Through February 1, 2017, the FDA received a total of 359 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including nine deaths. There are 231 reports with data on surface information at the time of reporting. Of these, 203 were on textured implants and 28 on smooth implants. There are 312 reports with data on implant fill type. Of these, 186 reported the use of silicone gel-filled implants, and 126 reported the use of saline-filled implants.
The table below summarizes the data that the FDA has received as of February 1, 2017.
|All MDR Reports (as of 2/1/2017)|
|Time from Implant to ALCL Diagnosis2 (yrs)||Median||7|
|Reason for Implant||Reconstruction||48||13|
|Anaplastic lymphoma kinase (ALK)||Positive||0||-|
1 Percentage in terms of the total 359 MDRs
2 Includes both pathology report confirmed and unconfirmed pending ALCL Diagnoses.
3 MDRs occasionally list more than one clinical presentation, e.g. seroma and peri-implant mass, in which two presentations were counted.
4 CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and ALCL
Of note, while 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 an event 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 breast implants. Because of this, MDRs comprise only one of FDA's current postmarket surveillance efforts.