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Catalog Number PMM3 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Fatigue (1849); Foreign Body Reaction (1868); Incontinence (1928); Inflammation (1932); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Anxiety (2328); Hypoesthesia (2352); Depression (2361); Fibrosis (3167); Not Applicable (3189); No Code Available (3191)
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Event Date 02/28/2017 |
Event Type
Injury
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Manufacturer Narrative
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(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.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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Event Description
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It was reported by the patient that the patient underwent a prolapse repair/hysteropexy procedure on unknown date and the mesh was implanted.48 hours after the procedure, the patient ¿s legs became cold, very painful, stiff and numb.The patient was having chemical sensitivity, neuropathy and fibromyalgia symptoms.In 5 weeks since the mesh implanted, the patient experienced fatigue and severe brain fog, then in 4-4.5 months had chronic fatigue and could not feel ground with her legs.After 18 months, the patient underwent a mesh and womb removal procedure.The surgeon opined that a lot of women react to a mesh and have same autoimmune symptoms.During mesh removal surgery, the mesh found to be adherent to the sacral promontory and was tracking down all the right side of the pelvis.The mesh was also adherent to the ureter on the right.A ureterolysis was performed.It was also reported that the mesh then came through into the broad ligament on the right side and cut cervix behind, on the front extending towards area just underneath the bladder base.It was also reported that the mesh became impregnated into the bladder wall.There were more findings reported such as foreign body giant cell reaction, chronic inflammation and fibrosis.The patient stated that since the mesh was removed, she never got chronic fatigue anymore and all symptoms improving slowly.It was also reported that the patient experienced abdominal pain, muscle spasms,numb left arm, weak calves, numbness, incontinence become worse and required another surgery in an early future.Additional information has been requested.
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Manufacturer Narrative
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Date sent to the fda: 01/24/2019.Additional information was requested, and the following was obtained: underwent a laparoscopic sacrohysteropexy on (b)(6) 2017.The prolene knitted polypropylene mesh was cut from a 15 x 15 cm graft.I am sure my health is in that state now because of the mesh and medical screws.I did not react to anaesthetics- dr.¿kicked¿ me out of the hospital on the next morning because ¿ i looked too well and healthy to keep a bed in the hospital¿.But less than 48 hours since the operation i called to the hospital as weird and scary things started happening to me.Before the surgery i was in extremely good health and pre-assessments tests was 'all good'.A mesh is removed because it cause allergic, immunologic and/or severe inflammatory reaction not just because of damaged organs and chronic pain." 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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Manufacturer Narrative
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(b)(4) date sent to the fda: 02/01/2019.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
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Manufacturer Narrative
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Date sent to the fda: 5/9/2019.
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Search Alerts/Recalls
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