June 1, 2017 · FLEMING | NOLEN | JEZ, L.L.P.
The attorneys at Fleming, Nolen & Jez are currently investigating Anaplastic large cell lymphoma (ALCL) related to breast implants.The attorneys at Fleming, Nolen & Jez are currently investigating Anaplastic large cell lymphoma (ALCL) related to breast implants.
BIA-ALCL is a rare disease associated with breast implants though the exact etiology and pathogenesis remain unclear.
BI-ALCL is a purely T-cell lymphoma arising either in the effusion or scar capsule surrounding a breast implant.
There was a median of 9 years between implantation and lymphoma diagnosis.
Most cases are diagnosed during implant revision surgery performed for a late onset problems at >1 year or more.
Periprosthetic capsulation is the most common complication resulting from breast implantation. The fibrous sacs of scar tissue that enclose the implant become contracted, causing pain and distortion of the breast, and depending on the degree of contracture, may require removal.
Patients presented with either a malignant effusion or seroma (70%) or a distinct mass (30%). A total capsulectomy with implant removal was performed in 93% of patients.
Any aspiration of periprosthetic fluid should be sent to pathology for a cytologic evaluation. The pathologist may also want to analyze the gel inside the implant, the capsule and any other tissue removed with the implant. They look for inflammation, pathological changes and infiltration of foreign materials such as silicone and polyurethane.
The recovery period after breast implant removal is usually similar to the initial breast surgery. Strenuous activities are postponed for about three weeks.
Patients with biopsy proven Bi-ALCL must be referred to an oncologist. Evaluation for systemic disease may include CT. PET scan and or MRI. Surgical treatment is a total capsulectomy which includes complete removal of the capsule including the posterior wall.
The lifetime risk for BIA-ALCL in previous epidemiological studies ranges from 1 :30,000 to 1 :50,000. The Australian government believes it to be 1: 1,000.
Early in 2016 the FDA issued a report that it had received 258 adverse event reports of breast implants and ALCL.
The US FDA and the American Society of Surgeons have initiated a registry of patients who are diagnosed with post-breast implant ALCL and are collecting data to gain a better understanding of the incidence of ALCL, type of implants associated and demographics of women. The program is called PROFILE – Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology.
To date, no specific causal factors have been identified. Implant texturing, bacteriologic contamination, and genetic factors have been implicated and are undergoing further study. Bacteria have been identified within the lymphoma and around implants in affected breasts, and there is accumulating evidence that a long-term inflammatory response to the presence of these bacteria is one of the factors that may cause BIA-ALCL. Research is ongoing and cases are being monitored through the PROFILE registry created in the U.S.
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