What is BIA-ALCL ??
BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma) is an emerging 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 metastatic disease.
*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.
Q: What are the symptoms of BIA-ALCL?
A: The most common symptom of BIA-ALCL is a fairly marked swelling of the breast (sometimes double in size) that can develop as early as a year after 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.
Q: What is the risk of developing BIA-ALCL? A: We are aware of 722 confirmed cases worldwide (as of May, 2019), and 28 confirmed in Canada (as well as 28 suspected).
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.
Q: What does Health Canada say in regards to BIA-ALCL?
A: In its initial safety review in 2017, Health Canada found that the rate of BIA-ALCL cases was low, with 5 confirmed Canadian cases of BIA-ALCL reported by Canadian manufacturers in the last 10 years. Increased awareness by healthcare professionals and the public about BIA-ALCL is believed to be the largest contributing factor to the increased reporting of cases of BIA-ALCL to Health Canada (25 to date)
Q: Is BIA-ALCL a major concern?
A: Patients do need to be aware of the risk. Though the risk is small, patients should educate and inform themselves about the symptoms and risk of BIA-ALCL.
"Although not announced to the public until 2011, there were published case studies of BIA-ALCL as early as 2008, and plastic surgeons were discussing their concerns about it with each other but not with patients. Why did it take more than 50 years to confirm this link to cancer? Implant manufacturers and plastic surgeons continued to state that breast implants did not cause cancer even after they suspected that implants could cause ALCL." **
Q: 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 ultrasound & MRI. 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.
Women should report adverse events involving health products to Health Canada by calling toll-free at 1-866-234-2345, or by reporting online, by mail or by fax.
Q: 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. Be sure that your Surgeon includes 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.
Q: 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 propensities for this disease.
Q: Should women with breast implants be screened for BIA-ALCL?
A: If you develop swelling or a lump in your breast, contact your surgeon’s office right away so that they can comprehensively evaluate you and order the appropriate imaging, and testing if needed.
Q: Should healthy women have their implants removed prophylactically?
A: You and your surgeon should make this decision 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.
Q: 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. According to Health Canada, "In order to diagnose BIA-ALCL [an anaplastic lymphoma kinase (ALK) negative, cell-surface protein CD30 positive T-cell lymphoma], a specific cytology workup is required, both of aspirated seroma fluid and representative samples of the capsule. The cytology work-up includes immunohistochemistry (IHC) and/or flow cytometry for T-cell markers and CD30. The diagnosis of BIA-ALCL may be missed if these specific tests are not done."
Mammograms are not useful in diagnosing BIA-ALCL. In confirmed cases, CT scans are performed to help stage the disease, evaluate for associated capsule masses, lymph node metastasis or organ metastasis.
Q. How is BIA-ALCL treated and what is the prognosis?
A. 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.
From the ASPS: This video was produced by the American Society of Plastic Surgeons, and is meant primarily for Plastic Surgeons & General Physicians, however much of what is discussed in this video is relevant for Canadian patients & their plastic surgeons.
Topics in the video:
1:36 Symptoms of BIA-ALCL
2:20 BIA-ALCL after removal of implants or expanders
2:45 Amount of fluid around implant necessary for aspiration
3:39 Steps in identifying BIA-ALCL. Benefits of breast MRI
4:35 Necessity of pathology for CD30 testing
5:49 Patients with Allergan Biocell
7:30 Informed Consent & Risks vs Benefits of explant surgery
8:05 Next steps for capsule after explantation
8:56 What is Enbloc? What is total capsulectomy?
10:52 Symptoms warranting explantation
13:08 Risk for patients with non-recalled textured implants
15:12 Risk of BIA-ALCL with textured expanders
15:35 Screening for asymptomatic patients
16:05 Common signs of BIA-ALCL
17:52 NBIR Registry