References and Disclaimers

UROPH-1411207-AD SEP2022

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

The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥ 50 years of age with a prostate volume 30cm3 ≤ 80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

1.    Mostafa A, Lim CP, Hopper L, et al. Single-incision mini-slings versus standard midurethural slings in surgical management of female stress urinary incontinence: an updated systematic review and meta-analysis of effectiveness and complications. Eur Urol. 2014 Feb;65 (2):402-27.

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.

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.

For Upsylon Y-Mesh: CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician trained in performing mesh procedures for surgical repair of pelvic organ prolapse.

Potential adverse events, any of which may be ongoing, include but are not limited to: Abscess (swollen area within the body tissue, containing a buildup of pus), Adhesion formation (when a scar extends from within one area to another), Allergic reaction (hypersensitivity) to the implant, Bruising, Bleeding, Constipation, Dehiscence (opening of the incision after surgery), De novo detrusor instability (involuntary contraction of the bladder wall leading to an urge to urinate), Dyspareunia (pain during sexual intercourse) that may not resolve, Sexual dysfunction (difficulty with sexual response, desire, orgasm or pain); including the inability to have intercourse, Erosion into organs; exposure/extrusion into vagina (when the mesh goes through the vagina into other organs or surrounding tissue), Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse, Fistula formation (a hole/passage that develops through the wall of the organs) which may be acute or chronic, Foreign body reaction (body’s inflammatory response to the implant) which may be acute or chronic, Granulation tissue formation (reddish connective tissue that forms on the surface when a wound is healing), Hematoma formation (a pool of blood under the skin/bruising), Hemorrhage (profuse bleeding), Infection, Inflammation (redness, heat, pain or swelling at the surgical site as a result of the surgery) which may be acute or chronic, Injury to ureter (the duct that urine passes from the kidneys to the bladder), Scarring/scar contracture (tightening of the scar), Mesh contracture (mesh shrinkage), Tissue contracture (tightening of the tissue), Necrosis (death of living tissue in a small area), Nerve injury (injury to the nerve fiber), Organ perforation (a hole in or damage to these or other tissues that may happen during placement), Pain: pelvic, vaginal, groin/thigh, dyspareunia—which may become severe, Perforation or laceration of vessels, nerves, bladder, or bowel (a hole in or damage to these or other tissues that may happen during placement), Post-operative bowel obstruction (blockage that keeps food or liquid from passing through the small or large intestines), Prolapse/recurrent prolapse (complete failure of the procedure), Vaginal shortening or stenosis which 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 (involuntary leakage of urine or reduced or complete inability to empty the bladder). 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.

Boston Scientific acquired the global surgical business of Lumenis Ltd. Some registered names of products manufactured and sold by Boston Scientific may contain the term “Lumenis.” Lumenis is a registered trademark of Lumenis Be.

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