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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA SILICONE BREAST IMPLANTS

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SIENTRA SILICONE BREAST IMPLANTS Back to Search Results
Model Number 10621-385MP
Device Problem Insufficient Information (3190)
Patient Problems Capsular Contracture (1761); Chest Pain (1776); Fatigue (1849); Headache (1880); Muscle Spasm(s) (1966); Muscle Weakness (1967); Pain (1994); Red Eye(s) (2038); Swelling (2091); Swollen Lymph Nodes (2093); Burning Sensation (2146); Anxiety (2328); Toxicity (2333); Neck Pain (2433)
Event Date 01/22/2015
Event Type  Injury  
Event Description
I had sientra implants on (b)(6) 2015. After getting my implants in, the next day my face was swollen. I had real bad thrush. I couldn't even swallow. It burned all the way down my throat. My iron was really low. I had chest pains shooting to my back on my left side for the whole time period i had my implants in which was 10. 5 months. As the weeks went by, i had upper back pain. After two months, i began having capsular contracture on both boobs especially my left. By the third month my surgeon said yes i did have capsular contracture. I had grade iv capsular contracture by the fifth month of having my implants in. I was sent to the emergency room for sharp intense pain in my mid level back, which they took ct scan. They said they didn't see anything and kept me in the hospital over night. I have been to e. R. Several times over sharp pains in my back i have had fatigue, exhaustion, anxiety, sore muscles, weak muscles, joint pains, tension headaches, locked up arm on my left side, muscle cramps throughout my body, red painful eyes, muscle burning on my ankle and wrist, neck pain. I was told by my primary doctor i had chronic pain all over my body, fibromyalgia, unusual large lymph nodes under my arm pits, which were very tender, my chest felt heavy, hard to breathe.
 
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Brand NameSILICONE BREAST IMPLANTS
Type of DeviceSILICONE BREAST IMPLANTS
Manufacturer (Section D)
SIENTRA
MDR Report Key5396776
MDR Text Key37083858
Report NumberMW5059723
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/21/2016
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10621-385MP
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/21/2016 Patient Sequence Number: 1
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