The Potential Benefits and Risks

General risks

• You may receive no benefit by the insertion of a valve(s) to control your air leak and/or your condition may get worse (see potential risks associated with the valve(s) below).
• There are risks associated with the bronchoscopy procedure (See potential risks associated with the procedure below).
• Although rare, with all drugs and devices, it is possible that you may have an allergic reaction to the materials used in the IBV Valve System. If you are, or think you are allergic to latex, you must notify the doctor because the balloon used to measure the airways inside your lung may be made with latex.
  

Potential benefits

• The severity of your air leak may be reduced and heal in a shorter period of time.
• The need for additional surgery to control your air leak may be avoided.
  

Potential risks associated with the procedure

Please discuss these potential risks with your doctor.

• You may have problems from sedation, anesthesia and intubation, which may include the failure to be able to be taken off a breathing machine (ventilator).
• You may have swelling inside of your lungs that could make breathing hard and make your recovery time longer. This problem may require you to get breathing help and medicines.
• You may get bronchitis or pneumonia (infection/fever).
• You may have a cough that lasts a long time.
• You may develop shortness of breath or your shortness of breath may get worse.
• The area of your lung near or around the valve(s) may be damaged from handling of the bronchoscope.
• Heart problems, including changes in blood pressure and changes in heart rhythm, may make your recovery more
  difficult and require medicines.
• Severe problems may require you to get medical treatment or even surgery. A severe problem also may result in death.
  

Potential risks associated with the valves

Please discuss these potential risks with your doctor.

• The valve(s) may move or wear away your lung tissue. The valve(s) may become loose and may move out of place or be coughed out of your lungs.
• The valve(s) may cause swelling or irritate the inside of your airway or lung.
• Damage may occur to the inside of your airway from the normal movement of the valve(s).
• You may get bronchitis or pneumonia (infection/fever).
• You may have a cough that lasts as long as you have the valve(s) in place.
• You may experience shortness of breath or your shortness of breath may get worse.
• There may be some bleeding or a new air leak in the area(s) of your lung that has the valve(s), which may not stop and may require treatment or surgery.
• You may not get any better from having the valve(s). So, your air leak may not get better or may get worse after
  treatment.
• The area of your airway and/or lung near or around the valve(s) may be damaged from handling of the valve(s).
• Area of your lung, which has a valve(s), may lose air and shrink. The areas of your lung without valve(s) may grow, which may tear the lung, and result in additional air leaks.
• Severe problems may require you to get medical treatment or even surgery. A severe problem may result in death.
  

Contraindications

The doctor will not place an IBV Valve(s) into your airway, if you are unable to tolerate a flexible bronchoscopic procedure.

Precautions and warnings

Use of the IBV Valve System requires technical skills with a bronchoscope. The operator of the system must be a doctor or medical person under the supervision of a doctor and be trained in bronchoscopic techniques and the use of the IBV Valve System. Sedation and/or anesthesia are used for this bronchoscopic procedure. Discuss with your doctor the risks that can occur with sedation and anesthesia. The doctor will not place an IBV Valve(s) into your airway for any reason other than its intended use.

 

Please note that this website is meant for informational purposes only and is not a substitute for professional advice or treatment. Patients should consult with a physician to discuss treatment alternatives.