MAUDE Adverse Event Report: MENTOR SMOOTH ROUND MOD GEL IMPLANT; BREAST IMPLANTS

Model Number 350-7340MC

Device Problem Material Rupture (1546)

Patient Problems Cellulitis (1768); Chest Pain (1776); Fatigue (1849); Hair Loss (1877); Hypersensitivity/Allergic reaction (1907); Menstrual Irregularities (1959); Muscle Weakness (1967); Rash (2033); Swelling (2091); Thyroid Problems (2102); Immunodeficiency (2156); Myalgia (2238); Arthralgia (2355); Weight Changes (2607); Alteration In Body Temperature (2682)

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.

• Brand Name: SMOOTH ROUND MOD GEL IMPLANT
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6292905
• MDR Text Key: 66394415
• Report Number: MW5067567
• Device Sequence Number: 2
• Product Code: FTR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 01/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 350-7340MC
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: TOO MANY TO LIST. ; RX MEDS: NATURE THROID.
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 61