In August 2017, FDA updated the announcement based on collaboration with other agencies and a more extensive literature review.
WHO recognized BIA-ALCL as a rare T-cell lymphoma occurring after breast implant placement.
FDA received medical device reports of 359 cases, 9 of which ended in death. Only 231 cases included the type of implant used and 203 cases had textured shell implants and 28 smooth shell implants.
Based on the above figures, FDA issued recommendations to health care providers and patients. FDA recommendation to health care providers can be summarized as following; As BIA-ALCL mostly occurred with the textured shell, inform the patients of the benefits and risks of different types of implants before surgery. Suspect BIA-ALCL if late seroma is seen around the implant and refer the patient to an appropriate specialist. For ALCL screening, collect seroma fluid and a piece of the capsule and send to pathology. Diagnostic screening involves cytological testing using wright giemsa stain of the seroma fluid and cell block immunohistochemistry (for verifying CD and ALK markers). Report all confirmed cases to FDA.
FDA recommended against removing implants for fear of this disease without specific problems.
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Clinical manifestation and pathophysiology
BIA-ALCL manifests itself as late seroma, a mass attached to the capsule, an infiltrating tumor or regional LN (cutaneous ALCL is excluded).
Gidengil et al. reported that most cases presented seroma (76%) and 48% of cases showed capsule-related symptoms. Most of the cases received chemotherapy and radiation therapy and 11% received stem cell transfer. ALCL recurred in about a quarter of the patients and 9% died (Breast Implant Associated Anaplastic Large Cell Lymphoma: A Systematic Review, Gidengil, Courtney A. M.D., M.P.H.; Predmore, Zachary B.A.; Mattke, Soeren M.D., D.Sc.; van Busum, Kristin M.P.A; Kim, Benjamin M.D., M.Phil., Plastic & Reconstructive Surgery: March 2015 – Volume 135 – Issue 3 – p 713–720).
ALCL is CD30+ NHL and makes up 3% of NHL and 0.5% of all breast cancer cases.
Due to the rarity of the disease, it is hard to verify association with the implant. Therefore, the term BIA-ALCL is used for convenience rather than scientific accuracy. WHO has categorized ALCL as ALK-. Primary cutaneous ALCL has 90% 5-year survival. The 5-year survival rate is 70% with Alk+ and 49% with Alk-.
However, despite being Alk-, BIA-ALCL shares the positive prognosis of cutaneous ALCL. Therefore, BIA-ALCL may be a unique disease category. It is a malignant tumor but has a very favorable prognosis and is definitely curable.
-To be continued
