Silicone implants are back

FDA approves after 14-year ban from U.S. market for most women.

By Aaron Smith, staff writer

NEW YORK ( -- FDA approved silicone implants Friday, ending America's 14-year hiatus.

The blessing from the Food and Drug Administration provides a boon to two California-based companies, Allergan (up $1.76 to $112.50, Charts) of Irvine, which owns the implant maker Inamed, and rival Mentor Corp. (up $1.47 to $47.58, Charts) of Santa Barbara.


"We are pleased to be able to provide women seeking breast augmentation and reconstruction with important new options," Mentor president Joshua Levine said in a statement.

"Allergan is pleased that the FDA has further recognized the vast body of scientific evidence supporting the performance of these devices," Allergan Chairman and CEO David Pyott said in a statement.

Both of these companies sell saline implants in the U.S. and silicone implants in other countries. But the FDA's approval of silicone is expected to double the $350 million U.S. market for implants.

Allergan and Mentor sell silicone implants in Europe and South America, but that only accounts for a fraction of corporate revenue.

The FDA banned silicone implants for most women in 1992 because of concerns about ruptured shells and leaking gel. Only women in need of post-mastectomy reconstructive surgery have been allowed to receive silicone implants in the U.S. during that time. Other women have either settled for the saline implants or jetted off to Europe and South America, where silicone implants are all the rage.

Proponents of silicone believe that it holds a better shape and feel than saline, though it's been dogged by controversy over its reputed dangers to women.

Allergan got some good news from the FDA in June, when the agency approved Juvederm, a dermal filler than can be used in conjunction with Botox to smooth wrinkles over the entire face. Juvederm competes with Medicis (Charts)' Restylane.


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