—For Immediate Release January 2004———–
Contact: Nikki Hudak at 202-223-4000 or Email
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FDA Silicone Breast Implant Panel Chairman
Urges FDA to Reject Recommendation for Approval
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Calls Panel Vote “Misguided” and Potentially Dangerous to Women’s Health
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Whalen Letter to FDA I Panelist Quotes I Clinical Data I Panel Vote
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Washington, DC: The chairman of the Food and Drug Administration’s advisory panel that voted last month to lift the restrictions on the sales of silicone gel breast implants is urging the FDA to reject the panel’s decision because “to approve this device poses threats to women that are clearly unknown.” In response, plastic surgeons on the panel have defended the safety of the implants and the integrity of their votes.
The chairman, Dr. Thomas Whalen, chief of pediatric surgery at the Robert Wood Johnson School of Medicine in New Brunswick, N.J., presided over the panel that voted 9 to 6 to lift current restrictions on the sales of silicone breast implants. The implants are currently widely available for mastectomy patients and women who need their older implants replaced, if they agree to participate in a clinical trial. A limited number of first-time augmentation patients also can obtain silicone gel implants through clinical trials.
Saying that long-term safety “was clearly not demonstrated,” Dr. Whalen wrote a letter to FDA Commissioner Mark McClellan calling the panel’s vote “misguided.” Whalen, who could only vote on whether to recommend silicone gel implants in the case of a tie, writes, “It is incumbent upon the FDA to demand that the manufacturer establish in a rigorous, prospective, controlled study that these devices, despite their established breakage and leakage rates, are safe in the long term.”
Whalen also expressed concerns that the “yes” votes from the four plastic surgeons on the panel provided the margin for approval. Whalen writes, “I have the utmost respect for my colleagues on the panel, one and all. This most assuredly includes the four well-respected and knowledgeable plastic surgeons. Certainly, it was essential to include board certified plastic and reconstructive surgeons when considering a PMA [FDA approval] on breast implants. On the other hand, it serves the reputation of the FDA in general, and the standing of the panel process in particular, exceedingly poorly to have had all of the plastic surgeons vote the PMA [silicone gel application] as approvable on such a close vote. Even in academic settings, plastic surgeons may stand to increase their own income with the use of these devices. To cite a worn aphorism, it does not play well in Peoria.”
Responding to Dr. Whalen’s comments, Dr. Michael Miller, one of the plastic surgeons that served on the panel and voted “yes” for approval wrote to the FDA Commissioner “I take strong exception with his views and personal offense at this challenge to my integrity and that of the other plastic surgeons on the panel….To suggest that the plastic surgeons had any motivation other than a genuine concern for safety and that they did not base their vote solely on a responsible and competent analysis of the data is presumptuous and inappropriate.” (Miller letter to FDA)
Although not mentioned by Dr. Whalen or Dr. Miller, Dr. Miller was a strong proponent of the safety of breast implants even before hearing the evidence presented at the recent FDA meeting. The question of the open-mindedness and independence of plastic surgeons on the FDA panel is amplified by Dr. Miller’s role as Project Director for a CD-ROM video entitled “Breast Reconstruction: What You Need to Know,” which features Dr. Miller describing the advantages of breast implants. The CD is sold to patients for “educational purposes” by the University of Texas MD Anderson Cancer Center, to help patients decide about reconstruction after breast cancer. The CD-ROM was funded by McGhan, the implant company that makes the Inamed silicone gel implants that Dr. Miller voted to approve. On the CD, Miller states that despite “confusion about breast implants in the mid-1990’s” there are now numerous studies that “show implants do not cause disorders such as cancer or autoimmune diseases.” Miller goes on to say “based on these studies, we are confident that breast implants are safe.” The CD-ROM does not warn patients about implant breakage or leakage as a potential risk, and includes Dr. Miller describing breast implants as the “simplest” surgical option for mastectomy patients.
The FDA’s advisory panel was not shown Dr. Miller’s CD-ROM to determine if his conflict of interest should disqualify him from the panel.
The panel’s recommendation to approve implants under certain conditions included more than 10 requirements proposed shortly before the final vote. Dr. Celia Whitten, director of the FDA division that reviews implants, told the panel members that the agency did not have the regulatory authority to force the implant manufacturer, Inamed, to complete long-term studies on the safety of silicone implants, which was the key condition of approval.
Dr. Whalen writes about the last-minute conditions in his letter to Commissioner McClellan:
“The plethora of approval conditions that had my head spinning during the panel deliberations is proof that even those who voted the PMA [Inamed gel implants] as approvable are deeply concerned about the lack of long-term safety data on this product. What will motivate the company to follow these FDA requirements? Most upsetting was when an FDA official admitted, at my pressing, that there is little if any remedy for the FDA if demands to demonstrate long-term safety are not carried out by the company.”
In conjunction with Dr. Whalen’s strongly expressed concerns, the panel’s numerous and generally unenforceable conditions for approval could help convince the FDA Commissioner to reject the panel’s recommendation to approve silicone gel implants. These factors could instead persuade him to keep the current restrictions in place.