MAUDE Adverse Event Report: MENTOR SMOOTH SALINE BREAST IMPLANT

Device Problems Contamination (1120); Device Operates Differently Than Expected (2913)

Patient Problems Autoimmune Reaction (1733); Fatigue (1849); Fever (1858); Fungus (1872); Hair Loss (1877); Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Toxins In Children (2098); Chills (2191); Myalgia (2238); Urinary Frequency (2275); Complaint, Ill-Defined (2331); Arthralgia (2355); Depression (2361); Sweating (2444); Ambulation Difficulties (2544); Polydipsia (2604); Weight Changes (2607)

Event Date 06/25/2015

Event Type  Injury  

Event Description

I had mentor smooth saline filled under the muscle breast implants.From the moment they were put in my body, my immune system reacted to everything.My body took twice as long to recover from surgery, childbirth, and everything in between.Over the 12 years i had them in my body.I gradually lost the ability to exercise.I grew up very athletic, so this was like dying.Toward the end of the 12 years, i was not able to be on my feet for long and not able to walk or run, other than grocery shopping and the duties of being a mom.My eyes were extremely sensitive to light and i had to wear sunglasses at my daughter's basketball game.Inside, i was chronically fatigued for a very long time and the last 4 years i had to take a nap every day to get through life.I had many headaches and so much brain fog that it was difficult to do my job as an actor who is supposed to memorize lines.I survived by using lists in everyday life.I had so much pain that it hurt just to be alive.My body ached on a daily basis.Any time i used any joint, whether it was my wrist on my shoulder, it would hurt for the next 5 days.My feet were constantly sore and i had to replace my arch supports every 30-60 days because it was like walking on bones, my foot doctor said my bottoms of my feet were the thinnest he had ever seen.I had so much tissue and muscle wasting and weight loss.I went from a (b)(6) muscular athletic woman to a (b)(6) frail woman who was malnourished because her body no longer had the ability to absorb nutrients.My gut lining was very damaged from the heavy metals in the lining of the implants.Also, the valves in the implants were faulty and had mold in them when they were removed in (b)(6) 2016.This mold caused me to be very sick.My children were also harmed by the implants while they were in uterus and while breastfeeding.Their immune systems are overreactive to everything.They have many allergies and sensitivities and have similar reactions to things that i have reactions to.Their reactions mimic mine so i know that heavy metals and chemicals have been passed through to them in utero and while breastfeeding i lost a lot of my eyelashes toward the end, and my hair thinned.I had fever and chills a lot toward the end, and night sweats.I had to pee multiple times during the night and always felt thirsty.I lost the ability to digest meat properly, and had to eat mostly fruits, veggies and beans.Life became so difficult at times that i became severely depressed at one point.I lost my hope until i realized that the root of all of my problems started when i got breast implants.As soon as i got them out, a year ago, the color returned to my face and the joint pain mostly disappeared.My brain fog is nearly gone now, and i no longer need daily naps.I am slowly working back into exercising and my eyes are much less sensitive to light.My skin was aging rapidly the last year, and now that the implants are out, the age spots have lightened and i have been complemented on my glowing skin again.I have put on 5 pounds and continue to regain my muscle and athletic ability.I was able to coach my daughter's basketball team this year for the first time ever.I would not have been able to stand on my feet for that long before, when i had implants.I now have hope for a beautiful future free of pain and full of love with my husband and 3 children.Breast implants stole 12 years of my life and i am so upset that they are allowed to be put in a woman's body.The destruction they cause is not ok.They should be remove from all surgeries.They are toxic in the human body and they harm babies in utero and while breastfeeding.I will speak with anyone about my experience.I want to share it with the world so no one else has to endure the pain and suffering the implants have caused to me and my family.Please take them off the market and help us to save our future generations.This needs to end.Thank you.

• Brand Name: SMOOTH SALINE BREAST IMPLANT
• Type of Device: SMOOTH SALINE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6653108
• MDR Text Key: 77970290
• Report Number: MW5070517
• Device Sequence Number: 2
• 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: 06/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: IMMUNOG PRP; LDN; MAGNESIUM; METHYL PROTECT; VITAMIN D
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 38 YR
• Patient Weight: 54