MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP ADVANTAGE FIT MIDURETHRAL SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Reaction (1733); Fatigue (1849); Pain (1994); Swelling (2091); Urinary Tract Infection (2120); Visual Impairment (2138); Reaction (2414); Numbness (2415); Cognitive Changes (2551)

Event Date 02/04/2016

Event Type  Injury  

Event Description

Boston scientific midurethral sling was surgically placed inside my body.I immediately experienced all sorts of immune issues, and due to the manufacturer not being honest about their product, my surgeon did not believe any of the issues i was having were related to the mesh.My eyes were swollen like an allergic reaction, i had terrible urinary tract pain like an infection.Over the next couple of years, i became extremely fatigued, my groin hurt so bad where my legs meet my inner hips i could barely rise from a sitting position to walk.I developed brain fog, my hands and feet would go numb, my vision went downhill, and it was basically a cascade of autoimmune issues triggered immediately upon implant of this toxic material.I can say with 100% surety it was due directly to the mesh, as when i had it removed, most of the symptoms have resolved and not come back.I may have a few remaining symptoms for my lifetime, and that is why i feel it is so important that the fda look into what exactly comprises this material and how it reacts long term, or immediately for that matter, in a human body.The 510k process is repeatedly showing that allowing manufacturers to do their own extremely inadequate and biased studies has devastating outcomes for unwitting victims such as myself.I don't have time to list every single test i had between the years of 2016 to 2019, when i had the mesh removed.However, i'd be glad to compile them if someone is actually looking into this matter.I sought help from primary care, who would run test such as routine blood and urinalysis, rheumatologists for joint pain, neurologists for hands and feet going numb and tingling, xrays, mri's, physical therapy for neck and stomach charley horsing, chiropractor, massage therapist, acupuncturist, functional medicine, nephrologist for kidney pain, endocrinologist to check my thyroid/fatigue.The problem with this product is most definitely causes an extensive list of symptoms that don't seem to align with and specific diagnosis.The closest thing i can find to match what i am feeling is asia syndrome - autoimmune syndrome induced by adjuvants.The fda really needs to look into accepting this diagnosis and how it pertains to the hundreds of thousands of patients who become victim of it and can't get any help from their doctors, because it's not recognized.It is causing incredible suffering.The device manufacturers have zero interest in having their products associated with this, as their products would likely only be used as a lifesaving measure versus a product that is slapped into human bodies just to make surgery "easier." surgeons historically have been trained on procedures in which these medical devices are not needed, and we need to go back to that.We need to consider the totality of the outcome for the patient, not just "did it help the specific thing that it was intended to fix." if it does that, and causes more problems than it solved - how does that make sense.Fda safety report id # (b)(4).

• Brand Name: ADVANTAGE FIT MIDURETHRAL SLING
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP
• MDR Report Key: 11404344
• MDR Text Key: 234938410
• Report Number: MW5099750
• Device Sequence Number: 1
• Product Code: PAG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 46 YR
• Patient Weight: 86