After 14 years, US lifts ban on silicone breast implants

In an official announcement late Friday, the Food and Drug Administration said it had granted permission to two California companies -- Allergan of Irvine and Mentor of Santa Barbara -- to resume marketing their silicone gel breast implants to women aged 22 and older.

"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," said Doctor Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, in a brief statement.

"The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices," he concluded.

The agency said it would continue to monitor the effects of the implants on women and would require the two companies to conduct a large post-approval study of 40,000 women over the next 10 years.

The ban on silicone implants was imposed in 1992, following scores of highly publicized cases of implant ruptures and leakages causing negative health effects in their recipients.

The imbroglio gave rise to the largest product liability case in US history that pitted thousands of women against Dow Corning, Baxter International and Bristol-Myers Squibb and was settled in 1994 for a record 3.75-billion dollars.

Since then, only women who have undergone mastectomies, or breast removal, had been allowed to receive silicone implants.

Saline implants have been used by the beauty industry as an alternative. But some users claim they are not as natural in appearance.

As expected, the two companies hailed Friday's decision as a step in the right direction.

Joshua Levine, president and chief executive officer of Mentor, said the ruling had ushered in a "historic moment," adding his company was "pleased" to be able to provide women "with important new options."

Mentor assured that its implants were made of "a proprietary silicone gel formulation" that is both safe and capable of giving women a more natural look and feel.

Allergan CEO David Pyott said his firm was "pleased that the FDA has further recognized the vast body of scientific evidence supporting the performance" of silicone-filled breast implants.

But not everybody offered plaudits.

Public Citizen, a watchdog monitoring the US government's performance and accountability, issued a statement by Doctor Sidney Wolfe, director of its health research group, who said the FDA's decision "makes a mockery of the legal standard that requires 'reasonable assurance of safety.'"

Wolfe said silicone gel breast implants had high rates of rupture and lymph node infiltration, which pose health risks and often require surgical intervention.

The expert called silicone gel breast implants "the most defective medical device ever approved by the FDA."

Meanwhile, Doctor Edward Melmed, a plastic surgeon from Dallas, Texas, told CBS News in a recent interview that, according to his observations, approximately 50 percent of silicone implants are ruptured within the first 10 years after implantation, 70 percent within 15 years, and over 90 percent within 20 years.

These warnings notwithstanding, breast augmentation is an increasingly popular -- and lucrative -- form of plastic surgery in the Unites States as this image-oriented society puts additional pressure on women of all ages.

More than 200,000 augmentation procedures had been performed annually in the country in late 1990s and early 2000s, according to experts.

However, the number jumped to approximately 300,000 last year, said the American Society of Plastic Surgeons.

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