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

MAUDE Adverse Event Report: MENTOR GEL BREAST IMPLANTS

  • 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 GEL BREAST IMPLANTS Back to Search Results
Lot Number 5930353
Event Type  No Answer Provided  
Event Description

Approx 7 years ago, i had a breast augmentation done, re-done actually. I went from saline smooth implants to textured cohesive gel implants. Within a matter of months, i was already having problems with them the right breast became hard and it wasn't until this year that i had the funds to have them removed. During the last few years, i've had a swollen lymph gland underneath my right arm that repeatedly i was told was benign and nothing to worry about. Now that i've seen the reports on tv and the studies associating silicone implants with a certain type of cancer. I was wondering what steps to take to ensure that i was healthy and safe. I've been to the doctor many times complaining about the lymph gland being swollen and getting dismissed repeatedly, i could really use to use some advice or support.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGEL BREAST IMPLANTS
Type of DeviceGEL BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6584830
Report NumberMW5069936
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/19/2017
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received05/19/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device LOT Number5930353
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

-
-