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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 3

MDR Year MDR Reports MDR Events
2019 15444 15444
2020 14022 14022
2021 11355 11355
2022 13660 13660
2023 11039 11039
2024 5379 5379

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 25606 25606
Material Rupture 25548 25548
Adverse Event Without Identified Device or Use Problem 11588 11588
Device Appears to Trigger Rejection 4957 4957
Patient-Device Incompatibility 2937 2937
Deflation Problem 1316 1316
Migration 719 719
No Apparent Adverse Event 318 318
Insufficient Information 304 304
Appropriate Term/Code Not Available 206 206
Peeled/Delaminated 138 138
Detachment of Device or Device Component 104 104
Off-Label Use 103 103
Improper or Incorrect Procedure or Method 91 91
Connection Problem 86 86
Unintended Deflation 82 82
Microbial Contamination of Device 80 80
Device Handling Problem 76 76
Break 64 64
Use of Device Problem 51 51
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
Failure to Fold 30 30
Defective Device 29 29
Material Split, Cut or Torn 28 28
Material Deformation 26 26
Material Discolored 25 25
Material Perforation 24 24
Inflation Problem 23 23
Leak/Splash 22 22
Defective Component 21 21
Short Fill 19 19
Air/Gas in Device 19 19
Contamination /Decontamination Problem 13 13
Migration or Expulsion of Device 12 12
Device Dislodged or Dislocated 11 11
Difficult to Open or Remove Packaging Material 10 10
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
Filling Problem 3 3
Output Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Biocompatibility 3 3
Deformation Due to Compressive Stress 3 3
Unintended Movement 3 3
Activation Failure 2 2
Failure to Fire 2 2
Structural Problem 2 2
Component Missing 2 2
Fungus in Device Environment 2 2
Optical Discoloration 2 2
Calcified 2 2
Contamination 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Emits Odor 2 2
Material Puncture/Hole 2 2
Decrease in Pressure 1 1
Particulates 1 1
Device Slipped 1 1
Material Separation 1 1
Difficult to Remove 1 1
Unintended Ejection 1 1
Positioning Failure 1 1
Labelling, Instructions for Use or Training Problem 1 1
Positioning Problem 1 1
Compatibility Problem 1 1
Overfill 1 1
Obstruction of Flow 1 1
Failure to Align 1 1
Device Displays Incorrect Message 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 30448 30448
Capsular Contracture 12497 12497
Deformity/ Disfigurement 10790 10790
No Code Available 10437 10437
Pain 2082 2082
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1534 1534
Seroma 1434 1434
No Clinical Signs, Symptoms or Conditions 920 920
Autoimmune Reaction 821 821
Breast Discomfort/Pain 751 751
Unspecified Infection 726 726
Insufficient Information 641 641
Wrinkling 508 508
Autoimmune Disorder 502 502
Fatigue 463 463
Lymphoma 437 437
Swollen Lymph Nodes/Glands 415 415
Breast Mass 411 411
No Known Impact Or Consequence To Patient 359 359
Swollen Lymph Nodes 298 298
Anxiety 281 281
Headache 279 279
Arthralgia 263 263
Hair Loss 249 249
Inflammation 242 242
Depression 235 235
Local Reaction 230 230
Injury 210 210
Weight Changes 189 189
Cancer 188 188
Rash 188 188
Neurological Deficit/Dysfunction 175 175
Memory Loss/Impairment 173 173
Cyst(s) 171 171
Sleep Dysfunction 166 166
Post Operative Wound Infection 160 160
Hypersensitivity/Allergic reaction 158 158
Cognitive Changes 151 151
Numbness 145 145
Paresthesia 141 141
Crushing Injury 139 139
Skin Irritation 130 130
Dyspnea 123 123
Calcium Deposits/Calcification 119 119
Anaplastic Large Cell Lymphoma 113 113
Palpitations 112 112
Swelling 111 111
Tinnitus 109 109
Confusion/ Disorientation 109 109
Granuloma 107 107
Impaired Healing 104 104
Dry Eye(s) 101 101
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) 93 93
Tingling 92 92
No Consequences Or Impact To Patient 91 91
No Patient Involvement 89 89
Wound Dehiscence 89 89
Vertigo 88 88
Thyroid Problems 86 86
Skin Inflammation/ Irritation 84 84
Hematoma 82 82
Emotional Changes 80 80
Dizziness 79 79
Chest Pain 78 78
Necrosis 78 78
Itching Sensation 72 72
Fungal Infection 71 71
Burning Sensation 70 70
Myalgia 66 66
Nausea 65 65
Blurred Vision 64 64
Sweating 64 64
Muscle Weakness 57 57
Arthritis 56 56
Visual Impairment 55 55
Breast Cancer 52 52
Pocket Erosion 51 51
Ptosis 50 50
Fluid Discharge 50 50
Foreign Body Reaction 48 48
Increased Sensitivity 47 47
Bacterial Infection 45 45
Unspecified Gastrointestinal Problem 45 45
Neck Pain 44 44
Complaint, Ill-Defined 39 39
Fall 39 39
Rheumatoid Arthritis 38 38
Abscess 38 38
Ambulation Difficulties 38 38
Arrhythmia 37 37
Raynauds Phenomenon 36 36
Cellulitis 35 35
Fever 34 34
Weakness 34 34
Malaise 32 32
Test Result 32 32
High Blood Pressure/ Hypertension 32 32
Dehydration 30 30
Swelling/ Edema 30 30
Menstrual Irregularities 29 29

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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