MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REPLIFORM MESH; MESH, SURGICAL, POLYMERIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Incontinence (1928); Pain (1994); Rash (2033); Swelling (2091); Urinary Tract Infection (2120); Blurred Vision (2137); Visual Impairment (2138); Ambulation Difficulties (2544)

Event Date 09/24/2009

Event Type  Injury  

Event Description

On (b)(6) 2009 i was implanted with repliform mesh for incontinence.Couple days later i broke out with a rash and went to my medical dr.He told me to go back to dr.Whom put the mesh in and tell him somethings not right.That dr.Told me everything looked good and that it was something else going on with me.So, i went back to my md.He referred me to an allergist.After sticking me with many of needles she could not come up with a cause to why i was rashed from head to toe.My md tried meds.And then shots until finally the rash disappeared.A few days later i woke up one morning with chest, belly, pelvis and right side severe pains.My md sent me to have a colonoscopy.That urologists also sent me for blood work.The findings of that blood work was i needed enzymes and needed to have my gall bladder removed.So my gall bladder was removed.Then one day my eyes became blurred.I called my md.He referred me to eye dr.My eyes had all of a sudden went down hill.I needed glasses.I could not read the newspaper without them.My teeth started rotting for no reason.My right leg was swelling to the point i could not walk.My right hip was in so much pain.The incontinence came back.I have to use 2 plus sanitary pads a day.I have constant uti's.It was painful to have sex with my husband.He finally divorced because of my health problems.Before all this i had a loving husband, a home and my children.I lost it all!! but.I finally figured it out, all these things were fine until i had that mesh operation.I was contacted by a lawyer whom sent me to an (b)(6) dr.In (b)(6) 2015 to have mess removed.Well, that did no good because i was told he only cut it to relieve the pain i was having in my pelvis so i could use my right leg.To this day the pains are still ongoing.I have been from one doctor to another and they tell me nothing they can do for me due to this mesh.I would like to know why boston scientific can still sell this repliform mesh to dr.'s? i have looked on their site and it is still being offered today.I have heard from other women that this same mesh has caused them the same or even other problems.I would like for boston scientific and you to help us women find a dr.That can help us with all this pain and that can remove this toxic mesh from us.I would like for there to be an investigation to how this was approved through the 501 k to be able to use polypropylene plastic in the "human body"? plastic has toxins and the toxins are causing all this pain and heat in my body and no one will help me.What can i do? why has the people i depended on and trusted with my health harmed me and left me to die? a slow death is what is happening to my body.I don't have the energy anymore to keep fighting this pain.My death is caused by boston scientific, the dr.Whom put the mesh in without explaining to me what and why, (b)(6) dr.And most of all you for approving this plastic in the fist place.I thought drs took an oath "first, do no harm".It seems these days.It's all about the money!".Fda safety report id # (b)(4).

• Brand Name: REPLIFORM MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1234
• MDR Report Key: 10566452
• MDR Text Key: 208369140
• Report Number: MW5096782
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): Y
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 56