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BY JULIAN KESNER
DAILY NEWS STAFF WRITER
Ladies, unhook your bras and your purse strings - silicone-gel
breast implants are back.
Allergan Inc. and Mentor Corp. both received Food and Drug Administration
approval yesterday to have their silicone implants used in cosmetic
surgery. The decision comes 14 years after a multibillion-dollar
verdict bankrupted Dow Corning, shelved its version and prompted
an FDA ban.
Since 1992, women could only receive saline implants in cosmetic
augmentation, though cancer patients remained able to choose silicone
for postmastectomy breast reconstruction.
Women getting implants for cosmetic reasons will have to be at
least 22 in order to get the silicone-gel models. The age minimum
was imposed because most women's breasts have not fully developed
before that.
Dr. Lloyd Gayle, plastic surgery director at New York-Presbyterian
Hospital Weill Cornell, worked on Allergan's clinical trial and
said the safety data was strong.
The new "cohesive gel" Allergan implant "offers
some clear aesthetic and textural benefits that the saline implant
just doesn't impart," said Gayle.
The FDA okay comes despite calls last month by Sens. Dianne Feinstein
(DCalif.) and Olympia Snowe (R-Maine) to delay approval and investigate
Mentor Corp. A former employee accused the company of fudging safety
data.
There were 291,000 breast augmentations nationwide last year, a
37% increase from 2000, according to the American Society of Plastic
Surgeons. Worldwide, silicone already accounts for 90% of implants.
While saline implants start at $575 each, silicone-gel models will
be over $1,000 per breast, excluding operating costs.
Despite the higher price, "there may now be a flurry"
of patients seeking silicone implants, said Dr. Joshua Levine at
the Center for Microsurgical Breast Reconstruction.
But "there's still a feeling in the general population that
silicone implants are not safe," he added. "While those
fears are largely unwarranted, it's going to take another generation
to get over that."
Originally published on November 18, 2006
http://www.nydailynews.com/11-18-2006/news/story/472507p-397601c.html
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