Polyurethane foam-coated breast implants were pulled off the market in 1991 due to safety concerns. Experts believed that polyurethane foam-coated breast implants increased the risk of breast cancer in women. A chemical called TDA, known to cause cancer in animals, was thought to be released in small quantities by the foam of polyurethane foam-coated breast implants.

Because of this serious safety concern, the makers of polyurethane foam-coated breast implants, Bristol-Myers Squibb's subsidiary Surgitek, conducted a urine analysis of women with polyurethane foam-coated breast implants. This study showed that, in fact, this harmful TDA chemical was present in the women's bodies. The concentration of this chemical was reportedly so small that a patient's risk of developing breast cancer was minimal.

The FDA and other medical experts expressed concern that over a longer period of TDA release, the risk of breast cancer from polyurethane foam-coated breast implants might increase, and the recall was still ordered. After the completion of the FDA investigation, the risk of developing cancer from polyurethane foam-coated breast implants has been found to be relatively small. It is estimated that about one in every 110,000 women who have polyurethane foam-coated breast implants will develop breast cancer from the release of TDA.