MAUDE Adverse Event Report: MENTOR SMOOTH ROUND HIGH PROFILE GEL BREAST IMPLANT

Model Number 350-3504BC

Device Problem Insufficient Information (3190)

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Micturition Urgency (1871); Hair Loss (1877); Headache (1880); High Blood Pressure/ Hypertension (1908); Memory Loss/Impairment (1958); Swelling (2091); Vertigo (2134); Blurred Vision (2137); Vomiting (2144); Dizziness (2194); Anxiety (2328); Numbness (2415); Confusion/ Disorientation (2553); Polydipsia (2604); Weight Changes (2607); No Code Available (3191)

Event Date 09/19/2012

Event Type  Injury  

Event Description

On the date listed above, i received breast augmentation with mentor smooth round high profile gel (silicone) implanted ref (b)(4), left lot #6528127, sn # (b)(4) and right lot #5950089, sn # (b)(4).As soon as 4 months after implantation i had an emergent visit to the er for "vertigo" persistent vomiting and dizziness.Over the next 3 years my health steadily declined with unexplained symptoms.Frequent migraines with vomiting extreme fatigue hair loss blurred vision acting joints right arm-numbness and pain 20 pound weight gain and bloating of abd and frequent heartburn, brain fog with memory loss and difficulty focusing anxiety and flat affect cold intolerance esp hands and feet.As time went on symptoms worsened with high blood pressure headaches with vomiting more frequent causing me to miss work excessive thirst, urinary urgency and changes in menstrual cycle neck pain.Up until getting implants i never had any significant health problems.I started seeking help starting with my gyn doctor who diagnosed hypothyroid at my yearly visit.I obtained a family doctor at this point who subscribed thyroid meds and followed me with maintaining therapeutic tsh levels.This somewhat lessened some of my symptoms but i still felt sick like i was dying slowly.After doing research on my own and some common sense.I had the breast implants removed on (b)(6) 2015 and began the process of detoxing the chemicals and heavy metals that are in silicone gel breast implants.Immediately after removing the implants began seeing a new dr for help with this who after further lab studies diagnosed me with hashimoto's thyroiditis which is an autoimmune disease more than likely caused by the endocrine disruptive toxins in the implants.I also had low levels of magnesium, vit d, zinc and other minerals as well, has fluctuations of female hormones.A lot of my symptoms have improved or disappeared after removing the implants.However, i am left with a chronic illness now that most likely will need some medication, supplement, and labs and doctor visits to manage for the rest of my life.I have good days and bad days and my life has forever been impacted after having these poison bags put in my body.I am reporting now in the hopes that eventually these implants will be removed from the market and further restrictions imposed on any implantable device put in the human body.I was told these implants were inert and safe for implantation and that was clearly not the case for me.

• Brand Name: SMOOTH ROUND HIGH PROFILE GEL BREAST IMPLANT
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6533467
• MDR Text Key: 74199290
• Report Number: MW5069446
• 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: 04/27/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 350-3504BC
• Device Lot Number: 6528127
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MAGNESIUM; NATURE-THROID; SELENIUM ; VITEX; ZINC
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 45 YR
• Patient Weight: 50