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WASHINGTON, Sep 21, 2005 (United Press International via COMTEX) -- The Food and Drug Administration Wednesday went against the advice of its advisory committee and issued an approvable letter to Inamed Corp. for its silicone breast implants.
The FDA's general and plastic-surgery-devices advisory committee recommended in April by a 5-to-4 vote that the implants not be approved.
"Since then, Inamed has provided FDA with additional information to address the primary safety concerns discussed by the panel," the FDA said in a statement. "Inamed has also said that it will no longer make available Style 153, which raised particular safety issues for the panel," the agency added.
The letter does not mean that the implants can be sold in the United States yet.
"An approvable letter is just another step in the approval process," FDA spokeswoman Suzanna Trevino told United Press International. "There are still issues that need to be worked out for it to be approved."
The FDA would not disclose the contents of the letter, but Inamed, based in Santa Barbara, Calif., said it stipulates several conditions the company must comply with in order to receive FDA approval.
"The conditions outlined in this letter are generally in line with our expectations and the discussions that took place at the October 2003 and April 2005 FDA advisory panel meetings, and we look forward to working with the Agency on a confidential basis in addressing them," Nick Teti, Inamed's chairman, president and chief executive officer, said in a statement.
The FDA's Trevino said there is no timeline for when these issues must be addressed.
Silicone breast implants came under scrutiny beginning in the 1980s, primarily due to concerns that they might cause autoimmune-related illnesses. The FDA removed them from the market in 1992, and lawsuits were filed against manufacturers, but numerous studies have failed to find a link between the implants and diseases.
The FDA has moved in recent years to bring the implants back to market. In June the agency sent Mentor Corp., based in Santa Barbara, an approvable letter for its silicone implants, which the advisory committee had recommended be approved.
By STEVE MITCHELL, Senior Medical Correspondent
Copyright 2005 by United Press International.
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