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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, breast, noninflatable, internal, silicone gel-filled
Regulation Description Silicone gel-filled breast prosthesis.
Definition Call for pmas to be filed by 7/9/91 per 56 fr 14627 on 4/10/91
Product CodeFTR
Regulation Number 878.3540
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
20 33 11 14 10 1

MDR Year MDR Reports MDR Events
2016 289 289
2017 927 927
2018 2635 2635
2019 21365 21365
2020 24231 24231
2021 6228 6228

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 24754 24754
Adverse Event Without Identified Device or Use Problem 15829 15829
Patient-Device Incompatibility 14086 14086
Device Appears to Trigger Rejection 2277 2277
Migration 1062 1062
Gel Leak 333 333
Insufficient Information 265 265
No Apparent Adverse Event 228 228
Appropriate Term/Code Not Available 199 199
Off-Label Use 170 170
Fluid Leak 148 148
Migration or Expulsion of Device 118 118
Break 103 103
Material Deformation 85 85
Material Discolored 71 71
Improper or Incorrect Procedure or Method 68 68
Leak/Splash 59 59
Device Contamination with Chemical or Other Material 54 54
Nonstandard Device 50 50
Malposition of Device 44 44
Device Dislodged or Dislocated 26 26
Short Fill 24 24
Defective Device 22 22
Delivered as Unsterile Product 21 21
Material Protrusion/Extrusion 14 14
Device Handling Problem 14 14
Device Operates Differently Than Expected 11 11
Inadequacy of Device Shape and/or Size 11 11
Product Quality Problem 11 11
Device Markings/Labelling Problem 11 11
Material Integrity Problem 11 11
Defective Component 10 10
Loss of or Failure to Bond 9 9
Use of Device Problem 9 9
Deflation Problem 8 8
Structural Problem 8 8
Biofilm coating in Device 8 8
Contamination /Decontamination Problem 7 7
Manufacturing, Packaging or Shipping Problem 7 7
Device Contaminated During Manufacture or Shipping 6 6
Contamination 6 6
Peeled/Delaminated 6 6
Shipping Damage or Problem 6 6
Microbial Contamination of Device 5 5
Unsealed Device Packaging 5 5
Burst Container or Vessel 5 5
Positioning Problem 5 5
Unintended Movement 4 4
Contamination of Device Ingredient or Reagent 4 4
Material Invagination 4 4
Therapeutic or Diagnostic Output Failure 4 4
Material Split, Cut or Torn 4 4
Noise, Audible 3 3
Patient Device Interaction Problem 3 3
Folded 3 3
Unintended Ejection 3 3
Degraded 3 3
Material Separation 3 3
Device Issue 3 3
Tear, Rip or Hole in Device Packaging 3 3
Air/Gas in Device 3 3
Scratched Material 2 2
Fungus in Device Environment 2 2
Dent in Material 2 2
Device Ingredient or Reagent Problem 2 2
Connection Problem 2 2
Metal Shedding Debris 2 2
Component Missing 2 2
Material Too Rigid or Stiff 2 2
Material Puncture/Hole 2 2
Material Disintegration 2 2
Explanted 2 2
Hole In Material 2 2
Melted 2 2
Deformation Due to Compressive Stress 2 2
Material Twisted/Bent 2 2
Measurement System Incompatibility 1 1
Optical Discoloration 1 1
Packaging Problem 1 1
Expulsion 1 1
Gas Leak 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Detachment of Device or Device Component 1 1
Application Security Problem 1 1
Split 1 1
Unintended Deflation 1 1
Material Opacification 1 1
Device Expiration Issue 1 1
Crack 1 1
Air Leak 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Out-Of-Box Failure 1 1
Incomplete or Missing Packaging 1 1
Material Perforation 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Extrusion 1 1
Compatibility Problem 1 1
Incorrect Device Or Component Shipped 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Capsular Contracture 25324 25324
No Code Available 13547 13548
Failure of Implant 13204 13204
Seroma 3499 3499
Pain 3118 3119
Unspecified Infection 1292 1292
Fatigue 1018 1019
Deformity/ Disfigurement 989 989
Autoimmune Reaction 931 931
Swollen Lymph Nodes 907 907
Inflammation 537 537
Anxiety 530 530
Breast Mass 529 529
Lymphoma 528 528
Headache 522 523
Granuloma 509 509
Hair Loss 502 503
Arthralgia 492 492
Anaplastic Large Cell Lymphoma 492 492
Wrinkling 404 404
Depression 389 389
Weight Changes 373 373
Memory Loss/Impairment 370 371
Rash 361 362
Autoimmune Disorder 324 325
Injury 319 319
Swelling 312 312
Sleep Dysfunction 295 295
Neurological Deficit/Dysfunction 292 292
Hematoma 286 286
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 280 280
Palpitations 270 271
Wound Dehiscence 262 262
Local Reaction 261 261
Skin Irritation 246 246
Hypersensitivity/Allergic reaction 245 245
Numbness 241 241
No Known Impact Or Consequence To Patient 237 237
Confusion/ Disorientation 233 233
Cognitive Changes 229 229
Thyroid Problems 221 221
Dyspnea 220 220
Cyst(s) 216 216
Complaint, Ill-Defined 212 212
No Consequences Or Impact To Patient 209 209
Chest Pain 192 192
Impaired Healing 190 190
No Patient Involvement 188 188
Blurred Vision 182 182
Tingling 177 177
Sweating 177 178
Necrosis 173 173
Tinnitus 164 164
Cancer 162 162
Dry Eye(s) 160 160
Burning Sensation 159 159
Vertigo 154 154
Dizziness 146 146
Itching Sensation 135 136
Nausea 124 124
Swollen Lymph Nodes/Glands 121 121
Emotional Changes 114 115
Myalgia 114 114
Weakness 108 108
Foreign Body Sensation in Eye 101 101
Visual Impairment 99 99
Increased Sensitivity 99 99
Toxicity 97 97
Edema 97 97
Insufficient Information 96 96
No Clinical Signs, Symptoms or Conditions 93 93
Fungal Infection 87 87
Rheumatoid Arthritis 84 84
Neck Pain 83 83
Muscle Weakness 80 80
Discomfort 78 78
Malaise 77 77
Scarring 76 76
Fever 76 76
Cellulitis 74 74
Test Result 74 74
Patient Problem/Medical Problem 69 69
Death 69 69
Calcium Deposits/Calcification 68 68
Arthritis 64 64
Lupus 62 62
Raynauds Phenomenon 61 61
Abdominal Distention 60 60
High Blood Pressure/ Hypertension 59 59
Bacterial Infection 59 59
Dehydration 56 56
Pocket Erosion 56 56
Visual Disturbances 56 56
Bruise/Contusion 55 55
Fluid Discharge 54 54
Paresthesia 54 54
Abscess 53 53
Crushing Injury 53 53
Muscle Spasm(s) 51 51
Abdominal Pain 50 50

Recalls
Manufacturer Recall Class Date Posted
1 Allergan PLC III Dec-18-2019
2 Allergan PLC I Sep-11-2019
3 Mentor Texas, LP. II Aug-03-2016
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