Style 168 Textured, Round Saline-Filled Breast Implant, Style 163, 468, 363LF Textured, Anatomical Saline-Filled Breast Implant, Style 120, 115, and 110 Silicone - Filled Breast Implants - BioCell Round (2019-05-30)
- Starting date:
- May 30, 2019
- Posting date:
- June 7, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-70137
Last updated: 2019-06-07
Affected Products
- Style 168 Textured, Round Saline-Filled Breast Implant
- Style 163 Textured, Anatomical Saline-Filled Breast Implant
- Style 468 Textured, Anatomical Saline-Filled Breast Implant
- Style 363LF Textured, Anatomical Saline-Filled Breast Implant
- Style 120 Silicone - Filled Breast Implants - BioCell Round
- Style 115 Silicone - Filled Breast Implants - BioCell Round
- Style 110 Silicone - Filled Breast Implants - BioCell Round
Reason
Health Canada has suspended the licenses for Allergan's BioCell textured breast implants (the only macro-textured implants available in Canada), based upon the rare but serious risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), Allergan is voluntarily recalling Biocell breast implants as a precautionary measure.
Affected products
A. Style 168 Textured, Round Saline-Filled Breast Implant
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
168-120
168-150
168-180
168-210
168-240
168-270
168-300
168-330
168-360
168-390
168-420
168-450
168-480
168-510
168-550
168-600
168-650
168-700
168-750
168-800
Companies
- Manufacturer
-
Allergan, Inc.
2525 DUPONT DRIVE
Irvine
92612
California
UNITED STATES
B. Style 163 Textured, Anatomical Saline-Filled Breast Implant
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
163-360
163-440
163-530
163-655
163-780
Companies
- Manufacturer
-
Allergan, Inc.
2525 DUPONT DRIVE
Irvine
92612
California
UNITED STATES
C. Style 468 Textured, Anatomical Saline-Filled Breast Implant
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
468-195
468-230
468-270
468-300
468-350
468-380
468-450
468-495
468-560
468-620
Companies
- Manufacturer
-
Allergan, Inc.
2525 DUPONT DRIVE
Irvine
92612
California
UNITED STATES
D. Style 363LF Textured, Anatomical Saline-Filled Breast Implant
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
363LF-170
363LF-200
363LF-230
363LF-260
363LF-300
363LF-330
363LF-370
363LF-410
363LF-450
363LF-510
363LF-560
363LF-620
363LF-690
Companies
- Manufacturer
-
Allergan, Inc.
2525 DUPONT DRIVE
Irvine
92612
California
UNITED STATES
E. Style 120 Silicone - Filled Breast Implants - BioCell Round
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
120-180
120-220
120-260
120-300
120-340
120-400
120-440
120-500
120-550
120-600
120-650
Companies
- Manufacturer
-
Allergan, Inc.
2525 DUPONT DRIVE
Irvine
92612
California
UNITED STATES
F. Style 115 Silicone - Filled Breast Implants - BioCell Round
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
115-150
115-167
115-185
115-203
115-222
115-253
115-272
115-290
115-322
115-354
115-378
115-401
115-435
115-469
115-507
115-547
115-586
115-627
115-666
115-716
Companies
- Manufacturer
-
Allergan, Inc.
2525 DUPONT DRIVE
Irvine
92612
California
UNITED STATES
G. Style 110 Silicone - Filled Breast Implants - BioCell Round
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
110-090
110-120
110-150
110-180
110-210
110-240
110-270
110-300
110-330
110-360
110-390
110-420
110-450
110-480
110-510
Companies
- Manufacturer
-
Allergan, Inc.
2525 DUPONT DRIVE
Irvine
92612
California
UNITED STATES