BIA-ALCL Summary and Quick Facts
As textured surfaced breast implants have been in the news lately I want to make sure that you have the latest information and get answers to any questions that you might have about BREAST IMPLANT ASSOCIATED-ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL) and your breast implants. I have compiled and edited the following information from documents available on the FDA website (www.fda.gov) and from the BIA-ALCL Resources of the American Society of Plastic Surgeons (www.plasticsurgery.org.) and from the American Society for Aesthetic Plastic Surgery (www.surgery.org) . It will provide you with the most recent and pertinent information available about BIA-ALCL. Please read this over completely in preparation for our discussion.
· Based on the data from case series, case reports, the FDA and implant registries, BIA-ALCL appears almost exclusively to be associated with textured surface implants. The FDA reports that they are aware of smooth only cases, however, they warn that this information is "unverified" and potentially "inaccurate." However, it is not possible to completely exclude the appearance of BIA-ALCL in association with smooth implants at this time.
· The most common presenting symptoms are spontaneous breast enlargement, swelling, or pain, most frequently due to a spontaneous collection of fluid or a mass around or adjacent to the breast implant.
· The lag time between implant insertion to diagnosis of BIA-ALCL has been from 8 months-27 years, with a mean of 9.2 years.
· The association of BIA‐ALCL and textured implants may be related to the increased surface area of the texturing or the interaction of the textured surface with the patient’s native tissue; however, this has not yet been definitively proven. As there is a variation in surface texturing among manufacturers, this may mean there are variable risks for the development of BIA-ALCL. From the FDA’s latest report released in July 2019, BIA-ALCL cases have been identified involving all of the different implant manufacturers who make textured implants, though based on this latest data, Allergan’s Biocell textured implant accounts for approximately 80% of these cases. (Historically, they have also had the largest market share of breast implants.)
· The disease has been associated with both silicone and saline implants with textured surfaces, and in cosmetic, as well as, reconstructive patients.
· About 80% of patients present with a swelling of the breast, but also can present with symptoms of a mass, skin rash, fever and night sweats, and lymphadenopathy. Diagnosis is made by laboratory tests performed on the peri-implant fluid obtained by ultrasound‐guided fine needle aspiration. One test is a screening test called CD30. If you don’t get that test, you can miss the disease.
· The majority of patients diagnosed with BIA-ALCL can be cured of their disease by bilateral total capsulectomy and implant removal.
· Currently, the FDA is not recommending removal of textured surface implants, but the FDA recommends, as do I, that every woman conduct regular self breast examination, and if you develop swelling or a lump in your breast, contact us and we can comprehensively evaluate you and order the appropriate tests to determine if any treatment is needed. I also recommend that you have your implants checked on a yearly basis, once they are over 5 years old.
· Again, ALCL is a rare condition, for as of July of this year (2019), the FDA has only identified a total of 573 unique cases worldwide for BIA-ALCL compared to the estimated 1.5 million patients who receive breast implants worldwide every year. However, it is certainly something that I want you to be aware of and take seriously.
(If you would like additional information, visit www.plasticsurgery.org/alcl or www.fda.gov and search “alcl” or “breast implants”. These websites have extensive accurate information that is updated regularly.)
Here are two of the latest FDA statements: