You may have heard or seen recent media reports regarding breast implants and a rare form of cancer. The FDA recently updated information regarding this Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL).  Dr. Raman Mahabir, the Vice Chair of the BIA-ALCL committee of the American Society of Plastic Surgeons answers your questions on Breast Implant Associated ALCL (BIA-ALCL).

What is BIA-ALCL?

A: BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma) is an uncommon T-cell lymphoma* that to date has only been reported in patients that have had a textured breast implant.  BIA-ALCL is not a cancer of the breast tissue itself but of the scar tissue that the body naturally forms around a breast implant – called the capsule.  When caught early, it may be curable in most patients. There is however a spectrum of the disease that ranges from fluid collections in the breast to capsular tumors to lymph node involvement and rarely distant metastatic disease.  Ongoing research continues to strive to better understand and define BIA-ALCL.

*Lymph cells are part of the body’s normal immune system that helps to protect us from foreign material. A lymphoma is cancer of the lymph system. Lymph nodes are glands in many locations in the body and are part of the lymph system.

What are the symptoms of BIA-ALCL?

A: The most common symptom of BIA-ALCL is fairly marked swelling of the breast (sometimes double in size) that develops after years of having a textured breast implant.  You may notice fluid collecting around the implant or noticeable breast asymmetry. It can also present as a lump in the breast or armpit, hardening of the breast or an overlying skin rash.

What is the risk of developing BIA-ALCL?

A: We are aware of almost 700 cases worldwide and 265 cases in the US.  The best estimates of the lifetime risk for BIA-ALCL is 1:1000 to 1:30,000.  The risk is higher with textured implants that have a higher surface-area, such as Allergan’s Biocell, than with lower surface area, such as Mentor’s Siltex.  However, all brands of textured implants have had cases of BIA-ALCL.  At this time there are no reported cases of a patient that has only ever had a smooth implant developing BIA-ALCL. BIA-ALCL in both cosmetic and reconstructive cases and with both saline and silicone implants.

What did the latest FDA statement say in regards to BIA-ALCL?

A: The February 2019 statement was mainly an update on the number of reported and cases and stressed that all BIA-ALCL cases be reported to the PROFILE registry for detailed tracking of cases. The statement also affirmed that if a breast implant patient is not experiencing symptoms then there “is no need to change your routine medical care and follow-up.”

Is BIA-ALCL a major concern?

A: We want patients to be aware of the risk.  Though the risk is small, patient safety is our primary focus, and we strive to educate and inform our patients and the public about the symptoms and risk of BIA-ALCL.

How does this impact those with breast implants?

A: We advocate that all women, including those with breast implants follow their normal routine in medical care and follow up, including mammography when appropriate.  Women should immediately contact their surgeon if they sense any abnormalities within the breast or notice any significant changes. There is no recommended screening for patients without symptoms. Most importantly, if you are not experiencing symptoms then there is no need to change your routine medical care and follow-up.

What about those considering breast implants?

A: Breast cancer patients considering implant reconstruction should discuss the benefits and risks of different types of implants with their surgeon. We include BIA-ALCL in breast-implant patient education materials and informed consent so that patients can determine the right procedure for them. There are many breast implant options such as smooth, textured, round, shaped, saline, and both liquid and solid silicone. You and your surgeon will make the shared decision for a specific implant shape, surface and fill to achieve an optimal reconstruction while minimizing potential complications. Breast implants remain among the most studied medical devices available – and the incidence of BIA-ALCL is low.

Are some patients at greater risk than others?

A: It is not possible to predict who will develop BIA-ALCL. It has occurred in women who have a history of textured breast implants for both cosmetic and reconstructive purposes and has occurred in women with both saline and silicone implants. Ongoing data collection worldwide will help to determine any genetic propensities for this disease.

Should women with breast implants be screened for BIA-ALCL?

A: Both the FDA and the Arizona Center for Reconstructive Breast Surgery advise that women without breast changes do not require more than routine follow-up. Rather, we recommend that every woman conduct regular self-examination. If you develop swelling or a lump in your breast, contact your surgeon’s office right away. We will comprehensively evaluate you and order the appropriate imaging, and testing if needed.

Should healthy women have their implants removed prophylactically?

A: While we are not recommending removal of textured implants, we do believe you and your surgeon best make decisions together. This collaborative approach is known as shared decision-making and studies show that it improves patient satisfaction and outcomes. There is no “right implant” when it comes to breast reconstruction.  Every individual’s needs are different and so are their reconstructive journeys. Our goal is to ensure you make the right decision for you.  We want you to feel confident in your breast reconstruction choices and results.

How is BIA-ALCL diagnosed?

A: For patients presenting with a swollen breast, fluid sampling in clinic or by interventional radiology is the first step. Mammograms are not useful in diagnosing BIA-ALCL. In confirmed cases, PET/CT scans are performed to help stage the disease, evaluate for associated capsule masses, lymph node metastasis or organ metastasis.

  1. How is BIA-ALCL treated and what is the prognosis?
  2. The National Comprehensive Cancer Network. Current recommendations for the treatment of BIA-ALCL call for removal of all of the scar tissue around the breast implant (en bloc or total capsulectomy) and removal of the breast implant as well as any associated lumps. Cases have been reported where both breasts are affected and therefore surgeons may consider the same procedure for the other side as well. Complete surgical excision is curative in the early stages of the disease and the majority require no additional treatment. Chemotherapy is reserved when the disease cannot be removed surgically or when the disease has spread to the lymph nodes or other organs.
  3. Have there been any deaths due to BIA-ALCL?
  4. There have been 17 confirmed deaths globally, which includes 5 U.S. cases, attributed to BIA-ALCL to date. These tragedies emphasize the importance of disease recognition and proper treatment in a timely fashion.

Where can I find more information on BIA-ALCL?

A: Additional information, downloadable manuscripts, and resources on BIA-ALCL are available online at www.thepsf.org/PROFILE and at www.plasticsurgery.org/alcl or speak with any one of the surgeons at the Arizona Center for Reconstructive Breast Surgery.