Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma
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Medical Device Reporting Overview
The Medical Device Reporting (MDR) regulation (21 CFR Part 803) describes the FDA’s requirements for medical device manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
MDR is one of the postmarket surveillance tools the FDA uses to monitor the performance of all medical devices, including breast implants, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.
It is important to note that although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, duplicate reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. These reports, along with data from other sources, can provide critical information that helps improve patient safety.
Summary of the FDA’s MDR Review
In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL). Since then, the FDA has received a total of 1,380 MDRs from the U.S. and outside of the U.S. 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 this BIA-ALCL MDR data. The FDA sometimes receives more than one report for the same issue (duplicate reports). The data summarized represents identified unique cases, although many reports do not include sufficient information to ensure all the duplicate reports are excluded from the analysis.
Table 1: Summary of U.S. and Worldwide Deaths Reported in MDRs Received as of June 30, 2024 (64 Deaths)
Table 1 below includes a summary of the 64 U.S. and worldwide deaths reported in MDRs and literature reported as MDRs since the FDA first identified a possible association between breast implants and the development of ALCL in 2011. The data were organized by the factors considered in our analysis. Data from previous analysis are available here.
| ALCL Deaths from MDRs and Literature reported as MDRsa | Deaths as of 6/30/2024 | ||
|---|---|---|---|
| Number (n) | Percent of MDRs (%)b | ||
| Age at time of diagnosis (years) | Median | 54 | - |
| Range | 37-83 | - | |
| Not specified (# of reports) | 38 | 59 | |
| Time from the last implant to diagnosis (years) | Median | 9 | - |
| Range | 1-22 | - | |
| Not specified (# of reports) | 49 | 77 | |
| Implant Surface | Textured | 34 | 53 |
| Smooth (with history of prior textured implant surface) | 1 | 2 | |
| Not specified | 29 | 45 | |
| Implant Fill | Silicone | 21 | 33 |
| Saline | 15 | 23 | |
| Not specified | 28 | 44 | |
| Reason for Implant | Reconstruction | 7 | 11 |
| Augmentation | 20 | 31 | |
| Not specified | 37 | 58 | |
| Clinical presentation (breast)c | Seroma | 13 | 20 |
| Breast swelling/pain | 9 | 14 | |
| Capsular contracture | 4 | 6 | |
| Peri-implant mass/lump | 19 | 30 | |
| Other | 8 | 13 | |
| Not specified | 25 | 39 | |
| Anaplastic lymphoma kinase (ALK) | Positive | 0 | 0 |
| Negative | 16 | 25 | |
| Not specified | 48 | 75 | |
| CD30 Statusd | Positive | 16 | 25 |
| Negative | 0 | 0 | |
| Not specified | 48 | 75 | |
| Implant Manufacturer | Allergan | 38 | 59 |
| Mentor | 1 | 2 | |
| Unknown | 25 | 39 | |
| Reporter Country: US or OUSe | US | 17 | 27 |
| OUS | 42 | 66 | |
| Not specified | 5 | 8 | |
a Includes 1 case of B-Cell Lymphoma
b Percentage in terms of total 64 deaths as of 6/30/2024. 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 U.S. and Worldwide BIA-ALCL Cases Reported as MDRs as of June 30, 2024 (1380 Cases)
Table 2 is a summary of data from 1,380 U.S. and worldwide BIA-ALCL cases reported to the FDA in MDRs since the FDA first identified a possible association between breast implants and the development of ALCL in 2011. The data and the table were organized by the factors that we considered in our analysis. Note, patients with bilateral BIA-ALCL are counted as 2 cases of BIA-ALCL, for a total of 1,380 unique cases.
For the category of Implant Surface “Smooth”, of the 40 cases, there is one case of smooth implants and no known textured implant.
Many MDR reports contain incomplete information on the prior implant history of the patient. Therefore, these numbers are subject to change if we receive more details pertaining to previously reported cases.
