As of January 5, 2020 , the Food and Drug Administration (FDA) has received a total of 733 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 January 5, 2020. 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 January 5, 2020 (N = 36)

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

^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

Table 2: Summary of US and Global Cases as of January 5, 2020 (N=733)

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 733 unique ALCL cases.

¹ Patients with bilateral BIA-ALCL are counted as 2 cases of BIA-ALCL.
^a Percentage in terms of the total 573 MDRs as of 7/6/2019.
^b Percentage in terms of the total 733 MDRs as of 1/5/2020.
^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 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  .
^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.