FDA Acts on Silicone Implants

January 11, 1992

The Food and Drug Administration has finally taken a strong step to sort out whether silicone breast implants pose a health threat. This after 30 years of risk to 2 million women. That it has happened speaks as much to manufacturers' desires to protect a $300 million a year industry as it does to regulatory sloth.

Although breast implants have been on the market since the 1960s, the FDA did not have power to regulate them until 1976 when Congress, reacting to the Dalkon Shield lawsuit, gave the agency broader power. Five years later, it classified silicone implants as a "significant risk device" and told manufacturers that safety data might be required. A predictable uproar from the medical and manufacturing communities was followed by a series of appeals. And the agency -- in lock step with the anti-regulatory climate of the Reagan administration -- dragged its feet.

Late last year, under the leadership of a new FDA Commissioner, Dr. David Kessler, the data collected by four manufacturers was evaluated by an FDA advisory panel. It concluded that there there wasn't enough information to prove the devices were either safe or unsafe, and allowed them to remain on the market.

Now comes evidence that the information presented was skewed and incomplete. A recent malpractice case against Dow Corning, the largest manufacturer of silicone implants, revealed that Dow had data from studies it had not provided to the FDA. Newly disclosed internal memos between Dow executives show the company knew from its own research that the devices could leak or rupture but failed to tell doctors, patients or the FDA.

Given the plethora of doubt about the safety of implants, Dr. Kessler was right to call a time out, for at least 45 days, so the agency can review the new data. Dr. Kessler has asked doctors to stop inserting the devices and manufacturers to stop supplying them. The commissioner's decision is not, as health-care advocates had hoped, an outright ban. Still, the manufacturers are complying, and though some doctors may have implants on hand, none can now ignore the potential liability of inserting the devices while the FDA is reassessing their safety. The FDA may find the devices perfectly acceptable; it may find them dangerous.

Regardless, women will at last be able to make informed choices. With 2 million women already having undergone implant surgery and 10,000 new implants being done every month, a moratorium and valid assessment of health data is the least American women have a right to expect.

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