Breast Implant Associated Large Cell Anaplastic Lymphoma

What is Anaplastic Large Cell Lymphoma?

Anaplastic large cell lymphoma (ALCL) is a rare type of T cell non-Hodgkin lymphoma (NHL). ALCL develops when white blood cells called T-cells become abnormal. These usually build up in the lymph nodes but can affect other parts of the body. It is more common in children and young adults. Usually, the first symptom is a painless swelling in the neck, armpit or groin. General symptoms may include loss of appetite and tiredness. Some people may also have night sweats, high temperatures (fevers) or weight loss. Other symptoms depend on where the lymphoma is in the body. The most common test for ALCL is to remove a sample of an enlarged lymph node and check it for lymphoma cells. You may also have other tests and scans to find out more about the lymphoma. Most people are treated with chemotherapy and steroids. Some people may also have radiotherapy or stem cell treatments.

What is Breast Implant Associated Large Cell Lymphoma?

Rarely, ALCL can develop in the scar tissue around a breast implant. This is called breast implant associated ALCL (BIA-ALCL). BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). Recent research suggests that the risk is higher in women who have textured implants rather than those with smooth surfaces. There appears to be something about the rough surface of the implant that predisposes to it. Implant types with a greater surface area texture may have an increased risk. Investigators believe that it originates with a bacterial infectionin the area surrounding the breast implants. This causes a chronic inflammation that increases T lymphocyte activity. The crevassed surface and higher surface area of textured implants may provide more opportunity for bacteria to lodge than a smooth-surfaced implant. The fill substance (liquid silicone, solid silicone, or saline) does not appear to be a factor in the development of the condition. 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. The most common symptom of BIA-ALCL is excessive fluid buildup around the breast implant, which can cause pain, swelling, or lumps in the breast or armpit. Symptoms usually occur between three and 14 years after implant placement. When BIA-ALCL does occur, it almost always can be cured. Treatment involves removal of the implant and the scar (capsule) around it. If lymphoma is limited to the capsule, there may be no other treatment required. If the disease extends outside of the capsule, treatment with chemotherapy, radiation, and/or stem cell treatment may also be required.

How Did We Become Aware of the Condition?

In 2011, the United States Food and Drug Administration (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 2016, the World Health Organizationdesignated breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a T-cell lymphoma that could develop following breast implants. The exact number of cases was difficult to determine due to significant limitations in world-wide reporting and lack of global breast implant sales data. Since 2016, there have been several advances in the description of the disease and treatment recommendations. These are summarized below. The Australian Therapeutic Goods Administration (TGA) reporteda detailed analysis of the 46 patients with confirmed cases of BIA-ALCL in Australia, including the deaths of 3 women. As of September 2016, TGA had confirmed 10 additional cases in Australian patients. The French National Agency for Medicines and Health Products Safety (ANSM) asked manufacturers of textured breast implants to perform biocompatibility testing(testing to determine how living tissues react to textured implants) and to report their findings. In December 2018 European regulators disallowed the sale of Allergan biocell and polyurethane textured implants. Health Canada and the Food and Drug Administration in the United States are now considering similar bans. Studies suggest that Silimed polyurethane textured implants pose a 23- times higher risk of ALCL, and Allergan Biocell textured implants pose a 16- times higher risk of ALCL, than lower surface area Siltex textured implants by Johnson & Johnson (previously MENTOR corporation). Mentor textured implants remain available worldwide as of April 2019.

Medical Device Reports (MDR)

As of September 30, 2018, the FDA had received a total of 660 medical device reports (MDRs)of BIA-ALCL, including the death of nine patients. Of the 660 total BIA-ALCL related MDRs the FDA received, many MDRs were identified as duplicate reports, including additional follow-up reports that were submitted to the FDA. The FDA has carefully reviewed the 660 MDRs to provide a more accurate analysis and to only provide unique BIA-ALCL reports. The resulting data reflected a total of 457 unique MDRs for BIA-ALCL. While the MDR reports provide information regarding the implant at the time of BIA-ALCL diagnosis, they do not typically give information about a patient’s history of breast implants. It is important to note that at the time of diagnosis, patients may have their original breast implants, or they may have had one or more replacements. The MDR system is a valuable source of information. However, it depends on accurate reporting, and therefore may contain incomplete, inaccurate, untimely, unverified, or biased data. It is difficult to determine the total number of cases or estimate risk from the MDR reporting system due to potential under-reporting of events, possible duplicate reporting, and lack of data about the exact number of breast implants.

What does all of this mean?

Because BIA-ALCL is rare, it is difficult to obtain accurate information about the condition. A better understanding of the condition will develop with time.

The risk of contracting the condition is about 1:25,000 women with textured breast implants. Smooth implants have either no, or much less risk. MENTOR company textured implants have been shown to have less than the industry average (1:50,000).

The risk of dying from BIA-ALCL is less than 1:250,000 women with textured implants. Compare this to the risk of dying from a flight to the Caribbean (1:500,000), a single drive from Sudbury to Toronto (1:167,000), a lightning strike (1:100,000) or having any kind of elective surgery (1:100,000)

There are no agencies recommending removal of any kind of breast implant.

Dr Fortin has most often used Johnson and Johnson (MENTOR) breast implants which have not been banned. These appear to have ten to twenty times less risk for developing BIA-ALCL.  She has refrained from using textured implants over the last few years. If you believe you have a textured implant and have concerns please call the office to arrange a consult for discussion. Overall if you have not had any symptoms of swelling it should not be a great concern. 

What to watch for:

The majority of patients who develop BIA-ALCL present with a fluid collection around the breast implant. This is seen as an enlargement of the breast. Other symptoms reported include the presence of a lump in the breast, skin rash, fever and night sweats, and swollen glands (lymphadenopathy).  

If you notice changes in the way your breast looks or feels, contact your health care provider.

Continue with routine mammography screening. Be sure to inform the mammography facility that you have breast implants, so enough time is scheduled for your mammogram.

If you have breast implants, there is no need to change your routine medical care and follow-up.