Potential risks for Polyform™ Synthetic 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.
Please refer to package insert provided with these products for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events, and Instructions prior to using these products.
Caution: Federal Law (USA) 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.
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