The Food and Drug Administration (FDA) issued a letter warning health care professionals to check women with breast implants for Anaplastic Large Cell Lymphoma (BIA-ALCL) a rare cancer that usually arises in the scar tissue that forms around implants.
The FDA said at least 457 women in the United States have so far been diagnosed with anaplastic large cell lymphoma, and nine women have died from the disease. Though the number of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL.
In most of the cases the patients were diagnosed with BIA-ALCL due to symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid, or masses surrounding the breast implant. Cytological examination of the fluid and histologic examination of the capsule surrounding the breast implant can lead to the BIA-ALCL diagnosis.
The FDA is asking health care providers to report cases of BIA-ALCL in patients with breast implants. The FDA request health care providers with questions to either email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, or call 1-800-638-2041 or 301-796-7100.
