This section describes safety outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
Crusting, granulation and scarring of the middle turbinate 1 week after the procedure was reported in 1 patient in a randomised controlled trial (RCT) of 105 patients treated by a corticosteroid‑releasing bioabsorbable stent in 1 side and a non‑corticosteroid‑releasing bioabsorbable stent in the other. The patient was treated by nasal irrigation, debridement and prednisone taper, and the condition resolved without sequelae.
Headache with sensation of sinus pressure and irritation was reported in 1 patient in a case series of 50 patients treated by corticosteroid‑eluting bioabsorbable stent insertion during endoscopic sinus surgery. This was determined to be primarily due to the functional endoscopic sinus surgery, but was considered to be exacerbated by presence of crusting sticking to the stent. The condition resolved without sequelae after stent removal.
Infection at 2‑week follow‑up was reported in 1 patient in the RCT of 105 patients treated by a corticosteroid‑releasing bioabsorbable stent in 1 side and a non‑corticosteroid‑releasing bioabsorbable stent in the other. The patient was treated with a prednisone taper and antibiotics. The infection resolved without sequelae.
Peri‑orbital cellulitis was reported in 1 patient on the FDA manufacturer and user facility device experience (MAUDE) database. The patient had insulin‑dependent diabetes and had been treated by revision functional endoscopic sinus surgery, including bilateral ethmoidectomies, maxillary antrostomies and frontal sinusotomies. Corticosteroid‑releasing bioabsorbable stents had been placed in the right and left ethmoid sinuses. A haemostatic agent had also been used. Three weeks after surgery, the patient experienced symptoms of rhinosinusitis and developed peri‑orbital cellulitis on the right side. Post‑surgical debridement was done and the patient was treated with antibiotics.
In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers reported the stent falling out as an anecdotal adverse event. They considered that the following were theoretical adverse events: damage to adjacent vital structures, including the cribriform plate (causing cerebrospinal fluid leak) or the orbital lamina (causing eye problems); foreign body reaction to stent components; biofilm formation on the stent; migration of the stent to another anatomical location, with possible aspiration or swallowing; fungal infection secondary to high local corticosteroid concentrations; systemic absorption of corticosteroids leading to idiosyncratic complications.