Risk information


(*) US Federal Law restricts this devices to sale by or on the order of a physician.

Prior to the intervention, visit the FDA Public Health Notification link:

Ask your doctor about the benefits and risks that can imply your chosen treatment option.

If you are pregnant or you know about your allergy/sensitivity to polypropylene mesh, do not undergo this surgery. You should consult with your physician if you are planning future pregnancies.

All surgeries implying synthetic meshes may have some potential complications associated with these surgical procedures that may require additional surgery, which may or may not correct the complications. Some potential complications include, among others: perforations of vessels/nerves/bladder/urethra/colon/bowel and other surrounding structures, pain, irritation, discomfort, foreign body reaction, hematoma, infection, mesh erosion/extrusion/migration, fistula formation/inflammation, pain during intercourse (dyspareunia), adhesions, fecal incontinence, constipation, urinary incontinence/retention/obstruction, de novo urgency urinary incontinence, de novo prolapse, nerve damage, mesh shortening.

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