MAUDE Adverse Event Report: BREAST IMPLANTS; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rheumatoid Arthritis (1724); Dyspnea (1816); Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Visual Impairment (2138); Weight Changes (2607); Cancer (3262); Skin Disorders (4543)

Event Date 09/01/2014

Event Type  Injury  

Event Description

Initially, i began to be tired all the time, then my entire body felt sore and my joints hurt.I could never really get a full breath of air.Next, my thoughts started to jumble and i couldn't focus on anything, couldn't remember things.My eyesight began to diminish, i started to gain weight even though my diet and exercise routine had not changed.I started to have trouble dressing/undressing myself.I have no energy whatsoever.My breasts began to hurt, then the chest wall around my breasts hurt.I was diagnosed with rheumatoid arthritis even though it does not run in my family.Fibromyalgia, ringing in my ears constantly, headaches, neck and back pain, i always feel like i have something stuck in my throat, dry skin, a lump in my right breast that has been diagnosed with cancer (also does not run in my family) as of last monday.I have an appointment with the oncological surgeon on wednesday so i have not explanted yet.Fda safety report id# (b)(4).

• Brand Name: BREAST IMPLANTS
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• MDR Report Key: 10613500
• MDR Text Key: 209628467
• Report Number: MW5097000
• Device Sequence Number: 1
• 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: 09/28/2020
• 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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 56 YR
• Patient Weight: 77