MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS

Model Number 350-2350

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Fatigue (1849); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Seizures (2063); Dizziness (2194); Urinary Frequency (2275); Numbness (2415); Ambulation Difficulties (2544); Confusion/ Disorientation (2553)

Event Date 08/04/2012

Event Type  Injury  

Event Description

The date above is around the time that i had my mentor saline breast implants put in.After my breast augmentation, i started to get intense neck and shoulder pain along with numbness in my hands and fingers.I went to the hospital a countless amount of times, always leaving with no answers.The only diagnosis i was able to receive was that i had anxiety.Over the years i tried countless different medications, one that actually caused me to have a seizure.I have explanted and i no longer take any psych meds.My blood pressure is no longer high, i have zero neck or shoulder pain, and almost all of my other symptoms have went away.I used to wake up every day in pain, and contemplating suicide many times because i thought i was going to have to live like that the rest of my life.Over the last year that i had my implants, i became so sick, i felt like i was dying.Chest pain, sinus problems, nausea, dizziness, chronic fatigue, muscle aches, pains, and spasms, frequent urination, dry hair, chest deformities with breast pain, hard breasts, one breast that was not ruptured, but looked deflated, skin issues, wobbly feeling when walking, loss of appetite, mental confusion, brain fog, and most likely some other symptoms that i forgot to mention.Almost 95 percent of these symptoms have went away since i have explanted.This is no coincidence, and women are getting more sick every day that passes with breast implant illness.

• Brand Name: SALINE BREAST IMPLANTS
• Type of Device: SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7178685
• MDR Text Key: 96967665
• Report Number: MW5074471
• Device Sequence Number: 2
• Product Code: FWM
• Combination Product (y/n): N
• 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: 01/08/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 350-2350
• Device Lot Number: 6570720
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Weight: 52