The Food and Drug Administration (FDA) recently updated reports (Feb 2019) related to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL). Since then, the FDA has collected more data to learn about the relation. As of September 2018, the agency had received 660 total medical device reports (MDR) regarding BIA-ALCL cases in the United States – an increase of 246 new MDRs (59 percent) from the previous year’s update. However, due to duplicate reporting, further analysis released Feb. 2019 suggests there are only 457 unique cases, including nine deaths, of BIA-ALCL reported (since 2010). The FDA recognizes the prevalence of BIA-ALCL cannot be determined from this reporting system alone, due to potential under-reporting, duplicate reporting and lack of information about the total number of breast implants world-wide.
Read the Full Statement by FDA here
What is BIA-ALCL?
BIA-ALCL stands for Breast Implant-Associated Anaplastic Large Cell Lymphoma. BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma. In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant.
What is the cause of BIA-ALCL?
At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.
How common is BIA-ALCL?
The FDA has found data to suggest 457 unique cases of BIA-ALCL. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global breast implant sales data. Current literature reported various estimates that BIA-ALCL may develop in 1 in between 3,817 to 30,000 women with textured breast implants.
How is BIA-ALCL Detected?
BIA-ALCL has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma (fluid collection around the implant). BIA-ALCL has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or breast asymmetry.
I am considering implants, are they safe?
Yes. Breast Augmentation is the most popular cosmetic surgery in the US with almost 300k per year. While the incidence of BIA-ALCL is extremely low, make sure to talk to your health care provider about the benefits and risks of both textured-surface and smooth-surfaced implants.
I have implants, what do I need to do?
If you have breast implants, there is no need to change your routine medical care and follow-up. You should expect swelling and pain immediately after surgery. If you notice changes in the way your breast looks or feels after you recover from surgery—including swelling or pain around the implant—be sure to talk to your health care provider about the possibility of BIA-ALCL.