Medical Devices

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

As of September 30, 2018, the Food and Drug Administration (FDA) has received a total of 660 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This total includes all MDRs the FDA retrieved with any mention of "ALCL" or other spelling variations (for example, "anaplastic lymphoma," "large cell lymphoma") in the event narrative. BIA-ALCL MDRs are counted for those with a diagnosed or treated as ALCL, or confirmed pathology/cytology test, or ALK or CD30 biomarkers.

The tables below summarize both raw and unique BIA-ALCL MDR data that the FDA received as of September 30, 2018. However, the FDA believes that the data in Table 2 more accurately reflects the number of MDR reports of unique BIA-ALCL cases (457) and deaths (9). Additionally, it is crucial to understand that due to under-reporting and missing data, the FDA is unable to confirm whether this dataset reflects the distribution of all BIA-ALCL cases. 

Table 1: Summary of Raw MDR Data Received as of September 30th, 2018 (N = 660)

Table 1 presents MDR data as originally received and tabulated as of September 30, 2018. Since September 30, 2017, 246 new MDRs were received, resulting in a cumulative total of 660 MDRs for BIA-ALCL, including death reports representing 9 patients.

The MDR system provides the FDA with timely information on medical device performance from patients, providers, and manufacturers. However, reports may contain duplicate, incomplete, inaccurate, unverified, or biased data, as well as revisions to the original information.

Summary of Raw MDR Data Received as of September 30th, 2018 (N = 660)

 n%a
Age at time of diagnosis (years)Median53-
Range24-90-
Not specified (# of reports)24036
Time from the last implant to diagnosisa (years)Median8.5-
Range0-44-
Not specified (# of reports)23135
Implant SurfaceTextured42564
Smooth396
Not specified19630
Implant FillSilicone39960
Saline26039
Not specified10
Reason for ImplantReconstruction11918
Augmentation12519
Not specified41663
Clinical presentation (breast)cSeroma35053
Breast swelling/pain18828
Capsular contracture7511
Peri-implant mass/lump8513
Others22634
Not specified18728
Anaplastic lymphoma kinase (ALK)Positive0 0
Negative23936
Not specified42164
CD30 StatusdPositive23936
Negative0 0
Not specified42164

a Percentage in terms of the total 660 MDRs.
b Includes physician-, pathology-, cytology-, or biomarker-confirmed diagnosis
c MDRs sometimes list more than one clinical presentation, e.g. seroma and peri-implant mass/lump, in which two presentations were counted.
d CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin's Lymphoma and BIA-ALCL.

Table 2: Summary of Filtered MDR Data as of September 30, 2018 (N=457)

Although the FDA received 660 total BIA-ALCL related MDRs, many MDRs were identified as duplicate reports, including additional follow-up reports that were submitted to the FDA. To fact check the raw data provided in Table 1 to only provide unique MDR ALCL reports, the FDA removed the duplicate reports, and considered additional information received at the follow-up reports. 

The filtered data in Table 2 reflects a total of 457 unique MDRs for BIA-ALCL. From these MDRs, 9 patient deaths were identified. The FDA identified 334 reports that provided information on the implant surface. Of these, 310 concerned textured implants and 24 concerned smooth implants. All 457 reports included the implant fill type. There were 274 reports on silicone gel-filled implants, and 183 reports on saline-filled implants.

Summary of Filtered MDR Data as of September 30, 2018 (N=457)

 n%a
Age at time of diagnosis (yrs)Median53-
Range27-90-
Not specified (# of reports)11124
Time from the last implant to diagnosisb (yrs)Median9.0-
Range0-34-
Not specified (# of reports)11024
Implant SurfaceTextured31068
Smooth245
Not specified12327
Implant FillSilicone27460
Saline18340
Not specified00
Reason for ImplantReconstruction10824
Augmentation10423
Not specified24554
Clinical presentation (breast)cSeroma26658
Breast swelling/pain13530
Capsular contracture6915
Peri-implant mass/lump8218
Rupture/deflated5412
Others439
Not specified10523
Anaplastic lymphoma kinase (ALK)Positive00
Negative22950
Not specified22850
CD30 StatusdPositive21547
Negative0-
Not specified24253

a Percentage in terms of the total 457 MDRs.
b Includes physician-, pathology-, cytology-, or biomarker-confirmed diagnosis
c MDRs sometimes list more than one clinical presentation, e.g. seroma and peri-implant mass/lump, in which two presentations were counted.
d CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin's Lymphoma and BIA-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 BIA-ALCL 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: 03/22/2019
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