In March 2017, the U.S. Food and Drug Administration (FDA) updated its warning about a link between breast implants and a very rare type of cancer called anaplastic large-cell lymphoma (ALCL). The update said that all the available information suggested that women with breast implants had a very low but increased risk of developing ALCL compared to women who didn’t have breast implants.
Lymphoma is cancer in the lymphatic system.
A Dutch study has better quantified the risk of ALCL in women with breast implants. The researchers estimated that for women with breast implants, the number who will develop ALCL is:
- 1 in 35,000 for women age 50
- 1 in 12,000 at age 70
- 1 in 7,000 at age 75
The research was published online on Jan. 4, 2018 by JAMA Oncology. Read the abstract of “Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast.”
To do the study, the researchers looked at the nationwide Dutch pathology registry and identified women diagnosed with primary non-Hodgkin lymphoma in the breast between 1990 and 2016. The researchers then looked at the women’s health records, including whether or not they had breast implants.
The researchers found that 43 women had been diagnosed with ALCL in the breast. Of these women, 32 of them had an implant in the same breast as the cancer.
There were 146 women in the study who were diagnosed with other types of breast lymphoma (meaning the lymphoma was not ALCL). Of these women, only one had an implant in the same breast as the cancer.
This means that women diagnosed with ALCL in the breast were about 421 times more likely to have breast implants than women diagnosed with other types of breast lymphoma.
The researchers also looked to see if the type of implant affected the risk of ALCL. The 2017 FDA update suggested that the risk of ALCL was higher in women who had textured implants, which have a bumpy surface, compared to smooth implants.
The researchers knew the type of implant in 28 of the women diagnosed with ALCL. Of the 28 women, 23 of them had textured implants.
The researchers then determined the overall risk of a woman with breast implants developing ALCL in her lifetime: For every 7,000 women who get breast implants, one woman will develop ALCL in the breast by age 75.
Most women who have mastectomy to treat breast cancer go on to have one or both breasts reconstructed. There are two main 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, silicone gel, or a combination of the two
Saline implants are the most common implant used. A saline implant has a silicone shell that is filled with saline. Silicone gel implants are filled with liquid or firm silicone gel. They tend to feel softer than saline implants and some women think the texture is more like natural breast tissue.
Most of the women who have been diagnosed with ALCL went to their doctors and were diagnosed because fluid had collected around the implant (called a seroma) YEARS after the implant was placed. In some cases, testing the seroma fluid led to the diagnosis. In other cases, ALCL was diagnosed 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, the FDA recommends:
- regular monitoring for symptoms of ALCL
- if you have no symptoms of ALCL, there is no need to remove the implant and no need to change your routine medical care and follow up
If you are considering breast reconstruction with an implant, talk to your doctor about the risks and benefits of implants, including the differences between textured and smooth implants.
Still, there are two questions that 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 ALCL?
- Is it safe to replace an implant removed because of ALCL with a new implant?
More research is needed to address these issues.
It’s important to know that the risk of ALCL in women with breast implants is extremely low. The FDA doesn’t think that the link should discourage women from implant reconstruction.
If you have a breast implant, be reassured by the FDA's advice for women and their doctors about implants. Still, don't hesitate to call your doctor if you're concerned. Definitely call your doctor if you have symptoms or problems with your implant, such as pain, lumps, swelling, or asymmetry, especially if these problems develop years after the implant was placed.
Visit the Breastcancer.org Breast Reconstruction pages to learn more about breast implant surgery and other breast reconstruction options.
Editor’s Note: On July 24, 2019, Allergan announced a global recall of Biocell textured breast implants and tissue expanders after the FDA requested the recall.