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Created: 9/21/2005 12:00:00 AM

Updated:9/22/2005 10:45:58 AM

The Food and Drug Administration announced on Wednesday that a second company would be able to resume selling silicone-gel breast implants, absent from the U.S. market for 13 years, if it met certain conditions.

The FDA said it had written Inamed Corp. to say that its implants would be approved if the unspecified issues were resolved. In April, an FDA advisory committee voted 5-4 against approving Inamed's application after panel members expressed concern about a lack of information on long-term safety.

"Since then, Inamed has provided FDA with additional information to address the primary safety concerns discussed by the panel," the agency said in a statement. In addition, according to the FDA, Inamed has said it would withdraw one implant model that "raised particular safety issues for the panel."

The FDA usually goes along with its advisory panels, but this is the second time it has gone against a recommendation on Inamed's silicone-gel implants. In January 2004, the agency turned Inamed down, despite its advisory panel's October 2003 vote in favor of the company's implants.

Inamed is the second manufacturer to receive an "approvable letter" for its silicone-gel implants. In July, the FDA issued an approvable letter to Mentor Corp. The advisory panel in April had voted 7-2 in favor of Mentor's silicone-gel implants, with numerous conditions, such as extending research into their safety.

The agency said it is prohibited from revealing the specific contents of approvable letters.

Inamed spokesman Kirill Goncharenko said the company would not comment beyond what it said in a press release: "The approvable letter stipulates a number of conditions that Inamed must comply with in order to receive FDA approval to market and sell responsive silicone gel filled breast implants in the United States."

The press release went on to quote CEO Nick Teti as saying that "the conditions outlined in this letter are generally in line with our expectations and the discussions" at the October 2003 and April 2005 advisory panel meetings.

Cindy Pearson, head of the National Women's Health Network, questioned how Inamed could have come up with long-term safety data just five months after the advisory panel cited a lack of it.

"It just doesn't make any sense," Pearson said. "It actually frightens me. One way to interpret what I'm seeing is they (FDA) have just given up. They can't stand the constant applications, committee meetings."

In response, FDA spokeswoman Julie Zawisza said, "We are very accustomed to handling complicated and sometimes lengthy product evaluations and we don't 'give up' just because we may be reviewing a controversial device."

Since safety concerns led then-FDA Commissioner David Kessler to pull silicone-gel implants off the market in 1992, U.S. women who want bigger breasts have been able to choose only the less-popular saline implants, which are considered cosmetically inferior. The most contentious questions about silicone-gel implants relate to when they tear and what happens then.

Michael Choti, a Johns Hopkins cancer surgeon who chaired the April advisory committee meeting, said he was not surprised that the agency went against the panel's Inamed recommendation.

"In an ideal world, we would like long-term clinical safety data," said Choti, who as chairman, could not vote. "The problem is, how realistic is it to ask for long-term data?"

By RITA RUBIN, USA TODAY