September 30, 2023
Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) by the FDA

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) by the FDA

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is not breast cancer but a rare type of T-cell lymphoma that usually presents as a fluid swelling around the breast implants.

This is a very rare non-Hodgkin’s type of lymphoma and was first studied in 2011. The main treatment is the removal of implants along with scar tissue formed around it.  Occasionally, some patients require chemotherapy or radiation. [1]

As of February 1, 2017, the FDA has received a total of 359 medical device reports of BIA-ALCL including nine deaths. Of these, 203 were textured implants and 28 were smooth implants; 186 implants were filled with silicone gel and 126 were filled with saline.

Presently, the US FDA has released safety information regarding the current understanding of the incidence and prevalence of BIA-ALCL. This has been released corresponding to the World Health Organization designation of BIA-ALCL as a rare type of T-cell lymphoma, which occurs after wearing breast implants.[1]

Highlights of March 2017 FDA Update

Certain information highlighted for patients, especially for women with breast implants.

  • Current data suggests that most cases of BIA-ALCL occur in patients using breast implants with a textured surface than breast implants with a smooth surface. This rare condition is mostly seen in patients who come for revised operations and persistent seroma. The lifetime risk is approximately between 1 in 1000 to 1 in 10,000 women with implants.
  • FDA recommends regular self-breast examination, especially if you are wearing breast implants. If you observe any lump or swelling, schedule an appointment with your surgeon.
  • Any new confirmed cases of ALCL in women with breast implants need to be reported to the FDA’s Med Watch Safety Information and Adverse Event Reporting Program. This can be done by either submitting a complete report online or by downloading the form from the site.

Exact determination of the number of cases remains difficult due to a lack of global sales data and worldwide reporting. However, receiving newer cases since 2011 and after finding the association between cancer and implants, FDA continues to collect and evaluate BIA-ALCL in women with breast implants.

Advice For Healthcare Providers

  • If you have patients with breast implants continue to provide care and support
  • Develop a complete plan for patients with their multidisciplinary team.
  • BIA-ALCL has shown a tendency to be observed only in patients with late onset of symptoms such as pain, swelling, and lumps. Also, most cases have occurred in women using textured implants, not smooth implants.
  • It is important to provide educational material regarding breast implants received from the manufacturer to the patients. Furthermore, discuss the various aspects of surgery, as well as the benefits and risks associated with breast implants.
  • It is mandatory to report all confirmed cases of ALCL with breast implants to the FDA.[1]


Credit: Dr. Rachita on behalf of Borderless Access

Copyright © 2017 BorderlessAccess



Breast Implants: Update – Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

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