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Dr. Jejurikar's Blog

When the Food & Drug Administration (FDA) approved silicone breast implants for cosmetic breast augmentation in 2006, it did so with recommendations regarding screening for breast implant rupture. Specifically, the FDA recommended that patients get a screening magnetic resonance imaging test (MRI) for breast implant rupture three years after breast augmentation and then every two years thereafter.

The reason for this recommendation is that, often, ruptured silicone breast implants are not detectable on physical examination. In these cases, MRI is the most sensitive method for detecting silicone breast implant rupture. Unfortunately, though, MRI can be an expensive exam and the costs usually are not covered by third-party insurance companies. Furthermore, the significance of a previously undetected silicone breast implant rupture is not clear, as it is not certain that the risks associated with ruptured implants is greater than the risks of the operation needed to take them out.

Last month, an expert FDA panel spent two days re-visiting the safety of silicone breast implants. The FDA’s chief scientist for devices, Dr. William Maisel, reaffirmed the safety of silicone breast implants. The panel agreed that patients no longer need to be told that they should get an MRI three years after getting silicone breast implants and every two years thereafter. The panel confirmed that MRI remains the gold standard for screening for silent breast implant rupture. This recommendation, however, has yet to be adopted by the FDA at large.

So what’s the conclusion? For now, the FDA recommendations from screening MRI three years after silicone breast augmentation and every two years thereafter remain intact. This guideline, though is a recommendation – not a requirement. Given the recommendations of the FDA’s expert panel, every patient should determine their own comfort level for living with a silent rupture, and make their own decision based on this.

For more information, please see the original article from the New York Times.

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