MAUDE Adverse Event Report: BOSTON SCIENTIFIC OBTRYX MESH

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problems Hemorrhage/Bleeding (1888); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Urinary Frequency (2275); Foreign Body In Patient (2687); Foreign Body In Patient (2687); Constipation (3274)

Event Date 06/23/2011

Event Type  Injury  

Event Description

I had problem with bladder incontinence, so my gyn told me he could stop that with the mesh implant.I agreed to have the surgery done because i trusted his judgement.After i came out of the hospital from the mesh implant, i had serious problems with urinating and bleeding.I phoned his office and he told me to go to a urologist.I did and the urologist had to do surgery on me due to the problem with the mesh implanted wrong.Urologist told me that mesh needed to come out, that it was causing me severe problems, but later the urologist changed her mind, saying it was too dangerous to remove.I would have to live with the pain and problems caused by the mesh.

Event Description

Add'l info received from reporter on 02/16/2017 for mw5060791: i had a mesh implant done by my gyn.He told me it was the best for incontinence.I believed him.From the 1st day of surgery implant, i had severe pain and bleeding.I contacted his office and he referred me to a urogyn.I had corrective surgery done on the mesh implant.My gyn implanted the mesh in backwards.My uro stated i need to have the mesh completely removed because of serious problems with the mesh.He informed me that surgery to remove the mesh would be very dangerous.So, i have to endure the uti and chronic pain associated with the mesh.Never had any problems whatsoever until i had the mesh implant.I am now in a wheel chair.Lost all my independence.Mesh implant has destroyed my life.

Event Description

Add'l info received from reporter on 03/06/2016 for mw5060791: (b)(4).Doctor requested i allow him to surgically implant obtryx mesh.Had problems with it from day 1.Been 5 yrs of pain.Trouble with urination, constipation with blood and infections.

Event Description

I had problem with bladder incontinence, so my gyn told me he could stop that with the mesh implant.I agreed to have the surgery done because i trusted his judgement.After i came out of the hospital from the mesh implant, i had serious problems with urinating and bleeding.I phoned his office and he told me to go to a urologist.I did and the urologist had to do surgery on me due to the problem with the mesh implanted wrong.Urologist told me that mesh needed to come out, that it was causing me severe problems, but later the urologist changed her mind, saying it was too dangerous to remove.I would have to live with the pain and problems caused by the mesh.

• Brand Name: OBTRYX MESH
• Type of Device: OBTRYX MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5489893
• MDR Text Key: 40054773
• Report Number: MW5060791
• Device Sequence Number: 0
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2017
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/16/2017; 02/16/2017
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 100