MAUDE Adverse Event Report: MENTOR SMOOTH SALINE BREAST IMPLANT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Reaction (1733); Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Tinnitus (2103); Tingling (2171); Anxiety (2328); Numbness (2415); Palpitations (2467)

Event Date 04/23/2017

Event Type  Injury  

Event 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
• Type of Device: SMOOTH SALINE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7178828
• MDR Text Key: 97001765
• Report Number: MW5074484
• Device Sequence Number: 1
• 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

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 01/09/2018 Patient Sequence Number: 1