ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Micturition Urgency (1871); Incontinence (1928); Pain (1994); Anxiety (2328); Depression (2361)
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Event Date 10/10/2005 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a sling procedure for bladder urgency on (b)(6) 2005 and mesh was implanted.The patient reported experiencing pain in the pelvis, lower back and hips which is now debilitating.For approximately 5 years, the patient has required injections of cortisone and other pain relieving medications in those areas.The patient also requires strong analgesia and anti- inflammatory medications daily, but still endures ongoing pain every day and every night.The patient is unable to engage in sexual intercourse because it is too painful.The patient reported this problem began straight after having the mesh implanted.The patient is suffering with increasing bladder and bowel incontinence and has to conduct life around having quick and easy access to a toilet.The patient also experiences some urinary incontinence daily and suffers from anxiety and depression which is due to the chronic pain.The patient believes she will have no option soon, but to have the mesh surgically removed.No further information is available.
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Manufacturer Narrative
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(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).
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