The number of cases in the united States of anaplastic large cell lymphoma of the breast, a type of cancer is rare, associated with the implants, textured surface, it could be two times as high according to estimates by the Food and Drug Administration of the united States.
The number of cases in the united States of anaplastic large cell lymphoma of the breast, a type of cancer is rare, associated with the implants, textured surface, it could be two times as high according to estimates by the Food and Drug Administration of the united States (FDA, acronym in English), according to a study.
The research is published Online July 21, 2022 in the magazine JAMA Oncology. Reads the summary is available in English “Incidence of Anaplastic Large-Cell Lymphoma of the Breast in the US, 2000 to 2018” (Incidence of anaplastic large cell lymphoma of the breast in the united states. UU., from 2000 to 2018).
Lymphoma is a cancer of the lymphatic system.
About anaplastic large cell lymphoma of the breast
In January 2011, the FDA reported for the first time a possible link between breast implants silicone or saline, and the anaplastic large cell lymphoma of breast tissue near the implant.
Many of the women who undergo a mastectomy to treat breast cancer choose to have the reconstruction of one or both breasts. There are two ways to reconstruct a breast:
- use tissue transplanted from another part of the body, such as the back, belly, or thighs
- to insert an implant filling of saline solution (salt water) or silicone gel
Saline implants have a silicone shell that is filled with saline solution. The silicone gel implants are filled with silicone gel firm. They tend to feel softer than saline implants, and some women find that the texture is more similar to the breast tissue naturally.
Once you place the breast implant, scar tissue forms around it, and it creates what's called a “capsule of tissue”. The anaplastic large cell lymphoma of the breast may appear inside or around the tissue capsule.
The risk of anaplastic large cell lymphoma of the breast is increased in women who have implants, textured surface implants with rough surfaces) than in women who have implants with a smooth surface, according to the FDA. The material within the implant, whether silicone or saline, did not appear to affect the risk of anaplastic large cell lymphoma of the breast.
In 2019, the National Comprehensive Cancer Network (NCCN, acronym in English) has developed formal guidelines for the treatment of anaplastic large cell lymphoma of the breast.
Also, in 2019, Allergan, a manufacturer of implants, announced the withdrawal from the market at the global level of the breast implants of textured surface and the tissue expanders Biocell in response to the withdrawal request of the FDA.
In 2020, the FDA demanded that added a warning about the anaplastic large cell lymphoma as part of the labelling of all the implants, silicone gel-filled or saline solution.
About the study
The research shows that there are increasing cases of anaplastic large cell lymphoma of the breast in Australia, New Zealand and the Netherlands. The scientists believe that this increase is associated with an increased use of implants, textured surface.
In this study, the researchers wanted to determine if there had been an increase of cases of anaplastic large cell lymphoma of the breast in the united States.
The researchers analyzed information from the database of the Surveillance, Epidemiology, and End Results (SEER, the acronym in English) on confirmed cases of anaplastic large cell lymphoma of breast cancer diagnosed in women between 1 January 2000 and 31 December 2018.
In general, the rate of anaplastic large cell lymphoma of the breast was 8.1 cases per year per 100 million women.
The rate of cases increased with time. These were the rates:
- Up to 3.2 cases per 100 million women between 2000 and 2005
- 4.4 cases per 100 million women between 2006 and 2011
- 14,5 cases per 100 million women between 2012 and 2018
The FDA estimated three cases per 100 million women in an analysis of the information of the database of the SEER from 2001 to 2007.
Therefore, in this study, it is estimated that the number of cases of anaplastic large cell lymphoma of the breast is more likely to be two times higher than the calculation of the FDA.
“Taking into account the strong relationship that exists between the implants, textured surface, and the [anaplastic large cell lymphoma of the breast], the increase in incidence may be associated with both the increase in the prevalence of this type of implant in the [united States] as the increased recognition of this disease. However, it can also be a reflection of the growth of the incidence of all lymphomas of the breast”, explained the researchers. “These trends are troubling, since the use of implants, textured surface grew more than five times, from 2.3% to 13 % in the procedures of increasing the size of the breasts, between 2011 and 2015, despite the security warning issued by the FDA in 2011.”
