Food and Drug Administration

FDA Approves Silicone Breast Implants After 14-Year Ban

The Food and Drug Administration in November 2006 lifted restrictions on the use of silicone breast implants for cosmetic augmentation. The decision came 14 years after the agency had limited the use of these implants to reconstructive surgery and clinical testing. The reason for the change in the FDA's decision was that the newer types of implants were less prone to tears that could cause the implants to leak, which was a major problem when the agency decided to limit the use of the implants in 1992. The FDA now requires manufacturers to warn consumers that the implants are not lifetime devices, and that the vast majority of women to receive the implants will need to replace or remove them at some point in time.

In November 1991, the FDA held a panel meeting to review information about the safety and effectiveness of breast implants that were filled with silicone gel. After the meeting, the agency asked the industry to cease marketing these types of implants until the FDA could review the information that had been submitted. Within months of this meeting, the FDA denied approval of the marketing of the silicone implants for purposes of augmentation. However, the agency determined that these devices should be available for those who underwent breast reconstruction or replacement of existing silicone implants. Since this time, saline-filled implants have remained on the market.

In 1998, a major manufacturer of silicone implants, Dow Corning of Midland, Michigan, agreed to pay $3.2 billion over a 16-year period to settle the claims of more than 300,000 women who alleged that the silicone implants had harmed them due to leakage and ruptures. Some claimed that these devices were linked with connective tissue disease or cancer. Since the 1990s, several independent studies, including one by the Institute of Medicine, tested these claims. However, these studies have concluded that there is no convincing evidence that the implants were associated with either of these diseases. According to Daniel Schultz, the director for the Center for Devices and Radiological Health of the FDA, "The silicone breast implant is one of the most extensively studied medical devices. We now have a good understanding of what complications of can occur and at what rates."

Between 1998 and 2005, the FDA approved several applications by private companies to study the use of silicone implants. These companies, which include Allergan Corp. (formerly Inamed Corp.) of Irvine, California and Mentor Corp. of Santa Barbara, conducted numerous clinical trials of women who had received the implants. The companies compiled a body of scientific evidence that detailed the benefits and risks of silicone implants. The FDA reviewed these companies' studies, tests completed by independent scientific bodies, and reports from advisory bodies made up of outside experts. The agency also conducted thorough inspections each of the companies' manufacturing facilities to determine whether they comply with FDA standards.

The majority of the women in the studies reported that they were satisfied with the implants. However, the studies also identified some complications that women would need to consider when deciding whether to received these implants. Some of the problems include the following: many of the changes to the women's breasts are irreversible; rupture of a silicone implant is usually silent, which means that neither the woman nor her doctor will know that the implant has ruptured; and the woman will need regular MRI examinations to determine whether a silent rupture has occurred. Moreover, some women in the studies complained of hardening of the area around the implant, change in nipple sensation, and breast pain.

Despite some concerns expressed by health advocates, the FDA on November 17, 2006 approved the marketing of silicone implants. Women of all ages may receive implants for reconstructive purposes. However, only women ages 22 and up can receive implants for augmentation purposes. The FDA has maintained that the decision is in the best interests of woman. "FDA has reviewed an extensive amount of data from clinical trials of women studied up to four years, as well as a wealth of other information to determine the benefits and risks of these products," Schultz said. "The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions."

The agency attached several conditions to its approval. The companies that market these implants must conduct patient and laboratory stud-ies to determine the failure rates of the devices. These companies must also track each implant in order to notify patients and their doctors of updated product information, as well as other purposes. The FDA stressed that breast implants are not lifetime devices and that a woman receiving an implant will likely need at least one additional surgery during her lifetime. Researchers with the FDA point out that the implants are prone to breakdown within the body.

Commentators expect the reintroduction of silicone implants to increase the number of women who seek breast augmentation. In 2005, plastic surgeons reportedly performed 291,000 augmentations, representing a 37 percent increase from 2000. An additional 58,000 women had breast reconstructions last year. The typical cost for an augmentation procedure is about $8,000.

Critics of the FDA's decision point out that women must not only pay the cost for the initial implant, but must also pay tens of thousands more for the regular MRI screenings as well as the replacement surgeries that will be necessary once the implants have reached their life spans. Moreover, the fact that the FDA has mandated further studies proves that the FDA is aware of the dangers associated with the implants, according to these critics.