Breast implants may be linked to rare cancer
Women with breast implants may face an increased risk of a rare immune-system cancer near their implants, according to the FDA.
Wed, Jan 26, 2011 at 04:23 PM
COSMETIC SURGERY: An estimated 5 million to 10 million women around the world have breast implants. (Photo: ZUMA Press)
WASHINGTON, D.C. - 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.
The cancer warning could hit sales of silicone-gel and saline implants sold by Allergan Inc and Johnson & Johnson's Mentor unit. Allergan shares fell more than 2 percent.
"At this point, we do not expect breast implants to be removed from the market but sales growth could be negatively impacted by the media coverage," Wachovia analyst Larry Biegelsen said in a research note.
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, 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.
Officials at Allergan and J&J could not immediately be reached for a comment.
Allergan shares fell about 2 percent to $70.60 in morning trading on the New York Stock Exchange. Johnson & Johnson shares slid 0.1 percent to $61.00, also on the NYSE.
(Additional reporting by Debra Sherman in Chicago; Editing by Lisa Von Ahn, Gerald E. McCormick and Steve Orlofsky)
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