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Upsylon™ Y-Mesh and Colpassist™ Vaginal Positioning Device

Upsylon Y-mesh is intentionally designed to offer a balance of low density and high durability to facilitate mesh positioning and placement during sacrocolpopexy. The Colpassist™ Vaginal Positioning Device is designed to enhance the procedure by providing multi-directional vaginal manipulation and a flat suturing surface.

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How it works

Designed to deliver both low density and high durability, driving procedural ease through exceptional handling and dynamic, tear-resistant design. Our unique finishing process provides a smoother, thinner mesh with optimal bending stiffness, allowing the mesh to lay flat and resist tenting during fixation.

Upsylon product image.

Why choose Upsylon Y-mesh

Upsylon product shot.
Upsylon™ Y-Mesh durable icon.

Durable

Proven strength at a low density. Bench studies show:

  • Greater resistance to tearing at attachment point than ultra-lightweight mesh*
  • Reduced risk of suture pullout (24% stronger suture pull-out strength vs. Restorelle, 39% stronger vs. Vertessa Lite)*
  • Upsylon weight 25g/m2 is stronger than ultra-lightweight mesh (≤20 g/m2) where construct is more susceptible to tearing at attachment point*

*Bench test results may not necessarily be indicative of clinical performance. The testing was performed by or on behalf of Boston Scientific.

 

Upsylon™ Y-Mesh dynamic design icon.

Dynamic design

Mesh properties optimized to match bio-mechanical characteristics of the vaginal wall.1

  • Pore size designed to help promote mesh integration with tissue
  • Anterior, posterior and sacral mesh panels are each approximately 12 cm long by 4 cm wide
  • Trimmable and customizable to meet patient needs 

 

Upsylon™ Y-Mesh exceptional handling icon.

Optimized handling

Handling characteristics designed for ease of positioning, placement, and fixation.

  • Blue color — Designed to provide enhanced visualization of mesh in the surgical field
  • A smoother, thinner mesh provides optimal bending stiffness and allows mesh to lay flat and resist tenting during fixation.
  • Enhanced with the Colpassist Vaginal Positioning Device to help create flat suturing surface and provide multi-direction vaginal manipulation

What makes Upsylon different?

Upsylon Y-Mesh showing different features.

A. Blue color and centering line

Enhance visualization and orientation during placement

B. Pore size: 2.8 mm2

Pore size (diameter ≥ 1.0 mm) designed to promote tissue integration and facilitate passage of needle and sutures.

C. 45-degree pore orientation

Diamond knit pattern allows mesh to adjust to applied force during implantation.

D. Light mesh weight: 25 g/m2

Lightweight, low surface area to minimize mesh contact with the vaginal wall following abdominal placement.

E. Thickness: 190 microns

Thin design due to proprietary mesh ironing process. 

Tensile strength: 56.7 N

High tensile strength designed to resist tearing and deformation while remaining flexible. In a bench test, Upsylon was 64% stronger than Restorelle and 49% stronger than Vertessa Lite.

Suture pull-out strength: 16.6 N

Designed to reduce the risk of suture pullout. Bench studies show Upsylon has 24% greater suture retention than Restorelle and 39% more than Vertessa Lite.

Bench test results may not necessarily be indicative of clinical performance. The testing was performed by or on behalf of Boston Scientific.

Colpassist vaginal positioning device product shot.

Colpassist™ Vaginal Positioning Device

The Colpassist Vaginal Positioning Device is specifically designed for vaginal positioning in gynecologic procedures and as a suturing platform for vaginal wall fixation during sacrocolpopexy.

  • Two size end options create a flat suturing surface
  • Multi-direction vaginal manipulation during dissection and mesh placement

Questions?

We are here to help answer any questions you may have about Upsylon Y-Mesh.

