As of July 6, 2019, the Food and Drug Administration (FDA) has received a total of 573 US and global medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This total includes all MDRs the FDA received with any mention of "ALCL" or other spelling variations (for example, "anaplastic lymphoma," or "anaplastic") in the event narrative. BIA-ALCL MDRs are counted for those reporting a diagnosis or treatment of ALCL, or confirmed pathology/cytology test, or Anaplastic Lymphoma Kinase (ALK) and CD30 biomarkers.
The tables below summarize unique BIA-ALCL MDR data from the U.S. and worldwide that the FDA has received as of July 6, 2019.
Table 1: Summary of US and Global Deaths Reported in MDRs Received as of July 6th, 2019 (N = 33)
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 7/6/29 (n=33)|
|Age at time of diagnosis (years)||Median||52|
|Not specified (# of reports)||13||39|
|Time from the last implant to diagnosis (years)||Median||9|
|Not specified (# of reports)||23||70|
|Smooth* history of textured||1||3|
|Reason for Implant||Reconstruction||5||15|
|Clinical presentation (breast)b||Seroma||6||18|
|Anaplastic lymphoma kinase (ALK)||Positive||0||0|
|Reporter country: US or OUSd||US||12||36|
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
Table 2: Summary of US and Global Data as of July 6, 2019 (N=573)
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
|Cases through 7/6/19
|Age at time of diagnosis (years)||Median||53||-||53||-|
|Not specified (# of reports)||111||24||161||28|
|Time from the last implant to diagnosis (years)||Median||9||-||8||-|
|Not specified (# of reports)||110||24||169||29|
|Reason for implant||Reconstruction||108||24||115||20|
|Clinical presentation (breast)d||Seroma||266||58||302||53|
|Anaplastic lymphoma kinase (ALK)||Positive||0||0||0||0|
|Implant manufacturer||Allergan* includes McGhan, Inamed||386||84||481||84|
|Reporter country: US or OUSg||US||276||48||320||56|
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).