PM-19737
Supris Retropubic Kit Brief Statement
Indications
The Supris Retropubic Kit consists of the Supris implantable midurethral support sling and disposable introducers for placement using a “top-down” or “bottom-up” retropubic surgical approach. The Supris sling and introducers are indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Contraindications
It is the responsibility of the physician to advise the prospective patients or their representatives, prior to surgery, of the contraindications associated with the use of this product. The Supris Retropubic Kit is contraindicated for use in patients with the following conditions:
- Pregnancy or desire for future pregnancy
- Potential for further growth (e.g., adolescents)
- Known active urinary tract infection and/or infection in operative field
- Taking anti-coagulant therapy
- Abnormal urethra (e.g., fistula, diverticulum)
- Intraoperative urethral injury
- Any condition, including known or suspected pelvic pathology, which could compromise implant or implant placement
- Sensitivity/allergy to polypropylene
Warnings & Precautions
It is the responsibility of the physician to advise prospective patients prior to surgery, of the warnings associated with the use of this product and the associated surgical risks.
Warnings
The Supris Retropubic Kit should only be used by physicians familiar with the surgical procedures and techniques involving transvaginal placement of non-absorbable, synthetic mesh slings. A thorough assessment of each patient should be made to determine the suitability of a synthetic mesh sling procedure.
The patient should be counseled that alternative incontinence treatments may be appropriate prior to surgical intervention. Obtain patient consent prior to surgery and ensure that the patient understands the postoperative risks and potential complications of transvaginal mesh sling surgery and that the Supris implant is permanent.
Patient Warnings
As with all surgical procedures, patients with certain underlying conditions may be more susceptible to postoperative bleeding, impaired blood supply, compromised/delayed healing, or other complications and adverse events.
The risks and benefits of using Supris should be considered in patients with:
- Age-related underlying conditions
- Autoimmune disease
- Coagulation disorder
- Connective tissue disorder
- Debilitated or immunocompromised state
- Diabetes
- Pelvic radiation therapy or chemotherapy
- Physical characteristics (e.g., body mass index)
- Renal insufficiency
- Smoking-related underlying conditions
- Urinary tract anomalies
Future pregnancy could negate the benefits of this surgical procedure. Patients should report any bleeding, pain, abnormal vaginal discharge or sign of infection that occur at any time.
Potential Complications
Adverse events are known to occur with transvaginal synthetic sling procedures and implants. Adverse events following mesh implantation may be de novo, persistent, worsening, transient, or permanent.
Adverse events may include but are not limited to: • Abscess (acute or delayed) • Adhesion/scar formation • Allergy, hypersensitivity or other immune reaction • Bleeding, hemorrhage or hematoma • Dehiscence • Delayed wound healing • Extrusion, erosion or exposure of mesh sling into the vagina or other structures or organs • Fistula formation • Infection • Inflammation (acute or chronic) • Local irritation • Necrosis • Pain Related: De novo and/or worsening dyspareunia; Neuromuscular symptoms (acute or chronic); Pain (acute or chronic); Partner pain and/or discomfort during intercourse • Perforation or injury of soft tissue (e.g., muscles, nerves, vessels), structures, or organs (e.g., bone, bladder, urethra, ureters, vagina) • Seroma • Sling migration • Urinary Related: Bladder storage dysfunction (e.g., increased daytime frequency, urgency, nocturia, overactive bladder, urinary incontinence); Ureteral obstruction; Urinary tract infection; Voiding symptoms (e.g., dysuria, urinary retention, incomplete emptying, straining, positional voiding, weak stream) • Vaginal Related: Granulation tissue formation; Palpable mesh (patient and/or partner); Sexual dysfunction; Vaginal discharge (abnormal); Vaginal scarring or tightening.
The occurrence of these events may require one or more revision surgeries, including removal of the sling. Complete removal of the sling may not always be possible, and additional surgeries may not always fully correct the complications. There may be unresolved pain with or without mesh sling explantation.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-04431 / Jan 2025
