Introduction
Breast implants are
commonly used for cosmetic augmentation as well as post-mastectomy cancer
reconstruction. Breast implants are
composed of a silicone shell, filled with silicone gel or saline. Historically, smooth-shelled implants were
used in the 1970s and 1980s. In the late 1980s, textured-shell breast implants
were introduced to reduce the incidence of capsular contracture (internal scar
formation), and their use significantly increased in the 1990s 1,2.
What is BIA-ALCL?
BIA-ALCL is a rare
peripheral T-cell lymphoma that was first reported in the medical literature in
1997 3, and more than 300 cases of BIA-ALCL have been reported to
the United States Food and Drug Administration (FDA) 4, mostly
occurring in patients who have undergone textured-surface breast implants. It is thought that development of BIA-ALCL is
a complex process involving many factors, including bacterial biofilm growth,
textured implant surface, immune response, and patient genetics 4. The estimated incidence of BIA-ALCL ranges
from 1 case per 30,000 4,5 to 1 case per 4,000 6. Because this is an uncommon disease, data is
still being accumulated and medical knowledge on this topic continues to
evolve.
How does BIA-ALCL
present?
The most common clinical
presentation is a late peri-implant effusion, which manifests as breast
enlargement more than one year following
the breast implant surgery. Other less
common symptoms include a breast mass, enlargement of the lymph nodes of the
axilla, or “B-type symptoms” (fever, night sweats, lymph node enlargement, and
fatigue). The average time to onset of
BIA-ALCL after implantation is 10.7 years 4,5. BIA-ALCL may affect patients with either
silicone- or saline-filled implants.
BIA-ALCL may be
diagnosed on ultrasound or MRI scan, in conjunction with the use of
image-guided needle fluid aspiration or biopsy.
If BIA-ALCL is confirmed, further investigations may be required to determine
the stage of the disease so as to guide appropriate treatment.
How is BIA-ALCL
treated?
Most cases are localized
(early) disease, which often follow an indolent course, and are cured by implant
removal and complete excision of the peri-implant capsule, without further
intervention 7. After
complete excision, regular surveillance with clinical examinations and imaging
investigations may be required. Patients
with more advanced disease, including patients with a tumor mass, lymph node
involvement, and/or distant spread, may require chemotherapy, radiotherapy, or
both 4.
What do I do if I
already have a textured breast implant inside me?
The US FDA states: “If
you have breast implants, there is no need to change your routine medical care
and follow-up” 8. Additional
screening or removal of implants is not required for asymptomatic women 8,9. The FDA continues to affirm that “BIA-ALCL is
a very rare condition” 8. Should
you experience any of the symptoms described above, do arrange for a
consultation with your plastic surgeon.
The History and Safety of
Breast Implants
In the late 1980s, early
reports appeared in the medical literature describing a possible association
between silicone-gel filled breast implants and certain autoimmune diseases,
such as scleroderma, rheumatoid arthritis and systemic lupus erythematosus. In 1992, the United States FDA restricted the
use of silicone breast implants to reconstructive purposes or clinical trials
only. Subsequent publications were later
unable to establish an association between silicone-gel implants and autoimmune
disease 10 and the implants were once again made available for
aesthetic purposes in 2006
7. This is an example of how plastic
surgeons, regulatory authorities, the device industry, and patients work
together for post-market device surveillance, ensuring short- and long-term patient
safety as a common goal.
Conclusion
There has been recent
association of textured breast implants with BIA-ALCL. Research will continue, and theories, data
and clinical recommendations will evolve.
Breast surgery involving implants remains a safe procedure in the hands
of trained plastic surgeons and appropriately selected patients, regardless of
whether it is performed for aesthetic or reconstructive purposes.
References
1. Lazzeri D, Agostini
T, Bocci G et al. ALK-1-negative
anaplastic large cell lymphoma associated with breast implants: a new clinical
entity. Clin Breast Cancer
2011;11(5):283-296.
2. O’Shaughnessy
K. Evolution and update on current
devices for prosthetic breast reconstruction.
Gland Surg 2015;4(2):97-110.
3. Keech JA HR, Creech
BJ. Anaplastic T-cell lymphoma in
proximity to a saline-filled breast implant.
Plast Reconstr Surg 1997;100(2):554-555.
4. Leberfinger AN,
Behar BJ, Williams NC et al. Breast
implant-associated anaplastic large cell lymphoma: A systematic review. JAMA Surg 2017;152(12):1161-1168.
4. Brody GS, Deapen D,
Taylor CR et al. Anaplastic large cell
lymphoma occurring in women with breast implants: analysis of 173 cases. Plast Reconstr Surg 2015;135(3):695-705.
5. Doren EL, Miranda
RN, Selber JC et al. U.S. epidemiology
of breast implant-associated anaplastic large cell lymphoma. Plast Reconstr Surg 2017;139(5):1042-1050.
6. McGuire P, Reisman
NR, Murphy DK. Risk factor analysis for
capsular contracture, malposition, and late seroma in subjects receiving
Natrelle 410 form-stable silicone breast implants. Plast Reconstr Surg 2017;139(1):1-9.
7. Calobrace MB,
Schwartz MR, Zeidler KR et al. Long-term
safety of textured and smooth breast implants.
Aesthet Surg J2017;38(1):38-48.
8. “Breast
implant-associated anaplastic large cell lymphoma (BIA-ALCL)”. 2017.
FDA. US Food and Drug
Administration. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplant.... Accessed June 30, 2017.
9. “ASPS/ASAPS update
breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) Quick Facts
and FAQs”. ASPS/ASAPS. American Society of Plastic Surgeons/American
Society of Aesthetic Plastic Surgeons.
2017. https://www.surgery.org/downloads/blasts/BIA-ALCL/. Accessed June 30, 2017.
10. Bar-Meir E,
Eherenfeld M, Schoenfeld Y. Silicone gel
breast implants and connective tissue disease – A comprehensive review. Autoimmunity 2003;36(4):193-197.
Released on 15 Mar 2019