Uterine Prolapse
PRR
DynaMesh®-PRR soft and DynaMesh®-PRR visible implants are intended to be used as bridging material and reinforce the soft tissue of the vaginal walls as part of surgical treatment for apical pelvic organ prolapse.
Surgical technique:
- hysterosacropexy
unilateral
(concomitant cystocele/rectocele)
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The target patient group are fully-grown female patients with apical pelvic organ prolapse (of the uterus, vaginal or cervical stump).
Colpo-/cervicosacropexy
- unilateral
- fixation on vaginal/cervical stump
Colpo-/cervicosacropexy
- unilateral
- fixation on vaginal/cervical stump and anterior mesh plasty for concomitant cystocele
Colpo-/cervicosacropexy
- unilateral
- fixation on vaginal/cervical stump and posterior mesh plasty for concomitant rectocele
Hysterosacropexy
- unilateral
- posterior cervical fixation
Hysterosacropexy
- unilateral
- posterior cervical fixation and posterior mesh plasty for concomitant rectocele
| DynaMesh®-PRR soft |
02/04 cm x 23 cm | PV360423F1/F3 |
| DynaMesh®-PRR visible |
02/04 cm x 23 cm | PV760423F1 |
| FX = X unit(s)/box (e.g. F3 = 3 unit(s)/box) |
| Product | DynaMesh®-PRR soft (1) DynaMesh®-PRR visible (2) |
| Surgical Treatment | Apical Pelvic Organ Prolapse (Uterus / Vaginal Stump / Cervical Stump) |
| Surgical Approach | Minimally Invasive / Open |
| Surgical Technique | Sacropexy |
| Fixation | – Anterior longitudinal ligament: non-absorbable suture or tacks – Vaginal stump or cervix: interrupted non-absorbable suture (preferably) |
| Smooth Warp-Knitted Selvedges |  |
| Defined Elasticity |
[TR110] |
| Visible Technology |
 (1) / (2) |
| Materials | – Polyvinylidene fluoride (PVDF) (CAS 24937-79-9) > 99% (w/w) (1) (2) – Phthalocyanine green (CAS 1328-53-6) < 1% (w/w) (1) (2) – Triiron tetraoxide (CAS 1317-61-9) < 1% (w/w) (2) |
| Polymer (Monofilament) | PVDF |
| Biocompatibility |
[TR1] |
| Ageing Resistance |
[2A, 5VIT, 27A, 52VIT, 93A, 101] |
| Effective Porosity | High effective porosity reduces inflammation and the risk of excessive scar formation. [103P, TR111] |
| Klinge’s Mesh Classification | Class 1a [102P, TR111] |
|
Applies to all product sizes |
|
Does not apply |
| [#] | Reference “#” (see “References”) |
| [TR#] | Internal test report (see “internal test report references”) |
| Limitations | “A” animal trial, “B” bench test, “VIT” in-vitro trial, “P” published results based on the analysis of human mesh explants, “PB” published results mainly based on bench tests |
