women in June that they would likely need to have the implants removed or replaced within 10 years to address complications such as rupturing.

In January, the FDA also said women with silicone or saline breast implants may face a small increase in risk for a rare type of cancer.

The agency held a two-day meeting in August about follow-up safety studies for silicone implants from Allergan and Johnson & Johnson's Mentor unit - though the FDA said the implants were safe enough to stay on the market.

Consumer groups in August urged regulators to take Johnson & Johnson's implants off the market because the company could not provide enough long-term safety data.

The National Women's Health Network, one of the groups that testified at the FDA's meeting in August, said all implants have consistent problems, including ruptures. But consumers may not be aware of the extent of issues because of the lack of data after a product is approved.

"Women have been done a terrible disservice because we just don't know the extent of problems since no one is collecting that data," said Amy Allina, program director at the Network.

"We have a very unfortunate history in this country, where we tend not to be willing to regulate until there's a tragedy," she said. "I hope that's not what we're going to see." (Reporting by Anna Yukhananov in Washington; Editing by Gerald E. McCormick)