At The Plastic Surgery Center, we are dedicated to providing patients with safe surgical treatment options. We remain up to date on the benefits and risks for all procedures we offer and ensure our patients are fully aware of these so they may make informed decisions about their care.
The U.S. Food & Drug Administration has prepared a statement regarding Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Below you will find an excerpt from their statement, including background information on this condition and patient recommendations. The full article can be found here.
Individuals with breast implants have a risk of developing breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. Precise risks are difficult to determine due to lack of information about how many patients have received breast implants in the US and worldwide.
In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL).
At that time, the FDA knew of so few cases of ALCL that it was not possible to determine what factors increased a patient’s risk. In a report summarizing the Agency’s findings, we emphasized the need to gather additional information to better characterize ALCL in individuals (cis- and trans-gender women and men) with breast implants.
Over time, we have strengthened our understanding of this condition. In 2016, the World Health Organization designated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma that can develop following breast implants. 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. At this time, most data suggest that BIA-ALCL occurs following implantation of breast implants with textured surfaces rather than those with smooth surfaces.
Educate yourself about breast implants before agreeing to surgery. Breast implants approved in the U.S. can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells). Additional information is available on FDA’s Breast Implants website.
Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of both textured-surface and smooth-surfaced implants.
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.
Although not specific to BIA-ALCL, you should follow standard medical recommendations including:
- Follow your doctor’s instructions on how to monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment.
- Follow your doctor’s instructions for routine mammography screening. Be sure to inform the mammography facility that you have breast implants so enough time is scheduled for your mammogram. Your doctor may also recommend other tests, such as magnetic resonance imaging (MRI).
*Source: U.S. Food and Drug Administration. (2019, March 22). Breast Implants – Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Retrieved from https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm239995
If you have any additional questions or concerns about BIA-ALCL or breast reconstruction, please contact our office at (844) 920-0212 to schedule an appointment with one of our plastic and reconstructive surgeons. Additional information can be found at www.fda.gov.