Formal Treatment Guidelines Developed for Rare Cancer Linked to Breast Implants

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A panel of expert oncologists and plastic surgeons from the National Comprehensive Cancer Network (NCCN) has developed treatment guidelines for breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), a rare type of cancer linked to textured breast implants.

The guidelines were published as a supplement to the January 2019 issue of the Aesthetic Surgery Journal. Read "2019 NCCN Consensus Guidelines on the Diagnosis and Treatment of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)."

Lymphoma is cancer of the lymphatic system.

The NCCN is an alliance of a group of the world's leading cancer centers. These NCCN centers collaborate on research, guidelines, and education to improve the care of people diagnosed with cancer.

About BIA-ALCL

In January 2011, the U.S. Food and Drug Administration (FDA) first reported a possible link between both saline and silicone breast implants and BIA-ALCL in the tissue near the implant.

Most 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 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.

Once a breast implant is in place, scar tissue forms around it, creating what's called a tissue capsule. BIA-ALCL can develop in and around the tissue capsule.

In January 2018, a Dutch study estimated the risk of BIA-ALCL in women with breast implants:

  • 1 in 35,000 for women at age 50
  • 1 in 12,000 at age 70
  • 1 in 7,000 at age 75

The risk of BIA-ALCL is higher in women with textured implants, which have a bumpy surface, as opposed to smooth implants, according to the FDA. The material inside the implant — silicone or saline — doesn't seem to affect the risk of BIA-ALCL.

So while the risk of BIA-ALCL is low, women with breast implants, especially textured breast implants, do have a higher risk of the disease compared to women without breast implants.

As of Sept. 30, 2018, the FDA reported that 457 cases of BIA-ALCL have been diagnosed. Nine women have died from the disease.

Read the FDA report here.

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.

Most BIA-ALCL has been 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.

The new treatment guidelines

The NCCN treatment guidelines include information on evaluating, treating, and monitoring a woman who is suspected to have BIA-ALCL.

Symptoms
As the FDA reported in 2018, most women eventually diagnosed with BIA-ALCL go to their doctors because fluid has collected around the breast implant, on average about 7 to 10 years after the textured implant was placed. According to the guidelines, there have been no confirmed cases of BIA-ALCL being diagnosed in a woman with a history of only smooth implants.

Other symptoms of BIA-ALCL:

  • 8–24% of women had a mass near the implant, as well as fluid build-up
  • 4–12% had enlarged lymph nodes in addition to fluid build-up
  • fewer than 5% of women had a rash, fever, and capsular contracture

Imaging and biopsy
The guidelines recommend imaging with ultrasound or MRI. If the imaging results show a mass or fluid build-up, fine needle aspiration or a core needle biopsy is recommended.

Treatment
If the pathology results indicate BIA-ALCL, stepwise en bloc resection is recommended. This surgery:

  • completely removes the scar tissue around the implant
  • removes the implant
  • completely removes any masses
  • removes any involved or suspicious lymph nodes

"With a complete oncologic resection of the lymphoma, the prognosis for BIA-ALCL is very good," said Sarah Tevis, M.D., investigator at the University of Colorado Cancer Center and assistant professor of surgery at the CU School of Medicine. Tevis was not one of the experts who wrote the guidelines, but she is currently studying BIA-ALCL and who is at highest risk for developing the disease.

"At the point of diagnosis, it's important to completely treat the condition with definitive surgery," she continued. "Incomplete resections, partial capsulectomies, and positive margins are all associated with high rates of disease recurrence and, in rare cases, accelerated progression of disease."

Radiation and chemotherapy are suggested if the cancer can't be completely removed or if the cancer has invaded the chest wall.

Monitoring
Women who are disease-free after treatment should see their doctor every 3 to 6 months for 2 years after BIA-ALCL treatment. After that, women can be seen as their doctors recommend or if they have symptoms.

While it's unclear if routine imaging is needed, the guidelines recommend considering a CT scan with contrast or a PET scan every 6 months for 2 years, then only if there are symptoms.

What this means for you

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.

According to Tevis, the risk of implant-associated lymphoma is small, and the condition is most often surgically corrected, but, "we're seeing more and more of it, so we feel strongly it should be involved in the consent process for patients receiving these textured implants.

"Our hope," Tevis said, "is that by raising awareness of common presenting symptoms, proper treatment strategies, and by continuing to build our understanding of the inner workings of BIA-ALCL, we can successfully treat the women who need treatment and, eventually, identify who is at highest risk for developing the disease."

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 Breast Reconstruction to learn more about breast implant surgery and other breast reconstruction options.

To talk with others about experiences with breast implants and other reconstruction options, join the Breastcancer.org Discussion Board forum Breast Reconstruction.

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.

Written by: Jamie DePolo, senior editor

Reviewed by: Brian Wojciechowski, M.D., medical adviser


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