WASHINGTON (Reuters) - Women with breast implants may face an increased risk of a rare immune-system cancer near their implants, U.S. regulators said on Wednesday.
Health officials need more data to tell if the implants are related to the cancer and are asking doctors to report any confirmed cases, the Food and Drug Administration said in a statement. Overall the agency still considers implants safe.
Safety concerns have dogged breast implants for years. Silicone breast implants were banned for most U.S. women in 1992 after some complained the devices leaked and made them chronically ill. Widespread sales resumed in 2006 with FDA approval over sharp protests from consumer advocates.
"This is exactly the kind of problem we were concerned about when we said we don't know enough about these products and whether they are safe," said Amy Allina, policy director at the National Women's Health Network.
The FDA said its review found about 60 cases of anaplastic large cell lymphoma (ALCL), a type of immune-system cancer. The number is tough to verify and some reports could be duplicates, the agency said. Data so far suggest women with silicone or saline-gel breast implants "may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant," the agency said.
"We need more data and are asking that healthcare professionals tell us about any confirmed cases they identify," said Dr. William Maisel, chief scientist in the FDA's device unit.
An estimated 5 million to 10 million women around the world have breast implants.
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