The number of U.S. cases of breast anaplastic large-cell lymphoma — a rare cancer linked to textured implants — may be twice as high as U.S. Food and Drug Administration (FDA) estimates, a study suggests.

The research was published online on July 21, 2022, by 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 cancer of the lymphatic system.

In January 2011, the FDA first reported a possible link between both saline and silicone breast implants and breast anaplastic large-cell lymphoma in the tissue near the implant.

Many women who have mastectomy to treat breast cancer go on to have one or both breasts reconstructed. There are two ways to reconstruct a breast:

using tissue transplanted from another part of your body, such as your back, belly, or thighs

inserting an implant that’s filled with saline (salt water) or silicone gel

A saline implant has 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 think the texture is more like natural breast tissue.

Once a breast implant is in place, scar tissue forms around it, creating what’s called a tissue capsule. Breast anaplastic large-cell lymphoma can develop in and around the tissue capsule.

The risk of breast anaplastic large-cell lymphoma is higher in women with textured implants (implants with a bumpy surface) than it is in women with smooth implants, according to the FDA. The material inside the implant — silicone or saline — doesn’t seem to affect the risk of breast anaplastic large-cell lymphoma.

In 2019, the National Comprehensive Cancer Network (NCCN) developed formal treatment guidelines for breast anaplastic large-cell lymphoma .

Also, in 2019, Allergan, an implant manufacturer, announced a global recall of Biocell textured breast implants and tissue expanders in response to the FDA’s requested recall.

In 2020, the FDA ordered that a warning about anaplastic large-cell lymphoma be part of the labeling of all saline and silicone gel implants.

Research has shown that cases of breast anaplastic large-cell lymphoma in Australia, New Zealand, and the Netherlands are increasing. Scientists believe the increase is linked to an increase in the use of textured implants.

In this study, the researchers wanted to see if there was also an increase of breast anaplastic large-cell lymphoma cases in the United States.

The researchers looked at information in the Surveillance, Epidemiology, and End Results (SEER) database on confirmed cases of breast anaplastic large-cell lymphoma cases diagnosed in women between Jan. 1, 2000 and Dec. 31, 2018.

Overall, the rate of breast anaplastic large-cell lymphoma was 8.1 cases per 100 million women per year.

The rate of cases increased over time. Rates were:

3.2 cases per 100 million women from 2000 to 2005

4.4 cases per 100 million women from 2006 to 2011

14.5 cases per 100 million women from 2012 to 2018

The FDA estimated three cases per 100 million women based on an analysis of SEER database information from 2001 to 2007.

So this study estimates the number of breast anaplastic large-cell lymphoma cases is likely more than twice as high as the FDA estimates.

“Given the strong association between textured implants and breast [anaplastic large-cell lymphoma], the rising incidence may be associated with both the increasing prevalence of textured implants in the [United States] and increased recognition of the disease, but may also reflect an increase in the incidence of all breast lymphomas,” the researchers wrote. “These trends are concerning, as the use of textured implants increased more than five-fold from 2.3% to 13% of augmentation procedures between 2011 and 2015 despite a safety communication from the FDA in 2011.”

Although the results of this study are very concerning, it’s important to know that the number of cases of breast anaplastic large-cell lymphoma are still small. Still, women with breast implants, especially textured breast implants, do have a higher risk of the disease than women without breast implants.

Most women who have been diagnosed with breast anaplastic large-cell lymphoma were diagnosed because fluid collected around the implant (called a seroma) years after they got the implants. In some cases, testing the fluid led to the diagnosis. In other cases, doctors diagnosed breast anaplastic large-cell lymphoma after a mass was found in the breast or because the tissue capsule tightened (called capsular contracture) and caused discomfort or cosmetic problems.

If you have an implant or tissue expanders, the FDA recommends:

regular monitoring for symptoms of breast anaplastic large-cell lymphoma

leaving the implant or expanders in place and making no changes to your routine medical care and follow-up if you have no symptoms of breast anaplastic large-cell lymphoma

Still, don’t hesitate to let your doctor know if you’re concerned. Definitely call your doctor if you have symptoms or problems with your implant or expanders, such as pain, lumps, swelling, or asymmetry, especially if these problems develop years after getting the implant.

If you are considering breast reconstruction with an implant, you may want to talk to your doctor about the risks and benefits of implants — including the differences between textured and smooth implants. Your doctor should discuss the risk of breast anaplastic large-cell lymphoma as part of the informed consent process before any implant surgery.

There are also two questions that still don’t have good answers:

Does it make sense to leave an implant with no problems in place if the opposite breast had an implant and tissue capsule removed because of breast anaplastic large-cell lymphoma?

Is it safe to replace an implant removed because of breast anaplastic large-cell lymphoma with a new implant?

Much more research is needed to address these issues.

Learn more about Breast Reconstruction .

Read the Special Report: Breast Implant Illness and BIA-ALCL .

To talk with others about their experiences with breast implants and other reconstruction options, join the conversation on Breast Reconstruction in our community.

Written by: Jamie DePolo , senior editor

— Last updated on August 1, 2022, 5:07 PM

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