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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, breast, inflatable, internal, saline
Definition Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99
Product CodeFWM
Regulation Number 878.3530
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
5 7 9 4 6 2

MDR Year MDR Reports MDR Events
2019 15444 15444
2020 14022 14022
2021 11355 11355
2022 13660 13660
2023 11038 11038
2024 2676 2676

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 24643 24643
Material Rupture 24450 24450
Adverse Event Without Identified Device or Use Problem 11277 11277
Device Appears to Trigger Rejection 4554 4554
Patient-Device Incompatibility 2931 2931
Deflation Problem 1316 1316
Migration 694 694
Insufficient Information 303 303
No Apparent Adverse Event 251 251
Appropriate Term/Code Not Available 197 197
Peeled/Delaminated 126 126
Off-Label Use 103 103
Detachment of Device or Device Component 94 94
Improper or Incorrect Procedure or Method 90 90
Connection Problem 81 81
Microbial Contamination of Device 75 75
Unintended Deflation 72 72
Device Handling Problem 67 67
Break 61 61
Device Contamination with Chemical or Other Material 48 48
Patient Device Interaction Problem 48 48
Loss of or Failure to Bond 44 44
Burst Container or Vessel 43 43
Gel Leak 38 38
Nonstandard Device 38 38
Use of Device Problem 38 38
Failure to Fold 30 30
Defective Device 29 29
Material Split, Cut or Torn 28 28
Material Deformation 26 26
Material Perforation 24 24
Material Discolored 24 24
Inflation Problem 23 23
Leak/Splash 22 22
Defective Component 21 21
Short Fill 19 19
Air/Gas in Device 17 17
Contamination /Decontamination Problem 13 13
Migration or Expulsion of Device 12 12
Device Dislodged or Dislocated 11 11
Malposition of Device 10 10
Material Invagination 8 8
Material Integrity Problem 7 7
Infusion or Flow Problem 6 6
Contamination of Device Ingredient or Reagent 6 6
Unsealed Device Packaging 6 6
Device Damaged Prior to Use 5 5
Device Contaminated During Manufacture or Shipping 4 4
Material Protrusion/Extrusion 4 4
Delivered as Unsterile Product 4 4
Product Quality Problem 4 4
Material Too Rigid or Stiff 3 3
Output Problem 3 3
Deformation Due to Compressive Stress 3 3
Difficult to Open or Remove Packaging Material 3 3
Tear, Rip or Hole in Device Packaging 3 3
Unintended Movement 3 3
Activation Failure 2 2
Component Missing 2 2
Fungus in Device Environment 2 2
Failure to Fire 2 2
Biocompatibility 2 2
Structural Problem 2 2
Optical Discoloration 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Emits Odor 2 2
Material Puncture/Hole 2 2
Filling Problem 2 2
Calcified 2 2
Contamination 2 2
Unintended Ejection 1 1
Positioning Failure 1 1
Labelling, Instructions for Use or Training Problem 1 1
Decrease in Pressure 1 1
Particulates 1 1
Device Slipped 1 1
Material Separation 1 1
Difficult to Remove 1 1
Positioning Problem 1 1
Compatibility Problem 1 1
Failure to Align 1 1
Device Displays Incorrect Message 1 1
Overfill 1 1
Obstruction of Flow 1 1
Device Difficult to Maintain 1 1
Explosion 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 29155 29155
Capsular Contracture 11897 11897
No Code Available 10437 10437
Deformity/ Disfigurement 10138 10138
Pain 2069 2069
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1476 1476
Seroma 1378 1378
No Clinical Signs, Symptoms or Conditions 828 828
Autoimmune Reaction 821 821
Breast Discomfort/Pain 718 718
Unspecified Infection 705 705
Insufficient Information 633 633
Wrinkling 495 495
Autoimmune Disorder 492 492
Fatigue 453 453
Lymphoma 425 425
Breast Mass 399 399
Swollen Lymph Nodes/Glands 382 382
No Known Impact Or Consequence To Patient 359 359
Swollen Lymph Nodes 298 298
Headache 276 276
Anxiety 273 273
Arthralgia 262 262
Inflammation 242 242
Hair Loss 239 239
Depression 233 233
Local Reaction 226 226
Injury 210 210
Rash 187 187
Weight Changes 183 183
Cancer 183 183
Neurological Deficit/Dysfunction 175 175
Memory Loss/Impairment 171 171
Cyst(s) 169 169
Sleep Dysfunction 166 166
Hypersensitivity/Allergic reaction 158 158
Post Operative Wound Infection 153 153
Cognitive Changes 148 148
Numbness 145 145
Crushing Injury 138 138
Paresthesia 134 134
Skin Irritation 130 130
Dyspnea 121 121
Calcium Deposits/Calcification 114 114
Anaplastic Large Cell Lymphoma 113 113
Palpitations 112 112
Swelling 111 111
Tinnitus 109 109
Confusion/ Disorientation 108 108
Impaired Healing 100 100
Dry Eye(s) 99 99
Tingling 92 92
No Consequences Or Impact To Patient 91 91
No Patient Involvement 89 89
Granuloma 89 89
Vertigo 88 88
Thyroid Problems 86 86
Wound Dehiscence 86 86
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) 85 85
Hematoma 81 81
Emotional Changes 80 80
Dizziness 79 79
Chest Pain 78 78
Skin Inflammation/ Irritation 78 78
Necrosis 75 75
Itching Sensation 72 72
Fungal Infection 71 71
Burning Sensation 70 70
Myalgia 65 65
Blurred Vision 64 64
Sweating 64 64
Nausea 63 63
Muscle Weakness 57 57
Visual Impairment 55 55
Arthritis 54 54
Breast Cancer 51 51
Ptosis 50 50
Pocket Erosion 49 49
Increased Sensitivity 47 47
Fluid Discharge 47 47
Bacterial Infection 45 45
Neck Pain 44 44
Unspecified Gastrointestinal Problem 41 41
Foreign Body Reaction 40 40
Fall 39 39
Complaint, Ill-Defined 39 39
Rheumatoid Arthritis 38 38
Raynauds Phenomenon 36 36
Arrhythmia 35 35
Abscess 35 35
Cellulitis 35 35
Ambulation Difficulties 35 35
Weakness 34 34
Fever 34 34
Test Result 32 32
Malaise 31 31
Dehydration 30 30
Menstrual Irregularities 29 29
Bruise/Contusion 28 28
Discomfort 28 28

Recalls
Manufacturer Recall Class Date Posted
1 Allergan PLC III Dec-18-2019
2 Allergan PLC I Sep-11-2019
3 Ideal Implant Incorporated II Aug-08-2019
4 Mentor Texas, LP. II Dec-10-2021
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