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Products marked with an asterisk (*) are not available in the US market

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:

www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm

Ask your doctor if you can benefit of these pelvic floor 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.

The sling to be implanted is a permanent implant, and some potential complications associated with surgical procedures present risks and may require additional surgery that 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.