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Macroplastique — Polydimethylsiloxane (PDMS)

Macroplastique is a permanent particulate urethral bulking implant. The current Laborie US product information specifies adult women with stress urinary incontinence primarily due to intrinsic sphincter deficiency (ISD) and endoscopic administration. Its international product information includes additional uses; those indications do not confer US approval.[1]

For treatment selection and operative context, see Urethral Bulking Agents.

Material and Tissue Response​

Solid, heat-vulcanized silicone elastomer particles are suspended in a water-soluble polyvinylpyrrolidone carrier. After injection, host tissue replaces the carrier and forms a collagen matrix around the implants. This provides coaptation without an implanted sling.[1][2]

Scanning electron micrograph of irregular textured silicone elastomer particles

Scanning electron micrograph of Macroplastique implants: irregular, textured solid silicone elastomer particles (scale bar 100 μm). From Ghoniem GM, Miller CJ. Int Urogynecol J. 2013;24(1):27-36, Fig. 1 (CC BY).[9]

In an early 13-dog study, large particles retained their local injection-site configuration better than small particles, but distant migration still occurred in one large-particle animal.[3] The FDA label lists migration, granuloma, embolic phenomena and vascular occlusion among potential adverse events.[2]

US Label Safety and Administration​

Infection, tissue viability and obstruction

The original FDA physician labeling contraindicates acute urogenital infection or inflammation and fragile urethral mucosa, including tissue fragility after radiation or bladder-neck surgery. It warns against injection into nonviable tissue and against intravascular injection. Correct urethral or bladder-neck strictures first, and avoid overcorrection that could cause obstruction.[2]

The posted original FDA physician label is PN4226 RevA, September 2006.[2] FDA approved a labeling update incorporating the ROSE registry in 2023.[4] The 2006 label describes transurethral implantation through a cystoscope with at least a 7 Fr working channel, 1.5 to 2.0 cm distal to the bladder neck, with the bevel toward the urethral lumen. Each site uses a tissue tunnel: the needle enters at 30 to 45 degrees for 0.5 cm and then advances parallel to the urethra for another 0.5 cm. Implants are placed at 6, then 2 and 10 o'clock, waiting about 30 seconds before withdrawing the needle; the cystoscope is not passed back over the implants, and later treatments are placed distal to the first.[2]

Important distinctions in the original label include:[2]

  • Do not perform implantation within 12 weeks of a previous Macroplastique injection or sling procedure. More than one retreatment and shorter retreatment intervals were outside the original evaluated regimen.
  • Periurethral injection and male use had not been established in the US labeling; pregnancy and lactation safety were unknown.
  • Confirm satisfactory voiding before discharge and provide a catheterization plan if retention occurs.
  • The original protocol allowed routine brief catheterization to drain the bladder.

The current US product page describes a 2.5-mL prefilled syringe, a reusable administration device and compatible endoscopic needles. Published experience with the nonendoscopic Macroplastique Implantation System (MIS) is a different delivery method; its port orientation and technique should not be substituted for the US endoscopic instructions.[1][5] In a 21-woman series with 12-month follow-up, the MIS was used under local anesthesia without cystoscopic guidance (mean 6.3 mL); 12 women (57.1%) considered themselves cured and 13 (62%) were dry on pad-weight testing.[5]

