We will also provide the most recent US and worldwide incidence statistics.
Our first update focuses on the presentation of BIA-ALCL not as a late seroma, but as delayed capsular contracture. As our understanding of the presentation of this entity has developed, the most common presenting finding was shown to be a late seroma, particularly in a patient with a textured surface implant an average of 8-10 years following implantation. 8-24% of cases also presented with a palpable mass and 4-12% with lymphadenopathy. In less than 5% of cases the presentation included skin rash, fever and capsular contracture.(1)
Recently, Dr. Melinda Haws and I encountered patients in whom the presenting finding was a late capsular contracture without any evidence of a seroma.
A brief description of each case can be found below:
Case 1 (Bruce W. Van Natta, MD )
A 44-year-old patient presented 11 years following bilateral breast augmentation with Allergan style 410 devices. Developed a left capsular contracture within a year of presentation which had progressed to grade 4. No evidence of swelling. Office ultrasound was negative for rupture or fluid. Surgical plan was for removal and replace to smooth gel implants with total capsulectomy on the contracted left side.
At the time of surgery during a complete capsulectomy, three large nodules were encountered on the anterior surface on the left and were sent to pathology for analysis and to rule out BIA-ALCL (see photo below).
No appreciable fluid was encountered on either side. A complete capsulectomy was performed on the non-contracted side as well. Histopathology revealed ALCL, CD 30+, ALK -. An initial PET scan was positive in the area of the pectoralis muscles on each side believed to be compatible with post-surgical change. A subsequent PET scan performed 3 months later was negative. The patient remains asymptomatic at 5 months.
Case 2 (Melinda J. Haws, MD)
A 34-year-old underwent primary augmentation with Biocell devices 9 ½ years ago. She developed an initial left capsular contracture 7 ½ years post augmentation. She declined capsulectomy and implant exchange at that time. Subsequent to receiving a recall letter she returned with no change in the grade 3 contracture. Office ultrasound showed no fluid or evidence of rupture bilaterally.
2 months later the patient returned with minimal swelling and a small amount of fluid on the left side, found on repeat ultrasound. Planned surgery was total capsulectomies, site change to subpectoral with new round smooth implants. A thick, yellow orange fluid—approximately 40cc’s was encountered at surgery and sent along with the capsules to pathology. Flow cytometry of the fluid was negative. Pathology revealed 2.8 x2.3 x 0.8cm mass with “extension through the fibrous capsule into the surrounding adipose tissue.”
Also noted, were “large dysplastic cells strongly and uniformly CD30 positive” and ALK negative. PET/CT skull base to thighs showed symmetric hyperactivity in the tonsils and mild hypermetabolic activity adjacent to the medial aspect of the left implant read as: “could be post-surgical.” A PET scan was felt to be nonspecific and non-concerning by oncology. Follow up PET scan was scheduled for 3 months later.
The Takeaway: While about 80% of new BIA-ALCL patients may present with the classic late seroma, the lack of a seroma does not rule out the disease.
Ideally, PET scans should be obtained preoperatively on patients presenting with a late developing capsular contracture and the patient should be informed of the possibility of the ALCL diagnosis.
Additionally, if surface nodules are encountered unexpectedly at the time of capsulectomy, every endeavor should be made to surgically obtain clear margins. This may include taking additional breast and adipose tissue around the anterior capsule and nodules.
Current Incidence of BIA-ALCL as of February 2020 (Source: PROFILE American Society of Plastic Surgeons – https://www.thepsf.org/research/registries/profile)
United States Cases: 307 Worldwide Cases: 885
US Deaths: 13 Worldwide Deaths: 25
Bradley Calobrace, MD
Chair, The Aesthetic Society BIA-ALCL Task Force
Bruce W. Van Natta, MD
Vice-Chair, The Aesthetic Society BIA-ALCL Task Force