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18 Nov 2006 10:30
The United States federal government gave the beauty industry a long-sought push-up late on Friday as it lifted a 14-year-old ban on women’s silicone-breast implants, despite concerns by some experts they might not be safe.
In an official announcement, the Food and Drug Administration (FDA) 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,” Doctor Daniel Schultz, director of the FDA’s Centre for Devices and Radiological Health, said 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 will continue to monitor the effects of the implants on women and will require the two companies to conduct a large post-approval study of 40Â 000 women over the next 10 years.
The federal ban on silicone implants was imposed in 1992, following a series of highly publicised cases of implant ruptures and leakages causing negative health effects in their recipients.
Since then, only women who have undergone mastectomies, or breast removal, due to cancer or other diseases 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 or texture.
As expected, the two companies that have been lobbying for the lifting of the ban for years hailed Friday’s decision as a step in the right direction.
Joshua Levine, president and chief executive officer of Mentor Corporation said the ruling had ushered in an “historic moment,” adding his company was “pleased to be able to provide women seeking breast augmentation and reconstruction 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 recognised 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 have 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”.—AFP
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