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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
Health Effect - Clinical Codes Unspecified Infection (1930); Inflammation (1932); Neurological Deficit/Dysfunction (1982); Seroma (2069); Complaint, Ill-Defined (2331); Toxicity (2333)
Date of Event 02/15/2016
Type of Reportable Event Serious Injury
Event or Problem 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 Name
SILICONE TEXTURED GEL IMPLANTS
Common Device Name
BREAST IMPLANTS
Manufacturer (Section D)
SIENTRA
MDR Report Key6669665
Report NumberMW5070654
Device Sequence Number1283642
Product Code FTR
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2017
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 06/25/2017
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 No Information
Device Lot Number20621-280HP
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/25/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Disability;
Patient Age49 YR
Patient Weight62
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