Textured polydimethylsiloxane elastomers in the human larynx: safety and efficiency of use.

For the treatment of unilateral laryngeal paralysis with glottic insufficiency injection laryngoplasty is a popular modality of treatment. This procedure augments the volume of the paralyzed vocal fold by endoscopic injection. However, the ideal substance has not yet been found for that purpose. We report for the first time the systematic application and long-term results of vulcanized polydimethylsiloxane (PDMS) particles in the treatment of glottic insufficiency in the human larynx. Of 10 patients treated with PDMS in the early 1990s, 7 patients could be retrieved for reevaluation. Laryngeal function was assessed by videostroboscopy, expert rating, and further characterized by the objective parameters of voice profile and maximum phonation time. In a standardized questionnaire, all patients were asked for their personal impression of the results. Mean follow-up time was 88.4 months (range 69-102 months). Glottic closure was complete in 5 of 7 patients. There were no signs of granuloma formation or other pathologic changes of the injected vocal folds. In 4 cases, voices were rated normal or near-normal; 2 voices were rated as fair; 1 usable. All the patients reported significant and lasting voice improvement. None of the patients reported any problems related to PDMS. PDMS particles provide permanent augmentation of human vocal fold volume without complications. Their use is a valuable and safe alternative when a definitive one-step procedure seems advantageous. However, further studies are needed to assess voice improvement in comparison to other materials. Copyright 2000 John Wiley & Sons, Inc.