Clinical Evidence in Women​

SourcePopulation and endpointResult and limitation
Pivotal randomized comparison with collagenOriginal FDA analysis: 260 enrolled, 247 treated according to allocation; endpoint 12 months after the last treatmentAmong the treated-per-protocol denominators, improvement by at least one Stamey grade was 75/122 (61.5%) versus 60/125 (48.0%); dryness was 45/122 (36.9%) versus 31/125 (24.8%). The original label's all-enrolled analysis gives lower improvement rates, 75/130 (57.7%) versus 61/130 (46.9%). Repeat injections were common. One-hour pad-weight reduction did not differ between arms (25.4 vs 22.8 mL, p = 0.64).[2][6]
ROSE five-year report, 2025Prospective observational registry, 274 enrolled at 22 US centers; 147 (54%) completed five-year follow-up70/147 (47.6%) had improved Stamey grade from baseline after their last injection. Quality of life improved among assessed patients.[7]
Long-term cohort, 2024106 women with at least five years of follow-up, median 7.4 years; success required low SUI symptom score and no further continence treatmentOverall success was 43% after the last injection; among successes, 54% had one injection and 46% had at least two. Seventeen percent of failures went on to an autologous sling. Selection for long follow-up, repeat injections and the study-specific success definition prevent direct comparison with registry Stamey-grade outcomes.[8]
Prospective cohort, Serati 201985 women with urodynamically confirmed SUI, at least 3 years of follow-up42/85 (49%) reported cure and 40/85 (47%) were objectively cured, with no significant deterioration over time. Prior radical pelvic surgery and low surgeon skill independently predicted failure. Single unit.[18]
Prospective observational, Zullo 200561 women with ISD without urethral hypermobility, followed to 60 monthsCure 18%, improvement 39% and failure 43% at 60 months (success 57%). Uncontrolled.[19]
Systematic review/meta-analysis, 2013958 patients in 23 cohorts from literature through 2010Pooled improvement was 75%, 73% and 64%, and cure or dryness 43%, 37% and 36%, at under 6 months, 6–18 months and beyond 18 months. Higher study-level reinjection rates were associated with higher long-term improvement rates; no statistically significant association with cure rates was detected at any time point. Different cohorts contributed to different time windows.[9]

A separate two-year durability report followed 67 women already successfully treated at 12 months.[10] Its 84% maintained improvement and 67% dryness describe that selected responder group.[10]

AUA/SUFU 2023 lists bulking agents among the options to discuss with index patients considering surgery . The panel considers bulking viable for women who wish to avoid more invasive surgery, are concerned about recovery time, or have insufficient improvement after a previous anti-incontinence procedure; it advises counseling on the expected need for repeat injections, finds the data inadequate to recommend one agent over another, and notes the view that patients may choose bulking despite a lower success rate because it is less invasive than sling surgery.[11]

Placement and Predictors of Outcome​

In 100 treatment-naive women examined with three-dimensional endovaginal ultrasound after injection, proximal urethral location and circumferential periurethral distribution were each associated with a good clinical outcome. Midurethral location was more frequent in the group with a poor outcome (p = 0.036). Among women with proximal deposits, the odds of circumferential distribution were higher in the good-outcome group than in the poor-outcome group (OR 22, 95% CI 3.05–203.49). The study was single-center with short-term outcomes.[20]

After Failed Midurethral Sling​

A 2022 meta-analysis of bulking agents for recurrent SUI after failed midurethral sling (11 publications) reported a pooled cure or improvement rate of 75%. In the subgroup analysis, pooled cure or improvement was 84% (95% CI 77–90%) for Macroplastique and 80% (95% CI 74–85%) for Bulkamid, without significant differences. Heterogeneity between the studies was significant.[21]

Complications and Follow-up​

Discuss retention, dysuria, hematuria, urgency and UTI. ROSE reported one device-related serious retention event, resolving within four months, as well as transient retention and UTIs.[7]

Exposure or erosion can present years later. A retrospective chart review identified 14 urethral exposures among 580 eligible cases, with a median 48 months from the last injection to presentation. Symptoms included recurrent UTI, urgency, leakage, retention and interrupted flow. Ten patients underwent extraction.[12]

Evaluate inability to void promptly. Persistent pain, hematuria, recurrent infection or new obstructive symptoms can warrant cystoscopy and assessment of the implant. Document the product and treatment history: inflammatory implant-related masses may also confuse subsequent imaging, including FDG-PET.[13]

