Summary and Quick Facts
The following provides a summary of what is currently known about BIA-ALCL.
- Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon and treatable type of T-cell lymphoma that can develop around breast implants. BIA-ALCL is not a cancer of the breast tissue itself.
- BIA‐ALCL should continue to be discussed with any patient considering breast implants as part of the informed-consent process.1
- The incidence of BIA-ALCL ranges from 1:2,207 to 1:86,000 depending on the type of implemented device. Published risk estimates vary widely and likely depend on the type of device being evaluated.
- The lag time between current implant insertion to diagnosis of BIA-ALCL has been from 0.8-27 years, with a mean of 9.75 years.
- No cases of BIA-ALCL have been reported with patients who have only had smooth implants in case series, case reports or registries. However, it is not possible to exclude the appearance of BIA-ALCL in association with smooth implants at this time. The FDA confirms that all confirmed cases worldwide either have a history of a textured device or an incomplete clinical history available for review.
- The association of BIA‐ALCL and textured implants may be related to the increased surface area of the texturing; however, this has not yet been definitively proven. The variation in surface texturing among manufacturers may mean there are variable risks for the development of BIA-ALCL.
- The disease has been associated with both silicone and saline implants in aesthetic as well as reconstructive patients.
- Most patients present as a delayed seroma, but also present with symptoms of mass, skin rash, fever and night sweats and lymphadenopathy. Diagnosis is based on ultrasound‐guided, fine-needle aspiration of the peri-implant fluid, which is assessed by both cytology and flow cytometry for CD 30-positive large anaplastic T-cell lymphocytes.
- PET‐CT is performed following a positive diagnosis. Mammograms are not helpful for evaluating lymphoma, but are important for the evaluation of breast cancer.
- Consideration should be given to a multidisciplinary approach including, when required, an oncological breast surgeon and an oncologist specializing in lymphoma.
- Incomplete capsular resection has been associated with both recurrence and significantly lower survival.
- The majority of patients can be cured of their disease by bilateral total capsulectomy and implant removal. Rare patients will present with more advanced disease and may require radiotherapy and chemotherapy. Treatment approach should follow international guidelines established by the National Comprehensive Cancer Network (NCCN) for BIA-ALCL, available at nccn.org.
- Current treatment recommendation is for bilateral complete capsulectomy and implant removal, as a small number of women have had contralateral disease found incidentally.2
- The FDA recommends that any suspected or confirmed cases of BIA‐ALCL be reported to the PROFILE registry, the MAUDE database and the device manufacturer. To report a case to PROFILE, go to ThePSF.org/PROFILE. To submit a case to the FDA's Manufacturer and User Facility Device Experience (MAUDE) database, which collects medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions, visit www.accessdata.fda.gov.
- For more information: visit PlasticSurgery.org/ALCL or search "ALCL" on RADAR.
1. Clemens MW, Jacobsen ED, Horwitz ST. 2019 NCCN Consensus Guidelines on the Diagnosis and Treatment of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). Aesthetic Surgery Journal, 39(1), 2019, Pages S3-S13.
2. Clemens MW, Brody GS, Mahabir RC, Miranda RN. How to Diagnose and Treat Breast Implant-Associated Anaplastic Large Cell Lymphoma. Plast Reconstr Surg. 2018 Apr;141(4):586e-599e. doi: 10.1097/PRS.0000000000004262.
*Page last updated on February 24, 2020