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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC SILICONE BREAST IMPLANTS - SMOOTH ROUND HIGH PROFILE GEL PROSTHESIS, BREAST, NONINFLATABLE, SILICONE GEL-FILLED

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MENTOR WORLDWIDE LLC SILICONE BREAST IMPLANTS - SMOOTH ROUND HIGH PROFILE GEL PROSTHESIS, BREAST, NONINFLATABLE, SILICONE GEL-FILLED Back to Search Results
Model Number LT 350-3254BC
Event Date 07/12/2017
Event Type  Injury  
Event Description

I am having a had reaction to my mentor silicone memory gel implants that were placed under the muscle three years ago. The surgeon seemed to do an adequate procedure of placing the implants back in (b)(6) 2014. Less than 6 months after having these implants, i started to develop multiple symptoms. It started with pain, fatigue, numbness, concentration, and memory loss, which has now triggered an autoimmune response and high levels of toxicity in my body. I had follow-ups with my surgeon and everything seemed to be fine but the symptoms continue to become worse and more frequent. In doing my research, i trusted the fdas recommendation that these were very safe implants. I have learned that the mentor company product was approved but was supposed to complete a 10 year study that has now been cancelled. I am ashamed of the mentor company because of the old and new medical research the proves these implants ar highly toxic. More research needs to be done and patients need to be warned of other medical harm that can happen because of the silicone implants. I researched and found tan excellent plastic surgeon. I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. I believed the fda and the plastic surgeon. I have followed every recommendation that has been made in regards to the breast augmentation surgery. I have also been very consistent with all of my medical visits and live a very healthy lifestyle however i continue to become more ill no matter how clean eating, exercising, and taking supplements and medication recommended by physicians. Besides seeing my primary care physician, i have seen a neurologist, rheumatologist, holistic/functional medicine, gynecologist, dermatologist, psychiatrist, therapist, chiropractor and have tried massage therapy, acupuncture, sauna, and more recently i saw a doctor at (b)(6) for heavy metal issues. Important information: i have been very diligent in following doctor's protocols and have preferred diet and exercise over medication if at all possible. I do not smoke cigarettes, and rarely ever drink any alcohol. In fact, since implantation i do not have a taste of alcohol and have become sick whenever i have tried to drink even in moderation. I have a supportive husband and family and have even resigned from my teaching position to help figure out my medical issues.

 
Event Description

Add'l info received for report mw5070992 on (b)(6) 2019. Reporter alleges after implants were taken out, the following symptoms resolved: joint pain, feet pain in both right and left, rashes on chest, face and back, no more flu like symptoms, insomnia went away, weight loss due to decreased inflammation, improvement in dry skin, yellowish eyes brightened to clear white, wound heals faster after explant and eyes are no longer dry. General improvement in health after explant, and has lab work to prove upon request.

 
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Brand NameSILICONE BREAST IMPLANTS - SMOOTH ROUND HIGH PROFILE GEL
Type of DevicePROSTHESIS, BREAST, NONINFLATABLE, SILICONE GEL-FILLED
Manufacturer (Section D)
MENTOR WORLDWIDE LLC
MDR Report Key6714016
Report NumberMW5070992
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial,Followup
Report Date 12/04/2019
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received07/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberLT 350-3254BC
Device Catalogue NumberLT 350-3254BC
Device LOT NumberLT 6791032
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/12/2017 Patient Sequence Number: 1
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