“Tumulus” stabilization of a total ossicular replacement prosthesis

Abstract

Functional failure of total ossicular replacement prostheses (TORP) is often due to secondary displacement, ranging from simple subluxation to prosthesis extrusion following recurrence of severe tympanic membrane retraction. Several surgical techniques have been proposed to stabilize a TORP, mostly using superimposed non-organic or resorbable heterologous materials. We describe a simple so-called "tumulus" surgical technique that limits prosthesis displacement and extrusion, regardless of the type of TORP, by using a few fragments of autologous cartilage that are always available and perfectly tolerated at no cost. Review of 31 cases treated by this technique did not reveal any cases of prosthesis displacement and only one case (3.2%) of prosthesis extrusion with audiometric results comparable to the best results reported in the literature.

Adverse Events Associated With Ossicular Prostheses: Utility of a Federal Database

“…Review of the FDA's MAUDE database identified various AEPs and DMs associated with ossicular prostheses over the preceding 10 years. Events reported in this study appear representative of adverse events discussed in the literature (8)(9)(10)(11)(12)(13). Also consistent with existing literature, some cases required return to the operating room for revision surgery (10).…”

“…Given the passive nature of this surveillance system, which depends on the mandatory and voluntary reporters responsible for submitting accounts of AEPs and DMs, adverse events associated with ossicular prostheses are likely underrepresented. With only six reports of displaced prosthesis over the 10-year period of study, compared to published rates of prosthesis displacement or extrusion of 0.8% to 19% (12)(13)(14)(15)(16)(17)(18)(19), the present data likely represent gross underreporting. The volume of ossicular prosthesis use and associated complication rates previously reported by many single institution studies further emphasizes this point (8)(9)(10)12,19).…”

“…Among these are decreased hearing or recurrent hearing loss, tinnitus, vertigo, and otalgia (8)(9)(10)(11). Prosthesis displacement and extrusion also have been identified as significant causes of ossiculoplasty failure (12,13). Furthermore, long-term complications associated with the use of ossicular prostheses have at times required revision surgery (10).…”

“…A more thorough understanding of the causal factors responsible for these adverse events may allow development of interventions aimed at decreasing their incidence, thus improving the overall safety and efficacy of these devices. While reference guides for ossicular prostheses highlight product features designed to decrease the likelihood of various complications, and device instruction manuals may provide guidance for effective use, postmarket surveillance reporting of adverse events has been restricted to various studies based out of single institutions which are often designed to evaluate the advantages of a specific type of prosthesis or modification in technique (8)(9)(10)12,13). Although complications generally have been reported to occur infrequently, published rates of prosthesis displacement or extrusion have ranged from 0.8% to 19% (12)(13)(14)(15)(16)(17)(18).…”

“…While reference guides for ossicular prostheses highlight product features designed to decrease the likelihood of various complications, and device instruction manuals may provide guidance for effective use, postmarket surveillance reporting of adverse events has been restricted to various studies based out of single institutions which are often designed to evaluate the advantages of a specific type of prosthesis or modification in technique (8)(9)(10)12,13). Although complications generally have been reported to occur infrequently, published rates of prosthesis displacement or extrusion have ranged from 0.8% to 19% (12)(13)(14)(15)(16)(17)(18). This wide range suggests lack of standardization of reporting of adverse events associated with ossicular prostheses.…”