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Breast CancerLymphomaSurvivorship

FDA Calls Attention to Risk Associated with Breast Implants: Anaplastic Large-Cell Lymphoma

In February 2019, the FDA issued a letter to raise awareness of the risk for a rare type of lymphoma, BIA-ALCL, that is linked to all types of breast implants. Although this is an uncommon reaction to implants, all women who have or intend to get an implant after breast cancer should be aware of this risk. Learn more about this risk here.
June 2019 Vol 5 No 3
Kristen Chanley

In February 2019, the FDA issued a letter to healthcare providers to raise their awareness of a type of lymphoma that is linked to all types of breast implants.1 This type of lymphoma is called “breast implant–associated anaplastic large-cell lymphoma,” or BIA-ALCL, which occurs within the scar adjacent to the implant and can lead to severe and painful symptoms.

“Though the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide each year,” the FDA said that it received reports of 660 cases and other confirmed data to “suggest that patients with breast implants have an increased risk of BIA-ALCL.”1

The FDA initially received reports of this risk in 2011, but it only recently took steps to inform healthcare providers of this risk. Therefore, until recently, most doctors who have been treating women with breast cancer were not aware of this risk and didn’t alert their patients to this possibility. It is likely that many doctors still don’t discuss this with their patients.

Daniel Hayes, MD, FACP, FASCO

“The good news is that BIA-ALCL is exceedingly rare, but it’s important for women to be aware of this condition so that if it develops, it can be diagnosed early,” said Daniel Hayes, MD, FACP, FASCO, Stuart B. Padnos Professor of Breast Cancer Research at the University of Michigan Rogel Cancer Center and past president of the American Society of Clinical Oncology.

BIA-ALCL is a type of lymphoma, which is a blood cancer and is not related to breast cancer itself but rather is caused by the implant. Although this adverse reaction to breast implants is rare and treatable, it is certainly something women should consider seriously before getting an implant.

Dr. Hayes emphasizes that women who had breast cancer should know that they are not at risk for this disease if they are not getting an implant. “BIA-ALCL is not in any way related to having a previous breast cancer diagnosis or radiation treatment,” said Dr. Hayes. “There are certainly malignancies related to those things, but BIA-ALCL is not one of them.”

Before Getting an Implant

Women who are considering breast implants should realize that their doctors will likely not mention the risk of lymphoma associated with breast implants and should therefore ask them specifically about it.

In April 2019, the Washington Post published an article titled “I beat breast cancer. Then I found out my implants could cause lymphoma.”2 The author, Renee Ridgeley, is a patient advocate and a volunteer at Cancer Support Community Los Angeles. After her bilateral mastectomy (removal of both breasts) because of breast cancer, she decided to get implants.

No one had mentioned to her the potential risk for a new cancer, but a few months after her reconstruction surgery to place the implants, she realized something was wrong. “I had skin necrosis from the mastectomy, a muscle torn from my sternum from the reconstruction and chronic pain; both shoulders were so frozen that I couldn’t pull up my pants or hug my kids,” Ms. Ridgeley writes.2 Only then did she found out, by searching online, about the risk of lymphoma associated with breast implants and had follow-up surgery to remove them.

Types of Implants

She also found out that she had the type of implants known as “textured implant,” which is more likely to result in lymphoma than “smooth-surface” implants.2 There are important differences in implants, and women should investigate the difference before making a final decision.

According to the American Society of Plastic Surgeons, BIA-ALCL has been found in connection to silicone and saline implants, and it can occur in any breast reconstruction, regardless of whether it’s done for cosmetic or medical reasons. However, the American Society of Plastic Surgeons notes that “BIA-ALCL occurs most frequently in patients who have breast implants with textured surfaces.”3

The FDA reports that most confirmed cases of BIA-ALCL have been found in women who have had textured-surface breast implants. Nevertheless, the FDA advises patients that there are known instances of BIA-ALCL found even in smooth-surface breast implants, and many reports don’t include the type of the implant at the time of the diagnosis of BIA-ALCL.1

Dr. Hayes advises that women who are considering breast implants talk with their plastic surgeon about the benefits and risks of the different types of implants available today and review all the evidence. Ms. Ridgeley said that she chose textured implants because of their appearance, since there was no mention of any risk with any type. She also mentioned she had 2 “textured implants,” wondering if this doubled her risk for lymphoma.2

The Symptoms of BIA-ALCL

According to the American Society of Plastic Surgeons, the symptoms associated with BIA-ALCL can develop as early as 1 year after receiving an implant, but they typically appear after an average of 8 to 10 years.3 The symptoms are caused by a collection of fluid or large mass surrounding the implant and may include3:

  • Breast enlargement
  • Pain
  • Lump in the breast or armpit
  • Asymmetry that develops after the surgical sites are healed
  • Skin rash
  • Hardening of the breast

Most cases of BIA-ALCL are diagnosed when patients seek medical treatment for implant-­related symptoms. “If you notice something wrong, you should notify your physician, talk about what that means, and get a full work up,” said Dr. Hayes. “Don’t wait.”

Treatment

If a diagnosis of BIA-ALCL is confirmed, the patient can expect to meet with a multidisciplinary team to discuss the treatment options.

The National Comprehensive Cancer Network suggests that the optimal treatment for most patients with BIA-ALCL is removal of the implant and the surrounding area. Patients with advanced lymphoma that has metastasized (spread), however, will require further treatment, likely with chemotherapy or radiation.4

“Once a patient is diagnosed with this cancer, the chances of her being cured by simple excision of the lymphoma appears to be very high, though it’s not a hundred percent,” said Dr. Hayes. “There are some patients who have required either post-operative chemotherapy or even radiation for this, but those patients are even more rare than what is already a rare event,” he added.

Ask Questions

All women who are considering breast implants or those who already have breast implants should be aware of this risk, although it is a small risk. To combat that increased risk, the FDA is urging all patients to discuss any concerns related to breast implants with their physicians. The FDA is also imploring all physicians to discuss this risk with their patients who may be considering breast implants, and to report confirmed cases of BIA-ALCL.

Key Points

  • Breast implants are associated with a risk for lymphoma called “breast implant–associated anaplastic large-cell lymphoma” or BIA-ALCL
  • Most reported cases of BIA-ALCL were with textured-surface breast implants, but some cases have also been reported with smooth-surface breast implants
  • Before considering a breast implant, ask your doctor questions about this risk and about the best type of implant

References

  1. FDA. Breast implant associated-anaplastic large cell lymphoma (BIA-­ALCL)—letter to health care providers. February 6, 2019. www.fda.gov/medicaldevices/safety/letterstohealthcareproviders/ucm630863.htm.
  2. Rene Ridgeley. I beat breast cancer. Then I found out my implants could cause lymphoma. Washing Post. April 17, 2019. www.washingtonpost.com/opinions/i-beat-breast-cancer-then-i-got-lymphoma-from-my-implants/2019/04/17/c18e713e-5c63-11e9-842d-7d3ed7eb3957_story.html?utm_term=.c6e7b1149ef2.
  3. American Society of Plastic Surgeons. Breast implant associated anaplastic large cell lymphoma (BIA-ALCL). www.plasticsurgery.org/patient-safety/bia­alcl-summary.
  4. Clemens MW, Jacobsen ED, Horwitz SM. 2019 NCCN consensus guidelines on the diagnosis and treatment of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Aesthetic Surgery Journal. 2019;39(Suppl 1):S3-S13.

Patient Resources

American Society of Plastic Surgeons
www.plasticsurgery.org/patient-safety/bia-alcl-summary

American Society of Aesthetic Plastic Surgery
www.surgery.org/media/resources

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