Member of FDA Breast Implant Advisory Committee Loses Vote
The Food and Drug Administration has revoked the voting status of a member of its advisory panel on silicone gel breast implants, saying that he apparently already has decided that the devices should be removed from the market, agency officials said Wednesday.
The FDA said it would allow Dr. Norman Anderson, a professor of medicine and surgery at Johns Hopkins School of Medicine, to remain on the panel as a non-voting member. He will be allowed to voice his opinions but not to vote on the fate of the devices.
Anderson has been an outspoken critic of Dow Corning Wright, the leading manufacturer of silicone implants, and has urged that they be banned.
“The problem is not that he has strong opinions but that he was quoted as having reached a conclusion,” said one senior FDA official, who requested anonymity. “Panel members are supposed to be impartial. The bottom line is to protect the integrity of the panel’s decision-making.”
Anderson could not be reached for comment Wednesday.
The committee, which is scheduled to reconvene Tuesday, decided in November that Dow Corning Wright and other manufacturers had failed to prove that the devices were safe. However, it also said there was a compelling public health need for them to remain on the market, particularly for reconstruction after breast cancer surgery.
But numerous women have blamed the implants for the development of lupus, arthritis and other disorders, although that association has not been proven.
Several weeks after the committee’s November meeting, the FDA reviewed new information--including hundreds of pages of internal Dow Corning Wright memos. They showed that the company had long been aware of silicone leakage from the implants.
As a result, the FDA on Jan. 6 called for a moratorium on the sale and use of the devices and said the advisory committee would meet again to re-examine the issue. The final decision will be made by FDA Commissioner David A. Kessler.
Rep. Ted Weiss (D-N.Y.), chairman of a House subcommittee that has been investigating the safety of silicone implants, criticized the agency’s decision.
“I fear that changing the advisory panel at the eleventh hour risks undermining the credibility of the advisory panel, and of the FDA,” he said in a letter to Kessler.
FDA officials insisted that credibility was the reason Anderson’s vote was taken away. They compared it to an earlier action, when the FDA removed several plastic surgeons from the committee before the November meeting because it had learned that their society had created a lobbying effort on behalf of implants.
