FDA Updates Warning on Link Between Textured Breast Implants and Rare Cancer
Women with breast implants have a very low but increased risk of developing anaplastic large-cell lymphoma compared to women who do not have breast implants.
On March 21, 2017, the U.S. Food and Drug Administration (FDA) updated its 2011 warning about a link between breast implants and a very rare form of cancer: anaplastic large-cell lymphoma. Because the cancer is linked to breast implants, the FDA calls the cancer breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL).
Lymphoma is cancer in the lymphatic system.
According to the FDA, “All of the information to date suggests that women with breast implants have a very low but increased risk of developing anaplastic large-cell lymphoma compared to women who do not have breast implants.”
If BIA-ALCL develops after a breast implant is placed, the lymphoma is almost always only in the capsule of scar tissue that forms around the implant. So the BIA-ALCL usually can be successfully treated by removing the implant and the scar tissue capsule. Additional treatments such as radiation therapy and chemotherapy usually aren’t needed, but may be recommended in some cases.
While the exact number of cases of BIA-ALCL has been difficult to figure out because of limited worldwide reporting, the FDA did say that it had received 359 reports of the cancer and that nine women had died from the disease.
The risk of BIA-ALCL is higher in women who have textured implants, which have a bumpy surface, as opposed to smooth implants, according to the FDA.
Of the 359 reported cases of BIA-ALCL, the FDA had information on the surface of the breast implant in 231 cases:
- 203 were textured implants
- 28 were smooth implants
The material inside the implant didn’t seem to affect the risk of BIA-ALCL. The FDA had information on the implant fill material in 312 BIA-ALCL cases:
- 186 were filled with silicone gel
- 126 were filled with saline (salt water)
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 (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.
Doctors estimate that anaplastic large-cell lymphoma is diagnosed in one of every 500,000 women, making it very uncommon. Anaplastic large-cell lymphoma can develop in other places in the body besides the breast. A BIA-ALCL diagnosis is quite rare: out of 100 million women, it's estimated that only 3 cases would be diagnosed in a year.
Most of the women who were diagnosed went to their doctors and were diagnosed with BIA-ALCL 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, BIA-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 BIA-ALCL
- if you have no symptoms of BIA-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 BIA-ALCL?
- Is it safe to replace an implant removed because of BIA-ALCL with a new implant?
More research is needed to address these issues.
It’s important to know that the FDA emphasized 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 section 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. This article was updated on Aug. 29, 2019, with more current information about breast implant reconstruction.
— Last updated on February 22, 2022, 9:56 PM
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