In a highly unusual move, the chairman of a government advisory panel that reluctantly backed resuming sales of silicone gel breast implants now is urging federal health officials and lawmakers to disregard that advice.
“I really have a lot of angst” about the panel’s vote, said Dr. Thomas Whalen of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School. “I felt morally compelled — it sounds corny, but morally compelled — to do something about it.”
Silicone gel implants were highly popular until 1992, when fears that leaking silicone caused serious diseases prompted the Food and Drug Administration to end routine sales. Now one manufacturer is seeking an end to the ban, arguing that silicone implants have been exonerated of causing serious diseases like cancer or lupus.
Last month, the FDA asked outside scientists for advice. In a two-day meeting, dozens of women blamed silicone implants for permanent disfigurement and dozens more begged for access to them.
The advisers recommended, on a 9-6 vote, the sale again of implants but only under very strict conditions. These include additional safety tests and warnings to recipients about lingering safety questions and the frequent need for repeated operations because of painful scar tissue and other problems.
As the panel’s chairman, Whalen could not vote unless there was a tie. But in a letter obtained Tuesday by The Associated Press, he wrote FDA Commissioner Mark McClellan and five members of Congress about his “very strong reservations concerning this vote.”
“Long-term safety, the concern that prompted the removal from the market 11 years ago, was clearly not demonstrated,” Whalen wrote.
Also “extraordinarily troubling,” he added, is the enormous costs that women face for additional surgeries and removal of broken or painful implants.
“This is a public health issue of no small import that must be addressed should the FDA second this misguided panel decision,” Whalen said.
The FDA said it had received and would consider Whalen’s comments.
