Department of Plastic and Reconstructive Surgery, Yeungnam University College of Medicine, Daegu, Korea
Copyright © 2021 Yeungnam University College of Medicine
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Conflicts of interest
No potential conflict of interest relevant to this article was reported.
ALCL deaths from MDRs and literature reported as MDRsa) |
Deaths through 7/6/2019 (n=33) |
||
---|---|---|---|
n | %b) | ||
Age at time of diagnosis (yr) | Median | 52 | |
Range | 37–83 | ||
Not specified (no. of reports) | 13 | 39 | |
Time from the last implant to diagnosis (yr) | Median | 9 | |
Range | 1–20 | ||
Not specified (no. of reports) | 23 | 70 | |
Implant surface | Textured | 15 | 48 |
Smootha) with 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)c) | 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 | Positive | 0 | 0 |
Negative | 12 | 36 | |
Not specified | 21 | 64 | |
CD30 statusd) | 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 OUSe) | US | 12 | 36 |
OUS | 21 | 64 | |
Not specified | 0 | 0 |
US, the United States; MDR, medical device report; ALCL, associated anaplastic large-cell lymphoma; OUS, outside the US.
a)Includes one case of B-cell lymphoma.
b)Percentage in terms of the total 33 deaths. 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, in which two presentations were counted.
d)CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s lymphoma and breast implant-ALCL.
e)US/OUS is counted as the country reported in the narrative or the recorded reporter’s country in the MedWatch form.
Adapted from the materials of U.S. Food and Drug Administration [6].
Unique ALCL casesa) |
Cases through 9/30/2018 (n=457) |
Cases through 7/6/2019 (n=573) |
|||
---|---|---|---|---|---|
n | %b) | n | %c) | ||
Age at time of diagnosis (yr) | Median | 53 | - | 53 | - |
Range | 27–90 | - | 27–90 | - | |
Not specified (no. of reports) | 111 | 24 | 161 | 28 | |
Time from the last implant to diagnosis (yr) | Median | 9 | - | 8 | - |
Range | 0–34 | - | 0–34 | - | |
Not specified (no. of reports) | 110 | 24 | 169 | 29 | |
Implant surface | Textured | 310 | 68 | 385 | 67 |
Smooth | 24 | 5 | 26d) | 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)e) | 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 | Positive | 0 | 0 | 0 | 0 |
Negative | 229 | 50 | 255 | 45 | |
Not specified | 228 | 50 | 318 | 55 | |
CD30 statusf) | 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 manufacturerg) | 5 | 1 | 6 | 1 | |
Unknown manufacturer | 28 | 6 | 42 | 7 | |
Reporter country: US or OUSh) | US | 276 | 48 | 320 | 56 |
OUS | 181 | 32 | 253 | 44 | |
Not specified | 0 | 0 | 0 | 0 |
US, the United States; MDR, medical device report; ALCL, associated anaplastic large-cell lymphoma; OUS, outside the US.
a)Patients with bilateral breast implant (BIA)-ALCL are counted as two cases of BIA-ALCL.
b)Percentage in terms of the total 457 MDRs.
c)Percentage in terms of the total 573 MDRs.
d)In the 26 cases of smooth implants, 12 have unknown prior history of implants, seven have a history of textured implants, and seven have a history of prior implants with an unknown texture. There are no reports of cases associated with tissue expanders.
e)MDRs sometimes list more than one clinical presentation, e.g., seroma and peri-implant mass/lump, in which two presentations were counted.
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.
Adapted from the materials of U.S. Food and Drug Administration [6].
ALCL deaths from MDRs and literature reported as MDRs |
Deaths through 7/6/2019 (n=33) |
||
---|---|---|---|
n | % |
||
Age at time of diagnosis (yr) | Median | 52 | |
Range | 37–83 | ||
Not specified (no. of reports) | 13 | 39 | |
Time from the last implant to diagnosis (yr) | Median | 9 | |
Range | 1–20 | ||
Not specified (no. of reports) | 23 | 70 | |
Implant surface | Textured | 15 | 48 |
Smooth |
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) |
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 | Positive | 0 | 0 |
Negative | 12 | 36 | |
Not specified | 21 | 64 | |
CD30 status |
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 OUS |
US | 12 | 36 |
OUS | 21 | 64 | |
Not specified | 0 | 0 |
Unique ALCL cases |
Cases through 9/30/2018 (n=457) |
Cases through 7/6/2019 (n=573) |
|||
---|---|---|---|---|---|
n | % |
n | % |
||
Age at time of diagnosis (yr) | Median | 53 | - | 53 | - |
Range | 27–90 | - | 27–90 | - | |
Not specified (no. of reports) | 111 | 24 | 161 | 28 | |
Time from the last implant to diagnosis (yr) | Median | 9 | - | 8 | - |
Range | 0–34 | - | 0–34 | - | |
Not specified (no. of reports) | 110 | 24 | 169 | 29 | |
Implant surface | Textured | 310 | 68 | 385 | 67 |
Smooth | 24 | 5 | 26 |
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) |
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 | Positive | 0 | 0 | 0 | 0 |
Negative | 229 | 50 | 255 | 45 | |
Not specified | 228 | 50 | 318 | 55 | |
CD30 status |
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 manufacturer |
5 | 1 | 6 | 1 | |
Unknown manufacturer | 28 | 6 | 42 | 7 | |
Reporter country: US or OUS |
US | 276 | 48 | 320 | 56 |
OUS | 181 | 32 | 253 | 44 | |
Not specified | 0 | 0 | 0 | 0 |
US, the United States; MDR, medical device report; ALCL, associated anaplastic large-cell lymphoma; OUS, outside the US. Includes one case of B-cell lymphoma. Percentage in terms of the total 33 deaths. There are no reports of deaths associated with tissue expanders. MDRs sometimes list more than one clinical presentation, e.g., seroma and peri-implant mass/lump, in which two presentations were counted. CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s lymphoma and breast implant-ALCL. US/OUS is counted as the country reported in the narrative or the recorded reporter’s country in the MedWatch form. Adapted from the materials of U.S. Food and Drug Administration [
US, the United States; MDR, medical device report; ALCL, associated anaplastic large-cell lymphoma; OUS, outside the US. Patients with bilateral breast implant (BIA)-ALCL are counted as two cases of BIA-ALCL. Percentage in terms of the total 457 MDRs. Percentage in terms of the total 573 MDRs. In the 26 cases of smooth implants, 12 have unknown prior history of implants, seven have a history of textured implants, and seven have a history of prior implants with an unknown texture. There are no reports of cases associated with tissue expanders. MDRs sometimes list more than one clinical presentation, e.g., seroma and peri-implant mass/lump, in which two presentations were counted. CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s lymphoma and BIA-ALCL. Other manufacturers include: Bristol Myers Squib, Nagor, Polytech Silimed, Silimed, and Sientra/Silimed. 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. Adapted from the materials of U.S. Food and Drug Administration [