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.

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. All images are owned by Boston Scientific.Īll trademarks are the property of their respective owners.įor 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.

Bladder sling