Your doctor will implant SINUVA in office, using local anesthesia.
After numbing your nose, your doctor will place SINUVA into your nostril on the end of a Delivery System, and place it in the ethmoid sinus where your nasal polyps are.
SINUVA is slightly larger than the head of a cotton swab (7.5 mm) when compressed in preparation for the procedure.
You don’t need to do anything to prepare for SINUVA placement, but your doctor may provide you with specific instructions prior to the procedure. Talk to your doctor if you have questions.
The whole procedure typically takes less than an hour, usually 30 to 40 minutes. This includes 10 to 30 minutes to numb your nose and about 5 to 10 minutes to place SINUVA.
Insertion of SINUVA has risks similar to other endoscopic sinus procedures. It may also cause local side effects such as nosebleed and injury to nerves or blood vessels in the nose/sinus, serious allergic reactions, weakened immune system, and adrenal insufficiency. The most common side effects of SINUVA in clinical studies were bronchitis, cold symptoms, middle ear infections, headache, lightheadedness or dizziness, asthma, and nosebleeds. During post-approval use of SINUVA, implant migration, lack of efficacy, nasal pain, headache, and nosebleeds, were also identified as side effects.
In clinical trials, most patients (over 85%) felt no pain to mild pain/pressure following placement.
SINUVA is designed to stay in your sinus and deliver medicine over the course of 90 days. Your doctor will remove SINUVA 90 days after placement or sooner.
You should talk with your doctor to determine what treatments you may need following the SINUVA procedure.
If you experience irritation or a choking sensation in the back of the throat, please contact your doctor, as SINUVA may have moved and should be evaluated.
SINUVA Sinus Implant is a prescription steroid-releasing (mometasone furoate) implant indicated for the treatment of nasal polyps in patients 18 years or older who have had ethmoid sinus surgery.
Do not use SINUVA if you are allergic to mometasone furoate or any ingredients of the implant.
Before you receive SINUVA, tell your doctor about all medical conditions you have including nasal/sinus problems (such as nasal ulcers or trauma), eye problems (such as glaucoma or cataracts), or any untreated fungal, bacterial, or viral infections.
Local reactions including nosebleed and injury to nerves or blood vessels in the nose/sinus.
Serious allergic reactions have happened in patients using mometasone furoate including rash, itching or swelling of the lips, face, tongue, and throat, and breathing problems. Call your doctor right away if you have any of these reactions.
Weakened immune system that may increase your risk of infections. Avoid contact with people who have contagious diseases such as chickenpox or measles. Call your doctor right away if you have been near someone with chickenpox or measles.
Adrenal insufficiency
is a condition in which the adrenal glands do not make enough steroid hormones and can cause tiredness, weakness, nausea and vomiting and low blood pressure. Talk to your doctor if steroid effects such as Cushing Syndrome and adrenal suppression appear.
The most common side effects of SINUVA in clinical studies were bronchitis, cold symptoms, middle ear infections, headache, lightheadedness or dizziness, asthma, and nosebleeds. The following side effects have been identified during post-approval use of the SINUVA sinus implant. These events include implant migration, lack of efficacy, nasal pain, headache, and nosebleeds.
Tell your doctor if you have any side effects that bother you or don’t go away.
Risks related with the insertion and removal of SINUVA are similar to other endoscopic sinus procedures.
SINUVA is made from materials designed to soften over time and may fall out of the nose on its
own as polyps decrease or if you sneeze or blow your nose forcefully. The implant will be removed 90 days after placement or earlier at your doctor’s discretion.
Contact your doctor immediately if you have any changes in vision, excessive nasal bleeding, symptoms of infection or symptoms suggesting that the implant has moved, such as irritation or a choking sensation in the back of the throat.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For important risk and use information, please see Full Prescribing Information for SINUVA.
Intersect ENT and SINUVA are
registered trademarks of
Intersect
ENT, Inc. in the
United States and other countries.
©2020 Intersect ENT.
All rights reserved.
MPM-11923. Rev. 1.0 12/20
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