Clinical highlights

Matthews CA, Geller EJ, Henley BR, Kenton K, Myers EM, Dieter AA, Parnell B, Lewicky-Gaupp C, Mueller MG, Wu JM
Published in Obstet Gynecol, 2020

Permanent compared with absorbable suture for vaginal mesh fixation during total hysterectomy and sacrocolpopexy (PACT): a randomized controlled trial

Mesh or permanent suture exposure rates and clinical success after minimally invasive total hysterectomy and sacrocolpopexy for primary advanced uterovaginal prolapse are not affected by suture type for vaginal graft attachment. The use of a lightweight mesh material resulted in a low rate of symptomatic mesh exposure, a high rate of success, and few serious adverse events within 1-year post surgery.

Study details

Prospective, randomized; 12-month follow-up; multi-center (5 sites); 198 patients

Objective 

The study aimed to compare mesh and permanent suture exposure rates in women undergoing minimally invasive total hysterectomy and sacrocolpopexy using either permanent (polytetrafluoroethylene, Gore-Tex) or delayed absorbable monofilament sutures.

Results

Mesh/suture exposure rates: The total rate of mesh or permanent suture exposure was 12 of 198 (6.1%): 5.1% for permanent compared with 7.0% for delayed absorbable. The majority (9/12) were asymptomatic.

Composite success was 93% for permanent compared with 95% for delayed absorbable suture.

Adverse events: Six (3.0%) women had a serious adverse event.

Matthews CA, Myers EM, Henley BR, Kenton K, Weaver E, Wu JM, Geller EJ
Published in Int Urogynecol J, 2023

Long-term mesh exposure after minimally invasive total hysterectomy and sacrocolpopexy (E-PACT)

The rate of incident mesh exposure between 1 and 3.9 years post-surgery was low, success rates remained high, and there were no delayed serious adverse events.

Study details

Prospective, randomized; 47-month follow-up; Multi-center (5 sites); 182 patients

Objective 

The study aimed to evaluate total and incident mesh exposure rates at least 2 years after minimally invasive total hysterectomy and sacrocolpopexy. Secondary aims included evaluating surgical success and late adverse events.

Results

Mesh/suture exposure rates: 7.7% overall exposure rate, with only 2 incident cases reported after 1-year follow-up.

Surgical success: 87.7% (93/106) success rate; 13 out of 94 (13.8%) failed by bulge symptoms, 2 out of 78 (2.6%) by prolapse beyond the hymen, 1 out of 85 (1.2%) by retreatment with pessary, and 0 by retreatment with surgery.

Adverse events: No serious adverse events reported.

Bretschneider CE, Myers ER, Geller EJ, Kenton KS, Henley BR, Matthews CA
Published in Int Urogynecol J, 2024

Long-term mesh exposure 5 years following minimally invasive total hysterectomy and sacrocolpopexy (E-PACTII)

Minimally invasive total hysterectomy and sacrocolpopexy with a gradual increase in (or slowly rising rate of) mesh exposure over time and high long-term surgical success over 5 years. Few patients experienced bothersome symptoms or required retreatment, and no delayed serious adverse events were reported.

Study details

Prospective, randomized; 60-month follow-up; multi-center (5 sites); 82 patients

Objective 

The study aimed to assess long-term mesh/suture exposure rates 5 years after minimally invasive total hysterectomy and sacrocolpopexy.

Results

Mesh/suture exposure rates: 9.9% cumulative exposure rate of 5 years.

Surgical success: 95% success rate, with few experiencing bothersome bulge symptoms or requiring retreatment.

Adverse events: No delayed serious adverse events reported.

Kulkarni M, Rolnik DL, Alexander J, McGannon F, Liu YA, Rosamilia A
Published in Int Urogynecol J, 2022

Outcomes following sacrocolpopexy using ultralight and lightweight mesh 

There was no significant difference in composite failure between ultralight and lightweight mesh. 

Study details

Retrospective, 36 and 63 months (ultralight and lightweight mesh, respectfully) median follow-up, multi-center (6 sites), 220 patients

Objective 

To evaluate long-term outcomes, including mesh exposure, composite failure, and repeat surgery rates, in patients undergoing sacrocolpopexy with ultralight versus lightweight mesh.

