(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: weight, bmi at the time of index procedure name of initial surgical procedure in 2004? the diagnosis/indication and initial approach for the initial surgical procedure? any concurrent procedure/device implantation? other relevant patient history/concomitant medications when was the mesh exposure first noted by a physician? was the device removed on (b)(6) 2018? if so, please provide details of the re-operation.What is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status?.
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Additional information was requested, and the following was obtained: name of initial surgical procedure in 2004? the diagnosis/indication and initial approach for the initial surgical procedure? any concurrent procedure/device implantation? other relevant patient history/concomitant medications.Prolapsus cure (rectocele) by vaginal route with interposition gynemesh (in intra-rectal-vaginal).Concomitant procedure: cystocele cure with gynemesh in intra-vesical-vaginal.When was the mesh exposure first noted by a physician? on (b)(6) 2018.Was the device removed on (b)(6) 2018? if so, please provide details of the re-operation.Yes, partially (partial exeresis of the portion exposed into the vagina).What is physician¿s opinion as to the etiology of or contributing factors to this event ? the vaginal surgery with prosthetic interposition exposes to this risk.Gynemesh was a prothesis which, a posteriori, turns out to be "heavy" (high grammage), so potentially a higher risk of prosthetic exposure.What is the patient's current status? asymptomatic, she is well.
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