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Essential Info: Indications, Warnings, and Risks

Indications for Use

The Opus Re-adjustable Sling System is intended for the surgical treatment of stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD) in adult women and men who have failed or are not candidates for conservative management or choose surgical treatment. The device provides sub-urethral or bladder-neck support using a synthetic sling material or an autologous fascial graft and allows postoperative adjustability of sling tension.

Contraindications

The Opus Sling System should not be used in patients with:

  • Active urinary tract infection (UTI).
  • Pelvic infection or untreated vaginal, urethral, or scrotal infection.
  • Pregnant patients or patients planning a future pregnancy.
  • Uncontrolled diabetes, coagulopathy, or conditions impairing wound healing.
  • Known sensitivity or allergy to implant materials.
  • Prior pelvic radiation with significant fibrosis at the intended implantation site.
  • Irreversible urinary retention unrelated to stress incontinence.
  • Active urethral erosion or significant urethral diverticulum.

Warnings

  • This device should be implanted only by surgeons trained in female or male sling surgery, familiar with pelvic anatomy, and experienced in the treatment of stress urinary incontinence.
  • Excessive sling tension may cause urinary retention, obstruction, or urethral injury.
  • Insufficient tension may result in persistent or recurrent incontinence.
  • Postoperative adjustments should be performed using aseptic technique and only by qualified clinicians.
  • Patients should be counseled that no sling procedure guarantees complete cure of stress urinary incontinence.
  • As with all pelvic floor implants, long-term outcomes vary based on patient anatomy, tissue quality, comorbidities, and surgeon experience.
  • The safety and effectiveness of this device have not been established in pregnant patients, pediatric patients, or patients with neurogenic bladder.
  • Use of synthetic mesh may be associated with erosion, exposure, or extrusion into the vagina, urethra, or bladder.
  • If using autologous tissue, surgeons must ensure adequate graft strength and fixation to support adjustability.

Precautions

  • Carefully evaluate patients for alternative causes of incontinence prior to surgery.
  • Prior pelvic surgery or radiation may increase the complexity and risk of complications.
  • Use caution when operating on patients with bleeding disorders or on anticoagulant therapy.
  • Over-manipulation of the adjustability mechanism may reduce long-term mechanical integrity.
  • The adjustability port should remain accessible postoperatively until tension stabilization is achieved.
  • Avoid contact of the sling or graft with sharp instruments or cautery that could weaken the material.
  • Patients should avoid strenuous exercise, heavy lifting, or sexual activity until cleared by their physician.

Potential Adverse Events or Risks

The following complications have been reported with sling surgery, pelvic mesh procedures, and adjustable urethral support systems:

Surgical and Intraoperative Risks

  • Bleeding or hematoma formation.
  • Bladder, urethral, or vascular injury.
  • Bowel injury (rare).
  • Infection.
  • Anesthesia-related complications.

Early Postoperative Risks

Long-Term Risks

Patient Counseling Information

Before surgery, patients should be advised of:

  • Expected benefits and limitations of sling surgery.

  • The possibility of needing postoperative adjustments.

  • Activity restrictions during healing.

  • Potential need for future procedures.

  • Risks associated with synthetic mesh versus autologous graft options.

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Empowering Patients Through Clear Guidance

Surgeons must ensure that all patient questions regarding safety, risks, and alternatives are addressed.

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