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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA SILICONE GEL BREAST IMPLANTS; BREAST IMPLANTS

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SIENTRA SILICONE GEL BREAST IMPLANTS; BREAST IMPLANTS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Pain (1994); Blurred Vision (2137); Dizziness (2194); Loss of consciousness (2418); Palpitations (2467)
Event Date 01/19/2017
Event Type  Injury  
Event Description
I got sientra silicone gel breast implants on (b)(6) 2017 and i immediately got severely sick.I had severe dizziness, shortness of breath, chest pain, chronic fatigue, heart paliptations, blurry vision, passing out, difficulty swallowing, and many other symptoms.I removed my breast implants on (b)(6) 2017 and my symptoms are improving already.I was perfectly healthy before implants.I had to visit the er several times as well as several doctors appointments since implanting.I believe that breast implants are not safe and need to be taken off the market as they ruined mylife.I was put on disability from work as i was bed ridden before explanting.Dates of use: (b)(6) 2017.Diagnosis or reason for use: cosmetic.
 
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Brand Name
SILICONE GEL BREAST IMPLANTS
Type of Device
BREAST IMPLANTS
Manufacturer (Section D)
SIENTRA
MDR Report Key6728955
MDR Text Key80759324
Report NumberMW5071113
Device Sequence Number1
Product Code FTR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/18/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age24 YR
Patient Weight59
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