Risks and Considerations
Your physician should explain all the potential risks of your heavy menstrual bleeding treatment to you. Possible risks for all endometrial ablation procedures are:
- Perforation (creation of a hole) of the uterus;
- Bleeding; infection;
- Injury to organs within the abdomen (e.g., bowel) and pelvis or to adjacent tissue (e.g., cervix and vagina);
- Post-ablation tubal sterilization syndrome (a complication in women who have undergone tubal sterilization following endometrial ablation which can occur as long as 10 years after your ablation); and
- Delayed diagnosis of cancer of the endometrium.
The risk of serious injury such as perforation (creation of a hole) of the uterus and injury to internal organs with the Genesys HTA System is low. However, there is a risk that heated fluid may leak out of your uterus during the procedure and result in a burn to your vagina or surrounding areas. These burns are usually treatable by your doctor with medicated cream. In very rare cases it may be necessary to seek specialized care from a burn center.
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Information is for use only in countries with applicable health authority product registrations. The information on this Site is provided for informational purposes only and is not intended or recommended as a substitute for professional medical advice or for diagnosis purposes. CAUTION: Federal Law (USA) and laws in other countries restrict these devices to sale by or on the order of a physician. Refer to Prescriptive Information for complete Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events, prior to using this product.