Polypropylene Pelvic Mesh: What Went Wrong and What Will Be of the Future?
Abstract
:1. Introduction
2. Pelvic Organ Prolapse
3. Material of the Mesh Implants: Synthetic or Biological?
4. Polypropylene and Its Properties Used as Mesh for Treatment of Pelvic Organ Prolapse
5. Clinical Complications Arising from the Polypropylene Mesh Material
- Chronic infection
- Chronic pain
- Dyspareunia
- Mesh exposure—display of mesh at or near the site of insertion
- Mesh extrusion—where the mesh passes out of a body structure
- Perforation of neighbouring organs secondary to erosion
- Mesh shrinkage
- Recurrence of prolapse with treatment failure and further surgery
6. Future Direction
- Nontoxic and biocompatible
- Chemically inert
- Lightweight with low density
- Low stiffness
- Large pores and high porosity
- Mechanically strong
- Nondegenerative
- Noncarcinogenic
- Noninflammatory and nonallergenic
- Affordable
- Sterile
- Resistant to mesh shrinkage
7. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Type | Sub-Type | Material | Advantages | Disadvantages |
---|---|---|---|---|
Biologic | Autologous | Rectus sheath |
|
|
Fascia lata | ||||
Allografts | Cadaveric fascia lata |
|
| |
Cadaveric human dermis | ||||
Xenografts | Porcine dermis | |||
Porcine small intestinal submucosa | ||||
Bovine pericardium | ||||
Synthetic | Polypropylene | Heavyweight polypropylene |
|
|
Lightweight polypropylene | ||||
Polyethylene terephthalate | Polyester mesh known as Mersilene® |
|
| |
Expanded—Polytetrafluoroethylene | Soft tissue patch Gore-Tex® |
|
|
Mechanical Properties | Chemical Properties |
---|---|
Low density (0.9 g/cm3) Lighter than water Floats | Great chemical resistance Resistant to most organic solvents at room temperature |
Tough Acts with elasticity over a range of deflection to prevent deformation | Highly resistant to dilute or concentrated acids, alcohols, and bases |
Flexible Semi-crystalline nature gives it a high flexural strength | Highly impermeable to water |
High resistance to fatigue Able to retain shape after a large degree of torsion and bending | High electrical resistance |
High tensile strength Around 4800 psi Able to withstand heavy loads despite being lightweight | Thermoplastic Becomes liquid at the melting point Can be melted, cooled, and reheated again without degradation |
High impact tolerance | |
Hard consistency Semi-rigid structure makes it more likely to bend and flex with impact |
Material | Pt Demographic | Country | Study Method | FU | Complications | Outcome | Year, Ref |
---|---|---|---|---|---|---|---|
A low-weight PP mesh | 202 with POP | Finland | A prospective RCT comparing low-weight PP mesh for anterior vaginal wall prolapse vs. traditional anterior colporrhaphy. | 24 | ME was seen in 8% of Pts. The dyspareunia score was lower in the mesh group. | Overall symptom rates did not differ in mesh and nonmesh groups. Recurrence rates were 11% in mesh group vs. 41% in nonmesh group. | 2003 [31] |
Pelivisoft—natural organic mesh made of porcine dermis vs. Pelvitex—PP mesh | 120 with POP | US | An RCT to compare the relative differences between the materials Pelivisoft vs. Pelvitex, as an adjunct to sacral colpopexy surgery. | 12 | One Pt in the Pelvisoft group experienced ME. Two Pts in the porcine group, compared to three Pts in the synthetic mesh group, experienced dyspareunia. | Anatomic cure rates for the Pelvisoft and Pelvitex groups were 81% and 86%, respectively. “Clinical cure” rates for the Pelvisoft and Pelvitex groups were 84% and 90%, respectively. | 2005 [32] |
