It was reported that a patient underwent a gynecological procedure for stress urinary incontinence on (b)(6) 2025 and mesh was implanted.The patient experienced return of symptoms, urgency after 4 years, recurrent urinary tract infections and doesn't feel empty after voiding.The patient wants "the mesh out".No further information available as reporter details have not been disclosed (confidential).
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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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