More than 350 reports of rare cancer and nine deaths have been have been linked to breast implants, the Food and Drug Administration (FDA) warned.
The cancer, called breast implant-associated anaplastic large cell ymphoma, or BIA-ALCL, was designated by the World Health Organization and recently confirmed by the FDA. ALCL is not breast cancer. It is a rare type of non-Hodgkin’s lymphoma, BIA-ALCL is even more rare. When it is identified, it is most frequently found in patients who have undergone implant revision operations for late onset, persistent serum, a collection of fluid that builds up under the surface of the skin, generally occurring after a surgical procedure where an incision was made or tissue was removed.
The FDA said it has received 359 reports of possible BIA-ALCL, but the exact number is likely higher as it “remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data.” Of the 231 reports the FDA received that had detailed information, 203 of the cases involved textured breast implants. The remaining 28 had smooth surfaces.
The FDA first identified BIA-ALCL with breast implants in 2011 and warned consumers of this risk. The agency is advising health care providers that since BIA-ALCL is generally identified in patients with late onset symptoms of pain, lumps, swelling, or asymmetry, it is not recommended to remove the implants in patients who do not have symptoms.
Anyone with breast implants who has been diagnosed with BIA-ALCL or ALCL should file a report with the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.