What this means for you
While the results of this study are really alarming, it is important to know that the number of cases of anaplastic large cell lymphoma of the breast remains low. Even so, women with breast implants, especially with implants, textured surface, have a higher risk of getting this disease than women without implants.
The majority of women diagnosed with anaplastic large cell lymphoma of the breast received this diagnosis because they had accumulated fluid around the implant, known as a “seroma”, years after it was placed in the implants. In some cases, the analysis of the fluid led to the diagnosis. In other cases, the anaplastic large cell lymphoma of the breast is diagnosed after they find a lump in the breast or because the capsule of tissue is hardened, which is called “capsular contracture”, and caused discomfort or cosmetic problems.
If you have an implant or tissue expanders, the FDA recommends the following:
- regularly monitor that you do not have symptoms of anaplastic large cell lymphoma of the breast
- leave the implant or implants in your place and do not make any changes in your routine medical care and follow-up if you do not have symptoms of anaplastic large cell lymphoma of the breast
Anyway, tell your doctor if you're concerned. Call your doctor if you have symptoms or problems with the implant or implants, such as pain, lumps, swelling, or asymmetry, in particular if you see these symptoms appear years after that placed the implant.
If you're thinking about the possibility of a breast reconstruction with an implant, speak with the doctor about the risks and benefits of breast implants, including the differences between the implants with smooth and textured. Your doctor should address the risk of anaplastic large cell lymphoma of the breast as part of the process of valid consent before any implant surgery.
There are still two questions for which we do not have clear answers:
- Does it make sense to leave an implant without problems in your place if on the other breast was removed the implant and the capsule of tissue because of the anaplastic large cell lymphoma of the breast?
- How safe is it to replace an implant removed because of anaplastic large cell lymphoma of the breast by a new one?
Further research is needed to answer these questions.
Get more information on the Breast reconstruction.
Read the Special report: Disease breast implants and ALCL-AIM.
The number of cases of anaplastic large cell breast lymphoma, a rare type of cancer associated with textured implants, in the United States may be twice as high, according to estimates by the U.S. Food and Drug Administration.
The number of cases of anaplastic large cell breast lymphoma, a rare type of cancer associated with textured-surface implants, in the United States may be twice as high, according to estimates by the U.S. Food and Drug Administration (FDA), a study suggests.
The research was published online July 21, 2022, in the journal JAMA Oncology . Read the abstract of “Incidence of Anaplastic Large-Cell Lymphoma of the Breast in the US, 2000 to 2018.”
Lymphoma is a cancer of the lymphatic system.
About Anaplastic Large Cell Lymphoma Of The Breast
In January 2011, the FDA first reported a possible link between silicone or saline breast implants and anaplastic large cell lymphoma of the breast in tissue near the implant.
Many women who undergo a mastectomy to treat breast cancer decide to have one or both breasts reconstructed. There are two ways to reconstruct a breast:
- use transplanted tissue from another part of the body, such as the back, belly, or thighs
- insert an implant filled with saline (salt water) or silicone gel
Saline implants have a silicone shell that is filled with saline. Silicone gel implants are filled with firm silicone gel. They tend to feel softer than saline implants, and some women find the texture more similar to natural breast tissue.
Once a breast implant is placed, scar tissue forms around it, creating what is called a “tissue capsule.” Anaplastic large cell lymphoma of the breast can develop in or around the tissue capsule.
The risk of anaplastic large cell lymphoma of the breast is higher in women who have textured-surface implants (rough-surface implants) than in women who have smooth-surface implants, according to the FDA. The material inside the implant, whether silicone or saline, does not appear to affect the risk of anaplastic large cell lymphoma of the breast.