Polyform—PP mesh developed by Boston Scientific | 100 with POP | US | A prospective single-blind RCT, to evaluate anterior colporrhaphy vs. cystocele repair using PP mesh or porcine dermis. | 24 | ME in 14% of Pts in the mesh group. Composite failure was 4% in the mesh group, 12% in porcine and 13% in colporrhaphy group. | Pts in PP mesh group had a significantly lower anatomic failure rate (18%) than the porcine (46%) and colporrhaphy groups (58%). | 2005 [33] |
Ugytex—low-weight and highly porous PP monofilament mesh | 194 with POP | France | A multicentre study to evaluate and compare the prosthesis Ugytex via the transobturator approach vs. anterior colporrhaphy for the surgical treatment of anterior vaginal wall prolapse. | 84 | ME in 13% of Pts during FU. Reintervention for prolapse took place in 9% of Pts. | Similar functional outcomes were seen for both mesh and native tissue repair. Use of mesh did not reduce repeat surgery rates but did reduce anatomical recurrence. | 2005 [34] |
PROLIFT® system—macroporous PP TVM using a transobturator or transgluteal approach | 260 with POP | Sweden | A prospective multicentre open labelled single cohort study to describe perioperative complications after TVM surgery for POP. | 6 | Serious complications were seen in 4% of Pts. Plus, an extra 15% of Pts experienced minor complications. | Perioperative serious complications are uncommon in the majority of cases after TVM procedure. | 2006 [35] |
NAZCA TC™ POP repair system—macroporous PP mesh | 104 with POP | Brazil | An RCT to compare colporrhaphy vs. NAZCA TC™ (Promedon HQ, General Manuel Savio L3 M3, Parque Industrial Ferreyra, X5123XAD, Córdoba, Argentina) for the surgical treatment of greater anterior vaginal wall prolapse. | 12 | ME was seen in 5.7% of Pts who underwent surgery with PP mesh adjunct. | Monoprosthesis with combined pre-pubic and trans-obturator arms had high success rates for anterior vaginal POP repair and simultaneous SUI treatment. | 2007 [36] |
Tension-free vaginal tape PP mesh and transobturator tape PP mesh and suprapubic sling PP mesh | 92,246 with SUI | UK | A retrospective cohort study using hospital episode statistics data measuring complications following tension-free vaginal tape, transobturator tape and suprapubic sling procedures for SUI. | 96 | Peri-procedural and 30-day complication rates were 2.4% and 1.7%, respectively; 6% were readmitted at least once within 5 years. | Study shows that estimated of 9.8% of women experience complications either peri-procedural, within 30 days or within five years of surgery. | 2007 [37] |
Synthetic monofilament PP mesh | 65 with POP | USA | A double-blind RCT testing the hypothesis that the addition of a standardised technique of inter-positional synthetic PP mesh placement improves the one-year outcome of vaginal reconstructive surgery for POP vs. traditional vaginal reconstructive surgery. | 36 | The study was prematurely halted once a ME complication rate of 16% had been met. | There was no difference in three-year cure rates when comparing Pts undergoing traditional vaginal prolapse surgery without mesh vs. those undergoing vaginal colpopexy repair with mesh. | 2007 [38] |
GYNECARE PROLIFT + M * Pelvic Floor Repair System—a new lightweight PP mesh | 127 with POP | Belgium | A prospective multicentre study to evaluate the clinical performance of the GYNECARE PROLIFT + M * Pelvic Floor Repair System for the repair of vaginal POP. | 12 | ME rate was 10.2% and rate of de novo dyspareunia was 2%. | 86% of Pts indicated their prolapse situation to be “much better” following surgery. | 2008 [39] |
Midurethral tension-free vaginal tape—macroporous PP mesh | 160 with SUI | Switzerland | A prospective RCT comparing retropubic transvaginal tape (TVT) with the transobturator tape (outside-in TOT or inside-out TVT-O) sling operation in the treatment of female SUI or stress dominated mixed urinary incontinence. | 12 | Five ME complications identified. 2% TVT, 17% TOT, and 0% TVT-O Pts reported de novo sexual dysfunction, considered significant enough to halt the study. | There was no difference for Q-max between TVT, TOT and TVT-O. Female sexual dysfunction and ME may be higher with a transobturator tape. | 2008 [40] |
