|July 2011 · Vol. 23, No. 7
Should women with breast implants undergo periodic MRI? FDA thinks so.
Periodic surveillance magnetic resonance imaging (MRI) scans are the recommendation of the US Food and Drug Administration for women who have silicone gel-filled breast implants, according to a report released by the agency recently.1 The safety update from the Center for Devices and Radiological Health builds on older clinical and scientific data and FDA advice about this sometimes contentious area or women’s health care.
How should ObGyns address the findings of the FDA report with their patients who have had, or who plan to undergo, implantation?
OBG Management asked Andrew M. Kaunitz, MD, a member of OBG Management’s Board of Editors, for his take on, in particular, the FDA’s declaration about MRI surveillance. Dr. Kaunitz is Professor and Associate Chairman of the Department of Obstetrics and Gynecology at the University of Florida College of Medicine-Jacksonville
“I heard about the FDA’s report the evening of June 22 on NBC’s Nightly News,” Dr. Kaunitz said. “[NBC Chief Medical Editor] Dr. Nancy Snyderman reviewed what the agency had to say about silicone implants—including that women who have them should undergo surveillance with a magnetic resonance imaging (MRI) scan 3 years after implantation and, after that, every 2 years.
“I researched the matter afterward,” Dr. Kaunitz explained. “I was surprised to find that the FDA has recommended surveillance MRI to detect silent rupture since 2006, when silicone implants for cosmetic augmentation came back on the market.”
“Yes, breast MRI does represent state-of-the-art technology for detecting silent leaks in silicone implants,” Dr. Kaunitz said, “but many health insurance plans don’t cover breast MRI for asymptomatic women. I did a Web search—an informal one—and found that the out-of-pocket cost of a breast MRI scan ranges from $500 to $2,000.
“Almost 300,000 US women underwent breast augmentation in 2010. Should we advise our asymptomatic patients who have silicone breast implants to undergo regular MRI surveillance?” Dr. Kaunitz asks.
Data don’t support the recommendation, absent symptoms
“Plastic surgeons at New York’s Memorial Sloan-Kettering Cancer Center, who examined the data in an article in Plastic and Reconstructive Surgery in 2008,2 concluded that conclusive support for such screening is lacking,” Dr. Kaunitz continued. “We just don’t have evidence that MRI surveillance leads to a reduction in patient morbidity, or that the benefits of screening outweigh the risks, which include unnecessary anxiety, false-positive results, and, even, unnecessary surgery.”
And more: “As the FDA report points out, silicone implants do not cause connective tissue disease, reproductive problems, or breast cancer. That’s why many plastic surgeons recommend an MRI scan only when a woman who has silicone implants presents with a specific problem or concern.
“Some women who have silicone breast implants may want to follow FDA recommendations and have screening MRI scans—particularly those whose health insurance covers such surveillance. In my practice, however, I don’t plan to encourage asymptomatic women who have silicone implants to do so.
“A final comment: The FDA’s June 22 report appropriately points out that 20% to 40% of women who had silicone breast implants underwent reoperation to modify, remove, or replace them within 8 to 10 years of their initial surgery. Clearly, this is information that women need to understand before they make the decision to proceed with implants.”—From The Editors, OBG Management
Dr. Kaunitz reports no financial relationships relevant to this article.
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1. Center for Devices and Radiological Health; U.S. Food and Drug Administration. FDA Update on the Safety of Silicone Gel-Filled Breast Implants. http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260090.pdf. Published June 2011. Accessed June 24, 2011.
2. McCarthy CM, Pusic AL, Kerrigan CL. Silicone breast implants and magnetic resonance imaging screening for rupture: do U.S. Food and Drug Administration recommendations reflect an evidence-based practice approach to patient care? Plast Reconstr Surg. 2008;121(4):1127–1134.
OBG Management ©2011 Quadrant HealthCom Inc.