(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.How are you currently feeling? if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.
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It was reported that the patient underwent a reconstruction surgery between 2009 and 2012 for vaginal prolapse after cancer treatment in the lower intestinal tract and the mesh was implanted.As soon as the mesh was implanted, the patient started to have urinary tract infections which are an on-going problem to date.She has between 10 and 20 infections a year.It was also reported that the use of antibiotics to treat these infections has badly affected her digestive system, and the patient has had to deal with severe upset stomach due to overuse of antibiotics.The patient has needed so many antibiotics to treat the infections that has created an antibiotic resistance.Several times she has needed hospital intervention for severe infections bordering on septicemia.The patient had two or three operations trying to remove some of the mesh but unfortunately it is embedded in her body so there is no chance of a full removal.It was also reported that side effects of the mesh affected the patient¿s quality of life.Device is still implanted.Additional information has been requested.
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