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Advantage™Advantage™ Transvaginal Mid-Urethral Sling System

Product Number: M0068502000
GTIN: 08714729470274

The mesh implant is intended as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The delivery devices are intended for use as an aid in insertion, placement, fixation, and anchoring of surgical mesh during urogynecological procedures.

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Product Details

Offers an ergonomic delivery device handle designed to provide tactile sensation and a curved needle tip that is designed to fit behind the pubic bone. Available with Advantage™ clear mesh or Advantage Blue mesh.

Delivery Device

  • Delivery Device Handle
    • Non-skid grip designed to prevent hands from slipping during the intra-operative manipulation
    • Ergonomic handle is designed to fit into operator's palm to allow for ambidextrous use
    • Hard surface of the back rim provides tactile sensation from the distal tip to the physician’s hand indicating contact with solid surfaces like bone
  • Curved Needle Tip
    • Needle curve is designed anatomically to fit behind the pubic bone
    • Needle is 5 mm in diameter
  • Dilator Pusher
    • Extends the dilator tube beyond the distal tip of the needle and is designed to provide the physician enough space to clamp the dilator

Advantage Mesh Sling

  • Centering Tab
    • Designed for proper alignment of the center of the mesh under the urethra
    • Allows the physician to apply counter tension to the sling assembly while preserving the mesh integrity
  • Mesh Assembly
    • Mesh is free floating in the protective sleeve
    • Ultra-smooth bond to dilator designed to facilitate a seamless transition with no "lip" to catch on tissue
  • Dilator
    • Smooth, tapered dilator is designed to slide through tissue
    • Slip on - slip off design allows for perioperative manipulation
    • Blue dilators, designed to improve visualization during cystoscopy

De-Tanged Polypropylene Material

  • A de-tanged suburethral portion designed to maintain its integrity during tensioning and potentially reduce irritation to the urethral wall

Caution: For Female Mid-Urethral Slings: Federal (US) law restricts this device to sale by or on the order of a physician trained in use of surgical mesh for repair of stress urinary incontinence.

Potential risks for Boston Scientific Suburetheral slings: The following adverse events have been reported due to suburethral sling placement, any of which may be ongoing, but are not limited to: As with all implants, local irritation at the wound site and/or a foreign body response may occur, Foreign body reaction may be acute or chronic, Pain (pelvic, vaginal, groin/thigh, suprapubic, dyspareunia) (acute or chronic), Dyspareunia, Tissue responses to the mesh implant could include: erosion into organs (urethra, bladder or other surrounding tissues); exposure/extrusion into the vagina, Mesh contact with urine via erosion/exposure/extrusion may result in stone formation, scarring/scar contracture, Necrosis, fistula formation (acute or chronic), inflammation (acute or chronic), Mesh contracture, Tissue contracture, Vaginal shortening or stenosis that may result in dyspareunia and/or sexual dysfunction, Pain with intercourse that may not resolve, Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse, Sexual dysfunction, including the inability to have intercourse. Like all foreign bodies, the mesh may potentiate an existing infection. Allergic reaction has been reported. Known risks of surgical procedures for the treatment of incontinence include: pain, ongoing pain (pelvic, vaginal, groin/thigh, suprapubic, dyspareunia), Severe, chronic pain, Apareunia, Leg weakness, Infection, De novo detrusor instability, Complete failure of the procedure/failure to resolve a patient’s stress urinary incontinence, Voiding dysfunction (incontinence, temporary or permanent lower urinary tract obstruction, difficulty urinating, pain with urination, overactive bladder, and retention), Bruising, bleeding (vaginal, hematoma formation), Abscess, Vaginal discharge, Dehiscence of vaginal incision, Edema and erythema at the wound site, Perforation or laceration of vessels, nerves, bladder, urethra or bowel may occur during placement. The following additional adverse events have been reported for the Solyx SIS System: Dysuria, Hematuria. The occurrence of these events may require surgical intervention and possible removal of the entire mesh. In some instances, these events may persist as a permanent condition after surgical intervention or other treatment. Removal of mesh or correction of mesh-related complications may involve multiple surgeries. Complete removal of mesh may not be possible and additional surgeries may not always fully correct the complications.

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