INDICATION FOR USE:
The TruClear™ system is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.
WARNINGS AND ADVERSE EFFECTS:
Adverse effects for operative hysteroscopy include but are not limited to fluid overload due to intravasation and uterine perforation. [Removal of retained products of conception in the setting of known or suspected placenta acreta, placenta increta, or placenta percreta poses a risk of significant and potentially life-threatening bleeding with the highest risk occurring in the immediate postpartum phase.] Please refer to Instructions for Use (IFU) for complete contraindication and risk information. Residual risks to the patients may include but are not limited to exposure to body fluids, laceration, carcinogen exposure, electric shock, uterine perforation, and air embolism.
CONTRAINDICATIONS:
The TruClear™ hysteroscopic tissue removal system should not be used with pregnant patients or patients exhibiting pelvic infection, cervical malignancies, or previously diagnosed endometrial cancer.
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