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