Are Breast Implants Safe?

Diana Zuckerman, PhD

Disclosures
In This Article

The Importance of Empirical Research

Many plastic surgeons and implant patients believe that silicone gel breast implants are safe. Medical opinion is not the standard for selling medical products in the United States, however. A recent example involving a different kind of breast implant illustrates the importance of empirical research. Trilucent breast implants, which have a soybean oil-based filler, were designed to interfere less with mammograms than saline or silicone implants. In recent years, these products were widely praised by the doctors who used them (mostly in the United Kingdom) and were embraced as the safe alternative to silicone implants by women and the media. The manufacturers had not sought FDA approval, however, and some plastic surgeons and patients criticized the FDA because the implants were not widely available in the United States. In 2000, Trilucent implants were removed from the market when serious problems were reported. The soya oil implants were found to cause swelling and, in some cases, leaking soybean oil had emulsified and turned rancid.[37] Moreover, the Trilucent implant filler was found to break down into aldehydes, which are genotoxic, raising concerns that the implants could increase cancer risk or reproductive toxicity. Because implant leakage or rupture would lead to increased exposure, the British Medical Device Agency advised women to avoid pregnancy until their Trilucent breast implants were removed. They also recommended that breastfeeding be avoided because the toxic chemical could migrate from the implants to the milk.[38]

The removal of Trilucent implants from the market, after doctors and patients involved had enthusiastically praised them, serves as a reminder that the long-term risks of implants are not always obvious during the first few years of use. That is why studies of the risks of long-term use are essential to establish the safety of implants, and why it is important to refrain from drawing conclusions until objective, comprehensive, long-term research is completed.

In summary, some of the most recent research raises serious questions about the long-term safety of breast implants, and most of the conclusions of the Medscape editorial are based on shorter-term studies that examined relatively few women and relatively few diseases. The fact that silicone gel implants can rupture without warning, and the silicone can migrate to organs where it can't be removed, raises concerns. Since the health risks of broken implants have been evaluated in only 1 study -- which found a statistically significant link to disease -- this should raise the threshold when the FDA finally reconsiders whether to approve silicone gel implants.

The bottom line, however, is that the studies that have been published thus far are not the basis for approval or disapproval of silicone gel implants. The law requires that the review of silicone gel implants must be based only on studies of the specific types of implants that are seeking approval -- not of implants no longer on the market, or studies of women with implants made by a variety of manufacturers. Since the currently used implants have been on the market for more than a decade, the FDA review should include long-term data, and an assessment of the health of women with ruptured implants, to examine whether systemic diseases are linked to long-term implant use.

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