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Does inflating the Flexi-Seal® FMS retention balloon with 45 mL vs 30 mL, used with Foley catheters, increase the risk of damaging rectal tissue?

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Does inflating the Flexi-Seal® FMS retention balloon with 45 mL vs 30 mL, used with Foley catheters, increase the risk of damaging rectal tissue?

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In the Flexi-Seal® FMS clinical trial, the retention balloon was inflated with 45 mL and there were no adverse events related to its use. No changes of the rectal mucosa, assessed by endoscopic exams before and after its use, were reported.

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