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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA TEXTURED BREAST IMPLANT; BREAST IMPLANTS
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SIENTRA TEXTURED BREAST IMPLANT; BREAST IMPLANTS Back to Search Results
Model Number 20621-285MP
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Autoimmune Reaction (1733); Seroma (2069); Swelling (2091); Thrombus (2101)
Event Date 12/22/2015
Event Type  Injury  
Event Description
I had textured silicone breast implants surgery (b)(6) 2014.After about one year my left breast starting swelling up.Finally i went to the doctor and under ultrasound they removed 3 large containers of blood tinged fluid from my left breast.Unfortunately the fluid all came back and more.So my plastic surgeon said we need to remove the implant and i agreed.At my request he removed both implants this time.After the surgery my doctor told me it was a good thing he took that out.He said it was a mess, seroma, blood clots and capsulated.He said he had to do a lot to clean it all out.I suggested he test for cancer that was associated with textured implants and seromas.He said the test came back negative for cancer.Ever since the swelling started i have been dealing with autoimmune issues.
 
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Brand Name
TEXTURED BREAST IMPLANT
Type of Device
BREAST IMPLANTS
Manufacturer (Section D)
SIENTRA
MDR Report Key6435789
MDR Text Key71067494
Report NumberMW5068663
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 03/22/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number20621-285MP
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
BUPROPION; COCONUT OIL; CYTOMIL; OTC MEDS: FISH OIL; PROBIOTIC; RX MEDS: SYNTHROID
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age48 YR
Patient Weight90
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