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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
Regulation Description Surgical mesh for transvaginal pelvic organ prolapse repair.
Definition Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally
Product CodeOTP
Regulation Number 884.5980
Device Class 3

MDR Year MDR Reports MDR Events
2020 175 176
2021 647 647
2022 114 114
2023 59 59
2024 36 36
2025 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 735 735
Migration 210 210
Appropriate Term/Code Not Available 94 94
Defective Device 9 9
Patient Device Interaction Problem 9 9
Material Erosion 7 8
Positioning Problem 7 7
Material Integrity Problem 6 6
Insufficient Information 5 5
Material Twisted/Bent 5 5
Migration or Expulsion of Device 3 3
Material Deformation 3 3
Detachment of Device or Device Component 3 3
Patient-Device Incompatibility 2 2
Material Protrusion/Extrusion 2 2
Difficult or Delayed Positioning 1 1
Device Appears to Trigger Rejection 1 1
Calcified 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 710 711
Erosion 456 456
Incontinence 332 332
Dyspareunia 264 264
Constipation 230 230
Insufficient Information 173 173
Abnormal Vaginal Discharge 139 139
Prolapse 115 115
Urinary Tract Infection 112 112
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 110 110
Unspecified Mental, Emotional or Behavioural Problem 98 98
Hemorrhage/Bleeding 88 88
Injury 80 80
Unspecified Infection 71 72
No Code Available 61 61
Discomfort 59 59
Urinary Incontinence 58 58
Micturition Urgency 57 57
Scar Tissue 52 52
Urinary Frequency 52 52
Abdominal Pain 46 46
Urinary Retention 44 44
Inflammation 43 44
Unspecified Tissue Injury 39 39
Not Applicable 34 34
Dysuria 31 31
Adhesion(s) 30 30
Cramp(s) /Muscle Spasm(s) 26 26
Obstruction/Occlusion 26 26
Depression 25 25
Hematuria 23 23
Anxiety 21 21
Fistula 20 20
Disability 19 19
Nausea 17 17
Nerve Damage 17 17
Blood Loss 16 16
Bacterial Infection 13 13
Hernia 13 13
High Blood Pressure/ Hypertension 13 13
Fatigue 12 12
Diarrhea 12 12
Fever 11 11
Unspecified Kidney or Urinary Problem 11 11
Fibrosis 11 11
Burning Sensation 10 10
Perforation 9 9
Fecal Incontinence 9 9
Cyst(s) 8 8
Skin Inflammation/ Irritation 8 8

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