Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare type of T-cell lymphoma (cancer of the immune system) that can develop in the scar tissue capsule and fluid surrounding a breast implant. In some cases, it can spread throughout the body.
BIA-ALCL is curable in most patients if it’s diagnosed early and treated appropriately, but a small number have died from the illness.
BIA-ALCL is not breast cancer. It can occur around saline-filled or silicone gel-filled implants that have been placed for breast reconstruction after mastectomy or cosmetic breast enlargement. BIA-ALCL seems to only develop in women who have implants with a textured surface (shell) or had them in the past.
Number of BIA-ALCL cases
The FDA reported in July 2019 that 573 women had at that time been diagnosed with BIA-ALCL and 33 women had died from the disease worldwide.1 Of the 573 cases, 481 are attributed to textured implants manufactured by Allergan. Of the 33 deaths, the implant maker was known for 13 women. Of these 13 women, 12 were confirmed to have an Allergan breast implant at the time of their BIA-ALCL diagnosis. To date, there are no confirmed reports of BIA-ALCL in women who only ever had smooth implants.
BIA-ALCL has occurred in at least four transgender women who had textured breast implants.
The number of BIA-ALCL cases reported in July 2019 led to a global recall of Biocell textured breast implants and tissue expanders manufactured by Allergan. But since then, the number of confirmed cases of BIA-ALCL has grown. As of October 25, 2019, the American Society of Plastic Surgeons said that there were 809 confirmed cases of BIA-ALCL worldwide.2
Allergan breast implant recall
In July 2019, Allergan announced a global recall of its Biocell textured breast implants and tissue expanders. (See the full list of recalled products here. It includes some products that in the past were sold under the McGhan and Inamed brands).
The FDA and Allergan have asked plastic surgeons to stop using Allergan Biocell implants and to return all unused Biocell implants to the manufacturer. The recall does not apply to implants that are already in use (in other words, women who have Biocell implants should not necessarily have them removed).
The FDA requested the recall because its analysis showed that the risk of BIA-ALCL with Allergan Biocell textured implants is approximately six times the risk of BIA-ALCL with other textured implants that are marketed in the U.S. In the months leading up to this announcement, 38 other countries had already taken Allergan Biocell textured implants and tissue expanders off the market. Currently, other types of textured implants that are thought to carry a lower risk of BIA-ALCL are still available in the U.S. — for example, Allergan’s Microcell implants, Mentor’s MemoryShape and MemoryGel implants, and Sientra’s OPUS implants.
The most common symptoms of BIA-ALCL are swelling (due to fluid build-up) or pain in the area of a textured breast implant. These symptoms tend to develop years after the implant is placed (on average, 7-10 years), but they may develop earlier. Some patients have had a lump adjacent to the implant surface or a lump in the lymph node in the armpit. Other less common symptoms can include enlarged lymph nodes, skin rash, fever, and weight loss.
Diagnosis of BIA-ALCL
According to guidelines from the National Comprehensive Cancer Network (NCCN), if BIA-ALCL is suspected, doctors should order imaging with ultrasound or MRI. If the imaging results show fluid collection around the implant or a mass near the implant, then a sample of the fluid should be collected using fine needle aspiration (a thin needle inserted through the skin). The fluid should be tested for CD30, a protein that is found in higher than normal amounts on lymphoma cells, including those in BIA-ALCL. The fluid should also be tested for anaplastic lymphoma kinase (ALK), a protein that helps control cell growth. In BIA-ALCL, the lymphoma cells do not make the ALK protein, so they test negative for ALK. A mass should be biopsied.
Treatment for BIA-ALCL
If the pathology results indicate BIA-ALCL, the NCCN guidelines recommend surgery to remove the implants and the entire surrounding scar tissue capsules. The surgeon should perform an “en bloc capsulectomy” (removing the breast implant and the capsule of scar tissue surrounding it in one piece). Even if only one implant is affected by BIA-ALCL, both implants should be removed. If there are any masses (tumors) or any involved or suspicious lymph nodes, those should also be removed during the surgery.
Some patients have also required radiation therapy, chemotherapy, and/or stem cell transplant therapy.
Since BIA-ALCL is so rare and is a relatively newly identified illness, not many doctors have experience diagnosing and treating it. A number of patients have reported that they did not receive appropriate care when they were going through the process of being diagnosed and treated for BIA-ALCL. If you are concerned that you might have BIA-ALCL, ask your doctors to follow the latest NCCN guidelines on the diagnosis and treatment of BIA-ALCL. Depending on your individual situation, it may be worth seeking care (or at least a virtual consultation if your state allows it) from a medical team at a large cancer center that has experience treating BIA-ALCL (such as at MD Anderson Cancer Center or Memorial Sloan Kettering Cancer Center).
