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Macroplastique ® Injectable Bulking Agent for Adult Female Stress Urinary Incontinence

Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD). Macroplastique has been used in Europe since 1991 and has proven to be an effective and safe treatment alternative for those suffering from SUI.

Predictable Procedure

Permanent Implants

  • Permanent implants: non-degradable, non-resorbable
  • Soft, flexible, textured implant particles create an excellent matrix for collagen deposition
  • Histological examination of tissue explants revealed no evidence of particle migration

Proven Performance
In a multi-center clinical study, Macroplastique demonstrated excellent clinical efficacy

  • 122 patients received Macroplastique and were followed for 12 months from initial treatment
    • 75 of 122 (61.5%) were improved at 12 months based on Stamey grade
    • 45 of 122 (36.8%) were dry based on Stamey grade
  • No serious treatment-related adverse events were associated with Macroplastique procedures
  • Twenty-four month follow-up data were available on 84 Macroplastique subjects. Of these 84 subjects, 63 had improvement in Stamey Grade at 24 months, 28 of whom were dry

Macroplastique is indicated for transurethral injection in the treatment of adult women diagnosed with SUI primarily due to ISD. Contraindications: Not to be used in patients with acute urogenital tract inflammation/infection or fragile urethral mucosal lining. Warnings: Do not use in patients with obstructive conditions until such conditions have been corrected. Overcorrection may lead to urinary obstruction. Potential genitourinary adverse effects that may occur include: post-operative catheterization, UTI, urinary retention, dysuria, hematuria, pain at implantation site, frequency, urgency. While not reported in the clinical study, other potential events include erythema, embolic phenomena, granuloma, migration and vascular occlusion.

0540017F 11/10