The American Academy of Otolaryngology—Head and Neck Surgery has determined that the use of FDA-approved biomaterials can be utilized in sinonasal procedures to improve patient outcomes and reduce complications. These items, such as implants, stents, and packing materials, have functions including, but not limited to, local drug delivery, stenting, and hemostasis. FDA-approved biomaterials for rhinologic application are not investigational, and the final decision regarding use of these biomaterials should be determined by the treating physician, factoring in best available scientific evidence, surgeon experience and the clinical situation, and individual patient preference.
Approved 9/26/2015
References:
- Berlucchi M, Castelnuovo P, Vincenzi A, et al. Endoscopic outcomes of resorbable nasal packing after functional endoscopic sinus surgery: a multicenter prospective randomized controlled study. Eur Arch Otorhinolaryngol 2009; 266: 839-845.
- Han JK, Forwith KD, Smith TL, et al. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. 2014 Nov; 4: 861-70.
- Han JK, Marple BF, Smith TL, et al. Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis. Int Forum of Allergy Rhinol, 2012; 2: 271-9.
- Lee JT and Han JK. Sinus Implants for Chronic Rhinosinusitis: Technology Evaluation. Expert Opinion on Drug Delivery 2013 Dec; 10: 1735-48.
- Marple BF, Smith TL, Han JK, et al. ADVANCE II: a prospective, randomized study assessing safety and efficacy of bioabsorbable steroid-releasing sinus implants. Otolaryngology Head Neck Surgery 2012; 146: 1004-1.
Important Disclaimer Notice (Updated 7/31/14)
Position statements are approved by the American Academy of Otolaryngology—Head and Neck Surgery or Foundation (AAO-HNS/F) Boards of Directors and are typically generated from AAO-HNS/F committees. Once approved by the Academy or Foundation Board of Directors, they become official position statements and are added to the existing position statement library. In no sense do they represent a standard of care. The applicability of position statements, as guidance for a procedure, must be determined by the responsible physician in light of all the circumstances presented by the individual patient. Adherence to these clinical position statements will not ensure successful treatment in every situation. As with all AAO-HNS/F guidance, this position statement should not be deemed inclusive of all proper treatment decisions or methods of care, nor exclusive of other treatment decisions or methods of care reasonably directed to obtaining the same results. Position statements are not intended to and should not be treated as legal, medical, or business advice.
