For years, there have been hints that some women with breast implants may be at risk for the development of a rare lymphoma. However, the evidence was at first rather flimsy, and statements from organizations such as the United States Food and Drug Administration (FDA) and the World Health Organization (WHO) had reflected that lack of evidence.
In 2011, the FDA put forth the following statement about breast implant-associated anaplastic large cell lymphoma (ALCL):
Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant. Based on available information, it is not possible to confirm with statistical certainty that breast implants cause ALCL.
At that time, the FDA also indicated that the incidence of ALCL was very low, even in breast implant patients. They were unable to identify a type of implant, for instance, silicone versus saline, that was associated with greater risk. Also in the 2011 statement, the language included guidance to healthcare providers, noting that the FDA did not recommend removing breast implants in patients without symptoms or other abnormalities, but also stating that as they learned more about ALCL in women with breast implants, these recommendations may change.
The 2017 Warning From the FDA
In 2017, the FDA updated its information in the wake of reports and actions taken by the WHO, the Australian Therapeutic Goods Administration, and the French National Agency for Medicines and Health Products Safety.
Here is part of the more recent 2017 US FDA statement:
“Since 2011, we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants. The exact number of cases remains difficult to determine due to significant limitations in worldwide reporting and lack of global implant sales data. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.”
What Does It Mean?
When the FDA issues approval of things like breast implants, sometimes it requires the companies that make these devices to perform additional studies to get more information about the risks of the product. In this way, a medical device can be approved based on the available evidence, but as additional data comes out, the FDA updates its language about cautions and risks.
Currently, the FDA is on record about the risks of breast implants, with a top-down approach, listing the most common complications first, including:
- Capsular contracture
- Implant removal (with or without replacement)
- Implant rupture
The FDA also notes a very low but increased likelihood of being diagnosed with anaplastic large cell lymphoma (ALCL).
Recent Trends in Surgical Procedures
According to the annual statistical report by the American Society for Aesthetic Plastic Surgery, the surgical procedures that saw the most significant increases in 2016 included:
- Fat transfer to the breast (up 41%)
- Labiaplasty (up 23%)
- Buttock lift (up 21%)
- Fat transfer to the face (up 17%)
- Breast implant removal (up 13%)
It is not known to what extent information about lymphoma risk has contributed to the uptick in removal of breast implants.
What Is Known About Breast Lymphoma, In General?
Primary breast lymphomas, meaning lymphomas that start growing in the breasts, are very rare cancers, representing about 0.5% of the cases of breast cancers and 2% of the cases of extranodal lymphomas.
They begin in the lymphoid tissues of the breast—patches and scatterings of white blood cells—that are around the ducts and lobes, and most of these cancers arise out of white blood cells known as B-cells. B-cells are the kind of white blood cells that can sometimes become activated and differentiate into antibody-producing plasma cells of the immune system. Tumors that come from another type of white blood cell, T-cells, are rare as well.
The average age at onset of primary breast lymphoma is 57 years. In terms of symptoms a woman might have, or findings on mammograms and scans, primary breast lymphomas act very much like other breast tumors, so special tests using antibodies (immunohistochemistry) are important to the diagnosis of these tumors. But the tumors are usually single, or lone, and pretty well defined, and they are said to have an elastic quality to them.
Anaplastic Large Cell Lymphoma (ALCL)
Lymphomas are basically categorized as Hodgkin and non-Hodgkin lymphoma, and then by subtypes, once you know the main category. Anaplastic large cell lymphoma, or ALCL, is a rare kind of non-Hodgkin lymphoma of the T cells. It is a very small slice of the pie when you are talking about non-Hodgkin lymphomas, and represents about 3% of all non-Hodgkin lymphoma cases.
Interest and research into ALCL has been boosted in recent years by reports of cases of primary breast lymphomas associated with saline and silicone breast implants. In these cases, the usual pattern was that something prompted surgery, which led to the diagnosis of lymphoma. If any cases of lymphoma have been diagnosed prior to surgery, this has not been widely reported.
It has been estimated that the risk of getting ALCL is 1 in 500,000 women with breast implants. The age at onset seems to be between 34 and 59 years, and the cancer seems to develop within about 3–7 years from the time of the breast implant procedure.
The first case of breast implant-associated ALCL was reported in 1997. In the 2011 FDA statement, 60 cases of ALCL associated with implant were confirmed. Since then, the number of cases of ALCL has increased, as has the number of breast implant procedures.
The ALCL affects the fibrous capsule around the implant, though occasionally there is a solid mass, and it does not involve the breast tissue, itself. In most cases the lymphoma begins with a collection of fluid that doesn’t go away by itself, perhaps with shrinkage of the capsule around the implant, or a mass to the side of the implant.
Other FDA Reports
As of February 2017, the FDA noted:
“FDA received a total of 359 medical device reports of breast implant-associated anaplastic large cell lymphoma, including nine deaths. There are 231 reports with data on surface information at the time of reporting. Of these, 203 were on textured implants and 28 on smooth implants. There are 312 reports with data on implant fill type. Of these, 186 reported the use of silicone gel-filled implants, and 126 reported the use of saline-filled implants.”
However, it seems there is still uncertainty about what these reports mean, in terms of specific risk to a woman with implants:
Of note, while the MDR system is a valuable source of information, this passive surveillance system has limitations, including incomplete, inaccurate, untimely, unverified, or biased data in the reports. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting, duplicate reporting of events, and the lack of information about the total number of breast implants.
A Word From Get Meds Info
The FDA summarized the medical literature on this topic, indicating that all of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants.
They note that most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation. The 2017 guidance to healthcare providers regarding prophylactic removal is not much different from past iterations:
“Because it has generally only been identified in patients with late-onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.”
The FDA advises that If you have breast implants, there is no need to change your routine medical care and follow-up, that BIA-ALCL is rare, and although not specific to BIA-ALCL, you should follow standard medical recommendations including:
- Follow your healthcare provider’s instructions on how to monitor your breast implants.
- If you notice any changes, contact your healthcare provider promptly to schedule an appointment.
- Get routine mammography screening and ask for a technologist specifically trained in performing mammograms on patients with breast implants.
- If you have silicone gel-filled breast implants, get periodic magnetic resonance imaging (MRI) to detect ruptures as recommended by your healthcare provider.
- The FDA-approved product labeling for silicone gel-filled breast implants states that the first MRI should occur three years after implant surgery and every two years thereafter.
In language addressed to patients and women considering breast implants, the FDA stresses having a good conversation with your healthcare provider about the known risks of implants prior to undergoing the procedure.