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

As of April 1, 2022, the Food and Drug Administration (FDA) has received a total of 1,130 US 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 April 1, 2022. 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 April 1, 2022 (N = 59)

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 MDRs*

Deaths as of 4/1/2022
(n=59)

n %a
Age at time of diagnosis (years) Median 52 -
Range 37-83 -
Not specified (# of reports) 34 58
Time from the last implant to diagnosis (years) Median 13 -
Range 1-22 -
Not specified (# of reports) 46 78
Implant Surface Textured 30 51
Smooth (with history of prior
textured implant surface)
1 2
Not specified 28 47
Implant Fill Silicone 18 30
Saline 13 22
Not specified 28 47
Reason for Implant Reconstruction 7 12
Augmentation 19 32
Not specified 33 56
Clinical presentation (breast)b Seroma 12 20
Breast swelling/pain 6 10
Capsular contracture 4 7
Peri-implant mass/lump 16 27
Others 7 12
Not specified 24 41
Anaplastic lymphoma kinase (ALK) Positive 0 0
Negative 13 22
Not specified 46 78
CD30 Statusc Positive 13 22
Negative 0 0
Not specified 46 78
Implant Manufacturer Allergan 34 58
Mentor 1 2
Unknown 24 41
Reporter Country: US or OUSd US 14 24
OUS 40 68
Not specified 5 8

a Percentage in terms of total 59 deaths as of 4/1/2022. There are no reports of deaths associated with tissue expanders.
b MDRs sometimes list more than one clinical presentation, e.g., seroma and peri-implant mass/lump, and more than one presentation may be counted.
c CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin's Lymphoma and BIA-ALCL.
d US/OUS is counted as the country reported in the narrative or the recorded reporter's country in the MedWatch form.
e Includes 1 case of B-Cell Lymphoma

Table 2: Summary of US and Global Cases Reported as MDRs as of April 1, 2022

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 1,130 unique ALCL cases reported as MDRs1

Unique ALCL Cases1 Cases as of 04/01/2022
(n=1,130)
n %a
Age at time of diagnosis (years) Median 53 -
Range 24-90 -
Not specified (# of reports) 407 36
Time from the last implant to diagnosis (years) Median 8 -
Range 0-34 -
Not specified (# of reports) 414 37
Implant Surface Textured 798 71
Smooth 37b 3
Not specified 295 26
Implant Fill Silicone 728 64
Saline 304 27
Not specified 98 9
Reason for Implant Reconstruction 170 15
Augmentation 173 15
Not specified 787 70
Clinical presentation (breast)c Seroma 551 49
Breast swelling/pain 256 23
Capsular contracture 152 13
Peri-implant mass/lump 119 11
Others 93 8
Not specified 358 32
Anaplastic lymphoma kinase (ALK)d Positive 0 0
Negative 444 39
Not specified 686 61
CD30 Statuse Positive 452 40
Negative 0 0
Not specified 678 60
Implant Manufacturerf Allergan 953 84
Mentor 67 6
Sientra 20 2
Other Manufacturer 10 1
Unknown Manufacturer 80 7
Reporter Country: US or OUSg US 505 45
  OUS 496-- 44
  Not specified 129 11

1 Patients with bilateral BIA-ALCL are counted as 2 cases of BIA-ALCL
a Percentage in terms of the total 1,130 MDRs as of 4/1/2022
b 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.
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 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.
e CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin's Lymphoma and BIA-ALCL.
f Other Manufacturers include: Bristol Myers Squib, Nagor, Polytech Silimed, Silimed and Sientra/Silimed.
g 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 4/1/22 update, there are 37 cases involving smooth implants, including 18 with an unknown prior history of implants, 8 with a history of at least one textured implant, 10 with a history of prior implants with unknown texture, and 1 with a history of one smooth implant and no known textured implant.
  • As of the 4/1/22 update, there are 8 individuals with bilateral ALCL, or ALCL affecting both breasts.  These are counted as 16 unique ALCL cases. 
  • As of 4/1/2022, there was one MDR 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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