Avaulta—collagen-coated prolene mesh | 138 with POP | Norway, Sweden, Finland and Denmark | An RCT comparing conventional anterior colporrhaphy vs. surgery with Avaulta. | 36 | ME occurred in 13% of Pts at one-year FU, this number did not change by three-year FU. | The objective outcome was superior in the mesh group, but the use of mesh had no impact on the subjective outcome. | 2008 [41] |
Alyte©—monofilament type 1 PP lightweight Y-mesh | 150 with POP | USA | A prospective study looking at the outcome of Pts who underwent a robotic approach to sacral colpopexy using a PP mesh. | 12 | Nil noted. | Robotic sacrocolpopexy using Alyte© offers excellent subjective and objective results, the clinical cure rate was 95%, and the objective anatomic cure rate was 84%. | 2009 [42] |
Rectangular PP mesh vs. one posterior rectangular and one anterior PP Y-mesh | 72 with POP | Italy | A prospective RCT to evaluate the outcomes of hysterocolposacropexy with one posterior rectangular and one anterior PP Y-mesh vs. colposacropexy with two rectangular meshes. | 51 | Recurrent low-grade cystoceles developed in 2.6% and 14.7% of Pts and low-grade rectoceles in 15.8% and 8.8% of Pts in the colposacropexy and hysterocolposacropexy groups, respectively. | Whether the uterus was preserved or not, Pts had similar results in terms of prolapse resolution, urodynamic outcomes, improvements in voiding and sexual dysfunctions. | 2010 [43] |
PP mesh vs. biological graft | 232 with POP | China | A single-blind randomised controlled prospective study evaluating the efficacy, quality of life and complication rates of PP mesh vs. biological graft. | 12 | Adverse events occurred with significantly different frequencies over 1 year. | Similar recurrence rates for PP mesh vs. biological grafts, at short-term FU. Eating soy products often and vaginal intercourse after surgery reduced recurrence. | 2010 [44] |
Vypromesh® vs. Ultrapromesh® vs. Prolene light mesh® | 144 with SUI | Turkey | A prospective RCT evaluating the effectiveness and complications of three types of synthetic mesh materials in sling surgery. | 48 | 4% of Vypromesh®, 2% of Ultrapro® and 4% of Prolene light mesh® Pts experienced ME, respectively. | Ultrapro® mesh can be used in sling surgery owing to its higher success rates, and lower rates of ME and de novo urgency rates, as shown in clinical studies. | 2011 [45] |
Ajust® sling vs. standard mid-urethral slings | 419 with SUI | Denmark, Norway and Sweden | An RCT (without blinding) investigating the Ajust® system vs. the current standard mid-urethral sling. | 36 | There were no major complications in either group. Minor complications of urinary tract infections were noted in both groups. | Ajust® appears equally as safe and effective as the standard mid-urethral sling with regards to long-term FU of Pt-reported outcomes. | 2012 [46] |
Four-arm PP TVM | 160 with POP | Poland | An interventional clinical trial to study the safety and efficacy of performing modified anterior TVM surgery using a four-arm PP mesh adjunct for the treatment of advanced urogenital prolapse after hysterectomy. | 24 | Intraoperative bladder injury in 4% of Pts. 3% complained of de novo SUI. Vaginal vault prolapse recurred in 6% of cases. ME seen in 1% of Pts at six months. | Four-arm PP TVM is safe and effective and provides an alternative treatment option for vaginal vault prolapse, especially in Pts with contraindications to laparotomy and laparoscopy. | 2014 [47] |