Outcomes after BIA-ALCL treatment
For patients who receive appropriate and timely treatment, the prognosis is very good. Research has shown that 93% of patients are disease-free at 3 years following treatment.3
What causes BIA-ALCL?
Researchers aren’t sure why BIA-ALCL develops around textured breast implants. One theory is that the rough, sandpaper-like surface of textured implants might cause chronic inflammation in some women that leads to lymphoma. Another theory is that the rough surface and the greater surface area of a textured implant traps more bacteria, creating what’s called a biofilm — a colony of microbes that stick to each other and to the surface of the implant — that causes inflammation and leads to lymphoma. It may be that Allergan Biocell implants are linked with more cases of BIA-ALCL because they are more deeply textured than other types of textured implants.
Genetic factors probably also play a role in in the disease. Researchers have identified certain genetic mutations that seem to increase the risk of developing BIA-ALCL — in particular, mutations in the JAK1 and STAT3 genes. In the future, it may be possible to use a combination of genetic testing and HLA testing (a blood test that checks for antibodies against human leukocyte antigens [HLA], which play important roles in the immune system) to determine whether an individual has an increased risk of BIA-ALCL.
When was BIA-ALCL first identified?
The first case report of BIA-ALCL was published in a medical journal in 1997. Fourteen years later (in 2011) the FDA first reported a possible link between breast implants and the development of ALCL in a safety communication for health professionals and people who have or are considering breast implants. At that time, the FDA said that there were so few cases that it was not possible to determine the specific factors that increased the risk.
BIA-ALCL gained wider recognition in 2016 when the World Health Organization (WHO) designated it as a unique form of lymphoma and the NCCN established standardized diagnosis and treatment guidelines for the disease. By this point, researchers had found that BIA-ALCL is linked either mainly or exclusively to textured breast implants.
BIA-ALCL and textured implants
First introduced in the 1980s, textured surface breast implants adhere to the surrounding tissue, so they are less likely to slip out of place or rotate than smooth surface implants. Textured implants can be round or teardrop-shaped and can be filled with silicone gel or saline (salt water). All teardrop-shaped implants are textured, because if they were to flip, then the breast would appear distorted. The risk of developing capsular contracture (when the capsule of scar tissue around an implant tightens, potentially causing pain and distortion in the shape of the breast) is lower with textured implants than with smooth implants.
In the U.S., textured implants have been used more often for reconstruction than for cosmetic breast augmentation. In 2018, less than 10% of implants sold in the U.S. were textured. The kind of implant known as “macro-textured” (which have a surface with bigger, deeper divots) — including Allergan’s Biocell implants — represented less than 5 percent of the market.1
Outside of the U.S. and Canada, textured implants have been much more widely used for both reconstruction and cosmetic augmentation. In some countries, they have represented 80 or 90% or more of the implant market.4
Some of the plastic surgeons we spoke with in the summer and fall of 2019, right after the global recall of Allergan Biocell implants, said that they are still using other types of textured implants for reconstruction surgery. Other plastic surgeons said they haven’t been using any textured implants in their practice for several years.
What all this may mean for you
- If you’re considering getting breast implants for the first time or replacing implants that you already have, talk with your plastic surgeon about the risks and benefits of implants, including the differences between textured and smooth implants. The risk of BIA-ALCL should be discussed as part of the informed consent process before any implant surgery. “This is an important conversation for patients to have with their physicians. An implant should be chosen through shared decision-making,” says Mark Clemens, M.D., F.A.C.S, an associate professor of plastic surgery at the University of Texas M.D. Anderson Cancer Center in Houston who studies BIA-ALCL and other health conditions linked to breast implants.
- If you have breast implants or tissue expanders but don’t have any symptoms of BIA-ALCL or other complications, the FDA and other health authorities are advising that you don’t need to get them removed. It’s important to monitor your implants for changes and to periodically schedule an appointment with a healthcare professional (such as a breast surgeon or plastic surgeon) who can check on your implants.
- Don’t hesitate to call your doctor if you develop any symptoms such as pain, lumps, swelling, or asymmetry at any point after breast implant surgery.
- FDA. News Release: FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market. July 2019. Available at: https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
- American Society of Plastic Surgeons. BIA-ALCL Physician Resources. October 2019. Available at: https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources
- Clemens M. BIA-ALCL Resources. American Society of Plastic Surgeons. August 2019. Available at: https://www.plasticsurgery.org/for-medical-professionals/health-policy/bia-alcl-physician-resources/by-the-numbers
- FDA. Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants. May 2019. Available at: https://www.fda.gov/news-events/press-announcements/statement-fda-principal-deputy-commissioner-amy-abernethy-md-phd-and-jeff-shuren-md-jd-director-fdas