MAUDE Adverse Event Report: MENTOR SMOOTH SALINE BREAST IMPLANT

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Cyst(s) (1800); Dry Eye(s) (1814); Fatigue (1849); Micturition Urgency (1871); Memory Loss/Impairment (1958); Red Eye(s) (2038); Respiratory Distress (2045); Tissue Damage (2104); Vertigo (2134); Electrolyte Imbalance (2196); Urinary Frequency (2275); Sweating (2444); Palpitations (2467); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Weight Changes (2607); Heavier Menses (2666); No Code Available (3191)

Event Date 05/01/2013

Event Type  Injury  

Event Description

On 2013 began the onset of several health problems that at the time, i had no idea why or what was creating all of the problems.I was healthy, more than healthy.I was an athlete and personal trainer.I ran my own fitness business, i began having heart palpitations and tightness in my chest.Ekg and labs showed no reason.I then began having issues with female health, cysts during ovulation, fibrous dense breast tissue that eventually also led to cysts.Pain, i underwent ultrasounds and blood tests again, no findings.Painful periods and excessive bleeding.Which led to an ablation attempt and eventually ended with hysterectomy last year.Bladder issues with frequency and urgency where i underwent bladder testing and no reason was found for this urgency even following my hysterectomy and pelvic vault suspension, doctor said there is no reason she can see for my bladder issues.Which did continue after this surgery.My eyes and mouth became unbearably dry.I had testing done on my eyes to see if my oil glands had degraded.No.Tear duct plugs were placed, which helped a bit.The addition of prescription eye drops that helped, but my eyes were still red and dry.Blood tests for sjogrens disease, came back negative, due to my dry mouth.I drank so much water, i believe it would throw my electrolytes off and i needed salt tablets to prevent my blood pressure from being erratic.I began to be light headed and eventually full blown vertigo episodes.All of my joints and muscles hurt so bad.I eventually closed my business as i could no longer teach fitness classes.My aerobic capacity diminished and recovery from my own personal workouts was long.I stopped making any strength or cardio goals and also gained about 25 pounds slowly over the following 3-4 years.Brain fog and decreased concentration and memory also took hold.Night sweats to literally being soaked in sweat with a fan blowing on me.Extreme fatigue and the inability to make it through my daily tasks without hours of napping.I was in bed longer periods than up.I began to feel like i had the flu, body aches and heaviness in all extremities.I couldn't eat anything without instantly bloating.Even healthy fruits and veggies, it didn't matter.There were moments that i was lying down to sleep and it felt like i was suffocating and would have to consciously direct myself to breathe.It wasn't until i discovered a website about breast implant illness that i put it all together.I had my explant on (b)(6) 2017 and only one week post op i can tell a huge difference in my dry eyes and mouth.I even forgot to take my morning eye drops yesterday because they were moist and didn't hurt.Prior to explant, i still immediately took the eye drops just so i could see.Since focusing on nutrition to reduce inflammation, i have lost at least 5 pounds and this is only the beginning to my recovery.I can't wait for my healing to continue and get my life back.

• Brand Name: SMOOTH SALINE BREAST IMPLANT
• Type of Device: SMOOTH SALINE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6600875
• MDR Text Key: 76432177
• Report Number: MW5070087
• Device Sequence Number: 1
• Product Code: FWM
• 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: 05/26/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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 Outcome(s): Disability
• Patient Age: 46 YR
• Patient Weight: 66