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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
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes Autoimmune Reaction (1733); Seroma (2069); Swelling (2091); Thrombus (2101)
Date of Event 12/22/2015
Type of Reportable Event Serious Injury
Event or Problem 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
Common Device Name
BREAST IMPLANTS
Manufacturer (Section D)
SIENTRA
MDR Report Key6435789
Report NumberMW5068663
Device Sequence Number14146680
Product Code FTR
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2015
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 03/22/2017
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 Lay User/Patient
Device Model Number20621-285MP
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/22/2017
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
BUPROPION; COCONUT OIL; CYTOMIL; OTC MEDS: FISH OIL; PROBIOTIC; RX MEDS: SYNTHROID
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age48 YR
Patient Weight90
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