BECHARA Y. GHORAYEB, MD
OTOLARYNGOLOGY – HEAD & NECK SURGERY
1140 BUSINESS CENTER DRIVE, SUITE 560
HOUSTON, TEXAS 77043

INFORMED CONSENT FOR BALLOON SINUPLASTY

Why Balloon Sinuplasty?
A Breakthrough in Endoscopic Sinus Surgery

Safe & Less Invasive
With Balloon Sinuplasty, there is no cutting of nasal bone or tissue. More than 330,000 patients suffering from sinusitis have been treated by physicians using Balloon Sinuplasty technology. With Balloon Sinuplasty, ENT doctors open inflamed sinuses in the same way that heart surgeons open up blocked arteries during balloon angioplasty. The procedure is less invasive than traditional sinus surgery, and effective at relieving symptoms of chronic sinusitis.
Proven Effective
Most chronic sinusitis patients report clinically meaningful improvement in sinus symptoms and quality of life through 2 years following surgery.
Fast Recovery
While recovery time varies with each patient, recovery is typically fast. In a study of in-office balloon dilation, most patients returned to work and normal activity within 2 days.
Available in the Office Under Local Anesthesia
Balloon Sinuplasty is now performed by some doctors in their office under local anesthesia.
Balloon Sinuplasty (BSP) is a safe procedure for many patients seeking relief from uncomfortable and painful sinusitis symptoms.

General Information and FAQ about Balloon Dilation Sinus Surgery (SINUPLASTY)
Almost everyone has experienced a sinus infection in their lifetime. The sinuses are outpouchings from the nose. Most people have develop sinuses in the forehead are, cheeks, and between the eyes, although there is some variability amongst individuals. The sinuses are connected to the nose by small tubes. Your nose and sinuses make about 1 liter of mucous a day! Normally, mucous drains from the sinuses to the nose. From the nose, it goes down to the back of the throat where it is swallowed. This mucous is normal and important for the natural cleaning process of the nose and sinuses. If the mucous is viscous or thicker, we may feel it as post-nasal drainage.

“Sinusitis” is a term frequently applied to a variety of nasal symptoms, but specifically refers to inflammation or infection of the sinus lining. Symptoms of sinusitis may include nasal congestion, runny nose, post-nasal drainage, cough, facial pressure, and fatigue. Acute viral sinusitis (“the common cold”) is caused by viruses where acute bacterial sinusitis is caused by bacteria. They are really identical in symptoms, but differ in their length of symptoms. If the nasal symptoms do not improve after 7-10 days, or worsen after 5, you should consider seeing your doctor to discuss antibiotic use. Antibiotics are not helpful, and may be harmful if used inappropriately for viral illnesses.

It is estimated by the CDC that 32 million people suffer with chronic sinusitis. Chronic sinusitis is sinus problems lasting more than 3 months, which have not been cured with antibiotics, nasal steroid sprays, and other medical therapies. It is in these cases not cured by medical therapy where surgery may be recommended. Sinus surgery evolved during the 1980’s from a procedure involving incisions on the face and in the mouth to treat the sinuses, to surgeries that can be accomplished through the nostril, with no visible incisions. 200,000 to 350,000 people undergo sinus procedures every year. Many of these patients will have significant improvement in their daily symptoms and quality of life. While not a cure for all sinus problems, the surgery may be very helpful for these patients. The surgery involved removing tissue (lining and bone) from around the openings of the sinuses, where they connect to the nose. By enlarging these opening, the drainage of the sinuses necessary for good health can be improved.

Q: What is balloon dilation sinus surgery, or Balloon Sinuplasty?
A: Traditional functional endoscopic sinus surgery (FESS) involves the removal of tissues around the sinus openings using instruments and cameras through the nostril. This tissue removal assists in sinus drainage, but yields raw areas which must then heal. The balloon dilation technique instead moves the bone and lining within the nose to open the sinuses, but does not remove tissue. Healing times and bleeding are thus reduced.

Q: How is the balloon sinus surgery done?
A: Balloon Sinuplasty is done in the office under local anesthesia.  A balloon catheter, similar to those used in blood vessel procedures like cardiac catheterizations, is inserted through the sinus openings. By inflating this balloon, the bone and tissues around the opening are moved to open the sinus drainage pathway.

Q: Does this balloon technique for sinus surgery work for everyone?
A: No. Consultation with an otolaryngologist with a sinus CT scan will be necessary to decide what surgical options may be available. The balloon technique can be used in many of the sinuses, but not all. Sometimes the balloon dilation technique is used in combination with traditional surgery in the operating room to yield the best results.

Q: What are the success rates with this surgery?
A: Sinus surgery as a whole is successful in reducing the severity and frequency of nasal symptoms of chronic sinusitis in most patients. The balloon technique has been shown to be safe and effective when compared with traditional techniques. A study from 2008 showed that 95% of patients had improved symptoms, and 74% were freed of sinus infection at an 8-month follow-up.
In a small percentage of patients, because of anatomic abnormalities, it may be impossible to insert the balloon in the sinuses and the procedure would have to be aborted.  The patient would have to undergo traditional endoscopic sinus surgery in the hospital or surgery center.

Q: How long does surgery take?
A: Surgery usually lasts about one hour, depending on how many of the sinuses must be addressed, and if both sides are involved.

Q: What is recovery like?
A: With sinus surgery, there is some expected discomfort, nasal bleeding, and drainage. When the balloon dilation technique is used, similar or reduced post-operative symptoms should be seen. Patients go home the same day, usually within hours.

Q: Are there any risks involved with this procedure?
A: As with any surgical procedure, risks exist. Traditional sinus surgery techniques carry a very small risk to surrounding tissues of the eye or brain. (less than 1 %), Balloon Sinuplasty has similar or smaller risks.

Risks of Surgery
1. Failure to eradicate facial pain and headaches.
2. Failure to decrease the frequency of sinus infections.
3. Failure to eradicate the signs and symptoms of chronic sinusitis.
4. Bleeding from the nose
5. It is important to understand that chronic sinusitis generally cannot be cured, even with surgery. Our goal is to improve the condition, decrease your symptoms and make you feel better. Surgery is not a cure-all but is one mode of therapy. Additional medical and allergy treatment is often necessary as well.
6. Loss or change of smell sensation. The nerves that carry our sense of smell come from the tip of the inside of the nose and nasal septum. The nerves can be affected by intranasal surgery resulting in a loss of, or a change in, the sense of smell. This is very rare but it can occur.
7. As in any surgery in close proximity to the orbits, there is an extremely remote possibility of eye or visual problems.

Alternatives to Surgery
1. Medical therapy for acute episodes of sinusitis including antibiotics, decongestants and possibly steroids.
2. Chronic antibiotic therapy to prevent episodes of sinusitis.
3. Medical therapy for allergies if allergies are thought to be a contributing factor to the sinus problems.
4. Pain medication to control headaches which are associated with sinusitis.



I have read the above description of the surgical procedure.  Dr. Ghorayeb and/or his staff discussed the surgery with me, explained the procedure, the risks and complications.  All of my questions were answered, enabling me to make an informed decision concerning the surgery. I wish to proceed with the surgery as it has been explained to me.



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