Male Continence Implant Devices (Sling Family)
Beyond the AMS 800 AUS and the ProACT periurethral balloon, the male post-prostatectomy SUI device landscape includes a family of suburethral sling implants — fixed-tension and adjustable variants — built around polypropylene mesh, silicone cushions, and bone- or transobturator anchoring. This page covers the devices themselves: components, materials, mechanism, and regulatory status.
For surgical technique, patient selection, outcomes, and comparative trial data see the procedure pages: AdVance Sling, Virtue Sling, ATOMS, Argus, Remeex MRS, and Male Urethral Slings — chooser. For the AUS see Artificial Urinary Sphincter. For ProACT see ProACT Adjustable Continence Balloons.
Device Family Overview
| Device | Manufacturer | Mechanism | Adjustable? | FDA / CE |
|---|---|---|---|---|
| AdVance / AdVance XP | Boston Scientific | Transobturator repositioning sling — relocates the bulbar urethra proximally | No | FDA 2007 / 2010 (XP) |
| Virtue | Coloplast | Quadratic four-arm sling (two transobturator + two prepubic) — combined compression + repositioning | No | FDA 2010 |
| ATOMS (Adjustable TransObturator Male System) | A.M.I. (Agency for Medical Innovations) | Transobturator suburethral cushion + scrotal port for postoperative volume adjustment | Yes (postop) | CE 2008; not FDA-approved |
| Argus | Promedon | Bilateral silicone-column anchoring to rectus fascia with washer tensioning at suburethral cushion; classic (suprapubic) and Argus-T (transobturator) variants | Intraoperative only | CE; not FDA-approved |
| Remeex MRS (Male Remeex System) | Neomedic | Polypropylene tape + varitensor suprapubic regulator for postoperative readjustment | Yes (postop, indefinitely) | CE; not FDA-approved |
| InVance (legacy) | American Medical Systems | Bone-anchored bulbourethral compression sling | No | Withdrawn |
| I-STOP TOMS (legacy / regional) | CL Medical | Transobturator polypropylene sling | No | CE |
Component & Materials Detail
AdVance & AdVance XP
- Body: Type 1 macroporous monofilament polypropylene mesh with central pre-shaped suburethral hammock.
- Arms: two transobturator arms passed via standard helical trocars.
- AdVance XP improvement: PROPEL® delivery system plus self-anchoring harpoon-tipped mesh arms to reduce postoperative slippage — addressing the historical AdVance failure mode (early sling migration).[1][2]
- No reservoir, no pump, no scrotal port — fixed at implantation.
Virtue
- Body: polypropylene mesh in a quadratic four-arm configuration.
- Two transobturator arms + two prepubic arms for combined ventral compression and proximal repositioning.[3]
- No postoperative adjustability.
ATOMS
- Suburethral cushion: silicone-elastomer fillable bladder placed against the bulbar urethra under a polypropylene mesh.
- Port: titanium scrotal injection port, accessed percutaneously for cushion fill / re-titration.
- Two transobturator arms anchor the mesh.
- Adjustability: cushion volume 0–25 mL; titrated weekly to monthly until continence achieved.[4][5]
- Third-generation Silicone-Covered Scrotal Port (SSP) model (since 2014) reduced port-pocket complications vs prior model.
Argus
- Cushion: large silicone foam pad placed beneath the bulbar urethra.
- Two silicone columns with serrated locking studs extending bilaterally through the obturator (Argus-T) or retropubic space (Argus-classic) to the rectus-fascia plane.
- Washers lock the columns at the desired tension; tension set intraoperatively under Valsalva leak-point testing.[6][7]
- Adjustability is intraoperative only; postoperative tension change requires reoperation to access the washers.
Remeex MRS
- Suburethral tape: polypropylene.
- Varitensor: subcutaneous suprapubic mechanical regulator with traction threads, accessible through a small skin incision (or a permanent transcutaneous manipulator in some configurations).[8]
- Adjustability: indefinite postoperative readjustment via a bedside manipulator — distinguishes Remeex from ATOMS, which uses fluid-volume titration rather than mechanical tape tensioning.
