In situ lifetime, causes for replacement, and complications of the Provox(TM) voice prosthesis

One hundred Provox(TM) voice prostheses consecutively inserted in 37 patients and replaced only when phonation was impaired or complications noted were analyzed for in situ lifetime, causes for replacement, and complications. The mean in situ lifetime was 311 days. Actuarial analysis (Kaplan-Meier method) of the in situ lifetime revealed that 65.9%, 23.7%, and 16.4% of the voice prosthesis were still in situ by the 6th, 12th, and 18th postinsertion month. Cause for replacement was salivary leakage through the prosthesis valve, salivary leakage around the prosthesis, deterioration of the prosthesis, and excessive crusting resulting in increased airflow resistance in 33%, 27%, 24%, and 16% of cases, respectively. Complications included granulation tissue formation, cervical cellulitis, necrosis of the tracheoesophageal puncture, tracheostomal stenosis, and swallowing impairment in six, two, one, three, and one patient, respectively.