MAUDE Adverse Event Report: MENTOR SALINE

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

Patient Problems Bacterial Infection (1735); Capsular Contracture (1761); Dyspnea (1816); Fatigue (1849); Headache (1880); Itching Sensation (1943); Memory Loss/Impairment (1958); Pain (1994); Swelling (2091); Swollen Lymph Nodes (2093); Loss of Vision (2139); Tingling (2171); Discomfort (2330); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Polydipsia (2604)

Event Date 01/25/2017

Event Type  Injury  

Event Description

I received my first set of implants in 2005.They were smooth, round, and saline, 270 on one side and 300 on the other.I started having serious difficulty breathing at all times, and especially when laying down at night.I could not get a deep breath.My pcp checked all labs and my heart and lungs and everything was normal.This felt like something physical.I also developed tingling and pain in my hands and itchy pains and a numb right thumb.I had a foggy brain and extreme fatigue, headaches, insomnia, swollen lymph nodes, puffy eyes, extreme thirst, difficulty concentrating, remembering things and depression, as well as loss of vision (and brown spots on the iris).Finally, i developed a goiter and a high cortisol level.I had the implants removed at the end of 2015.Immediately, my breathing was cured! i no longer had shortness of breath.I know it was the implants pushing on my chest, probably due to the capsular contraction.They were hard as a rock from the beginning and extremely uncomfortable throughout and especially toward the end.They were very ripply as well.My breasts were so deformed from the explantation (muscle had attached to the breast tissue and every time i flexed it pulled my breasts inward) that i decided to have new implants put in to see if it would help the deformity and improve my self confidence.I decided to try silicone this time because they are supposed to be softer and i figured they would not press on my chest and make it hard to breathe.I also thought maybe i wouldn't have all the adverse effects with silicone as i did with saline (thought maybe it was due to mold).Immediately and every day since my surgery 3 weeks ago, i've had all of the same symptoms reappeared but even worse.I even developed (b)(6) 3 weeks after the surgery under my armpit, which i've never had.I haven't even had a cold for at least 2 years or more.But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds.I want them removed as soon as possible because i know they are toxic and my body is reacting to them.There should be some kind of warning about the dangers of breast implants.I've been reading endless stories online.Implants should be taken off the market, they are so hazardous to our health.I even contacted mentor and the fda via email before and neither seemed to care.So i am reporting my situation.All i want is for my original breasts to look normal and not have the muscle flex deformity.My doctor said there is nothing that can be done to prevent or fix the deformity once the implants are removed.I thought maybe an expander that would be placed between the muscle and tissue to push the muscle back down to the chest wall or maybe stitches to stick the muscle back down so that it's not pulling the breast tissue when i flex.What is your recommendation? my first ones were removed via the area incision and now i have an incision in the inframammary location.Do you think that made a difference in the muscle deformity? i'm so frustrated and depressed about the last 12 years of feeling horrible and i wish i never decided to get new implants.I feel my breasts are ruined forever now.At this point, though, i really just want to feel healthy again and get these toxic bags out!.

• Brand Name: SALINE
• Type of Device: SALINE
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6442320
• MDR Text Key: 71274344
• Report Number: MW5068721
• Device Sequence Number: 3
• 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: 03/27/2017
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• 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
• Treatment: OTC MEDS: MULTIVITAMIN.; POSSIBLY DUE TO IMPLANT SURGERY.; RX MEDS: MUPIROCIN DUE TO (B)(6) INFECTION
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 33 YR
• Patient Weight: 45