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

MAUDE Adverse Event Report: MENTOR SILICONE IMPLANT

  • 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
 

MENTOR SILICONE IMPLANT Back to Search Results
Event Date 05/20/2005
Event Type  Injury  
Event Description

I had 220 cc silicone breast implants and their capsule, which were implanted in 1987, burst during a routine mammogram. I had informed the technician that i had them. Within 3 hours of the mammogram i felt very ill, and had hives on my torso. I went to the er, where they weren't sure what was wrong and gave me antibiotics, which had no effect. I was acutely ill for several months, until the physician who had ordered the mammogram phoned me that something was peculiar on the mammogram film. I hadn't been contacted for several months because the breast tissue itself looked normal. The mammogram film showed the bursting of the implant. I contacted a plastic surgeon at (b)(6), and scheduled an explant. At this point, it had been about 9 months of sustained acute illness. The plastic surgeon at (b)(6), removed the implant material by opening up what was left of the capsules rather than using the en bloc method, which is now standard. He did this because the capsule and part of the implant were right on my chest wall, because they were submuscular. I did not get well after the surgery, although he was able to take out 130 ccs of material on one side and 210 ccs on the other. I finally found a surgeon who could explain why i was still acutely ill, and she was able to remove the remaining capsule and silicone, which she was able to find. Most of the missing silicone was never accounted for, though. I started to feel better after that surgery. It has been a year of feeling acutely ill. Then in 2011, i was diagnosed with a rare blood cancer. Polycythemia vera rubra. I am being treated for this currently.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSILICONE IMPLANT
Type of DeviceSILICONE IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6435876
Report NumberMW5068667
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 03/23/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received03/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
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: 03/23/2017 Patient Sequence Number: 1
Treatment
ASPIRIN 81 MG DAILY
COQ10
FISH OIL
OTC MEDS: PROBIOTICS
RX MEDS: PEGASYS 45 MCG/WEEKLY
VITAMIN D
-
-