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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
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)
2017 2018 2019 2020 2021 2022
33 11 14 10 21 5

MDR Year MDR Reports MDR Events
2017 927 927
2018 2640 2640
2019 21374 21374
2020 24288 24288
2021 23300 23300
2022 16685 16685

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 39616 39616
Adverse Event Without Identified Device or Use Problem 25084 25084
Patient-Device Incompatibility 14344 14344
Device Appears to Trigger Rejection 12201 12201
Migration 1909 1909
Gel Leak 569 569
Appropriate Term/Code Not Available 400 400
Patient Device Interaction Problem 357 357
Off-Label Use 265 265
Fluid Leak 240 240
Insufficient Information 233 233
No Apparent Adverse Event 164 164
Break 151 151
Material Discolored 124 124
Migration or Expulsion of Device 116 116
Material Deformation 114 114
Improper or Incorrect Procedure or Method 91 91
Device Handling Problem 78 78
Device Contamination with Chemical or Other Material 67 67
Nonstandard Device 66 66
Leak/Splash 60 60
Malposition of Device 58 58
Defective Device 36 36
Device Dislodged or Dislocated 36 36
Short Fill 27 27
Material Protrusion/Extrusion 26 26
Delivered as Unsterile Product 24 24
Microbial Contamination of Device 23 23
Use of Device Problem 21 21
Material Integrity Problem 15 15
Air/Gas in Device 14 14
Inadequacy of Device Shape and/or Size 13 13
Product Quality Problem 12 12
Biocompatibility 12 12
Device Markings/Labelling Problem 11 11
Biofilm coating in Device 10 10
Material Invagination 10 10
Defective Component 10 10
Device Contaminated During Manufacture or Shipping 10 10
Unsealed Device Packaging 10 10
Loss of or Failure to Bond 9 9
Structural Problem 9 9
Deflation Problem 8 8
Device Operates Differently Than Expected 8 8
Peeled/Delaminated 8 8
Contamination 7 7
Shipping Damage or Problem 7 7
Contamination /Decontamination Problem 7 7
Device Damaged Prior to Use 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Material Split, Cut or Torn 6 6
Burst Container or Vessel 6 6
Unintended Movement 5 5
Positioning Problem 5 5
Volume Accuracy Problem 4 4
Output Problem 4 4
Tear, Rip or Hole in Device Packaging 4 4
Material Too Rigid or Stiff 4 4
Material Separation 4 4
Folded 3 3
Contamination of Device Ingredient or Reagent 3 3
Noise, Audible 3 3
Material Puncture/Hole 3 3
Degraded 3 3
Unintended Ejection 3 3
Connection Problem 3 3
Scratched Material 2 2
Fungus in Device Environment 2 2
Melted 2 2
Packaging Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Component Missing 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Deformation Due to Compressive Stress 2 2
Device Ingredient or Reagent Problem 2 2
Dent in Material 2 2
Device Issue 2 2
Material Disintegration 2 2
Hole In Material 2 2
Material Twisted/Bent 2 2
Measurement System Incompatibility 1 1
Optical Discoloration 1 1
Expulsion 1 1
Gas Leak 1 1
Inaccurate Information 1 1
Difficult to Remove 1 1
Fracture 1 1
Device Emits Odor 1 1
Material Opacification 1 1
Application Security Problem 1 1
Out-Of-Box Failure 1 1
Incomplete or Missing Packaging 1 1
Charging Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Compatibility Problem 1 1
Incorrect Device Or Component Shipped 1 1
Failure To Adhere Or Bond 1 1
Rupture due to capsulotomy 1 1
Unexpected Color 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Capsular Contracture 42590 42590
Failure of Implant 20966 20966
No Code Available 13534 13535
Seroma 5120 5120
Deformity/ Disfigurement 5115 5115
Pain 3568 3569
Unspecified Infection 1662 1662
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1422 1422
Fatigue 1081 1082
Autoimmune Reaction 928 928
Swollen Lymph Nodes 897 897
Granuloma 862 862
Wrinkling 763 763
Swollen Lymph Nodes/Glands 733 733
Breast Mass 718 718
Lymphoma 672 672
Inflammation 589 589
Anxiety 586 586
Autoimmune Disorder 570 571
Headache 558 559
Breast Discomfort/Pain 557 557
Arthralgia 553 553
Hair Loss 538 539
Local Reaction 521 521
Insufficient Information 513 513
No Clinical Signs, Symptoms or Conditions 442 442
Depression 429 429
Anaplastic Large Cell Lymphoma 429 429
Hematoma 426 426
Weight Changes 405 405
Memory Loss/Impairment 393 394
Rash 391 392
Wound Dehiscence 343 343
Sleep Dysfunction 326 326
Injury 316 316
Post Operative Wound Infection 294 294
Cyst(s) 293 293
Neurological Deficit/Dysfunction 289 289
Cognitive Changes 288 288
Hypersensitivity/Allergic reaction 286 286
Swelling 284 284
Impaired Healing 283 283
Numbness 266 266
Palpitations 259 260
Necrosis 253 253
Skin Irritation 245 245
Dyspnea 241 241
Cancer 238 238
No Known Impact Or Consequence To Patient 237 237
Confusion/ Disorientation 234 234
No Consequences Or Impact To Patient 209 209
Thyroid Problems 208 208
Crushing Injury 207 207
Chest Pain 201 201
Blurred Vision 193 193
Paresthesia 189 189
No Patient Involvement 188 188
Tinnitus 188 188
Dry Eye(s) 179 179
Complaint, Ill-Defined 176 176
Burning Sensation 170 170
Sweating 165 166
Vertigo 165 165
Tingling 164 164
Dizziness 159 159
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) 154 154
Emotional Changes 148 149
Itching Sensation 142 143
Rupture 141 141
Myalgia 134 134
Nausea 125 125
Calcium Deposits/Calcification 123 123
Pocket Erosion 115 115
Foreign Body Reaction 115 115
Cellulitis 112 112
Visual Impairment 109 109
Foreign Body Sensation in Eye 101 101
Skin Inflammation/ Irritation 101 101
Weakness 101 101
Increased Sensitivity 98 98
Fungal Infection 97 97
Malaise 96 96
Muscle Weakness 95 95
Rheumatoid Arthritis 93 93
Neck Pain 93 93
Edema 89 89
Toxicity 88 88
Abscess 88 88
Fluid Discharge 83 83
Bacterial Infection 82 82
Fever 82 82
Discomfort 81 81
Scarring 75 75
Test Result 73 73
Arthritis 70 70
Abdominal Distention 64 64
High Blood Pressure/ Hypertension 63 63
Swelling/ Edema 63 63
Patient Problem/Medical Problem 62 62
Urinary Tract Infection 59 59

Recalls
Manufacturer Recall Class Date Posted
1 Allergan PLC III Dec-18-2019
2 Allergan PLC I Sep-11-2019
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