One major obstacle to getting proper treatment, Dr Miranda said, is lack of awareness on the part of clinicians, pathologists, and patients of the potential that a capsule could be malignant. “What happens is when [patients] come in with a lot of fluid around the implant, many physicians will think that’s an infection, so they give antibiotics,” he says. If the capsule is not completely removed, the cancer will continue to grow and could eventually invade the surrounding tissue or spread to the lymph nodes.

For women who already have textured implants, removal is not recommended in the absence of symptoms; nor are there BIA-ALCL–specific screening recommendations. Dr Rakszawski said that awareness of the disease, and monitoring any symptoms carefully, will be enough in most cases. He noted that women who develop BIA-ALCL after reconstruction from breast cancer treatment tend to get diagnosed faster than those whose implants are inserted for cosmetic enhancement—not because the 2 cancers are necessarily related, but because the survivors of the primary cancer more often continue routine follow-up care with a physician.

Amy Rose, media relations director for Allergan, said in a written statement (and reiterated to Cancer Therapy Advisor) that the company stands behind the benefit/risk profile of its breast implant products.8 “The ANSM request, and this action, are not based on any new scientific evidence regarding these products,” she said. “Global regulatory authorities have continuously evaluated case reports of BIA-ALCL and acknowledge that known cases represent an uncommon occurrence of the condition in the population of patients with textured breast implants.”

Despite this statement, in late 2018, researchers of an Allergan-supported study acknowledged that implant surface texture does play a role in host tissue response. While there was no mention of lymphoma throughout the study, the researchers compared 12 different breast implant textures across manufacturers, and found in rat models that increasing complexity of the surface texture of implants led to more tissue ingrowth.9

Disclosure: Dr Miranda has attended a 1-day Allergan Inc.-sponsored meeting as an advisory scientific expert.

References

  1. The National Agency for the Safety of Medicines and Health Products (ANSM). The CE marking of the Allergan brand textured breast implants (Microcell and Biocell) has not been renewed by the notified body GMED – Information point. https://www.ansm.sante.fr/S-informer/Actualite/Le-marquage-CE-des-implants-mammaires-textures-de-la-marque-Allergan-Microcell-et-Biocell-n-a-pas-ete-renouvele-par-l-organisme-notifie-GMED-Point-d-information. Published December 18, 2018. Accessed January 15, 2018.
  2. Calobrace MB, Schwartz MR, Zeidler KR, Pittman TA, Cohen R, Stevens WG. Long-term safety of textured and smooth breast implants. Aesthet Surg J. 2018;38(1):38–48.
  3. Leberfinger AN, Behar BJ, Williams NC, Rakzsawski KL, Potochny JD, Mackay DR, Ravnic DJ. Breast implant–associated anaplastic large cell lymphoma: a systematic review. JAMA Surg. 2017;152(12):1161-1168.
  4. Quesada AE, Medeiros LJ, Clemens, MW, Ferrufino-Schmidt MC, Pina-Oviedo S, Miranda RN. Breast implant-associated anaplastic large cell lymphoma: a review [published online September 11, 2018]. Mod Pathol. 2018. doi: 10.1038/s41379-018-0134-3
  5. Haioun C, Laurent C, Le Bras F, et al. Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL): The French Lymphoma Study Association (LYSA) registry data. J Clin Oncol. 2018;36(15_suppl):7554-7554.
  6. US Food and Drug Administration. Breast Implant Associated Anaplastic Large Cell Lymphoma. http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm239995.htm. Published August 28, 2018. Accessed January 10, 2019.
  7. James GA, Boegli L, Hancock J, et al. Bacterial adhesion and biofilm formation on textured breast implant shell materials [published online October 1, 2018]. Aesth Plast Surg. 2018.doi: 10.1007/s00266-018-1234-7
  8. Allergan. FAQ on CE mark non-renewal of textured breast implants and textured tissue expanders. www.allergan.com/getmedia/c305b7a3-f3c8-46e6- 9ff0-378247d23184/FAQ-on-CE-Mark-Non-Renewal-of-Textured-Breast-Implants-and-Textured-Tissue-Expanders-121918.aspx. Published December 19, 2018. Accessed January 15, 2019.
  9. Atlan M, Nuti G, Wang H, Decker S, Perry T. Breast implant surface texture impacts host tissue response. J Mech Behav Biomed Mater. 2018;88:377-385.