Are Breast Implants Safe?

Diana Zuckerman, PhD

Disclosures
In This Article

The Role of the FDA

Breast implants were first sold in the 1960s, at a time when there was no government regulation of implants or most other medical devices. When the FDA finally obtained that authority in 1976, breast implants were still relatively rare, and the agency was confronted with an enormous backlog of devices that needed to be evaluated. Most devices were allowed to remain on the market until those reviews were completed, and breast implants were generally considered a much lower priority than potentially life-saving devices such as heart valves and shunts.

By 1990, almost one million women had breast implants and the numbers were increasing substantially, but the FDA had not yet required the manufacturers to evaluate their safety and no empirical studies had been published regarding their effects on human health. In 1991, pressured by Congressional hearings and media reports of illness and complications, the FDA finally required the manufacturers of breast implants to submit safety studies. As a Congressional investigator, I had access to all those studies and to internal FDA documents involving them. FDA scientists pointed out that the studies were inadequate -- they included few women, the women had implants for very short periods of time, and many women were lost to follow-up.[6] The law requires that products be proven safe and effective in order to be sold in the United States, but the FDA could not conclude whether the implants were safe or effective because of the shortcomings of the research. (There is no requirement that products be proven unsafe to keep them off the market.)

However, there was enormous pressure to keep breast implants on the market from breast cancer patients and their Congressional representatives, thanks in large part to public relations campaigns that were generously funded by the manufacturers and the plastic surgeons' organizations.[6,7] As a compromise, implants were allowed to remain on the market as a "public health need," and in 1992, the FDA limited their availability to clinical trials, primarily for women who have mastectomies, breast deformities, or who want to replace a gel implant that was put in for augmentation prior to these restrictions. Any woman who has had implant surgery with silicone gel implants since 1992 is required to be regularly evaluated by her plastic surgeon as part of the study, in order to provide safety data that the manufacturers will use to try to obtain FDA approval. Currently, a limited number of women can also receive gel implants for first-time augmentation as part of clinical trials.

Ten years have passed since the manufacturers submitted inadequate studies of silicone gel implants to the FDA. The manufacturers have the responsibility to submit new safety studies to the FDA as part of the "Premarket Approval" (PMA) process to get implants approved. The FDA has not required them to submit new studies, and the manufacturers have not chosen to do so. Silicone gel implants, like any other medical product, cannot be approved until those studies are submitted and reviewed by the FDA. This decision is not made on the basis of physicians' or patients' opinions, or research on implants that are no longer on the market. It is a decision that, according to law, must be based on the FDA's objective review of new empirical studies of the specific implants that would be sold. That decision cannot be made until each manufacturer submits its studies for review, and it seems premature for Medscape editors to speculate on that decision until they have seen that research. However, the information we have thus far raises several serious concerns.

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