Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: TUESDAY, January 7, 1992 TAG: 9201070073
SECTION: NATIONAL/INTERNATIONAL PAGE: A1 EDITION: METRO
SOURCE: Associated Press
DATELINE: WASHINGTON LENGTH: Medium
FDA ASKS FOR HALT ON IMPLANTS
The government said Monday it cannot assure that breast implants made of silicone gel are safe, and it asked surgeons to stop using them while it studies new information.The action by the Food and Drug Administration fell short of the outright ban sought by some critics of the devices, which are implanted in about 150,000 American women a year and have been on the market for more than 30 years.
But it would stop their use until the FDA and an advisory panel, to be convened within 45 days, can assess the latest data.
Never before has the agency called for a halt, even temporarily, to use of a medical device employed so widely. The action was based, in part, on new reports regarding ruptures and "anecdotal" evidence that recipients may be at greater risk of immunity system disorders.
The moratorium does not affect saline filled breast implants, which will continue to be available. Saline implants are encased in silicone, but are not believed to pose the same risk as silicone-gel implants because rupture or leakage releases salt water, rather than silicone gel, into the body.
According to FDA figures, about 1 million women have received silicone gel breast implants, and more than 10,000 receive implants monthly. About 80 percent are for cosmetic purposes, with the rest used to reconstruct breasts removed as the result of disease or injury.
The FDA previously had estimated that 2 million women were affected based on the number of reported implants, but it halved that estimate Monday because most women receive two implants instead of one, agency spokeswoman Betsy Adams said.
The FDA has received about 3,400 reports of problems with silicone gel breast implants and 3,000 reports on saline implants.
"Until the panel meets and we have had an opportunity to review its recommendations, I am asking that physicians cease using silicone gel implants," FDA Commissioner David Kessler told a news conference. "As physicians, our first obligation is to do no harm."
Kessler set no time limit on the moratorium, but said the agency would move as quickly as possible to resolve the issue.
The American Society of Plastic and Reconstructive Surgeons said its members would comply, but its president, Dr. Norman Cole, called on Kessler to release the new information that triggered the moratorium.
"If the commissioner has new information it is essential that it become available to physicians and their patients," Cole said.
Kessler also asked manufacturers to stop distributing the implants, and companies said they were complying, though they disagreed with the FDA's action.
"We are still totally convinced that we have established both the safety and the efficacy of these . . . devices," said Robert Rylee, chairman of Dow Corning Corp.'s Health Care Businesses.
Another Dow Corning official, Barbara Carmichael, said, "We believe the process up until this point has been compromised by politics and not a fair and equitable review of the science. And all that has done is provide a huge amount of concern on the part of women in this country."
Jan Varner, president of McGahn Medical Co., a leading manufacturer of silicone gel implants, said the FDA's action is "panicking a lot of people" when "we don't have any scientific reason to concern them." He called the FDA's action "unfortunate" and said "we're going to explore all recourse, and hopefully it won't take 45 days." He declined to elaborate.
Dr. Sidney M. Wolfe, director of the Public Citizen Health Research Group, said the FDA's action is inadequate.
"I think it's irresponsible for the FDA to do anything other than recall" silicone gel implants, he said. "As long as they are out there, women are likely to get silicone breast implants," he said.
Kessler disagreed, and said that "when the head of the Food and Drug Administration gets up and asks for a moratorium, I believe all physicians and manufacturers will abide by it . . . and we're asking patients to understand that the FDA cannot assure the safety of these devices at the present time."
He added, "We don't think we're going to get to the question of enforcement."
Asked whether the agency could take action against anyone who violated the moratorium, FDA spokeswoman Betsy Adams said, "that's something we're just going to face if the situation arises . . . but we don't expect to have to deal with that. We expect cooperation."
The FDA advisory panel recommended in November that the implants remain on the market while manufacturers collect additional data.