Resorption rate and biocompatibility characteristics of two polyester ventilation tubes in a guinea pig model

OBJECTIVES: Determine the resorption rate and biocompatibility characteristics of 2 polyester ventilation tubes, and to determine whether soap and water exposure accelerates polyester tube degradation. STUDY DESIGN AND SETTING: 50/50 poly (D, L-lactide-co-glycolide; PLGA-50) and poly (L-lactide; PLA) polymers were placed into the tympanic membranes of Hartley pigmented guinea pigs. Integrity of the tubes was determined by weekly otoscopic examination. Biocompatibility was assessed by comparing auditory brainstem response (ABR) thresholds and by examining tympanic membrane changes following tube resorption. Shah minigrommet ventilation tubes were used as controls. In the second portion of this study, implanted PLGA-50 and PLA tubes were exposed weekly to a mixture of soap and water (1:5) until complete resorption was observed. Biocompatibility was assessed by periodic ABR testing and tympanic membrane examination. RESULTS: The PLA tubes remained in the tympanic membrane for a longer period (63.2 +/- 19.3 days) than the PLGA-50 (18.8 +/- 8.1 days). The tympanic membrane and resorbable tube interface demonstrated equivalent findings for auditory thresholds and tissue histopathology at the implant site compared to nonresorbable controls. The resorption behavior was not altered by exposure to soap and water. Tympanic membranes of all animals following tube degradation and soap water exposure were intact with minimal scarring and no signs of persistent foreign body response. The histological analysis showed that implantation of resorbable tubes was not accompanied by secondary infection with otorrhea through the tube, did not result in a permanent perforation or dislocation of the tube into the middle ear cavity, and was not followed by excess tympanosclerosis or localized or diffuse membrane atrophy. CONCLUSIONS AND SIGNIFICANCE: Resorbable polyester pressure equalization tubes demonstrate predictable resorption behavior and similar biocompatibility characteristics when compared with nonresorbable Shah minigrommet ventilation tubes. Exposure to soap water does not accelerate polyester tube degradation nor change the host tissue response during the indwelling period or after complete resorption. The data suggests that resorbable ventilation tubes are substantially equivalent to other FDA-approved tympanostomy devices with regard to safety and biocompatibility in the guinea pig model examined and may provide improved clinical performance by combining this approach with sustained release technology. EBM RATING: B-2.     

Acceptance of Surgery for Obesity by Academic Surgeons in North America

BACKGROUND: Have surgeons in North America accepted operations for the treatment of severe obesity? This question was posed by organizers of the Ninth International Symposium on Obesity Surgery that met in Stockholm in September, 1995. Study design: In order to obtain opinions which might help to answer the question posed, a 1-page questionnaire was sent to 151 chairmen of academic departments of surgery in North America in December 1994 asking about the acceptance and use of surgical operations for the treatment of severe obesity. RESULTS: Answers, received from 112 or 74%, indicated that operative treatment should be used (74%), was effective (77%) and safe (71 %). However, only 65% of departments provided such operations. Operative treatment for obesity was available outside the department in 53%. The operations most frequently used were Roux-en-Y gastric bypass (RGB) and vertical banded gastroplasty (VBG). A single operation was offered by 44 departments and a choice of two or more operations in 30 departments. RGB and VBG were equally in use. Gastric banding was used as an alternative to VBG in six departments. Other operations were in use in six departments either alone (three) or as alternatives to RGB and VBG (three). CONCLUSIONS: It appears that surgical treatment of obesity is accepted and available in the majority of academic departments of surgery.