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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
Medical Device Problem Code Insufficient Information (3190)
Health Effect - Clinical Codes Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Pain (1994); Blurred Vision (2137); Dizziness (2194); Loss of consciousness (2418); Palpitations (2467)
Date of Event 01/19/2017
Type of Reportable Event Serious Injury
Event or Problem 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
Common Device Name
BREAST IMPLANTS
Manufacturer (Section D)
SIENTRA
MDR Report Key6728955
Report NumberMW5071113
Device Sequence Number1498574
Product Code FTR
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 07/18/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/18/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention; Disability;
Patient Age24 YR
Patient Weight59
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