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Panel Chair Opposes Advice On Breast Implants
The Washington Post
November 6, 2004
The chairman of the federal advisory panel that voted last month to allow silicone breast implants back on the market after an 11-year absence is urging the Food and Drug Administration to override the recommendation because of lingering long-term safety concerns. Thomas V. Whalen, a professor of surgery at the Robert Wood Johnson Medical School, said he decided to take the unusual step of speaking out against his own panel's action because "to approve this device poses threats to women that are clearly unknown."
The palm-size gel implants were pulled from U.S. markets in 1992 because of fears that ruptures and leakage could cause complications such as neurological and tissue damage. In a letter to FDA Commissioner Mark McClellan, Whalen said the questions remain unanswered.
"It is incumbent upon the FDA to demand that the manufacturer establish in a rigorous, prospective, controlled study that these devices, despite their established breakage and leakage rates, are safe in the long term," he wrote. Calling last month's 9 to 6 recommendation "misguided," Whalen said it was tainted because every plastic surgeon on the panel voted to approve the implants.