Medical Devices

Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma

Through February 1, 2017, the FDA received a total of 359 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including nine deaths. There are 231 reports with data on surface information at the time of reporting. Of these, 203 were on textured implants and 28 on smooth implants. There are 312 reports with data on implant fill type. Of these, 186 reported the use of silicone gel-filled implants, and 126 reported the use of saline-filled implants.

The table below summarizes the data that the FDA has received as of February 1, 2017.

Table 1: Patient/Case Characteristics
All MDR Reports (as of 2/1/2017)
Age (yrs)Median 53 
Range 25-91 
Not specified7220
Time from Implant to ALCL Diagnosis2 (yrs)Median7 
Not specified15343
Implant SurfaceTextured20357
Not specified12836
Implant FillSilicone18652
Not specified4713
Reason for ImplantReconstruction4813
Not specified/others23064
Presentation (breast)3Seroma15844
Capsular contracture216
Peri-implant mass216
Not specified/uncertain14440
Anaplastic lymphoma kinase (ALK)Positive0-
Not specified24067
CD30 Status4Positive12033
Not specified23967

1 Percentage in terms of the total 359 MDRs
2 Includes both pathology report confirmed and unconfirmed pending ALCL Diagnoses.
3 MDRs occasionally list more than one clinical presentation, e.g. seroma and peri-implant mass, in which two presentations were counted.
4 CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and ALCL

Of note, while the MDR system is a valuable source of information, this passive surveillance system has limitations, including incomplete, inaccurate, untimely, unverified, or biased data in the reports. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting, duplicate reporting of events, and the lack of information about the total number of breast implants. Because of this, MDRs comprise only one of FDA's current postmarket surveillance efforts.

Page Last Updated: 02/04/2018
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