Risk and Safety Information
All surgical treatments have inherent and associated side effects, some of which may lead to serious outcomes and may require intervention. Individual’s outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics and/or surgeon behavior. The most common side effects are mild and transient and may include mild pain or difficulty when urinating, discomfort in the pelvis or penis, blood in the urine, inability to empty the bladder or a frequent and/or urgent need to urinate, and bladder or urinary tract infection. Other risks include but are not limited to: anesthesia risk; sexual dysfunction, including ejaculatory or erectile dysfunction; injury to the urethra, such as false passage or stricture, or to the rectum, including rectal incontinence/perforation; bladder or prostate capsule perforation; infection, including the potential transmission of blood borne pathogens; bleeding; incontinence; embolism; electric shock/burn; transurethral resection (TUR) syndrome; bladder neck contracture; and bruising. No claim is made that the AquaBeam® Robotic System, HYDROS® Robotic System or Aquablation® therapy will cure any medical condition, or entirely eliminate the diseased entity. Repeated treatment or alternative therapies may sometimes be required.
Aquablation therapy is performed by urologists. Patients should talk to their doctor to determine if Aquablation therapy is right for them. Patients and doctors should review the potential benefits and limitations of treatment together. For more information about potential side effects and risks associated with Aquablation therapy, speak with your urologist or surgeon.
Caution: Federal law restricts this device to sale by or on the order of a physician.