FDA Approves Silicone Breast Implants—with Conditions

BUSINESS NEWS

After a 14-year hiatus, silicone breast implants are back on the market following approval by FDA in December. The devices were banned in 1992 due to concerns about leakage and the potential for causing bodily harm and disease. The agency's approval follows years of opposing scientific claims—and hundreds of lawsuits—regarding the safety of the implants.

Mentor Corp. (Santa Barbara, CA) and Allergan Inc. (Irvine, CA) are the primary manufacturers of silicone breast implants in the United States. FDA approval came with a number of conditions for both companies, including extensive follow-up studies to determine the long-term safety and efficacy of the devices, better physician training, more-detailed product labeling, continued analysis of device failure, and the development of a tracking system to notify patients and surgeons of any potential problems.

The conditions of approval also require physicians to inform patients that the implants are "not lifetime devices" and that most recipients will require a future surgical procedure to replace or remove them. Additionally, recipients will need to undergo magnetic resonance imaging (MRI) every two to three years to make certain that the implants are not leaking. Use of the implants for cosmetic breast augmentation is restricted to women age 22 and older. Both companies said they will fully comply with the conditions of approval.

David E. I. Pyott, Allergan's chair and CEO, said, "Allergan is pleased that FDA has further recognized the vast body of scientific evidence supporting the performance of these devices and has approved Inamed silicone-filled breast implants for reentry to the U.S. market."

Several women's groups and consumer protection agencies, however, opposed FDA's lifting of the ban. Diana Zuckerman, PhD, president of the National Research Center for Women and Families (Washington, DC), said the regulatory agency's standards for implants "have reached a new low" and called the decision "a triumph of corporate lobbying and hype over sound science and women's health."