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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA SILICONE GEL BREAST IMPLANTS

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SIENTRA SILICONE GEL 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 NameSILICONE GEL BREAST IMPLANTS
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
SIENTRA
MDR Report Key6728955
MDR Text Key80759324
Report NumberMW5071113
Device Sequence Number2
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
Was Device Available for Evaluation? Yes
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: 07/18/2017 Patient Sequence Number: 1
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