References and Disclaimers

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

Caution: For Female Mid-Urethral Slings: U.S. Federal 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.

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.

SpaceOAR and SpaceOAR Vue Hydrogels are intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR and SpaceOAR Vue Hydrogels to reduce the radiation dose delivered to the anterior rectum. SpaceOAR and SpaceOAR Vue Hydrogels contain polyethylene glycol (PEG). SpaceOAR Vue Hydrogel contains iodine. Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events. As with any medical treatment, there are some risks involved with the use of SpaceOAR and SpaceOAR Vue Hydrogels. Potential complications associated with SpaceOAR and SpaceOAR Vue Hydrogels include, but are not limited to: pain associated with SpaceOAR and SpaceOAR Vue Hydrogels injection, pain or discomfort associated with SpaceOAR and SpaceOAR Vue Hydrogels, local inflammatory reactions, infection (including abscess), urinary retention, urgency, constipation (acute, chronic, or secondary to outlet perforation), rectal tenesmus/muscle spasm, mucosal damage, ulcers, fistula, perforation (including prostate, bladder, urethra, rectum), necrosis, allergic reaction (localized or more severe reaction, such as anaphylaxis), embolism (venous or arterial embolism is possible and may present outside of the pelvis, potentially impacting vital organs or extremities), syncope and bleeding. The occurrence of one or more of these complications may require treatment or surgical intervention. URO-989811-AB.

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UROPH-1411207-AG JUL2024