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)
  N %1
Age (yrs) Median 53  
Range 25-91  
Not specified 72 20
Time from Implant to ALCL Diagnosis2 (yrs) Median 7  
Range 0-40  
Not specified 153 43
Implant Surface Textured 203 57
Smooth 28 8
Not specified 128 36
Implant Fill Silicone 186 52
Saline 126 35
Not specified 47 13
Reason for Implant Reconstruction 48 13
Aesthetic 81 23
Not specified/others 230 64
Presentation (breast)3 Seroma 158 44
Capsular contracture 21 6
Peri-implant mass 21 6
Others 46 13
Not specified/uncertain 144 40
Anaplastic lymphoma kinase (ALK) Positive 0 -
Negative 119 33
Not specified 240 67
CD30 Status4 Positive 120 33
Negative 0 -
Not specified 239 67

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: 03/21/2017
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