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 FDA knew of so few cases of this disease that it was not possible 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 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. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data. 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.
We continue to collect and evaluate information about ALCL in women with breast implants. 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) (a collaborative effort with the American Society of Plastic Surgeons (ASPS) and the Plastic Surgery Foundation (PSF).
- Review information that breast implant manufacturers include about BIA-ALCL in their patient and health care professional labeling.
In 2016, there were several advances in the description of the disease and treatment recommendations. These are described below:
- The World Health Organization recognized breast implant-associated anaplastic large cell lymphoma as a rare T-cell lymphoma that can develop following breast implants.
- Professional organizations including the Plastic Surgery Foundation and the National Comprehensive Cancer Network (NCCN) published information to help physicians understand the disease and provide diagnosis and treatment.
- Regulatory bodies outside the United States issued communications on BIA-ALCL.
- The Australian Therapeutic Goods Administration (TGA) reported a detailed analysis of the 46 confirmed cases of BIA-ALCL in Australia, including 3 deaths. TGA estimated the risk of developing BIA-ALCL to be between 1-in-1000 and 1-in-10,000 women with breast implants.
- The French National Agency for Medicines and Health Products Safety (ANSM) asked manufacturers of textured breast implants to perform biocompatibility testing (testing to determine how living tissues react to textured implants) and to report their findings within a year.
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. Most of the reports contained no information about the surface textures of any previous implants. In addition, 312 of the 359 reports included information on implant fill types. Of these, 186 reported implants filled with silicone gel and 126 reported implants filled with saline.
It is important to note that details on breast implant surface and fill type are limited. While the MDR system is a valuable source of information, it may contain incomplete, inaccurate, untimely, unverified, or biased data. Over time, we may gather more information about a report and thus the numbers listed above may change.
In addition, the incidence or prevalence of an event cannot be determined from the MDR reporting system due to potential under-reporting, duplicate reporting of events, and the lack of information about the total number of breast implants.
A significant body of medical literature has been published since our 2011 report, including additional case histories and comprehensive reviews of the natural history and long-term outcomes of the disease. Most of the cases in the literature reports describe a history of the use of textured implants. Several recent journal articles explore the risk factors for BIA-ALCL, including the methods used to create surface texture of the implant and the role of biofilm in causing disease, among others. All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants. Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.
Health Care Providers:
If you have patients with breast implants, you should continue to provide them routine care and support. BIA-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.
- 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. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, refer her to an appropriate specialist for evaluation. When testing for BIA-ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-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.
- Develop an individualized treatment plan in coordination with the patient's multi-disciplinary care team. Consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation or the National Comprehensive Cancer Network (NCCN) when choosing your treatment approach.
- 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.
- Submit case reports of BIA-ALCL to the PROFILE Registry to contribute to a better understanding of the causes and treatments of BIA-ALCL.
Educate yourself about breast implants before agreeing to surgery. Breast implants approved in the U.S. can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells). Additional information is available on FDA's Breast Implants website.
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. BIA-ALCL is rare. Although not specific to BIA-ALCL, you should follow standard medical recommendations including:
- 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. 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.
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.
We will continue to report on significant findings as new information and analyses become available.
Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses[ARCHIVED] Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: FDA Safety Communication[ARCHIVED]
- FDA: Breast Implants