FDA lifts Ban on Silicon Breast Implants

Unrestricted sales of silicon breast implants will resume in the United States after 14 years, with the virtual ban being taken off by the Government, despite lingering safety concerns. The devices will now be made available to tens of thousands of women who have clamored for them.

Less than a month after health officials in Canada allowed such implants back onto the market, the Food and Drug Administration approved the implants made by Allergan Inc. and Mentor Corp. A teleconference was planned by FDA late Friday to announce the product approval.

The action opens the implants to much wider use by women looking forward to reconstruct their breasts and breast augmentation being the second most-popular cosmetic surgery procedure in the United States, the decision will have big connotation for the industry.

Nearly 365,000 women went under breast augmentation surgery in the past year, and the number was exceeded only by that for liposuction, say the statistics from the American Society for Aesthetic Plastic Surgery

"Silicon gel breast implants are the most defective medical device ever approved by the FDA," said Sidney Wolfe, director of the Health Research Group of Public Citizen, a consumer safety group. "The approval makes a mockery of the legal standard that requires `reasonable assurance of safety."

According to Michael Olding, chief of the division of plastic surgery at George Washington University Medical Center in Washington, and a member of the FDA's General and Plastic Surgery Devices Panel, studies have concluded that there is no scientific link between silicone implants and the systemic diseases many believed were connected to their use

Silicone gel implants are used to enlarge breasts for reconstruction after breast cancer surgery and for cosmetic reasons and the companies that manufacture them hold that silicone implants have a texture similar to breast tissue.

The FDA said implants still have risks of serious localized health complications like hardening of the breast tissue, pain, infection, calcium deposits, shape and position change, lost sensation, muscle pain and fatigue.

Shares of Allergan went up $1.76, or 1.6 percent, to $12.50 in New York Stock Exchange composite trading while those of Mentor shares rose $1.47, or 3.2 percent, to $47.58. The announcement was made after the official closure of U.S. stock markets.