It was reported that a patient underwent a sling procedure on (b)(6) 2012 and mesh was implanted.The patient experienced immediate bowel blockage requiring rehospitalization following discharge on day 3.Additionally, the patient experienced immediate acute pain becoming chronic in pelvis, legs, vagina and groin, inability to have sexual intercourse due to pain, chronic urinary tract infections, new onset depression and anxiety, relationship difficulties, extreme weight gain, extreme difficulty mobilizing, unexplained body rash, fatigue and brain fog.The mesh implant was removed on (b)(6) 2023.Most of the above complications remain with only slight improvement and new onset incontinence with implant removal.No further information is 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.H6 component code: g07002 ¿ device not returned.
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