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

MAUDE Adverse Event Report: MENTOR SMOOTH ROUND MOD GEL BREAST IMPLANT 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 SMOOTH ROUND MOD GEL BREAST IMPLANT BREAST IMPLANTS Back to Search Results
Model Number 350-7340MC
Event Date 11/01/2015
Event Type  Injury  
Event Description

Seven years ago i went from my lovely, natural b-cup to silicone (mentor memory gel) d-cup breasts. The plastic surgeon performed what is called a dual-plane approach half under/half over the muscle to give a tear drop shape). Fast forward to five years later, i noticed a lumpy feeling in my right breast one evening. I had an mri and confirmed i had ruptured my implant. I have no clue when or how i did this. My implants were under warranty so mentor paid for a new set and most of the surgery. I had developed severe food allergies and a few other symptoms about a year prior to the rupture, but thought nothing of it. So, i had the surgery to replace them and it was an absolute breeze! it was a walk in the park! a few months later things went downhill fast! i was confronted with a whole host of issues- developed hypothyroidism, adrenal fatigue, hormonal imbalance, irregular periods, candida, 15lb weight gain, fatigue, constant pain in my chest (especially on the rt side), all over muscle soreness, joint pain, hair loss, hair texture changes, strange rashes, heavy legs and swelling, low body temperature, skin elasticity changes, cellulite, muscle loss, brain fog, more food allergies, ibs, and a few vitamin deficiencies. The changes i have had in my body in the past 15 months have been so drastic for me. I have seen 10 doctors over the past 3 years and i have been able to "manage," but most of my symptoms remain at large. The symptoms are all still there and the issues persist despite medication and extreme lifestyle and diet overhaul. So, i began my research for answers. My diet is impeccable, the products i use on my body are as clean as it gets- completely 100% organic, all natural, no preservatives, etc. I am the poster child of healthy. I am as active as i possibly can be, but lately it has become hard- i am always tired! i am certain my breast implants are causing all of my health issues.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSMOOTH ROUND MOD GEL BREAST IMPLANT
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6292905
Report NumberMW5067567
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/29/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received01/29/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number350-7340MC
Device LOT Number6736268
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/29/2017 Patient Sequence Number: 1
Treatment
OTC MEDS: TOO MANY TO LIST.
RX MEDS: NATURE THROID.
-
-