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FDA Update on Breast Implants

You may have heard recent media reports regarding breast implants and a rare form of cancer.  The FDA recently updated information regarding this disease (Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)). My specialty societies, The American Society of Plastic Surgery and the American Society for Aesthetic Plastic Surgery, are working closely with the FDA in monitoring the disease.

BIA-ALCL is not a breast cancer, but a rare and treatable T-cell lymphoma (a type of non-Hodgkins lymphoma) that involves the scar tissue around the implant (capsule) and usually develops as a fluid accumulation (non-traumatic seroma) around a breast implant.

The lifetime risk for this disease appears to be about 1 case for every 30,000 textured implants.  This equates to a 0.003 percent risk.  Thus far, there have been no confirmed cases of BIA-ALCL in women who have had only “smooth surface” breast implants.

The FDA is not recommending prophylactic removal of textured implants.  Rather, the FDA recommends, as do I, that every woman conduct regular self breast examination.  If you develop a seroma or a lump in your breast and do not have a doctor familiar with BIA-ALCL, contact my office right away.  I will comprehensively evaluate you and order the appropriate tests to determine if any treatment is indicated.

Women who develop BIA-ALCL can often be cured by simply removing the implant and the capsule around the implant (capsulectomy).  Some patients may require additional treatment (such as radiation or chemotherapy).  Following removal and capsulectomy, replacement with a smooth surface  implant may be an option.

For additional information about BIA-ALCL, I am happy to answer your questions or you may consult the following websites/links:  The American Society of Plastic Surgery website at  www.plasticsurgery.org/alcl or the FDA updated website at

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm