After a 14-year hiatus, silicone breast implants are back on the market following last month's approval by FDA. 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.

In announcing the decision, Daniel Schultz, MD, director of FDA's Center for Devices and Radiological Health (CDRH; Rockville, MD), said, “The decision to approve these implants was based on a thorough review of each company's clinical and preclinical studies, a review of studies by independent scientific bodies, and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders. In addition, FDA conducted inspections of each company's manufacturing facilities to determine that they comply with FDA's good manufacturing practices. The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices.”

Opponents of silicone breast implants have long insisted that the devices play a causative role in certain cancers and connective-tissue diseases such as Lupus erythematosus. However, numerous investigations conducted by organizations such as the National Institutes of Health (NIH; Bethesda, MD), the Mayo Clinic (Rochester, MN), and the Institute of Medicine (IOM; Washington, DC) have failed to establish a link between the implants and such diseases.

Nevertheless, the fact that the implants can rupture is not disputed. According to the IOM, the devices can silently rupture at any time following implantation, with rupture rates as high as 77%.

After FDA ordered the devices off the market in 1992—in spite of the absence of a proven link to any disease or adverse medical condition—claims about alleged health threats associated with silicone breast implants generated hundreds of lawsuits. The legal actions culminated in a $2.35 billion class-action settlement by silicone supplier and breast-implant manufacturer Dow Corning Corp. (Midland, MI), which no longer manufactures implants of any type.

Roxanne Guy, MD, president of the American Society of Plastic Surgeons (ASPS; Arlington Heights, IL), said, “Silicone breast implants have been scrutinized more than any medical device, and we applaud FDA for making its well-thought-out decision and allowing American women to make informed choices about their healthcare.” According to ASPS, more than 290,000 women had breast augmentation surgery in the United States last year—a 37% increase since 2000. Because of the ban on silicone-based devices, these surgeries were almost exclusively performed with saline-filled implants. Yet, during the same time period, the use of implants for reconstructive surgery declined by 29% to 58,000 procedures. In 2005, ASPS reports that 39,000 women had their implants removed.

Responding to the approval announcement, David E. I. Pyott, Allergan's chair and CEO said, “Allergan is pleased that the 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.” Allergan acquired Inamed Corp. in March 2006, after a pitched and convoluted battle involving offers by Medicis Pharmaceutical Corp. (Scottsdale, AZ) and Inamed competitor Mentor Corp. (Santa Barbara, CA). The $3.2 billion acquisition of Inamed's line of breast implants, antiwrinkle ointments, and minimally invasive devices to treat obesity represented Allergan's first move into the medical device industry and “a significant expansion of our existing medical aesthetics franchise,” according to Pyott.

Mentor president and CEO, Joshua Levine, said, “ Over the past 14 years we have remained devoted to returning MemoryGel implants to the U.S. market, and we are pleased to be able to provide women seeking breast augmentation and reconstruction with important new options.”

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.”

Referring to silicone breast implants as “the most defective medical device ever approved by the FDA”, Sidney Wolfe, MD, director of the Health Research Group at Public Citizen (Washington, DC), called the approval “a mockery of the legal standard that requires ‘reasonable assurance of safety'.” Wolfe is a frequent critic of the FDA.

Allergan's Inamed and Mentor each posted near-identical revenues of around $230 million from breast implants in 2005. With the lifting of the ban on silicone-based devices, industry analysts expect the market for breast implants to double over the next few years. Some analysts have speculated that U.S. sales could reach $2 billion by 2015.

© 2006 Canon Communications LLC

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