| Unique ALCL Casesa | Cases as of 06/30/2024 (n=1,380) | ||
|---|---|---|---|
| Number (n) | Percent of MDRs (%)b | ||
| Age at time of diagnosis (years) | Median | 53 | - |
| Range | 24-90 | - | |
| Not specified (# of reports) | 524 | 38 | |
| Time from the last implant to diagnosis (years) | Median | 8 | - |
| Range | 0-40 | - | |
| Not specified (# of reports) | 507 | 37 | |
| Implant Surface | Textured | 1010 | 73 |
| Smooth | 40c | 3 | |
| Not specified | 330 | 24 | |
| Implant Fill | Silicone | 922 | 67 |
| Saline | 352 | 26 | |
| Not specified | 106 | 8 | |
| Reason for Implant | Reconstruction | 220 | 16 |
| Augmentation | 223 | 16 | |
| Not specified | 937 | 68 | |
| Clinical presentation (breast)d | Seroma | 666 | 48 |
| Breast swelling/pain | 366 | 27 | |
| Capsular contracture | 200 | 14 | |
| Peri-implant mass/lump | 147 | 11 | |
| Others | 163 | 12 | |
| Not specified | 410 | 30 | |
| Anaplastic lymphoma kinase (ALK)e | Positive | 0 | 0 |
| Negative | 576 | 42 | |
| Not specified | 804 | 58 | |
| CD30 Statusf | Positive | 599 | 43 |
| Negative | 0 | 0 | |
| Not specified | 781 | 57 | |
| Implant Manufacturerg | Allergan | 1182 | 86 |
| Mentor | 75 | 5 | |
| Sientra | 29 | 2 | |
| Other Manufacturer | 10 | 1 | |
| Unknown Manufacturer | 83 | 6 | |
| Reporter Country: US or OUSh | US | 588 | 43 |
| OUS | 650 | 47 | |
| Not specified | 142 | 10 | |
a Patients with bilateral BIA-ALCL are counted as 2 cases of BIA-ALCL
b Percentage in terms of the total 1,380 MDRs as of 6/30/2024
c In the 40 cases of patients with smooth implants, 18 have unknown prior history of implants, 8 have a history of at least one textured implant, 13 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 BIA-ALCL is characterized as an ALK- lymphoma, so 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
- There are 9 patients with bilateral (affecting both breasts) BIA-ALCL. These are counted as 18 BIA-ALCL cases.
- There are 5 MDRs that reported BIA-ALCL under the product code of a tissue expander, LCJ, and not the breast implant product code, 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.
Previous Reports
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.
| ALCL Deaths from MDRs and Literature reported as MDRsa | Deaths as of 6/30/2023 | ||
|---|---|---|---|
| Number (n) | Percent of MDRs (%)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.
| Unique ALCL Casesa | Cases as of 06/30/2023 (n=1,264) | ||
|---|---|---|---|
| Number (n) | Percent of MDRs (%)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 | 1 | |
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 BIA-ALCL is characterized as an ALK- lymphoma, so 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.
These data are a tabulation of global deaths reported in MDRs and literature reported as MDRs. The data is stratified by the factors that we considered in our analysis.
Table 1. Summary of Unique Deaths
| ALCL Deaths from MDRs and Literature reported as MDRs* | Deaths as of 4/1/2022 | ||
|---|---|---|---|
| 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 textured | 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)c | 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 Statusd | 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 OUSe | 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
These data are a tabulation of all US and global BIA-ALCL cases reported to the FDA in MDRs. The data is stratified by factors we considered in our analysis.
Table 2. Summary of 1,130 unique ALCL cases.
| 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 BIA-ALCL is characterized as an ALK- lymphoma, so 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.
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.
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.
These data are a tabulation of global deaths reported in MDRs and literature reported as MDRs. The data is stratified by the factors that we considered in our analysis.
Table 1. Summary of Unique Deaths
| ALCL Deaths from MDRs and Literature reported as MDRs* | Deaths as of 1/5/2020 | ||
|---|---|---|---|
| n | %b | ||
| Age at time of diagnosis (years) | Median | 53 | - |
| Range | 37-83 | - | |
| Not specified (# of reports) | 15 | 42 | |
| Time from the last implant to diagnosis (years) | Median | 10 | - |
| Range | 1-20 | - | |
| Not specified (# of reports) | 25 | 69 | |
| Implant Surface | Textured | 16 | 44 |
| Smooth (with history of prior textured implant surface) | 1 | 3 | |
| Not specified | 19 | 53 | |
| Implant Fill | Silicone | 15 | 42 |
| Saline | 10 | 28 | |
| Not specified | 11 | 31 | |
| Reason for Implant | Reconstruction | 7 | 19 |
| Augmentation | 17 | 47 | |
| Not specified | 12 | 33 | |
| Clinical presentation (breast)c | Seroma | 8 | 22 |
| Breast swelling/pain | 4 | 11 | |
| Capsular contracture | 2 | 6 | |
| Peri-implant mass/lump | 15 | 42 | |
| Other | 7 | 19 | |
| Not specified | 7 | 19 | |
| Anaplastic lymphoma kinase (ALK) | Positive | 0 | 0 |
| Negative | 12 | 33 | |
| Not specified | 24 | 67 | |
| CD30 Statusd | Positive | 12 | 33 |
| Negative | 0 | 0 | |
| Not specified | 24 | 67 | |
| Implant Manufacturer | Allergan | 15 | 42 |
| Mentor | 1 | 3 | |
| Unknown | 20 | 56 | |
| Reporter Country: US or OUSe | US | 13 | 36 |
| OUS | 23 | 64 | |
| Not specified | 0 | 8 | |
a Percentage in terms of the total 33 deaths as of 7/6/2019. There are no reports of deaths associated with tissue expanders.
b Percentage in terms of the total 36 deaths as of 1/5/2020. 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.
