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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (ENDO) MINARC SLING

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AMERICAN MEDICAL SYSTEMS (ENDO) MINARC SLING Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abdominal Pain (1685); Diarrhea (1811); Edema (1820); Emotional Changes (1831); Fatigue (1849); Headache (1880); Pyrosis/Heartburn (1883); Liver Damage/Dysfunction (1954); Muscle Spasm(s) (1966); Muscle Weakness (1967); Nausea (1970); Pain (1994); Rash (2033); Urticaria (2278); Anxiety (2328); Depression (2361); Ambulation Difficulties (2544); Claudication (2550); Cognitive Changes (2551); Abdominal Distention (2601); Dysuria (2684); No Code Available (3191); Constipation (3274)
Event Date 08/11/2014
Event Type  Injury  
Event Description
When i was told by my friend about mesh lawsuits i questioned dr.(b)(6) prior to my surgery about their safety, why there were all these lawsuits and whether there was another way to correct my problem.He again stated this was the only way to correct my problem, that the mesh was safe, that the mesh was small, the lawsuits were for earlier mesh and also that he doesn't get sued, the manufacturer does if there are complications.Following the surgery and during a follow up appointment after i went to the er at (b)(6), i could barely walk and was in excruciating pain, the doctor told me this was all due to my ob-gyn, dr.(b)(6) who performed a vaginal exam after 2 weeks causing a fibromyalgia flare which was the reason for all this pain and that a pelvic and abdomen were spasming.I have had fibromyalgia for years and this is not a flare.At (b)(6) i was prescribed tramadol for pain.Now dr.(b)(6) also prescribed belladonna and opium suppositories (cost #(b)(4)), i still feel all the pain despite these two medications.Dr.(b)(6) also told me that it is too soon to be having complications with the mesh.Other stories from other women suing say they started having problems after 3 weeks (same as me!).After receiving my operative report i saw that the mesh used was miniarc sling.This is listed on the federal drug administration website as dangerous.On every website for every lawyer pursuing these case, this mesh is listed as one with lots of complications.A law firm in (b)(4) was awarded by endo (b)(4) for american medical systems for the miniarc sling (b)(4).This is the sling inside of me so why would the doctor use this dangerous mesh? the doctor who is performing the mesh removal surgery on (b)(6) 2014 told me that i need to have the mesh removed immediately, that i was not too far gone and could have had a bladder lift and he doesn't know why this mesh was placed inside of me by dr.(b)(6).What the doctor did not tell me: he did not explain that the mesh is something that becomes permanent in my body and attaches to my other organs in my body.He did not explain that if there are complications that it can take several surgeries to remove, total removal may not be possible, the pain may never subside.He did not tell me that i had a herniated disk which was an mri he ordered and i only found out a couple weeks ago from a chiropractor i just began seeing.What i can't do without any pain: can't sit, walk, stand, lay down without pain, can't hold things, can't hang up clothes, can't walk dog, can't do litter box, can't take out garbage, can't do laundry, can't brush hair, can't cross legs can't even carry an arizona iced tea jug.Symptoms: trouble urinating, painful urination like a burning, pubic bone pain, pelvic/abdominal pain, feels like muscles are pulling, hip pain, back pain, neck pain, electrical shocks throughout my abdomen, vagina, and my entire body, nauseous, fatigued, neuromuscular problems - muscle weakness and hands, fingers, elbows, entire arms/both feet (i now walk with a limp), headaches like migraines, tired all the time, can't concentrate, emotional problems, depression, loss of confidence/self-worth, problems going to poop, diarrhea, constipation, very swollen abdomen, acid reflux, swollen feet, anxiety and panic attacks, broken out hives/skin rashes.Pain feels like knives cutting inside me.Residual symptoms from mesh: abdominal pain, it feels like muscles are pulling, hip pain, back pain, neck pain, fatigued, neuromuscular problems - muscle weakness in hands fingers, elbows, my entire arms, tired all the time, can't concentrate, emotional problems, depression, problems going to poop swell belly getting worse not better, anxiety and panic attacks, problem with liver, possible thyroid problems.
 
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Brand Name
MINARC SLING
Type of Device
MINARC SLING
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS (ENDO)
MDR Report Key4699637
MDR Text Key5716305
Report NumberMW5042105
Device Sequence Number1
Product Code PAH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/11/2015
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age43 YR
Patient Weight91
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