MAUDE Adverse Event Report: BOSTON SCIENTIFIC MESH

Model Number MOO68502000051

Device Problem Material Erosion (1214)

Patient Problems Autoimmune Reaction (1733); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Perforation (2001); Seizures (2063); Malaise (2359); Ambulation Difficulties (2544); Dysuria (2684)

Event Date 07/18/2008

Event Type  Injury  

Event Description

After having a j and j vaginal mesh surgery i became to become very ill.It started with seizures, then polyps in my thyroid and colon resulting in several surgeries and removal of my thyroid to hashimotos.I continued to remain ill with very high inflammatory markers repeated infections and serious autoimmune responses to the point of being bed ridden.It then went on to become extremely painful to urinate and at times not being able to urinate at all due to the inflammation.Part of the mesh was removed after it proceeded to perforate my vagina and bladder.Upon removal the mesh had significant tissue being embedded in it.I have been in and out of the er room, countless dr.Appointments and to mayo clinic with very high levels of inflammation in most of my body.It has now progressed to the point that i suffer serious autoimmune issues and allergies to a multiple of things with the list of things continuing to grow at a rapid rate.The mesh has grown into my bowels, vagina, urethra and is now effecting nerves causing walking to be difficult.There is no doubt in my mind that this product not only causes erosion but is also the source of a full body reaction to its ingredients.I was an active very healthy individual until this product was placed into my body.The reaction to it showed within weeks.Please take this off the market.At the rate i am digressing i will probably not live to see it but i beg you to stop this from happening to other women.Your attention to this matter should be immediate not another day should go by with people's lives being put at risk.Thank you.Enough to know that this mesh is eating away at multiple blood tests for inflammation, high selenium and other metals present.Scopes, surgeries, biopsies.

• Brand Name: MESH
• Type of Device: MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5932660
• MDR Text Key: 54280040
• Report Number: MW5064571
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MOO68502000051
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 82