• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. PINNACLE MESH MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORP. PINNACLE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problems Material Erosion (1214); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981); Migration (4003)
Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Inflammation (1932); Pain (1994); Scar Tissue (2060); Dysuria (2684); Foreign Body In Patient (2687); Dyspareunia (4505)
Event Date 02/23/2009
Event Type  Injury  
Event Description
Boston scientific mesh placed for vaginal prolapse and bladder sling suspension. From the time i woke up i was in severe pain. "nothing is wrong it's working as it should". Sent home, unable to care for myself. Suffered thru the pain. Tried to have relations several months later, unable to pain was unbearable. Again "everything is fine". Over the years had multiple doctor visits for severe abdominal pain. Unable to urinate properly. Again, "there is no infection, everything is fine" still not able to have relations. Multiple diagnostic tests. Felt like a knife was being shoved into me. Felt like someone had kicked me in my pubic bone. Again, "everything is fine" by 2019, saw my pcp and uro/gyn again for severe pain. Pcp was concerned. Uro/gyn refused to see me only then did i realize that i truly was not crazy and there was something wrong that he would not own up to. After researching and joining a support group months later, i realized it was the mesh and i needed to get it removed. Problem is, there are very few uro/gyn's that know how to remove it. Had multiple visits again and diagnostics. Unable to prove anything. Sought help from a specialist out of my own state because i had no choice. Dr. (b)(6) at (b)(6), did my removal on (b)(6) 2020. Postoperative dx: urethral scarring, foreign body in vaginal, exposed mesh. Name of operation: bilateral paravaginal dissection, bilateral pararectal dissection, removal of advantage sling, urethral lysis, removal of pinnacle mesh, anterior colporrhaphy, posterior colporrhaphy. The surgery was very difficult and complicated. There was severe scarring. The pinnacle fibers were eroded. The sling was in the right obturator muscle, the bladder wall and lateral to the rectus muscle. The pinnacle mesh was rolled/twisted and folded on the left. Sections of the pinnacle mesh and advantage fit mesh showed fibrosis, chronic inflammation and foreign body type giant cell reaction. I developed sjogren's disease because of this mesh my life has been destroyed. I still suffer with pain, my husband and i are no longer able to be intimate because of this. This mesh is toxic poisonous it should not be placed in anyone's body at. I had multiple diagnostics over the course of 11years - too many to list. Fda safety report id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePINNACLE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORP.
300 boston scientific way
marlborough MA 01752
MDR Report Key12342869
MDR Text Key267674219
Report NumberMW5103346
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/17/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/18/2021 Patient Sequence Number: 1
-
-