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Recent FDA study shows breast implants can be associated with rare type of lymphoma


As reported by STAT, the FDA released an updated report on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a very rare complication occurring in women who have received breast implants.  The FDA first required manufactures to warn patients of the risk of lymphoma in 2011.  Since then, the FDA has received 359 reports of BIA-ALCL with 9 deaths.  The risk of developing this rare complication ranges in estimate from 1 in 1,000 to 1 in 300,000.  On average, BIA-ALCL was diagnosed 8 years after implantation.  Factors that may increase the risk for some women are not known, but it appears implants made with a textured surface (rather than smooth) may present a higher risk.  There does not appear to be a difference between silicone and saline filled implants. 

Dr. Andrew Evens, Chief of the Division of Hematology/Oncology and Director of the Tufts MC Cancer Center noted that “Altogether, the association of lymphoma with breast implants is quite rare.  In addition, if identified early, patient outcomes are quite good”.   Dr. Andreas Klein, Director of the Hematologic Malignancy Program at Tufts Medical Center continued, “Women should be concerned if they develop pain and swelling in the area of their implant, particularly starting one year or more after surgery.  In this scenario, they should seek attention of their surgeon and/or oncologist.”

The American Society of Plastic Surgeons and the Plastic Surgery Foundation have compiled a summary of Frequently Asked Questions for patients and clinicians.