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    Compliance cost

    FDA's MRI recommendation for silicone implants yet another hurdle

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    Dr. Antell
    NATIONAL REPORT — The U.S. Food and Drug Administration (FDA) recommends that a woman take several things into consideration when deciding whether to select silicone gel-filled breast implants. One is its recommendation that she have her first MRI breast examination three years after her silicone implant surgery and every two years thereafter because it is the "best way to determine whether or not" a silicone gel-filled implant has ruptured, FDA spokesperson Heidi Rebello tells Cosmetic Surgery Times.

    Cost will be one of the bigger challenges when it comes to patient compliance with this recommendation — especially given the fact that MRIs cost in the neighborhood of $1,000 each, says Darrick Antell, M.D., American Society of Plastic Surgeons (ASPS) spokesman and assistant clinical professor of surgery at Columbia University. According to Ms. Rebello, the cost for the screenings will most likely come out of the patient's pocketbook.

    "Over a woman's lifetime, the cost of MRI screening may exceed the cost of her initial surgery. This cost may not be covered by medical insurance," she adds.

    MOUNTING DRAWBACKS While Dr. Antell understands the necessity for gathering information on silicone gel implants, he says that yet another drawback to their use might make them obsolete, at least in his New York City practice. Telling patients about the FDA's recommendations is part of Dr. Antell's consultation process.

    "I always tell them that there are two implants available, silicone and saline. In my practice, at least 95 percent of the patients opt for saline and do not even want to hear about silicone. They have already made up their minds," Dr. Antell says. "It is not the MRI issue that dissuades the remaining 5 percent, in general. It's the higher capsular contracture rate of silicone versus saline."

    Even reconstructive patients tend to overwhelmingly choose saline, he notes.


    Dr. Erhardt
    OVERZEALOUS OR APPROPRIATE? Walter L. Erhardt, Jr., M.D., plastic surgeon, ASPS past president and current chair of the ASPS Public Education Committee, says women do not always comply with getting mammograms, let alone an expensive test for the purpose of data gathering.

    "The FDA's MRI recommendation, in my mind, seems very overzealous," Dr. Erhardt says. "When it comes to justifying costs and overall compliance, I think the yield will be minimal."

    By the time a woman has silicone-gel filled implants for a decade, she would have had four MRIs, according to the FDA's recommendation. In Dr. Erhardt's view, MRIs starting at 10 years might be more sensible, given that rupture of even the old silicone implants was uncommon within the first 10 years and is rare for the newer silicone implants. But the FDA seems concerned about the possibility of silent rupture. In its patient labeling for the Allergan silicone-gel implants, FDA writes that rupture of silicone gel-filled breast implants is most often silent. "This means that neither you nor your surgeon will know that your implants will have a rupture most of the time. In fact, the ability of a physical examination by a plastic surgeon who is familiar with breast implants to detect silicone breast implant rupture is 30 percent compared to 89 percent for MRI. You will need regular screening MRI examinations over your lifetime in order to determine if silent rupture is present," the FDA label states.

    Symptoms of rupture, if they do occur, include hard knots or lumps surrounding the implant or in the armpit, change or loss of size or shape of the breast or implant, pain, tingling, swelling, numbness, burning or hardening of the breast, according to FDA.

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    Lisette Hilton
    Lisette Hilton is a writer in Boca Raton, Fla., who heads up her company, Words Come Alive.

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