A decision to restore the marketing of silicone breast implants hangs in the balance after a senior medical adviser has called for the move to be reversed.
In an unprecedented step, the chairman of the advisory panel on medical devices to the US Food and Drug Administration, Dr Thomas Whalen, wrote at the end of October to the agency's commissioner, Dr Mark McLellan, and five congressman, urging them to ignore the panel's recommendation.
In October the panel had voted by nine to six in favour of lifting the agency's 1992 ban on the marketing of silicone breast implants, after considering evidence from Inamed, a US manufacturer of the devices.
Several panel members had expressed concern about repeat surgery, rupture of the implants, and the lack of long term safety data (25 October, p 947).
During the two day meeting of the panel, dozens of women blamed silicone implants for permanent disfigurement, and dozens more, pleading informed choice, begged to be allowed to use them.
The implants have never been shown to cause autoimmune or neurological disease, lupus, chronic fatigue syndrome, or cancer, nor had these long term risks shown up in large epidemiological studies.
But Dr Whalen, of the University of Medicine and Dentistry of New Jersey, said: "I really have a lot of angst about the panel's vote. I felt morally compelled . . . to do something about it."
"Long term safety, the concern that prompted the removal [of these products] from the market 11 years ago, was clearly not demonstrated," he pointed out.
He added: "Extraordinarily troubling is the enormous cost that women face for additional surgery 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."
Dr Sidney Wolfe, director of Public Citizen's Health Research Group, a Washington based consumer group, who testified before the panel, said in a statement: "We strongly urge the Food and Drug Administration to side with the six panel members who voted against approval and require much more data before reaching a decision to lift the implant ban."
The interests of public health would be better served waiting to collect the full 10 years of information on the thousands of women who already have had implants than precipitously approving the marketing of these devices to hundreds of thousands of women a year "in what would amount to a massive experiment," he added.
By lifting the ban, the agency would be failing to uphold the law that requires "reasonable assurance of safety" before approving such devices and would make a dangerous mockery of the informed consent process, he said.
The agency said that it would consider Dr Whalen's comments.