Exair® Versus Native Tissue Repair for Prolapse

Exclusion Criteria

• •Subject is pregnant or intends to become pregnant during the study
• •Subject has an active or chronic systemic infection including any gynecologic infection, untreated urinary tract infection (UTI), or tissue necrosis
• •Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical)
• •Subject has had prior or is currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area
• •Subject has taken systemic steroids (within the last month), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
• •Subject has a systemic connective tissue disease (e.g. scleroderma, systemic lupus erythematosus (SLE), Marfan syndrome, Ehlers Danlos, collagenosis, polymyositis or polymyalgia rheumatica)
• •Subject has chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
• •Subject has uncontrolled diabetes mellitus (DM)
• •Subject has a known neurologic or medical condition affecting bladder function (e.g. multiple sclerosis, spinal cord injury, or stroke with residual neurologic deficit)
• •Subject is seeking obliterative vaginal surgery as treatment for pelvic organ prolapse (colpocleisis)
• •Subject is not able to conform to the modified dorsal lithotomy position
• •Subject is currently participating in or plans to participate in another device or drug study during this study
• •Subject has a known sensitivity to polypropylene
• •Subject has had previous prolapse repair with mesh in the target compartment(s)