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Silicon Approval Enhances Surgery
Hammond has designed a new implant on behalf of Mentor Corp. that he now expects will arrive on the U.S. market in the near future. The new tissue expander creates a larger shape for reconstructed breasts, and will also be used in cosmetic procedures.
"Saltwater-filled implants definitely don't work well in reconstructive cases," said Hammond, principal of The Center for Breast and Body Contouring and an assistant professor at Michigan State University. "Silicone will be a definite step forward, in particular for these cases, where the skin is so thin after a mastectomy."
The major complaints against implants filled with saline, or salt water, is an unrealistic shape that tends to ripple or balloon.
The Food and Drug Administration banned silicone-gel breast implants in 1992 due to fears that ruptures in the devices could cause a variety of diseases, including cancer and lupus. Since then, most studies have failed to find a link between silicon breast implants and the diseases.
"We've been waiting for this to happen," said Hammond. "The FDA has had their data in hand for quite awhile."
The November FDA decision approves implants for women ages 22 and older or who are undergoing breast reconstruction surgery, under the condition that patients undergo annual MRI exams to detect potential ruptures and be forewarned to expect a second operation later in life.
The approval clears the way for two California manufacturers, Inamed Corp., a division of the publicly traded Allerga Inc., and the New York Stock Exchange-listed Mentor, to introduce new devices to the market.
Although research and development of new silicone devices ground to a halt during the moratorium, research has escalated in the past few years under the expectation of FDA approval. Mentor is set to launch a new family of devices this year, including the ones designed by Hammond.
He believes the ongoing safety concerns are negligible, noting that the new silicone devices are less likely to rupture than those filled with saline. He has hopes the new device will last many patients for their lifetimes. If a rupture does occur, Hammond said, the thicker gel should be less likely to leak into the body. HQX