Upsylon™ (Boston Scientific, 300 Boston Scientific Way, Marlborough, MA 01752-1234, USA) —light-weight PP mesh using permanent sutures vs. delayed absorbable sutures for attachment | 198 with POP | US | An RCT to compare mesh and suture exposure rates in women undergoing robotic total hysterectomy and sacrocolpopexy with mesh adjunct with attachment using permanent sutures vs. delayed absorbable sutures. | 12 | Mesh/suture exposure rate of 5.1% in surgery with permanent sutures vs. 7% in surgery with delayed absorbable sutures. 3% of women experienced a serious adverse event. | Suture type used (permanent or delayed absorbable) for vaginal graft attachment did not significantly exposure rates. | 2015 [48] |
Bilateral abdominal sacral hysteropexy with Prolen®—PP mesh | 22 with POP | Turkey | A single-blind RCT investigating anatomic and sexual outcomes of bilateral sacral hysteropexy with Prolen®. | 18 | Too few Pts to evaluate complications. | This technique appears to provide an adequate clinical resolution, and it has potential to be the primary surgical option for women with POP. | 2015 [49] |
TiLOOP® PRO A-titanised PP mesh (alloplastic mesh) | 54 with POP | Germany | A multicentre nonrandomised observational clinical investigation to determine usability and collect post-market information on the TiLOOP® PRO A anterior pelvic floor reconstruction meshes, and to determine its effect on quality of life. | 12 | No adverse events related to the investigational device. | Positive outcomes achieved in the reconstruction of the anatomical position of the pelvic floor organs. Pts benefit from anatomical stability as well as improved quality of life, with justifiable risks. | 2016 [50] |
Ethicon J&J Prolene mesh | 15 with POP | Turkey | An observational study assessing cases of Pts with POP undergoing laparoscopic lateral suspension with mesh and anatomic success measured using transperineal ultrasonography. | 12 | OS | OS | 2016 * |
Synthetic PP mesh vs. synthetic sutures | 358 with POP | Canada | An interventional randomised controlled multicentre trial to compare experimental bilateral sacrospinous vaginal vault fixation with synthetic mesh arms vs. standard sacrospinous ligament suspension with synthetic sutures. | 24 | OS | OS | 2016 * |
Two rectangular PP meshes using four absorbable sutures with a nonabsorbable 0.0 PP suture | 100 with POP | Italy | A perspective randomised trial comparing laparoscopic sacrocolpopexy (LASC) vs. robotic-assisted colposacropexy (RASC) for POP repair, both using PP mesh adjunct. In cases of uterus preservation, the anterior mesh was Y-shaped. | 24 | ME rate of 4% in the RASC and 6% in LASC group, all asymptomatic and managed expectantly. | RASC provides outcomes as good as those of LASC with 100% anatomic correction of the apical compartment. RASC was somewhat more efficient and associated with fewer cases of persistent prolapse. | 2018 [51] |
Ethicon J&J PP mesh | 52 with POP | Egypt | An RCT comparing lateral suspension vs. sacropexy for the treatment of apical POP. | 18 | OS | OS | 2019 * |
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Seifalian, A.; Basma, Z.; Digesu, A.; Khullar, V. Polypropylene Pelvic Mesh: What Went Wrong and What Will Be of the Future? Biomedicines 2023, 11, 741. https://doi.org/10.3390/biomedicines11030741
Seifalian A, Basma Z, Digesu A, Khullar V. Polypropylene Pelvic Mesh: What Went Wrong and What Will Be of the Future? Biomedicines. 2023; 11(3):741. https://doi.org/10.3390/biomedicines11030741
Chicago/Turabian StyleSeifalian, Amelia, Zeinab Basma, Alex Digesu, and Vikram Khullar. 2023. "Polypropylene Pelvic Mesh: What Went Wrong and What Will Be of the Future?" Biomedicines 11, no. 3: 741. https://doi.org/10.3390/biomedicines11030741