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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH SILICONE BREAST IMPLANT

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MENTOR SMOOTH SILICONE BREAST IMPLANT Back to Search Results
Event Date 05/01/2014
Event Type  Injury  
Event Description

After being implanted with silicone breast implants (cohesive gel by mentor) i became incredibly sick and my body started having a six-year downward spiral of auto-immune issues, endocrine issues, and adrenal dysfunction. Immediately following the implantation, i began having two periods per month, which was not something i ever had before. I told my plastic surgeon about it, said i was concerned but he brushed it off and said it was not related, even though it began right after implantation. Following this initial symptom, i was then diagnosed, three years later with endometriosis, adrenal fatigue, auto-immune disorder and was living with over 30 auto-immune symptoms that i never had prior to implant. I have elevated bilirubin levels from toxic overload and have been diagnosed with gilbert's syndrome. I did not smoke, do not use drugs, do not consume alcohol and eat very clean. I was a very healthy, active person up until all of this happened. At the time year mark of getting implants, after being diagnosed with all of these issues, i saw multiple doctors and kept telling them i have a concern it was my implants making me sick. None of them would even acknowledge it because they said "all implants are fda approved" and then would change the subject. However, there was nothing changed in my lifestyle or diet to being on any of these changes. This past year has been the worst so far and i just explanted without replacing the implants because i am 100% certain they have been poisoning me and i am disgusted how the medical industry does not take these type of complaints seriously. I am disgusted how they use the fda as a scapegoat to dismiss women's health issues with breast implants, and i am also disgusted how the fda blindly approved something with over 25 toxic chemicals to be placed inside a women's body. Not every women is genetically the same and there are many that will not be able to tolerate the implants. Since explanting, i already am noticing symptoms subsiding such as my brain fog, temperature regulation and ability to focus clearly. I am carefully monitoring my progress but something needs to be done about this as i am one of thousands upon thousands of women who have all had this same problem. I lost six years of my life to the implants and now am being told i have to have a hysterectomy from the endometriosis that was brought on by the increased periods that were triggered from the endocrine disruption from the implants. I am only (b)(6) and should not have any of these health issues.

 
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Brand NameSMOOTH SILICONE BREAST IMPLANT
Type of DeviceSMOOTH SILICONE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6607428
Report NumberMW5070135
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/31/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received05/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
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: 05/31/2017 Patient Sequence Number: 1
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