Medical Devices

Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma

As of September 30, 2017, the FDA has received a total of 414 medical device reports (MDRs) of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including 9 deaths1. BIA-ALCL are counted for those with a confirmed pathology test, or ALK or CD30 biomarkers, or reported by health care professionals. There are 272 reports with data on surface information at the time of reporting. Of these, 242 were on textured implants and 30 on smooth implants. There are 413 reports with data on implant fill type. Of these, 234 reported the use of silicone gel-filled implants, and 179 reported the use of saline-filled implants.

The table below summarizes the data that the FDA has received as of September 30, 2017.

Table 1: Patient/Case Characteristics

All MDR Reports (as of 9/30/2017)

 

N

%2

Age at time of diagnosis (yrs)

Median

53

 

Range

24-90*

 

Not specified (# of reports)

174

42

Time from the last implant to diagnosis3 (yrs)

Median

8

 

Range

0-44

 

Not specified (# of reports)

173

42

Implant Surface4

Textured

242

60

Smooth

30

7

Not specified

142

34

Implant Fill

Silicone

234

56

Saline

179

43

Not specified

1

0.2

Reason for Implant

Reconstruction

58

14

Augmentation

88

21

Not specified

268

65

Clinical presentation (breast)5

Seroma

203

49

Breast swelling/pain

101

24

Capsular contracture

42

10

Peri-implant mass/lump

45

11

Others

141

34

Not specified/ uncertain

141

34

Anaplastic lymphoma kinase (ALK)

Positive

0

 -

Negative

124

30

Not specified

290

70

CD30 Status6

Positive

126

30

Negative

0

 -

Not specified

288

70

1 One of them mentioned BIA-ALCL and B-cell lymphoma.
2 Percentage in terms of the total 414 MDRs.
3 Includes both pathology or ALK or CD30 confirmed, and those reported by health care professionals.
4 5 of the 30 smooth cases had a reported history of prior implant(s), and the rest of them had not provided prior implant history.
5 MDRs occasionally list more than one clinical presentation, e.g. seroma and peri-implant mass/lump, in which two presentations were counted.
6 CD30 is a cell membrane protein associated with diagnosis of classic Hodgkin’s Lymphoma and BIA-ALCL.

*Upper range previously reported as 91. Updated based on additional information/analysis.

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.

Page Last Updated: 03/21/2018
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