MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH ADJUSTABLE IMPLANTS; PROSTHESIS, BREAST, INFLATABLE, INTERNAL SALINE

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

Patient Problems Dysphagia/ Odynophagia (1815); Flatus (1865); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Skin Erosion (2075); Blurred Vision (2137); Dizziness (2194); Shaking/Tremors (2515); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)

Event Date 08/01/2008

Event Type  Injury  

Event Description

Mentor saline breast implants in 2001 - over the muscle.Here is my list of health issues, that began in 2011.Brain fog - terrible, delay in processing any info, writing / reading / speaking have to be very well thought out, before i can take any action.Memory - zero memory.Feeling off-brain/ nervous system / sensory system - similar to how you feel after multiple nights of no sleep.Dizziness / light headedness - all the time, irregular heartbeats, daily exhaustion, beyond normal.Blurry vision, visual disturbances, bruising takes months to heal, wounds take months to heal.Eye floaters, hip pan, can barely walk after sitting.Shaky hands, high cholesterol, not a high fat diet.Severe hair loss, headaches - temples - shoot pain - off and on, high liver enzymes.Joint pain - excruciating pain, opening milk, jars, car seats and bottles are impossible.I am (b)(6).Muscle pain, back pain, gingivitis even with excellent oral hygiene.Spine pain (not the same as back pain, more of a tender spine).Fatty liver - ultrasound proven, yellow around the eyes.Body odor - every hole chemical sensitivity.Cannot use or smell perfume or scented anything, laundry soaps, hand soaps, dish soaps, body lotion, sprays, candles, shampoo / conditioner, deodorant, cleaning supplies.Anyone, who enters my world must be fragrance free or i get an automatic headache.I cannot even enter (b)(6).Swollen armpit lymph nodes - daily, mammogram clear.Allergies to adhesive-localized thyroid issues - cannot regulate it and i never had this problem before.Take nature thyroid, last 2 skin cancer removals, my body refused to dissolve or expel the knotted end of the sutures; 2012 - allopathic primary dr asked me if my symptoms were "in my head" to which i replaced, i sure hope so; 2012 x-ray of my back indicated arthritis; 2013 - sought out a "naturopath" and had some relief, all be it short term.

• Brand Name: MENTOR SMOOTH ADJUSTABLE IMPLANTS
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL SALINE
• Manufacturer (Section D): MENTOR
• MDR Report Key: 8023908
• MDR Text Key: 125974400
• Report Number: MW5080965
• 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: 10/28/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 72