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By Marc Kaufman

Washington Post Staff Writer

Wednesday, May 11, 2005; Page A08

Thomas Whalen, the surgeon often credited with persuading the Food and Drug Administration in 2003 to reject wider use of silicone gel breast implants, has changed his mind.

Whalen, now a private citizen, wrote to acting Commissioner Lester M. Crawford last month that the implant makers have made their case that the devices are safe and that the FDA should approve the applications of two companies that want to sell them for general use.

In 2003, as chairman of an expert panel advising the FDA on the issue, Whalen criticized the group's majority vote in favor of the implants and persuaded the agency to turn down the application, arguing that the company had not proved their safety.

He was not a member of a separate expert panel that reheard the issue last month and unexpectedly recommended approval of one company's silicone implants while rejecting a competitor's. The FDA has said it will make a decision in the near future.

"Much of my change in philosophy over this difficult issue arises from a newfound perspective that to not allow these devices for women who knowingly make the choice to have them is sexist," Whalen wrote. "I feel that the time has arrived and the data is sufficient to approve these devices."

Because Whalen's criticisms of the silicone gel application after the 2003 meeting were widely seen as an important factor in the FDA's subsequent rejection, the turnaround was hailed yesterday by some implant makers.

"We certainly believe that we provided FDA the information it needs to support our approval," said Dan Cohen, vice president for global government affairs for Inamed Corp., whose implants were reviewed in 2003 and last month. "We're pleased to hear that Dr. Whalen, who chaired the 2003 panel, also believes the [application] is approvable."

But Diana Zuckerman, president of the National Research Center for Women & Families, said the letter should be disregarded because Whalen had not attended the most recent hearing and had not seen a transcript of the proceeding before writing his letter. As a result, she said, he was not aware of what she considered the dangerous shortcomings of the safety data presented.

"He was greatly criticized for his position last time by the plastic surgeons, who are his fellow surgeons, and it seems that they may have pressured him to write a letter showing his confidence in them and this product that they want approved," she said. "But unfortunately he didn't have the information he needed to make a well-informed recommendation."

Currently, silicone implants are available only to women needing reconstructive surgery or who agree to take part in a clinical trial; all others must use implants filled with saline solution, which many say look and feel less natural.

Whalen, a pediatric surgeon at the University of Medicine and Dentistry of New Jersey at the Robert Wood Johnson Medical School in New Brunswick, declined to discuss his letter to Crawford, a copy of which was obtained by The Washington Post.

The most recent expert advisory panel voted in favor of an application by Mentor Corp. but against a competing bid by Inamed.