IMPORTANT SAFETY INFORMATION
The MyoSure® tissue removal system, consisting of the MyoSure tissue removal devices (LITE, REACH, XL) and MyoSure controller, is intended for hysteroscopic intrauterine procedures by trained gynecologists to resect and remove tissue including submucous myomas, endometrial polyps, and retained products of conception. The MyoSure MANUAL tissue removal device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception. MyoSure products are not appropriate for patients who are or may be pregnant, or are exhibiting pelvic infection, cervical malignancies, or previously diagnosed uterine cancer.
For more details on risks and benefits of the MyoSure system, MyoSure MANUAL tissue removal device, MyoSure hysteroscope and the Aquilex® fluid control system please see their respective IFUs.
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