Mountain Mind

Breast Implant Resources

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

In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma. Since 2011, we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants.

At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces.

On an ongoing basis, we:

  • Receive and review medical device reports (MDRs).
  • Review the current medical literature.
  • Exchange information with other international regulators and scientific experts.
  • Review data from the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE Registry).
  • Review information that breast implant manufacturers include about BIA-ALCL in their patient and health care professional labeling.

Medical Device Reports

As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including nine deaths. There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants.

Recommendations for Health Care Providers

  • Be aware that most confirmed cases of BIA-ALCL have occurred in women with textured breast implants.
  • Provide the manufacturers' labeling as well as any other educational materials to your patients before surgery and discuss with them the benefits and risks of the different types of implants.
  • Consider the possibility of BIA-ALCL when you have a patient with late onset, persistent peri-implant seroma.
  • If you have a patient with suspected BIA-ALCL, refer her to an appropriate specialist for evaluation.
  • Develop an individualized treatment plan in coordination with the patient's multi-disciplinary care team.
  • Report all confirmed cases of ALCL in women with breast implants to the FDA.

Recommendations for Patients

  • Educate yourself about breast implants before agreeing to surgery.
  • Although it is rare, BIA-ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants. Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants.
  • If you have breast implants, there is no need to change your routine medical care and follow-up.
  • Follow your doctor's instructions on how to monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment.
  • Get routine mammography screening and ask for a technologist specifically trained in performing mammograms on patients with breast implants.
  • If you have silicone gel-filled breast implants, get periodic magnetic resonance imaging (MRI) to detect ruptures as recommended by your health care provider.

Related Information