Product complaint # (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, 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.(b)(4).If further details are received at a later date a supplemental medwatch will be sent.
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It was reported that a patient underwent a trans vaginal tape procedure on (b)(6) 2008 and the mesh was implanted.It was reported that the procedure was due to stress incontinence and urgency.It was reported that the procedure did not work.It was reported that the symptoms that make the patient's incontinence worse are a full meal, standing too long, sexual intercourse, full bowel, walking, coughing, sneezing, lifting, bowel movements, exercise, full bladder and stress.It was reported that the patient had menorrhagia and had a mirena put in, and also has vaginal discharge.It was also reported that the procedure has also made sexual intercourse very painful, consequently the patient no longer has intercourse.It was reported that the patient experiences a lot of lower abdominal sharp pains and lower back pain which the patient had physio, chiro and steroid injections with no help.It was also reported that the incontinence and pain have all impacted on the patient's mood and the patient has suffered from depression for some time now.
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