Important safety information

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.

Please consult your physician to discuss the associated risk and complications for the specific surgical material you receive.

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, Bleeding, Bruising, 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, 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), Mesh contracture (mesh shrinkage), 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), Scarring/scar contracture (tightening of the scar), Sexual dysfunction (difficulty with sexual response, desire, orgasm, or pain); including the inability to have intercourse, Tissue contracture (tightening of the tissue), 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.