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
| Device Type ID | 4073 |
| Device Name | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Physical State | Synthetic Woven Or Non-woven Fabric Of Varying Material Properties (e.g., Resorption, Density, Pore Size, Weave, Etc.); Design Can Be Pre-configured For Specific Repair Or Can Be A Sheet To Allow Surgeon To Cut Mesh To Desired Size And Shape |
| Technical Method | Permanent Implant Placed Transvaginally That Provides Mechanical Support For Weakened Tissues Of The Pelvic Floor |
| Target Area | Vagina, Pelvic Floor, Uterus |
| Regulation Description | Surgical Mesh For Transvaginal Pelvic Organ Prolapse Repair. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | PMA |
| CFR Regulation Number | 884.5980 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OTP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4073 |
| Device | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed |
| Product Code | OTP |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Surgical Mesh For Transvaginal Pelvic Organ Prolapse Repair. |
| CFR Regulation Number | 884.5980 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 357 |
Detachment Of Device Component | 328 |
Needle | 303 |
Insufficient Information | 201 |
Break | 130 |
Migration Or Expulsion Of Device | 123 |
Suture | 121 |
Detachment Of Device Or Device Component | 106 |
Extrusion | 75 |
Carrier | 64 |
Appropriate Term/Code Not Available | 59 |
Material Erosion | 49 |
Retraction Problem | 29 |
Migration | 15 |
Patient-Device Incompatibility | 9 |
Surgical Graft | 8 |
Use Of Device Problem | 8 |
Torn Material | 7 |
Material Separation | 6 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 4 |
Malposition Of Device | 3 |
Device Packaging Compromised | 3 |
Misfire | 3 |
Degraded | 2 |
Material Deformation | 2 |
Missing Value Reason | 2 |
Mechanical Problem | 1 |
Disconnection | 1 |
Unintended Movement | 1 |
Material Protrusion / Extrusion | 1 |
Deformation Due To Compressive Stress | 1 |
Material Split, Cut Or Torn | 1 |
Fire | 1 |
Device Operates Differently Than Expected | 1 |
Difficult To Remove | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
| Total Device Problems | 2027 |