Washington, DC – U.S. Senators Dianne Feinstein (D-Calif.), Barbara Boxer (D-Calif.), and 8 of their Senate colleagues today urged the Food and Drug Administration (FDA) to address their concerns about Silicon Gel Breast Implants before it decides whether to lift the 11-year ban on these devices.

On October 14 and 15, 2003, the General and Plastic Surgery Devices advisory panel recommend approval of the implants by a 9 to 6 vote, despite the fact that several outstanding issues remain unresolved. These issues include concerns about:

Data showing high complication and re-operation rates in the first two to three years of its clinical trials -- 46 percent of reconstruction patients (breast cancer patients) and 20 percent of augmentation patients needed at least one additional operation due to complications related to the silicone gel breast implant in the first three years;

The lack of long-term clinical safety data, despite 11 years in which to compile such data;

Post-approval conditions agreed to in principle by the manufacturer and the FDA, which may:

Consideration of the device now goes to Food and Drug Administration Commissioner, Mark B. McClellan, who will make the decision on whether Silcone Gel Breast Implants are approved for general use. In a letter to Commissioner McClellan, the Senators wrote:

“We are deeply concerned about the [General and Plastic Surgery Devices advisory] panel’s recommendation, and would like the FDA to consider our concerns before reaching a formal decision on premarket approval of silicone gel breast implants.

We believe that the approval of these devices based on clinical data that does not meet minimum regulatory safety standards would set an unfavorable precedent at the Food and Drug Administration (FDA). Unfortunately, the devices’ manufacturer, Inamed Corporation, failed to provide long-term clinical safety data to the FDA at the premarket approval hearing. The short-term clinical data Inamed did provide to the FDA showed high complication and re-operation rates. Specifically, the company’s own research revealed high re-operation rates in the first two to three years of its clinical trial – 46 percent of reconstruction patients (breast cancer patients) and 20 percent of augmentation patients needed at least one additional operation due to complications related to the silicone gel breast implant in the first three years.

We are also concerned about the postapproval conditions agreed to in principle by the manufacturer and the FDA and that those conditions may be viewed as an acceptable substitute for adequate premarket data on long-term safety. Additionally, some of the postapproval conditions shift responsibility for monitoring safety from the manufacturer to the patient and the FDA. Implementation of these postapproval conditions will likely result in greater costs to patients, the FDA and the federal government. We would also like to know how the FDA plans to actively enforce the postapproval conditions that were agreed to in principle by the manufacturer and the FDA.

We request that the FDA address our concerns prior to a formal decision on approval by the agency. Thank you for your consideration, and we look forward to working with you to protect the health of American women.”

The letter is cosigned by Senators Mary Landrieu (D-LA), Frank Lautenberg (D-NJ) , Ron Wyden (D-OR), Richard Durbin (D-IL), Jon Corzine (D-NJ), Debbie Stabenow (D-MI), Blanche Lincoln (D-AR), and Byron Dorgan (D-ND).

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