WASHINGTON -- For Dr. David A. Kessler, the decision on whether silicone gel breast implants are safe for women will be the most difficult of his first year as head of the Food and Drug Administration.
After three days of conflicting testimony from implant recipients, manufacturers and doctors, the implant issue arrived last week in his "urgent" in-basket.
Dr. Kessler has until Jan. 6 to make a decision on whether to ban breast implants or allow their continued general or limited use. An FDA advisory panel voted to keep silicone gel breast implants on the market despite questions about their safety.
Until the arrival of the implants controversy, he considered his toughest call was permitting use of the unproven AIDs-related drug, didanosine, in uncontrolled trials.
"Letting hundreds of thousands of patients take a drug before all the trials -- it was certainly a weighty decision. We decided to approve it, and we may be wrong.
"But I don't think it was as difficult as breast implants. Breast implants is certainly a much more emotion-ridden issue. It's a much more difficult risk-and-benefit balance.
"I need to approach the breast implants not only on the basis of what the statute says, but also as a doctor.
"In the end I am a doctor. This agency is not going to do a dumb thing for patients. To me that's the most important thing."
He will consult with his specialists in the FDA's Center for Devices and Radiological Health and other experts.
"There is always a lot of give and take initially and a lot of discussion, but at the end of the day always a collective wisdom seems to emerge," he said. "I am certainly prepared to take a decision."
Criteria for that decision, he said, would be: Are breast implants safe? If not, do the benefits outweigh the risks sufficiently to justify continuing use?
A third option was to authorize further tests.
A pediatrician, Dr. Kessler said he never counseled any woman on breast implants, but was now acutely aware that whatever he said on the issue took on major significance.
"Every time I utter a word about breast implants, or I talk about a risk, it hits home to millions of women who already have these implants."
From what he knew, there was no need for "undue" concern. He quickly added:
"But simply stating that I don't think people should loose sleep on this is not synonymous with saying they are safe for future generations of women."
Breast implants have been on the market for 30 years. They were grandfathered into a 1976 medical-device law on the understanding that the FDA could call on the manufacturers to produce data to prove their safety at any time.
The FDA put manufacturers on notice to prepare data in 1982, 1983, 1988 and 1990. Shortly after he became FDA commissioner, Dr. Kessler called for the data.
Dr. Kessler said he would now judge the device as if it was just being introduced.
"I recognize that it's a device that has been used for 30 years and people say, 'Gee, it's been used for a long time,' " Dr. Kessler said.
"The issue alone is not whether these devices have caused major problems, [or] are they unsafe. The issue is, does the [manufacturers'] application [for FDA approval] support the same standard as if these were never on the market: Would they be approved today?"
If the manufacturers failed to prove their safety, he must decide whether there was " public health need" for them, or if further trials should be carried out.
If they are judged unsafe, should patients with them already implanted be able to get new ones?
Should women who have undergone mastectomies be allowed to have reconstructive surgery? Should breast augmentation surgery be permitted?
Would certain patients, perhaps because they had undergone radioactive therapy, be more at risk?
There are problems with the devices, he said. For one thing, they could rupture.
What did silicone do to the body? What was the chemical composition of the silicone? There could be leakage, seepage, interference with mammography, possibly a link with cancer.
"The risks we are concerned about are not solely cosmetic risks. I think they are very much a public health concern," said Dr. Kessler. "Just because there are known risks, it doesn't mean there are not benefits that outweigh that risk.
"What makes it even more challenging and tests our mettle even more is if you look at the risk, they are in terms of public health risks. What are the benefits? The benefits go to the issue of self-esteem, self-image, correction of disfiguring conditions."
Dr. Kessler said he was a "great believer in informed consent," but consumers were not free to choose potentially harmful medical devices as they were to smoke cigarettes.
"Informed consent, informed choice, is simply not sufficient because the law requires us to say these devices are safe. Choice here doesn't meet the requirements of medical device law," said Dr. Kessler.