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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA SILICONE TEXTURED GEL IMPLANTS BREAST IMPLANTS
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SIENTRA SILICONE TEXTURED GEL IMPLANTS BREAST IMPLANTS Back to Search Results
Lot Number 20621-280HP
Device Problem Material Integrity Problem (2978)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Neurological Deficit/Dysfunction (1982); Seroma (2069); Complaint, Ill-Defined (2331); Toxicity (2333)
Event Date 02/15/2016
Event Type  Injury  
Event Description
I was implanted with silicone gel textured implants. I began experiencing neurological problems one month following mammogram. My implants were voluntarily removed from the us market in (b)(6) 2015 for "quality concerns at the manufacturing plant in (b)(4)". I was explanted on (b)(6) 2017, i had abnormal cells growing within the scar capsule around one implant and a seroma. My surgeon said my entire chest cavity was terribly inflamed. I had a second surgery in (b)(6) to remove affected axillary lymph nodes and began a detox protocol for mold and chemical toxicity by my surgeon. Beyond the fact that this has affected my quality of life, i have been left with a huge financial burden. And then to have a mainstream medicine refuse to believe my implants were the source of my problems is hard. I have never notified by sientra that there were problems with my implants.
 
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Brand NameSILICONE TEXTURED GEL IMPLANTS
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
SIENTRA
MDR Report Key6669665
MDR Text Key78600846
Report NumberMW5070654
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 06/25/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number20621-280HP
Was Device Available for Evaluation? No
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: 06/25/2017 Patient Sequence Number: 1
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