In January 2011, the U.S. Food and Drug Administration (FDA) reported a possible link between both saline and silicone breast implants and a very rare form of lymphoma -- anaplastic large-cell lymphoma (ALCL) -- in the tissue near the implant. Lymphoma is cancer in the lymphatic system.
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 extraordinarily uncommon. ALCL can develop in other places in the body besides the breast. A diagnosis of ALCL in the breast is extraordinarily rare: among 100 million women, experts estimate that only three cases would be diagnosed in a year.
The possible link between breast implants and ALCL came to light when a study identified 34 women diagnosed with ALCL in a breast with an implant. Because ALCL is incredibly rare, the researchers doing the study and the FDA took notice when 34 women were diagnosed with breast ALCL; both groups 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 identified six 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.
A study has found that the most effective treatment for implant-associated ALCL is surgically removing the implant and surrounding tissue capsule.
The research was published online on Nov. 30, 2015 by the Journal of Clinical Oncology. Read the abstract of “Complete Surgical Excision Is Essential for the Management of Patients With Breast Implant-Associated Anaplastic Large-Cell Lymphoma.”
In the study, the researchers collected and reviewed detailed treatment and outcome information from 87 women diagnosed with ALCL. Thirty researchers from 14 institutions around the world reviewed the information.
The number of the women in the study is small because ALCL is so rare.
The researchers looked at the treatments in relation to disease-free survival (how long the women lived without ALCL coming back) and overall survival (how long the women lived whether or not the ALCL came back). They found that surgery was the optimal treatment for ALCL.
Many of the women in the study received two or more treatments for ALCL:
- 43 women had limited surgery
- 74 women had complete surgical removal of the implant and the capsule
- 51 women had chemotherapy
- 39 women had radiation therapy
Recurrence rates at 5 years by treatment were:
- complete surgical removal of implant and capsule: 4%
- radiation therapy: 28%
- chemotherapy: 32%
"We determined that complete surgical excision was essential for the management of this disease," said Mark Clemens, M.D., assistant professor of plastic surgery at the University of Texas MD Anderson Cancer Center and lead author of the study. "Patients did not do as well unless they were treated with full removal of the breast implant and complete excision of the capsule around the implant."
Treating ALCL with surgery is a much different recommended treatment than the standard treatment for most other lymphomas, which is usually chemotherapy alone.
"Although this disease is rare, it appears to be amenable to treatment and, in the vast majority of patients, the outcome is very good," said Dr. Clemens. "The disease can be reliably diagnosed, and when treated appropriately it has a good prognosis."
It’s very important to know that the FDA isn’t sure that a link exists between breast implants and ALCL. The FDA also has emphasized that even if there is a link, the risk of ALCL in women with breast implants is extremely low. Currently available FDA-approved breast implants are safe when used as recommended by the manufacturer. The FDA has said that 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'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.
If you have an implant, be reassured by the FDA’s advice 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 are ever diagnosed with ALCL, discuss this study with your doctor and ask if complete surgical removal of the implant and the capsule is a good option for you.
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.