Male Incontinence: Different Regulatory and Evidence Context​

The current manufacturer distinguishes international male-SUI use from the US female-ISD indication.[1] A 2005 randomized study of 45 men stratified by severity (12 after radical prostatectomy, the rest after BPH surgery; follow-up 48 months, range 6–84, after injection) found no significant difference between Macroplastique and the AUS in minimal incontinence (21 men), whereas the AUS was significantly better in total incontinence (24 men).[14] An uncontrolled series of 50 men with mild to moderate postoperative incontinence (46 after radical prostatectomy) reported 6 completely dry after the first injection, with 10, 9 and 5 more after the second, third and fourth injections (total volume 2.5–13.5 mL, mean 7.1 mL); repeated injections were needed and follow-up was 3 months after each injection.[22]

AUA/GURS/SUFU 2024 recommends counseling men with incontinence after prostate treatment that urethral bulking efficacy is low and cure is rare . Use the male-incontinence operative pathways for contemporary procedure selection.[15]

Pediatric VUR: Keep Reflux and Infection Endpoints Separate​

Macroplastique has been studied and used internationally for VUR, but that is not its US indication.[1] In a prospective comparison with random allocation (275 patients, grades I–V), reflux was fully corrected at three-month VCUG in 182/202 ureters (90%) treated with Macroplastique versus 159/197 (81%) with Deflux; obstruction occurred in 5 ureters.[16]

The 2019 Cochrane review found less persistent reflux with Macroplastique in two trials, but limited evidence for infection outcomes and no reported renal-parenchymal outcome data in this agent comparison. Limitations in study quality and patient-important outcomes prevent an unqualified claim of clinical superiority. Choice must account for local authorization, obstruction risk, anatomy and the child's management pathway.[17]

See also: Bulkamid, Coaptite, Deflux.

References​

1. Laborie. Macroplastique / Plastique Family of Products. Current US/international product information.

2. US Food and Drug Administration. Macroplastique physician labeling and patient brochure. P040050; PN4226/4231 RevA, September 2006. Original approved labeling.

3. Henly DR, Barrett DM, Weiland TL, et al. Particulate Silicone for Use in Periurethral Injections: Local Tissue Effects and Search for Migration. The Journal of Urology. 1995;153(6):2039-2043. PubMed. doi:10.1016/s0022-5347(01)67398-1

4. US Food and Drug Administration. P040050/S013: ROSE registry labeling update. May 9, 2023. Approval record.

5. Tamanini JT, D'Ancona CA, Tadini V, Netto NR. Macroplastique Implantation System for the Treatment of Female Stress Urinary Incontinence. The Journal of Urology. 2003;169(6):2229-2233. doi:10.1097/01.ju.0000067472.94016.e8

6. Ghoniem G, Corcos J, Comiter C, et al. Cross-Linked Polydimethylsiloxane Injection for Female Stress Urinary Incontinence: Results of a Multicenter, Randomized, Controlled, Single-Blind Study. The Journal of Urology. 2009;181(1):204-210. doi:10.1016/j.juro.2008.09.032

7. Ghoniem G, Lane F, Farhan B, et al. Five-Year Follow-Up Study on Safety and Efficacy of Macroplastique® in Female Patients With Stress Urinary Incontinence (The ROSE Study). International Urogynecology Journal. 2025. doi:10.1007/s00192-025-06163-5

8. Kusin SB, Carroll TF, Alhalabi F, Christie AL, Zimmern PE. Long-Term Outcomes With Macroplastique in Women With Stress Urinary Incontinence Secondary to Intrinsic Sphincter Deficiency. Urology. 2024;185:36-43. doi:10.1016/j.urology.2023.12.019

9. Ghoniem GM, Miller CJ. A Systematic Review and Meta-Analysis of Macroplastique for Treating Female Stress Urinary Incontinence. International Urogynecology Journal. 2013;24(1):27-36. doi:10.1007/s00192-012-1825-9