In 2019, the National Comprehensive Cancer Network (NCCN) developed formal guidelines for the treatment of anaplastic large cell lymphoma of the breast.
Also in 2019, Allergan, an implant manufacturer, announced a global recall of textured surface breast implants and Biocell tissue expanders in response to the FDA recall request.
In 2020, the FDA required a warning about anaplastic large cell lymphoma to be added to the labeling of all silicone gel- or saline-filled implants.
About The Study
Research shows that cases of anaplastic large cell lymphoma of the breast are increasing in Australia, New Zealand and the Netherlands. Scientists believe that this increase is associated with the increased use of textured implants.
In this study, researchers wanted to determine whether there had also been an increase in cases of anaplastic large cell lymphoma of the breast in the United States.
Researchers analyzed information from the Surveillance, Epidemiology, and End Results (SEER) database on confirmed cases of anaplastic large cell lymphoma of the breast diagnosed in women between January 1, 2000, and December 31, 2018.
Overall, the rate of anaplastic large cell lymphoma of the breast was 8.1 cases per year per 100 million women.
The rate of cases increased over time. These were the rates:
- 3.2 cases per 100 million women between 2000 and 2005
- 4.4 cases per 100 million women between 2006 and 2011
- 14.5 cases per 100 million women between 2012 and 2018
The FDA estimated three cases per 100 million women based on an analysis of information from the SEER database from 2001 to 2007.
Therefore, in this study, the number of cases of anaplastic large cell lymphoma of the breast is estimated to be probably more than twice as high as the FDA estimate.
“Given the strong association between textured-surface implants and [anaplastic large cell lymphoma of the breast], the increased incidence may be associated with both the rising prevalence of these implants in the [United States] and the increasing recognition of this disease. However, it may also reflect the increasing incidence of all breast lymphomas,” the researchers explained. “These trends are concerning, as the use of textured-surface implants increased more than fivefold, from 2.3% to 13% in breast augmentation procedures, between 2011 and 2015, despite a safety warning issued by the FDA in 2011.”
What Does This Mean For You
While the results of this study are certainly alarming, it is important to know that the number of cases of anaplastic large cell lymphoma of the breast remains low. Still, women with breast implants, especially those with textured implants, are at higher risk of developing the disease than women without implants.
Most women diagnosed with anaplastic large cell lymphoma of the breast received this diagnosis because fluid had built up around the implant, known as a “seroma,” years after the implants were placed. In some cases, analysis of the fluid led to the diagnosis. In other cases, anaplastic large cell lymphoma of the breast was diagnosed after a lump was found in the breast or because the tissue capsule had hardened, called “capsular contracture,” and caused discomfort or cosmetic problems.
If you have an implant or tissue expander, the FDA recommends the following:
- Regularly monitor for symptoms of anaplastic large cell lymphoma of the breast
- Leave the implant or expanders in place and make no changes to your medical care and follow-up routine if you do not have symptoms of anaplastic large cell lymphoma of the breast
However, let your doctor know if this is a concern for you. Call your doctor if you have symptoms or problems with your implant or expanders, such as pain, lumps, swelling or asymmetry, especially if you notice these symptoms appearing years after the implant was placed.
If you are considering breast reconstruction with an implant, talk to your doctor about the risks and benefits of implants, including the differences between smooth and textured implants. Your doctor should discuss the risk of anaplastic large cell lymphoma of the breast as part of the informed consent process before any implant surgery.
There are still two questions for which we do not have clear answers:
- Does it make sense to leave an implant in place if an implant and tissue capsule were removed from the other breast due to anaplastic large cell lymphoma of the breast?
- Is it safe to replace an implant removed due to anaplastic large cell lymphoma of the breast with a new one?
More research is needed to answer these questions.
Learn more about Breast Reconstruction .
Read the Special Report: Breast Implant Illness and ALCL-AIM .
Written by Jamie Polo | Revised by 1 medical adviser
25 jul 2022.
