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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]

Permanent particles do not guarantee permanent continence or absence of migration. 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. The FDA label lists migration, granuloma, embolic phenomena and vascular occlusion among potential adverse events. Animal results cannot quantify the incidence in treated women.[2][3]

US Label Safety and Administration​

Infection, tissue viability and obstruction

The original FDA physician labeling contraindicates acute urogenital infection/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. FDA approved a subsequent labeling update incorporating the ROSE registry in 2023; the complete revised IFU was not retrieved for this review. Obtain the current supplied IFU for the actual device rather than treating the older label as a complete current procedure manual.[2][4]

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. Its catheterization rate is therefore not equivalent to its urinary-retention rate.

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]

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. These analyses and improvement versus dryness must remain distinct.[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. This is not a 47.6% complete-dryness rate or a five-year success rate for all 274 enrolled women; substantial attrition limits interpretation.[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. Selection for long follow-up, repeat injections and the study-specific success definition prevent direct comparison with registry Stamey-grade outcomes.[8]
Systematic review/meta-analysis, 2013958 patients in 23 cohorts from literature through 2010Pooled long-term improvement was 64%, and dryness 36%, for follow-up beyond 18 months. Different cohorts contributed to different time windows; these estimates are not a within-patient deterioration curve or a comparison with modern PAHG trials.[9]

A separate two-year durability report followed 67 women already successfully treated at 12 months. Its 84% maintained improvement and 67% dryness describe that selected responder group, not all women starting Macroplastique.[10]

AUA/SUFU 2023 considers bulking a viable option when a woman prefers a less invasive procedure or has persistent SUI after prior treatment. Counseling should include lower likelihood of complete dryness than more invasive continence operations and the possibility of repeat treatment. Available evidence does not establish one bulking agent as best for every patient.[11]

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. The absence of serious adverse events in an earlier small cohort does not establish a zero-risk device.[7]

Exposure/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. This selected retrospective estimate is not a universal incidence and exposure is not unique to Macroplastique among bulking agents.[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 included only 45 men, with mixed prior procedures: 12 radical prostatectomies and the remainder predominantly BPH surgery. Its small “minimal incontinence” subgroup did not establish equivalence to an AUS or justify calling injection the current treatment of choice.[14]

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, reflux resolved in 182/202 ureters (90%) treated with Macroplastique versus 159/197 (81%) with Deflux. These are ureter-level anatomical outcomes, not proportions of children free of febrile UTI or renal injury.[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.

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. AUA/GURS/SUFU. Incontinence after Prostate Treatment Guideline. 2024 amendment, statement 25. Guideline.

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