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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA IMPLANTS BREAST IMPLANT

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SIENTRA IMPLANTS BREAST IMPLANT Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Capsular Contracture (1761); Chest Pain (1776); Dyspnea (1816); Erythema (1840); Extreme Exhaustion (1843); Fatigue (1849); Inflammation (1932); Pain (1994); Rash (2033); Red Eye(s) (2038); Swelling (2091); Weakness (2145); Burning Sensation (2146); Phototoxicity (2165); Myalgia (2238); Arthralgia (2355); Deformity/ Disfigurement (2360); Disability (2371); Sore Throat (2396); Fungal Infection (2419); Neck Pain (2433)
Event Date 12/17/2015
Event Type  Injury  
Event Description
After implants in (b)(6) 2015 my health started going downhill. Right after implants i had severe thrush, throat burned very bad. I could not eat without having very bad pain in throat. I had very bad, sharp, shooting pains in my left side of chest which shot to my back side immediately after implants put in. The sharp pains did not go away. Face swollen the very next day after implants put in. Immediately had back, spine pain, lower back pain, shoulder pain, upper back pain after implants put in, in (b)(6) of 2015. Two months after implants put in i had capsular contractions in both breasts from implants. Still sharp pains shooting from left breast to my left side of back. Upper back pains even more at this time, "misformed" shaped breast. Now was getting neck pains. Three and a half months after implants i now have eye pains in both eyes, breast getting more uneven shaped. Six months after implants in, very hard to breathe at times. I now have joint and muscle pains throughout my body, in my feet, calves, hands, back, neck, shoulders, inflamed lymph nodes under my armpits. Still shooting pains from left breast to my left back. By nine months out, i am very weak, fatigued, exhausted, can barely work at my job. At 10 months i am now getting burning, inflamed, red spots/patches throughout body, so painful it feels like i had sprained a body part. Eyes blood shot red and in pain and very sensitive to light.
 
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Brand NameIMPLANTS
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
SIENTRA
MDR Report Key5319715
MDR Text Key34239661
Report NumberMW5058657
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 12/17/2015
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/17/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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: 12/17/2015 Patient Sequence Number: 1
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