Background: Presently, there are no U.S. Food and Drug Administration (FDA)-approved adhesive bone cements for the surgical fixation of prosthetic materials in the middle ear. A promising new cement, 4-META/MMA-TBB opaque resin, has shown remarkable adhesive properties as a bone cement in vivo. The cement is composed of 4-methacryloyloxyethyl trimellitate anhydride (4-META) and methyl methacrylate (MMA) as monomers and tri-n-butyl borane (TBB) as an initiator. Methods: An electromagnetic semiimplantable hearing device presently under development was implanted into the middle ear of six cats using 4-META/MMA-TBB resin to cement a titanium-encased magnet to the incus. The animals were subsequently killed (at a mean of 9.6 months) to assess the temporal hones and specifically the magnet-incus complex in each animal. Results: The titanium-encapsulated magnet was firmly adherent to all incuses without any failure of the cement-bone interface. Histopathologic examination of the implanted temporal bones demonstrated lack of middle ear inflammation. Transmission electron microscopy of the incuses demonstrated a unique 'hybrid layer' in the bone-side subsurface of the bone-cement interface that elucidates the mechanism of interfacial adhesion. Conclusions: Our investigation highlights the special biomechanical properties as well as the biocompatibility of 4-META/MMA-TBB resin that make it an attractive bone- bonding agent for use in otologic surgery, including its potential usefulness during ossicular reconstruction.
|Original language||English (US)|
|Number of pages||6|
|Journal||American Journal of Otology|
|State||Published - May 1 1997|
- Adhesive bonding materiaI
- Implantable devices
- Otologic surgery