10. Ghoniem G, Corcos J, Comiter C, Westney OL, Herschorn S. Durability of Urethral Bulking Agent Injection for Female Stress Urinary Incontinence: 2-Year Multicenter Study Results. The Journal of Urology. 2010;183(4):1444-1449. doi:10.1016/j.juro.2009.12.038

11. Kobashi KC, Vasavada S, Bloschichak A, et al. Updates to Surgical Treatment of Female Stress Urinary Incontinence (SUI): AUA/SUFU Guideline (2023). The Journal of Urology. 2023;209(6):1091-1098. doi:10.1097/JU.0000000000003435

12. Ramirez-Caban L, Malekzadeh M, Ossin DA, Hurtado EA. Clinical Presentation and Treatment of Macroplastique® Urethral Exposures: A Retrospective Case Series. International Urogynecology Journal. 2022;33(3):681-687. doi:10.1007/s00192-021-04910-y

13. Richard C, Dejust S, Moubtakir A, Bruna-Muraille C, Morland D. Periurethral Mass Mimicking Neoplasm After Injection of Macroplastique for Postprostatectomy Stress Incontinence: A Pitfall on 18F-FDG PET/CT. Clinical Nuclear Medicine. 2018;43(5):381-382. doi:10.1097/RLU.0000000000002043

14. Imamoglu MA, Tuygun C, Bakirtas H, Yiğitbasi O, Kiper A. The Comparison of Artificial Urinary Sphincter Implantation and Endourethral Macroplastique Injection for the Treatment of Postprostatectomy Incontinence. European Urology. 2005;47(2):209-213. doi:10.1016/j.eururo.2004.08.019

15. Breyer BN, Kim SK, Kirkby E, et al. Updates to Incontinence After Prostate Treatment: AUA/GURS/SUFU Guideline (2024). The Journal of Urology. 2024;212(4):531-538. doi:10.1097/JU.0000000000004088

16. Moore K, Bolduc S. Prospective Study of Polydimethylsiloxane vs Dextranomer/Hyaluronic Acid Injection for Treatment of Vesicoureteral Reflux. The Journal of Urology. 2014;192(6):1794-1799. doi:10.1016/j.juro.2014.05.116

17. Williams G, Hodson EM, Craig JC. Interventions for Primary Vesicoureteric Reflux. Cochrane Database of Systematic Reviews. 2019;2:CD001532. doi:10.1002/14651858.CD001532.pub5

18. Serati M, Soligo M, Braga A, et al. Efficacy and Safety of Polydimethylsiloxane Injection (Macroplastique) for the Treatment of Female Stress Urinary Incontinence: Results of a Series of 85 Patients With ≥3 Years of Follow-Up. BJU International. 2019;123(2):353-359. doi:10.1111/bju.14550

19. Zullo MA, Plotti F, Bellati F, et al. Transurethral Polydimethylsiloxane Implantation: A Valid Option for the Treatment of Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency Without Urethral Hypermobility. The Journal of Urology. 2005;173(3):898-902. doi:10.1097/01.ju.0000152568.40199.a8

20. Hegde A, Smith AL, Aguilar VC, Davila GW. Three-Dimensional Endovaginal Ultrasound Examination Following Injection of Macroplastique for Stress Urinary Incontinence: Outcomes Based on Location and Periurethral Distribution of the Bulking Agent. International Urogynecology Journal. 2013;24(7):1151-1159. doi:10.1007/s00192-012-1983-9

21. Braga A, Caccia G, Papadia A, et al. Urethral Bulking Agents for the Treatment of Recurrent Stress Urinary Incontinence: A Systematic Review and Meta-Analysis. Maturitas. 2022;163:28-37. doi:10.1016/j.maturitas.2022.05.007

22. Kylmälä T, Tainio H, Raitanen M, Tammela TL. Treatment of Postoperative Male Urinary Incontinence Using Transurethral Macroplastique Injections. Journal of Endourology. 2003;17(2):113-115. doi:10.1089/08927790360587450