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

As of June 30, 2023, the Food and Drug Administration (FDA) has received a total of 1264 U.S. and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This total includes all breast implant related MDRs the FDA received with any mention of "ALCL" or other spelling variations (for example, "anaplastic lymphoma," or "anaplastic") in the narrative text. In the data presented, BIA-ALCL MDRs are only counted for those reporting a diagnosis or treatment of ALCL, or confirmed pathology/cytology test, or Anaplastic Lymphoma Kinase negative (ALK-) and CD30 biomarkers rather than just mentioning ALCL.

The tables below summarize BIA-ALCL MDR data from the U.S. and worldwide that the FDA has received as of June 30, 2023. The data summarized represents identified unique cases, although many reports do not include sufficient information to ensure all duplicates are excluded.

Table 1: Summary of US and Global Deaths Reported in MDRs Received as of June 30, 2023 (N = 63)

These data are a tabulation of global deaths reported in MDRs and literature reported as MDRs. The data are stratified by the factors that we considered in our analysis.  Data from previous analysis are available here.

Table 1. Summary of Unique Deaths Reported as MDRs

ALCL Deaths from MDRs and Literature reported as MDRsa

Deaths as of 6/30/2023
(n=63)
n %b
Age at time of diagnosis (years) Median 54 -
Range 37-83 -
Not specified (# of reports) 37 59
Time from the last implant to diagnosis (years) Median 10 -
Range 1-22 -
Not specified (# of reports) 49 78
Implant Surface Textured 33 52
Smooth (with history of prior
textured implant surface)		 1 2
Not specified 29 46
Implant Fill Silicone 20 32
Saline 15 24
Not specified 28 44
Reason for Implant Reconstruction 7 11
Augmentation 20 32
Not specified 36 57
Clinical presentation (breast)c Seroma 13 21
Breast swelling/pain 9 14
Capsular contracture 4 6
Peri-implant mass/lump 19 30
Other 8 13
Not specified 24 38
Anaplastic lymphoma kinase (ALK) Positive 0 0
Negative 16 25
Not specified 47 75
CD30 Statusd Positive 16 25
Negative 0 0
Not specified 47 75
Implant Manufacturer Allergan 37 59
Mentor 1 2
Unknown 25 40
Reporter Country: US or OUSe US 16 25
OUS 42 67
Not specified 5 8

a Includes 1 case of B-Cell Lymphoma
b Percentage in terms of total 63 deaths as of 6/30/2023. Due to rounding, the total may not exactly equal 100%. There are no reports of deaths associated with tissue expanders.
c MDRs sometimes list more than one clinical presentation, e.g., seroma and peri-implant mass/lump, and more than one presentation may be counted.
d CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin's Lymphoma and BIA-ALCL.
e US/OUS is counted as the country reported in the narrative or the recorded reporter's country in the MedWatch form.

Table 2: Summary of US and Global Cases Reported as MDRs as of June 30, 2023 (N = 1264)

These data are a tabulation of all US and global BIA-ALCL cases reported to the FDA in MDRs. The data are stratified by factors we considered in our analysis.

For the category of implant surface, there is one case of BIA-ALCL in a patient with smooth implants; in this case, the history of other implants is unknown. It should be noted that many MDR reports contain incomplete information on the prior implant history of the patient. Therefore, these numbers are subject to change as we accumulate more details pertaining to previously reported cases.

Table 2. Summary of 1,264 unique ALCL cases reported as MDRsa

Unique ALCL Casesa Cases as of 06/30/2023
(n=1,264)
n %b
Age at time of diagnosis (years) Median 53 -
Range 24-90 -
Not specified (# of reports) 476 38
Time from the last implant to diagnosis (years) Median 8 -
Range 0-40 -
Not specified (# of reports) 475 38
Implant Surface Textured 918 73
Smooth 37c 3
Not specified 309 24
Implant Fill Silicone 829 66
Saline 329 26
Not specified 106 8
Reason for Implant Reconstruction 199 16
Augmentation 192 15
Not specified 873 69
Clinical presentation (breast)d Seroma 609 48
Breast swelling/pain 316 25
Capsular contracture 178 14
Peri-implant mass/lump 141 11
Others 139 11
Not specified 376 30
Anaplastic lymphoma kinase (ALK)e Positive 0 0
Negative 529 42
Not specified 735 58
CD30 Statusf Positive 538 43
Negative 0 0
Not specified 726 57
Implant Manufacturerg Allergan 1079 85
Mentor 71 6
Sientra 22 2
Other Manufacturer 10 1
Unknown Manufacturer 81 6
Reporter Country: US or OUSh US 552 44
  OUS 573 45
  Not specified 139 11

a Patients with bilateral BIA-ALCL are counted as 2 cases of BIA-ALCL
b Percentage in terms of the total 1,264 MDRs as of 6/30/2023
c In the 37 cases of patients with smooth implants,18 have unknown prior history of implants, 8 have a history of at least one textured implant, 10 have a history of prior implants with unknown texture, and 1 has a history of one smooth implant and no known textured implant. It should be noted that many MDR reports contain incomplete information on the prior implant history of the patient. Therefore, these numbers are subject to change as we accumulate more details pertaining to previously reported cases.
d MDRs sometimes list more than one clinical presentation, e.g., seroma and peri-implant mass/lump, and more than one presentation may be counted.
e As the World Health Organization categorizes BIA-ALCL as an ALK- lymphoma, reports of ALCL diagnosis with ALK+ pathology results are not included in this analysis.
f CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin's Lymphoma and BIA-ALCL.
g Other Manufacturers include: Bristol Myers Squib, Nagor, Polytech Silimed, Silimed and Sientra/Silimed.
h US/OUS is counted as the recorded reporter's country in the MedWatch form, or if the event was noted to be from a foreign source in box G3 of the MedWatch form. Please note that the reporter country may not reflect the country where the event occurred or the country where the device is marketed.

Certain Findings

  • As of the 6/30/2023 update, there are 8 individuals with bilateral ALCL, or ALCL affecting both breasts.  These are counted as 16 unique ALCL cases. 
  • As of 6/30/2023, there are 4 MDR's that reported BIA-ALCL under the product code of a tissue expander, LCJ, with no other device history given. The patient history, including whether there were prior breast implants or subsequent breast implants after the tissue expander, is unknown.

Although 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 patients who have breast implants. Because of this, MDRs comprise only one of FDA's current postmarket surveillance efforts.

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