Solyx™ Single Incision Sling System

Please note that access to certain information on the following pages is intended for health care professionals.

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

Refer to package insert provided with this product for complete Indications for use, contraindications, warnings, precautions, adverse events, and instructions prior to using this product.

IMPORTANT INFORMATION: These materials are intended to describe common clinical considerations and procedural steps for the use of referenced technologies but may not be appropriate for every patient or case.

Decisions surrounding patient care depend on the physician’s professional judgment in consideration of all available information for the individual case.

Boston Scientific does not promote or encourage the use of its devices outside their approved labeling. Case studies are not necessarily representative of clinical outcomes in all cases as individual results may vary.

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.

Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.

Bench test study results may not necessarily be indicative of clinical performance. 

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician trained in use of surgical mesh repair of stress urinary incontinence. Refer to package insert provided with this product for complete indications for use, contraindications, warnings, precautions, adverse events, and instructions prior to using these products.

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