Table 3.

Summary of epidemiological studies on BIA-ALCL

Author	Year	Country	Study design	Study period	Level of evidence	BIA-ALCL cases	Sample size	Patient specific incidence	Standardized patient specific incidence	Implant specific incidence	Standardized implant specific incidence	Incidence rate (person-years)	Quality assessment (max score 10)
Largent et al.	2011	USA	Retrospective	1994–2007	II	3	NR	NR	N/A	NR	N/A	1.46 per 100,000	6
McGuire et al.	2016	USA	Prospective cohort	-2014	II	4 initially (now 8)	17,656	1:2,207 Allergan	0.45 per 1,000 Allergan	NR	N/A	NR	8
Cordeiro et al.	2020	USA	Retrospective cohort	1992–2019	III	10	3,456	1:355	2.81 per 1,000	1:602 Allergan	1.66 per 1,000 Allergan	NR	5
Nelson et al.	2020	USA	Retrospective cohort	1991–2017	III	11	9,373	1:559	1.79 per 1,000	1:871 Allergan	1.15 per 1,000 Allergan	NR	7
De Boer et al.	2018	The Netherlands	Retrospective cohort	1990–2016	III	43	3,000	1:6,920 at 75 years of age	0.14 per 1,000	NR	N/A	NR	8
Campanale et al.	2018	Italy	Retrospective cohort	2015–2017	III	22	10,000,000	2.8 per 100,000	0.028 per 1,000	NR	N/A	NR	6
Loch-Wilkinson et al.	2019	Australia	Retrospective	2015–2019	III	104	?	NR	N/A	1:9,457 Silimed; 1:36,730 Mentor	0.11 per 1,000 Silimed; 0.03 per 1,000 Mentor	NR	7
Doren et al.	2018	USA	Case series	1996–2015	IV	100	3,000,000	NR	N/A	1:8,500 Allergan; 1:51,000 Mentor	0.12 per 1,000 Allergan; 0.02 per 1,000 Mentor	2.03 per million; (0.203 per 100,000)	8

BIA-ALCL, breast implant-associated anaplastic large cell lymphoma.