* Includes 1 case of B-Cell Lymphoma
These data are a tabulation of global deaths reported in MDRs and literature reported as MDRs. The data is stratified by the factors that we considered in our analysis.
Table 2. Summary of 733 unique ALCL cases
| Unique ALCL Cases1 | Deaths as of 1/5/2020 | ||
|---|---|---|---|
| n | %b | ||
| Age at time of diagnosis (years) | Median | 53 | - |
| Range | 24-90 | - | |
| Not specified (# of reports) | 237 | 32 | |
| Time from the last implant to diagnosis (years) | Median | 8 | - |
| Range | 0-34 | - | |
| Not specified (# of reports) | 226 | 31 | |
| Implant Surface | Textured | 496 | 68 |
| Smooth | 28c | 4 | |
| Not specified | 209 | 28 | |
| Implant Fill | Silicone | 447 | 61 |
| Saline | 248 | 34 | |
| Not specified | 38 | 5 | |
| Reason for Implant | Reconstruction | 127 | 17 |
| Augmentation | 118 | 16 | |
| Not specified | 488 | 67 | |
| Clinical presentation (breast)d | Seroma | 369 | 50 |
| Breast swelling/pain | 191 | 26 | |
| Capsular contracture | 96 | 13 | |
| Peri-implant mass/lump | 103 | 14 | |
| Other | 64 | 9 | |
| Not specified | 207 | 28 | |
| Anaplastic lymphoma kinase (ALK)e | Positive | 0 | 0 |
| Negative | 298 | 41 | |
| Not specified | 435 | 59 | |
| CD30 Statusf | Positive | 289 | 39 |
| Negative | 0 | 0 | |
| Not specified | 444 | 61 | |
| Implant Manufacturer | Allergan*includes McGhan, Inamed | 620 | 85 |
| Mentor | 50 | 7 | |
| Sientra | 10 | 1 | |
| Other Manufacturerg | 6 | 1 | |
| Unknown Manufacturer | 47 | 6 | |
| Reporter Country: US or OUSh | US | 384 | 52 |
| OUS | 334 | 46 | |
| Not specified | 15 | 2 | |
1 Patients with bilateral BIA-ALCL are counted as 2 cases of BIA-ALCL.
a Percentage in terms of the total 733 MDRs as of 1/5/2020.
b In the 28 cases of patients with smooth implants,10 have unknown prior history of implants, 8 have a history of at least one textured implant, 9 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 In the 28 cases of smooth implants, 10 have unknown prior history of implants, 8 have a history of at least one textured implant, 9 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 do not contain information, or contain incomplete information, on the prior implant history of the patient. Therefore, this section may be updated as new information emerges. As of January 5, 2020, there are no reports of cases associated with tissue expanders.
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 BIA-ALCL is characterized as an ALK- lymphoma, so 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.
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.
These data are a tabulation of global deaths reported in MDRs and literature reported as MDRs submitted to the FDA. We excluded apparent duplicates. The data is stratified by factors that we considered in our analysis.
