Former Opponent of Silicone Breast Implants Reverses Opinion
Thomas Whalen, a pediatric surgeon "often credited with persuading" FDA to reject an application to allow the commercial sale of silicone breast implants in 2003, said in a letter last month to FDA Acting Commissioner Lester Crawford that adequate evidence currently exists to support approval, the Washington Post reports (Kaufman, Washington Post, 5/11).
An FDA advisory committee in April recommended that the agency approve an application submitted by medical device company Mentor to allow the company to sell silicone breast implants to the general population but also called for several conditions to regulate use of the implants. The committee also recommended that FDA reject a similar application submitted by medical device company Inamed over concerns that the company did not provide adequate safety data (California Healthline, 4/14).
As chair of a 2003 FDA advisory committee, Whalen said that adequate evidence did not exist on the safety of silicone breast implants, and the committee recommended that the agency reject an application to allow the commercial sale of the implants. However, Whalen last month wrote, "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. I feel that the time has arrived and the data is sufficient to approve these devices." FDA officials said they will make a decision on whether to approve the Mentor and Inamed applications in the near future.
Dan Cohen, vice president for global government affairs for Inamed, said, "We certainly believe that we provided FDA the information it needs to support out approval. We're pleased to hear that Dr. Whalen, who chaired the 2003 panel, also believes the (application) is approvable."
However, Diana Zuckerman, president of the National Research Center for Women & Families, said that Whalen "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 added, "But unfortunately he didn't have the information he needed to make a well-informed recommendation" because he did not attend the most recent FDA advisory committee hearings and has not read a transcript of the hearings (Washington Post, 5/11).