MAUDE Adverse Event Report: MENTOR SMOOTH SALINE BREAST IMPLANT

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Autoimmune Reaction (1733); Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Tingling (2171); Anxiety (2328); Numbness (2415); Palpitations (2467)
Date of Event	04/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
I had mentor saline breast implants augmented under the muscle in (b)(6) 2006 at the age of (b)(6).In (b)(6) 2014, i had a 2 - week occurrence of vertigo.Shortly after, i began experiencing numbness and tingling in my arms and legs.I was given chiropractic and physical therapy treatments that did not help.I began having severe heart palpitations so i wore a heart halter monitor with no major findings.I began to experience anxiety and panic for unknown reasons so i began increasing my b vitamins, but nothing helped.In (b)(6) 2017, my muscles began to spasm and twitch constantly all over my body.By (b)(6), i began experiencing multiple sclerosis-like symptoms such as cramping muscles, vibrating/ electrical sensations throughout my body, continuing numbness and tingling in my limbs, continual muscle spasms, sore muscles, fibromyalgia, ear ringing, and a constant vibration sensation inside of my head.My vision became blurry, i had difficulty getting a full breath, my anxiety became worse, and i often felt as though i was going to pass out.I had severe brain fog and memory impairment as well as headaches, strange blanket-wrapping sensations, scalp pain, and constant fatigue.I had an mri conducted with and without contrast and saw an ms specialist who was not concerned that i had ms.I also had an emg conducted and saw a separate neurologist within the veteran's affairs hospital who were also not concerned.I was tested for a multitude of disease such as lyme, eb, anemia, ms, als, etc.All tests came back as normal.In (b)(6) 2017, i learned about breast implant illness or autoimmune syndrome induced by adjuvants.By this time, i had eliminated all caffeine, alcohol, and non-organic cosmetics to lower my overall toxic load.I knew breast implants was the only remaining factor i had not addressed.I had them removed (b)(6) 2017 and have experienced major healing.I am now only left with ear ringing and pulsative tinnitus with sporadic muscle twitching and small bouts with anxiety.

• Brand Name: SMOOTH SALINE BREAST IMPLANT
• Common Device Name: SMOOTH SALINE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7178828
• Report Number: MW5074484
• Device Sequence Number: 17006896
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2017
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 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?: No
• Operator of Device: No Information
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Weight: 64