| ALCL Deaths from MDRs and Literature reported as MDRs* | Deaths through 7/6/19 (n=33) | ||||
|---|---|---|---|---|---|
| n | %a | ||||
| Age at time of diagnosis (years) | Median | 52 | |||
| Range | 37-83 | ||||
| Not specified (# of reports) | 13 | 39 | |||
| Time from the last implant to diagnosis (years) | Median | 9 | |||
| Range | 1-20 | ||||
| Not specified (# of reports) | 23 | 70 | |||
| Implant Surface | Textured | 15 | 48 | ||
| Smooth* history of textured | 1 | 3 | |||
| Not specified | 17 | 48 | |||
| Implant Fill | Silicone | 14 | 42 | ||
| Saline | 8 | 24 | |||
| Not specified | 11 | 33 | |||
| Reason for Implant | Reconstruction | 5 | 15 | ||
| Augmentation | 17 | 52 | |||
| Not specified | 11 | 33 | |||
| Clinical presentation (breast)b | Seroma | 6 | 18 | ||
| Breast swelling/pain | 3 | 9 | |||
| Capsular contracture | 1 | 3 | |||
| Peri-implant mass/lump | 13 | 39 | |||
| Others | 7 | 21 | |||
| Not specified | 7 | 21 | |||
| Anaplastic lymphoma kinase (ALK) | Positive | 0 | 0 | ||
| Negative | 12 | 36 | |||
| Not specified | 21 | 64 | |||
| CD30 Statusc | Positive | 12 | 36 | ||
| Negative | 0 | 0 | |||
| Not specified | 21 | 64 | |||
| Implant manufacturer | Allergan | 12 | 36 | ||
| Mentor | 1 | 3 | |||
| Unknown | 20 | 61 | |||
| Reporter country: US or OUSd | US | 12 | 36 | ||
| OUS | 21 | 64 | |||
| Not specified | 0 | 0 | |||
a Percentage in terms of the total 33 deaths. 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, in which two presentations were 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.
* Includes 1 case of B-Cell Lymphoma
These data are a tabulation of US and global BI-ALCL cases reported to the FDA in MDRs. We excluded apparent duplicates. The data is stratified by factors we considered in our analysis.
| Unique ALCL cases1 | Cases through 9/30/18 (n=457) | Cases through 7/6/19 (n=573) | |||
|---|---|---|---|---|---|
| n | %a | n | %b | ||
| Age at time of diagnosis (years) | Median | 53 | - | 53 | - |
| Range | 27-90 | - | 27-90 | - | |
| Not specified (# of reports) | 111 | 24 | 161 | 28 | |
| Time from the last implant to diagnosis (years) | Median | 9 | - | 8 | - |
| Range | 0-34 | - | 0-34 | - | |
| Not specified (# of reports) | 110 | 24 | 169 | 29 | |
| Implant surface | Textured | 310 | 68 | 385 | 67 |
| Smooth | 24 | 5 | 26c | 5 | |
| Not specified | 123 | 27 | 162 | 28 | |
| Implant fill | Silicone | 274 | 60 | 343 | 60 |
| Saline | 183 | 40 | 197 | 34 | |
| Not specified | 0 | 0 | 33 | 6 | |
| Reason for implant | Reconstruction | 108 | 24 | 115 | 20 |
| Augmentation | 104 | 23 | 111 | 19 | |
| Not specified | 245 | 54 | 347 | 61 | |
| Clinical presentation (breast)d | Seroma | 266 | 58 | 302 | 53 |
| Breast swelling/pain | 135 | 30 | 150 | 26 | |
| Capsular contracture | 69 | 15 | 73 | 13 | |
| Peri-implant mass/lump | 82 | 18 | 94 | 16 | |
| Others | 43 | 9 | 56 | 10 | |
| Not specified | 105 | 23 | 147 | 26 | |
| Anaplastic lymphoma kinase (ALK) | Positive | 0 | 0 | 0 | 0 |
| Negative | 229 | 50 | 255 | 45 | |
| Not specified | 228 | 50 | 318 | 55 | |
| CD30 statuse | Positive | 215 | 47 | 246 | 43 |
| Negative | 0 | 0 | 0 | 0 | |
| Not specified | 242 | 53 | 327 | 57 | |
| Implant manufacturer | Allergan* includes McGhan, Inamed | 386 | 84 | 481 | 84 |
| Mentor | 36 | 8 | 38 | 7 | |
| Sientra | 2 | 0.4 | 6 | 1 | |
| Other Manufacturerf | 5 | 1 | 6 | 1 | |
| Unknown Manufacturer | 28 | 6 | 42 | 7 | |
| Reporter country: US or OUSg | US | 276 | 48 | 320 | 56 |
| OUS | 181 | 32 | 253 | 44 | |
| Not specified | 0 | 0 | 0 | 0 | |
1Patients with bilateral BIA-ALCL are counted as 2 cases of BIA-ALCL.
a Percentage in terms of the total 457 MDRs.
b Percentage in terms of the total 573 MDRs.
c In the 26 cases of smooth implants, 12 have unknown prior history of implants, 7 have a history of textured implants, and 7 have a history of prior implants with an unknown texture. There are no reports of cases associated with tissue expanders.
d MDRs sometimes list more than one clinical presentation, e.g., seroma and peri-implant mass/lump, in which two presentations were counted.
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.
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 to more actively leverage clinical experience with medical devices in the National Evaluation System for health Technology (NEST).