Mechanical evaluation of a ruptured Swedish adjustable gastric band.
BACKGROUND
Leakage of a laparoscopically placed Swedish adjustable gastric band (SAGB) was observed 2 1/2 years after placement. The band was evaluated for mechanical inaccuracies by a laboratory.


METHODS
The ruptured SAGB was investigated microscopically and wall thicknesses were measured. An unused SAGB was tested, both empty and filled, for mechanical deformity after exposure to saline solution.


RESULTS
A permanent transformation of the silicone rubber was found, caused by bowing of the device. 2 tears were present at the end of a kink. The mean wall thickness was within acceptable limits. Exposure of the gastric band to saline solution did not cause any sign of permanent deformity of the silicone rubber.


CONCLUSIONS
The rupture of the gastric band did not seem to be caused by a production error. Long-term deformity, in combination with a continuous dynamic load, may increase the risk of tearing. Long-term follow up is recommended for patients treated with this device.
Reijnen
Michael M P J
MM
Department of Surgery, Hospital Rijnstate, Arnhem, the Netherlands. mmpj.reijnen@worldonline.nl
Naus
J H
JH
Janssen
Ignace M C
IM
D004868:Equipment Failure; D019544:Equipment Failure Analysis; D015391:Gastroplasty / Q000295:instrumentation*; D006801:Humans; D008422:Materials Testing; D012826:Silicone Elastomers; D013314:Stress, Mechanical; D013997:Time Factors
D012826:Silicone Elastomers