February 7, 2006

Studies of silicone breast implants lack long-term safety data, especially for breast cancer patients who undergo reconstruction, according to a new report.

The National Research Center for Women and Families (NRC), a nonprofit health advocacy group, accuses two southern California manufacturers -- Inamed and Mentor -- of not providing adequate long-term safety data for their silicone gel breast implants in reconstruction after mastectomy.

Under the FDA's compassionate-need exemption, silicone implants can be used in breast reconstruction after mastectomy. Currently, no silicone implant has FDA approval for use in cosmetic surgery, though Inamed and Mentor have received "approvable letters" for their implants.

In its report, the NRC finds fault with Inamed's prospective studies on the health of implant patients. The company's adjunct study, which enrolled over 17,000 reconstruction patients, failed to include magnetic resonance imaging (MRI) among its data, the report alleges. Earlier FDA guidance specifies the inclusion of MRI when reporting implant ruptures, says NRC.

A later Inamed study, which did include MRI data, reported ruptures in 21 percent of reconstruction patients within the first three years after implantation, the NRC claims. An FDA advisory panel subsequently recommended rejection of Inamed's application for approval.

According to the NRC, breast cancer patients who undergo reconstructive surgery are at increased risk for local complications. The most common complications are capsular contracture, rupture, wound complications and tissue necrosis, the report says.

The NRC also finds that reconstruction patients undergo additional surgeries more often than patients who receive implants for cosmetic purposes. Its review of Inamed's data shows a reoperation rate of 46 percent, and removal or replacement of the implant at a rate of 25 percent. A review of Mentor's data shows rates of reoperation and removal or replacement at 26 percent and 13 percent, respectively.

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