I have been flooded this week with questions from patients and friends concerning the warning to women at risk of Anaplastic Large Cell Lymphoma (ALCL) from breast implants. On January 26, 2011 the FDA released a safety signal on ALCL in women with breast implants. Although the number of patients who have developed the disease is extremely small, only 34 identified cases out of an estimated 5 to 10 million women with breast implants, I feel it is necessary to to review the recommendations presented by the FDA.
But first, what is ALCL?
1) ALCL is a late onset seroma or fluid collection around the implant, and is very rare and noticeable.
2) The American Society of Plastic Surgeons and the Food and Drug Administration are working together to study those rare cases.
3) Breast implants are the most studied implant in the body and it remains to be seen if there is a connection between the two.
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If you have breast implants, the FDA urges that there is no need to change your routine medical care and follow up. ALCL is very rare and has only occurred in a very small amount of the millions of women with breast implants. However, the following standard medical recommendations include:
– Monitor your breast implants. If you notice any changes, contact your health care provider immediately to schedule an appointment.
– Get your routine mammography screening.
– If you have silicone-gel filled implants, see a specialist for periodic MRI’s to detect ruptures as recommended by your health care provider. The FDA-approved product labeling for these said implants states that the first MRI should occur three years after implant surgery, and every two years after that.
– Patients with persistent fluid around their breast implants will have to be tested for ALCL in the future.
If you have more questions or concerns about your breast implants, or feel that you may be at risk, contact your doctor immediately.
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