Eclipse System Important Safety Information

Indications for Use

The Eclipse System is indicated for the treatment of fecal incontinence in adult women. It is intended for prescription use.

Contraindications

The Eclipse System is contraindicated in the presence of a vaginal infection or open vaginal wound.

Warnings

The Insert should be removed before obtaining an MRI to avoid adverse events. Women should consult a doctor before obtaining a pelvic X-ray since the Insert may obscure images. The Insert and the Pump are for single-patient use only. Sharing the devices could result in transmission of disease and/or infection. Women should remove the Insert immediately and notify their doctor if they experience any of the following: a foul odor or excessive vaginal discharge, difficulty urinating or defecating, significant bleeding not associated with menstruation, or any new onset or worsening pelvic pain or discomfort.

Risks

In a clinical study of the Eclipse System, 117 women participated in the fitting process, and 61 women were successfully fit and entered a 1-month Treatment Period evaluation. Among the 61 women who entered the Treatment Period, there were no serious device-related adverse events. The most common adverse event was pelvic cramping and discomfort, and other observed events included pelvic pain, vaginal spotting and urinary incontinence. All adverse events were rated as mild or moderate, and lower rates of adverse events were observed after the initial Fitting Period was complete. All adverse events were resolved without surgery or signification intervention; most simply required removing the Insert.

Please refer to the Eclipse System Instructions for Use for a complete discussion of risks, contraindications, warnings and precautions.