IMPORTANT SAFETY INFORMATION

PROPEL steroid releasing sinus implants Patient Safety Information

What is a PROPEL steroid releasing sinus implant?

PROPEL steroid releasing sinus implants are small, dissolvable and bio-compatible devices that are coated with an anti-inflammatory drug, mometasone furoate. They are used by ENT (otolaryngology) surgeons to prop open the sinuses following sinus surgery and to locally deliver the corticosteroid mometasone furoate (MF). PROPEL steroid releasing sinus implants are designed to dissolve approximately 30-45 days after being placed in a patient’s sinus following sinus surgery.

Propping-open the sinus after sinus surgery is important because scarring and inflammation that are part of the normal healing process after sinus surgery can result in narrowing of the sinuses, which can cause problems after sinus surgery. The local, targeted delivery of MF to the sinuses after surgery helps this process.

Who should not have PROPEL steroid releasing sinus implants?

PROPEL steroid releasing sinus implants should not be used in patients with a suspected or confirmed sensitivity (allergic response, or other sensitivity) to:

• mometasone furoate;
• lactide, glycolide, or caprolactone copolymers

If a patient doesn’t know whether they have a suspected or confirmed intolerance to these substances, they should talk to their doctor. PROPEL steroid releasing sinus implants have only been CE marked for use in patients 18 years and older. PROPEL steroid releasing sinus implants have not been studied in patients who are less than 18 years old.

The safety of PROPEL steroid releasing sinus implants have not been studied in pregnant or nursing females. Pregnant and nursing patients should discuss the possible risks and benefits with their doctors before deciding whether to have PROPEL steroid releasing sinus implants.

What are some potential serious side effects from PROPEL steroid releasing sinus implants?

In addition to the possible side effects from MF, since the PROPEL steroid releasing sinus implants is left in a patient’s body, as with any medical product that is left in the patient’s body, it can possibly cause a:

• Foreign body reaction (the body’s normal response to a foreign object, which, depending on the patient’s immune response, can be more aggressive and be harmful).
• Toxic shock syndrome (TSS)—this is a very rare, but life-threatening reaction that is also a risk of any surgical procedure.

While not observed in any of the clinical trials on PROPEL steroid releasing sinus implants, it is possible that a patient could experience:

• Aspiration of small implants—small pieces of the device going into the patient’s lungs. While this is possible, it was not observed to occur in any of the clinical trials on PROPEL steroid releasing sinus implants.
• Glaucoma/elevation of the intraocular pressure—since the PROPEL steroid releasing sinus implants is coated with mometasone furoate, a corticosteroid, it is possible that there could be an increase in the pressure of the naturally-occurring fluid in the patient’s eye.
• Cataracts/change in lens opacities—since PROPEL steroid releasing sinus implants is coated with mometasone furoate, a corticosteroid, it is possible that it could make a patient more likely to have cataracts.

What are some other potential side effects from PROPEL steroid releasing sinus implants?

• Premature displacement of the steroid releasing sinus implants —the device may come out sooner than it was designed to.
• Swallowing of the implant or implant fragments—if the steroid releasing sinus implants becomes displaced, since a patient’s airway passage is connected to their throat, the steroid releasing sinus implants may go down the patient’s throat. Since the steroid releasing sinus implants is small and dissolvable, this should not cause anything more serious than discomfort. However, if it becomes stuck, the patient has difficulty breathing, or has any other concerns or symptoms if this happens, the patient should contact his or her doctor or seek immediate medical attention.
• Pain/pressure/headache may result from the adherence of crusting to, or presence of the implant.
• Nasal irritation—a patient’s sinus passages and nose may be irritated from PROPEL steroid releasing sinus implants and/or from the sinus surgery.
• Hypersensitivity reaction—a patient could be sensitive or allergic to PROPEL steroid releasing sinus implants or any of its components and not know that they are before it is placed. While it is not common, if it does occur, the device can typically be easily removed and the reaction easily treated by the patient’s doctor.
• Nose bleed—typically very minor and not needing medical attention. However, if a patient does have a significant nose bleed from the PROPEL steroid releasing sinus implants or from his or her sinus surgery (or any other cause), the patient should contact a doctor.
• Infection—it is possible that a patient could have an infection (viral, fungal, or bacterial) after sinus surgery or PROPEL steroid releasing sinus implants placement. They should contact a doctor if they suspect they have an infection.
• Nasal dryness or burning.

What side effects were reported during the clinical trials on PROPEL steroid releasing sinus implants?

• Sinusitis—inflammation or infection of the sinuses
• Headache
• Nose bleeds
• Infection of other parts of the respiratory tract
• Lightheadedness
• Ear infection
• Swelling of the eyelid
• Nausea
• Nasal polyps—benign growths inside the nose
• Asthma attacks in patients who have had or have asthma

Although many patients benefit from PROPEL steroid releasing sinus implants, results vary. Please talk to your doctor to see if PROPEL steroid releasing sinus implants are right for you. Your doctor can discuss the benefits and risks with you. Each patient experience is unique and Intersect ENT does not provide any guarantee regarding the response to PROPEL steroid releasing sinus implants.