FDA Lifts 14-Year Ban on Silicone Breast Implants

In a surprising and controversial move, the U.S. Food and Drug Administration has decided to remove the ban on silicone breast implants, meaning that one of the most notorious and divisive medical procedures of the past 20 years is poised to regain its old popularity.

“After rigorous scientific review, the U.S. Food and Drug Administration (FDA) approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older,” the agency announced. “The products are manufactured by Allergan Corp. (formerly Inamed Corp.), Irvine, Calif., and Mentor Corp., Santa Barbara, Calif.”

Said Dr. Daniel Schultz, the Director of the FDA’s Center for Devices and Radiological Health: “FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products. 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.”

As part of their decision, the FDA is requiring the manufacturers to conduct a 10-year “postapproval study” that would include approximately 40,000 women. The FDA also said that there was “no convincing evidence” that these implants are related to either connective tissue disease or cancer, the two risks most commonly cited by opponents. The FDA is also forcing the manufacturers to conduct focus-group research related to its labeling, continue laboratory testing, and keep detailed tracking records of every implant.

Added Schultz, “The silicone breast implant is one of the most extensively studied medical devices. We now have a good understanding of what complications can occur and at what rates.” Yet, Schultz also noted that “women who get these devices will probably need to have additional breast implant surgery at least once,” an important caveat. Women would also be subject to frequent MRI exams in order to check for leaks and would face other irreversible side effects.

In a report, MSNBC.com noted that one-time market leader Dow Corning Corp. faced 19,000 lawsuits related to their silicone implants, resulting in its going Chapter 11 in 1995. In 2004, the company finally shook off its Chapter 11 status after earmarking $2.35 billion for settlement claims.

Dr. Sidney Wolfe, who works for Public Citizen, a national non-profit public interest organization, said, “In terms of adverse safety and health information known at the time of approval–such as high rates of rupture, the need for repeat surgery and clear evidence of lymph node infiltration and damage by leaked silicone–silicone gel breast implants are the most defective medical device ever approved by the FDA. The approval makes a mockery of the legal standard that requires ‘reasonable assurance of safety.’”

Wolfe, who is the Director of Public Citizen’s Health Research Group, also said that the “approval of such a defective medical device raises again the larger issue of the poor leadership and dangerously poor performance of the FDA’s Center for Devices and Radiological Health. Recent examples of this include the large number of defibrillator and pacemaker recalls, primarily the fault of manufacturers such as Guidant but abetted by the lack of FDA promptness.”

The silicone implant first hit the market in 1962 and remained on the market legally for 30 years. According to the American Society of Plastic Surgeons, nearly 300,000 women per year undergo surgical breast augmentation procedures. That number is sure to rise now that silicone-gel implants are cleared for use.