Medical Devices

Anaplastic Large Cell Lymphoma (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. At that time, the Agency was aware of approximately 60 cases of ALCL in women with breast implants, out of approximately 5-10 million women who had received breast implants worldwide. This included 34 unique cases that were described in the medical literature from January 1, 1997 through May 21, 2010, and additional cases identified by international regulatory agencies, scientific experts and breast implant manufacturers. Based on this data, the FDA cautioned patients and health care providers that women with breast implants might have a very low but increased risk of developing ALCL.

The FDA also posted on this website a detailed analysis of the 34 cases of ALCL in women with breast implants, provided physicians with interim recommendations on identifying and confirming ALCL, and worked with breast implant manufacturers to include information regarding ALCL in the patient and physician labeling.

Because the FDA knew of so few cases of this disease, it was impossible to determine what factors increased the risk. In a report summarizing the Agency’s findings, we emphasized the need to gather additional information to better characterize ALCL in women with breast implants.

Since our 2011 report, we have continued to gather information about ALCL in women with breast implants.

In that time, we:

  • Received medical device reports (MDRs),
  • Reviewed the medical literature,
  • Exchanged information with other international regulators and scientific experts, and,
  • Initiated a collaborative effort with the American Society of Plastic Surgeons (ASPS) and the Plastic Surgery Foundation (PSF) to collect data through the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE Registry).

Medical Device Reports

From August 25, 2010 through September 10, 2015, the FDA received 258 MDRs, including those in our original report, of anaplastic large cell lymphoma in in women with breast implants , with reports of three deaths. Although the MDR system is a valuable source of information, it has limitations, including incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system due to potential under-reporting, duplicate reporting of events, and the lack of information about the total number of breast implants.

Medical Literature

A significant body of medical literature has been published since our last report, including additional case histories and comprehensive reviews of the natural history and long-term outcomes of the disease. Many of these papers now refer to the condition as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

Based on the information we have received and reviewed, our current estimate is that there have been 100-250 known cases of ALCL in women with breast implants worldwide. All of the information to date still suggests that women with breast implants may have a very low but increased risk of developing ALCL. We continue to reconcile the data between the various sources. We will continue to provide updated findings as new information and analyses become available.

Recommendations

After our review of information since our 2011 report, FDA recommends the same measures.

Health Care Providers:

If you have patients with breast implants, you should continue to provide them routine care and support. ALCL is a very rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.

Current recommendations include the steps below.

  • Consider the possibility of ALCL when you have a patient with late onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. If you have a patient with suspected ALCL, refer her to an appropriate specialist for evaluation. When testing for ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation (CD) and Anaplastic Lymphoma Kinase (ALK) markers.
  • Report all confirmed cases of ALCL in women with breast implants to the FDA. In some cases, the FDA may contact you for additional information. The FDA will keep the identities of the reporter and the patient confidential.
  • The Agency recommends also reporting to the PROFILE Registrydisclaimer icon where more comprehensive case data can be provided, which will help us have a better understanding of the ALCL etiology in women with breast implants.
  • Develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team. Because of the small number of cases worldwide and variety of available treatment options, there is no single defined consensus treatment regimen.

Patients:

If you have breast implants, there is no need to change your routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants. Although not specific to ALCL, you should follow standard medical recommendations including:

  • Monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment. For more information on self breast exams, visit MedlinePlus: Breast Self Exam.
  • Get routine mammography screening.
  • If you have silicone gel-filled breast implants, get periodic magnetic resonance imaging (MRI) to detect ruptures as recommended by your health care provider. The FDA-approved product labeling for silicone gel-filled breast implants states that the first MRI should occur three years after implant surgery and every two years thereafter.

If you do not currently have breast implants but are considering breast implant surgery, discuss the risks and benefits with your health care provider. You may also visit FDA’s Breast Implants website for additional information.

To improve our understanding of this rare finding, please continue to report all confirmed cases of ALCL in women with breast implants, with as much detail as possible, through FDA’s MedWatch Program.

Page Last Updated: 01/20/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.