Results

Composite failure rates: No significant difference in composite failure between ultralight and lightweight mesh groups.

Mesh exposure rates: 7% for ultralight mesh and 8% for lightweight mesh.

Repeat surgery rates: Repeat surgery for recurrent apical prolapse occurred in 5% of patients in the ultralight mesh group and 13% in the lightweight mesh group, while repeat surgery for mesh exposure was 1% in ultralight mesh group and 3% in lightweight mesh group.

Upsylon™ Y-Mesh Competitive Bench Study Comparison

Upsylon™ Y-Mesh closeup. Upsylon™ Y-Mesh closeup
Restorelle™ Y Mesh closeup. Restorelle™ Y Mesh closeup
Vertessa™ Lite Mesh closeup. Vertessa™ Lite Mesh closeup



BasicsMesh handlingDurabilityColor
MeshMesh weight (g/m2)Pore size (mm2)Fiber diameter (microns)Pliability (ASTM Standard D-4032) stiffness (N)*Thickness (microns)Tensile strength (N)*Suture pull-out (machine direction) strength (N)*Mesh color
Upsylon Y-Mesh (BSC)252.81000.5319056.716.6Blue with natural center stripe
Restorelle™ Y-Mesh193.0750.1130534.513.4Natural

Vertessa™ Lite
20.91.575Not tested25437.911.9Blue
*Bench test results may not necessarily be indicative of clinical performance. The testing was performed by or on behalf of Boston Scientific.

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Upsylon™ Y-Mesh resources

Ordering information

 

Order numberUPNGTINDescriptionQuantity
831820M006831820008714729839217Upsylon Y-MeshEach
831821M006831821008714729848097Colpassist vaginal positioning deviceEach
831222M006831822008714729848103Upsylon Y-Mesh and Colpassist vaginal positioning device kitEach

Reference:

  1. Baah-Dwomoh, A., McGuire, J., Tan, T., and De Vita, R. (September 2, 2016). “Mechanical Properties of Female Reproductive Organs and Supporting Connective Tissues: A Review of the Current State of Knowledge.” ASME. Appl. Mech. Rev. November 2016; 68(6): 060801.

For Upsylon Y-Mesh: CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician trained in performing mesh procedures for surgical repair of pelvic organ prolapse.

For Colpassist Vaginal Positioning Device: CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

Please refer to package insert provided with these products for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events, and Instructions prior to using these products.

Potential risks for Upsylon™ Y-Mesh and Polyform™ Synthetic Mesh: Potential adverse events, any of which may be ongoing, include but are not limited to: Abscess, Adhesion formation, Allergic reaction (hypersensitivity), Bruising, Bleeding (hematoma formation), Constipation, Dehiscence, De novo detrusor instability, Dyspareunia, Pain with intercourse that may not resolve, Sexual dysfunction; including the inability to have intercourse, Erosion into organs; exposure/extrusion into vagina, Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse, Failure to resolve a patient’s prolapse, Fistula formation (acute or chronic), Foreign body reaction (acute or chronic), Granulation tissue formation, Hemorrhage, Infection, Inflammation (acute or chronic), Injury to ureter, Scarring/scar contracture, Mesh contracture, Tissue contracture, Necrosis, Nerve injury, Organ perforation, Pain (pelvic, vaginal, groin/thigh, dyspareunia) (acute or chronic), Perforation or laceration of vessels, nerves, bladder, or bowel may occur during placement, Post-operative bowel obstruction, Prolapse/recurrent prolapse, Vaginal shortening or stenosis that may result in dyspareunia and/or sexual dysfunction, Voiding dysfunction (incontinence, temporary or permanent lower urinary tract obstruction, difficulty urinating, pain with urination, overactive bladder, and retention). The occurrence of one or more of these complications may require treatment or surgical intervention. In some instances, the complication may persist as a permanent condition after the surgical intervention or other treatment. Removal of mesh or correction of mesh-related complications may involve multiple surgeries. Complete removal of mesh may not be possible and additional surgeries may not always fully correct the complications.

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