In January 2011, the U.S. Food and Drug Administration (FDA) issued a warning about a possible link between breast implants and a very rare form of lymphoma: anaplastic large-cell lymphoma (ALCL). Lymphoma is cancer in the lymphatic system. A group of experts from the RAND Corporation reviewed most of the available information on ALCL and breast implants and concluded that:
- There's likely a link between breast implants and an increased risk of ALCL.
- If ALCL develops after a breast implant is placed, the ALCL is almost always only in the capsule of scar tissue that forms around the implant. So the ALCL can usually be treated successfully by removing the implant and the tissue capsule. Additional treatments such as radiation therapy and chemotherapy (called systemic adjuvant treatments) usually aren't needed.
These conclusions were published online in Plastic and Reconstructive Surgery, a professional journal. The RAND Corporation is a non-profit organization devoted to careful and thorough research and analysis aimed at providing guidance for better decision-making. The RAND Corporation does research and analysis in many areas including education, the environment, technology, and health.
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 salt water (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.
Doctors estimate that ALCL is diagnosed in one of every 500,000 women, making it very uncommon. ALCL can develop in other places in the body besides the breast. An ALCL diagnosis in the breast is quite rare: out of 100 million women, it's estimated that only 3 cases would be diagnosed in a year.
The possible link between breast implants and ALCL came to light when a study found 34 women diagnosed with ALCL in a breast with an implant. Because ALCL is incredibly rare, researchers and the FDA began to think there could be a link between breast implants and breast ALCL. FDA scientists looked at results from other studies, consulted implant experts and manufacturers, and contacted international health agencies. The scientists found 6 more U.S. women and about 24 international women who were diagnosed with breast ALCL in a breast with an implant. Most of the women with breast ALCL had a breast implant to enlarge the breast, not as reconstruction after breast cancer surgery.
Once a breast implant is in place, scar tissue forms around it, creating what's called a tissue capsule. The FDA found that breast ALCL usually developed in and around the tissue capsule. Breast ALCL was found around both silicone and saline implants, though more cases of ALCL were in women with silicone implants.
Most of the women went to their doctors and were diagnosed with breast 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. Seromas often develop a week or so after breast implant surgery when the drainage tubes have been removed. 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.
Based on their analysis, the RAND experts believe that ALCL may have developed but was never diagnosed in some women who developed seromas or other tissue capsule problems around an implant. (Doctors didn't recognize ALCL as a distinct type of cancer until 1994.) Still, the ALCL was effectively treated when the implant and tissue capsule were removed to treat the seroma or capsule problem.
There are 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 ALCL?
- Is it safe to replace an implant removed because of ALCL with a new implant?
More research is needed to address these issues.
To further study any links between ALCL and breast implants and determine how large the risk, the FDA has asked doctors to:
- consider a possible ALCL diagnosis if a woman with a breast implant placed years ago develops unexplained fluid around the implant that doesn't go away in a timely way; the FDA recommends a fluid sample be sent to a pathologist who can look for ALCL
- report any women who have a confirmed diagnosis of breast ALCL
- register all women who have implant surgery in a special database to track how they do over time
The FDA also has asked implant manufacturers to help in monitoring efforts.
The FDA has emphasized that even if there is a link, the risk of breast ALCL in women with breast implants is extremely low. FDA-approved breast implants are safe when used as recommended by the manufacturer. The FDA said, "Women with breast implants who are not showing any symptoms or problems, such as pain, lumps, swelling, or asymmetry, require only routine follow-up."
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.
If you've been diagnosed with breast cancer and are considering reconstruction with an implant, you might want to discuss the possible link between implants and ALCL with your doctor. Still, it's important to know that the FDA doesn't think the possible link should discourage women from implant reconstruction.
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.