U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Implants and Prosthetics
  5. Breast Implants
  6. Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma
  1. Implants and Prosthetics

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

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) Median 53 -
Range 24-90 -
Not specified (# of reports) 240 36
Time from the last implant to diagnosisa (years) Median 8.5 -
Range 0-44 -
Not specified (# of reports) 231 35
Implant Surface Textured 425 64
Smooth 39 6
Not specified 196 30
Implant Fill Silicone 399 60
Saline 260 39
Not specified 1 0
Reason for Implant Reconstruction 119 18
Augmentation 125 19
Not specified 416 63
Clinical presentation (breast)c Seroma 350 53
Breast swelling/pain 188 28
Capsular contracture 75 11
Peri-implant mass/lump 85 13
Others 226 34
Not specified 187 28
Anaplastic lymphoma kinase (ALK) Positive 0  0
Negative 239 36
Not specified 421 64
CD30 Statusd Positive 239 36
Negative 0  0
Not specified 421 64

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) Median 53 -
Range 27-90 -
Not specified (# of reports) 111 24
Time from the last implant to diagnosisb (yrs) Median 9.0 -
Range 0-34 -
Not specified (# of reports) 110 24
Implant Surface Textured 310 68
Smooth 24 5
Not specified 123 27
Implant Fill Silicone 274 60
Saline 183 40
Not specified 0 0
Reason for Implant Reconstruction 108 24
Augmentation 104 23
Not specified 245 54
Clinical presentation (breast)c Seroma 266 58
Breast swelling/pain 135 30
Capsular contracture 69 15
Peri-implant mass/lump 82 18
Rupture/deflated 54 12
Others 43 9
Not specified 105 23
Anaplastic lymphoma kinase (ALK) Positive 0 0
Negative 229 50
Not specified 228 50
CD30 Statusd Positive 215 47
Negative 0 -
Not specified 242 53

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.