Mechanistic Comparison
| Device | Acts on | Principal mechanism |
|---|---|---|
| AdVance / AdVance XP | Bulbar urethra | Proximal repositioning without compression |
| Virtue | Bulbar urethra | Quadratic compression + repositioning |
| ATOMS | Bulbar urethra | Suburethral adjustable cushion compression |
| Argus | Bulbar urethra | Suburethral static foam compression |
| Remeex | Bulbar urethra (suburethral tape) | Adjustable tape tension via suprapubic regulator |
| ProACT | Bladder neck | Bilateral periurethral balloon compression (not a sling) |
| AMS 800 AUS | Bulbar urethra | Circumferential cuff occlusion |
The clinically meaningful split is compressive vs repositioning (AdVance is the only purely repositioning device) and adjustable vs fixed (ATOMS, Remeex postop-adjustable; Argus intraop only; AdVance, AdVance XP, Virtue fixed).
Materials Across the Family
| Material class | Devices | Role |
|---|---|---|
| Type 1 macroporous polypropylene | AdVance, AdVance XP, Virtue, ATOMS (mesh), Remeex (tape) | Suburethral support |
| Silicone elastomer | ATOMS (cushion), Argus (columns + foam pad), ProACT (balloons) | Compression / cushioning |
| Titanium | ATOMS port, ProACT port | Percutaneous access |
| Polypropylene + mechanical regulator | Remeex varitensor | Adjustable tape tensioning |
Type 1 polypropylene mesh is the same material used in female mid-urethral slings; see Polypropylene Mesh for the broader mesh-safety, erosion, and FDA-classification discussion that applies to all polypropylene-based male sling devices.
Regulatory & Distribution Status (US)
- FDA-approved for male SUI: AdVance, AdVance XP, Virtue, AMS 800 AUS, ProACT.
- CE-marked, not FDA-approved: ATOMS, Argus, Remeex MRS (widely used in Europe and Latin America; limited US availability under research / off-label pathways).
- Withdrawn: InVance (bone-anchored sling; abandoned over osteitis pubis and explant rates).
Failure Modes (Device-Level)
- Mesh erosion / extrusion — polypropylene-based devices (AdVance, Virtue, Remeex tape, ATOMS mesh).
- Cushion failure / leak — ATOMS, ProACT.
- Tape / cushion migration — AdVance original (addressed by AdVance XP harpoon arms); Argus column slippage.
- Tensioning hardware failure — Argus washer slip; Remeex varitensor mechanical fault.
- Port-pocket infection — ATOMS, ProACT (titanium scrotal port shared failure mode).
- Bladder / urethral injury during trocar passage — all transobturator and retropubic-anchored devices.
References
1. Rehder P, Gozzi C. "Transobturator sling suspension for male urinary incontinence including post-radical prostatectomy." Eur Urol. 2007;52(3):860–7. doi:10.1016/j.eururo.2007.01.110
2. Bauer RM, Soljanik I, Füllhase C, Karl A, Becker AJ, Stief CG, Gozzi C. "Mid-term results for the retroluminar transobturator sling suspension for stress urinary incontinence after prostatectomy." BJU Int. 2011;108(1):94–8. doi:10.1111/j.1464-410X.2010.09729.x
3. Comiter CV, Rhee EY, Tu LM, Herschorn S, Nitti VW. "The Virtue sling — a new quadratic sling for postprostatectomy incontinence: results of a multinational clinical trial." Urology. 2014;84(2):433–8. doi:10.1016/j.urology.2014.04.044
4. Hoda MR, Primus G, Fischereder K, et al. "Early results of a European multicentre experience with a new self-anchoring adjustable transobturator system for treatment of stress urinary incontinence in men." BJU Int. 2013;111(2):296–303. doi:10.1111/j.1464-410X.2012.11482.x
5. Esquinas C, Angulo JC. "Effectiveness of adjustable transobturator male system (ATOMS) to treat male stress incontinence: a systematic review and meta-analysis." Adv Ther. 2019;36(2):426–41. doi:10.1007/s12325-018-0852-4
6. Romano SV, Metrebian SE, Vaz F, et al. "An adjustable male sling for treating urinary incontinence after prostatectomy: a phase III multicentre trial." BJU Int. 2006;97(3):533–9. doi:10.1111/j.1464-410X.2006.06002.x
7. Hübner WA, Gallistl H, Rutkowski M, Huber ER. "Adjustable bulbourethral male sling: experience after 101 cases of moderate-to-severe male stress urinary incontinence." BJU Int. 2011;107(5):777–82. doi:10.1111/j.1464-410X.2010.09619.x
8. Sousa-Escandón A, Cabrera J, Mantovani F, et al. "Adjustable suburethral sling (male remeex system) in the treatment of male stress urinary incontinence: a multicentric European study." Eur Urol. 2007;52(5):1473–9. doi:10.1016/j.eururo.2007.05.017