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Important Pelvic Floor Safety Information

Potential Risks for Mid-Urethral 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.

Potential Risks for Y-Mesh:

Potential adverse events, any of which may be ongoing, include but are not limited to: Abscess, Adhesion formation, Allergic reaction (hypersensitivity), Bruising, Bleeding (hematoma formation), Constipation, Dehiscence, De novo detrusor instability, Dyspareunia, Pain with intercourse that may not resolve, Sexual dysfunction; including the inability to have intercourse, Erosion into organs; exposure/extrusion into vagina, Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse, Failure to resolve a patient’s prolapse, Fistula formation (acute or chronic), Foreign body reaction (acute or chronic), Granulation tissue formation, Hemorrhage, Infection, Inflammation (acute or chronic), Injury to ureter, Scarring/scar contracture, Mesh contracture, Tissue contracture, Necrosis, Nerve injury, Organ perforation, Pain (pelvic, vaginal, groin/thigh, dyspareunia) (acute or chronic), Perforation or laceration of vessels, nerves, bladder, or bowel may occur during placement, Post-operative bowel obstruction, Prolapse/recurrent prolapse, Vaginal shortening or stenosis that may result in dyspareunia and/or sexual dysfunction, Voiding dysfunction (incontinence, temporary or permanent lower urinary tract obstruction, difficulty urinating, pain with urination, overactive bladder, and retention). The occurrence of one or more of these complications may require treatment or surgical intervention. In some instances, the complication may persist as a permanent condition after the 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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