MAUDE Adverse Event Report: SIENTRA TEXTURED BREAST IMPLANT; BREAST IMPLANTS

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.

• Brand Name: TEXTURED BREAST IMPLANT
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): SIENTRA
• MDR Report Key: 6435789
• MDR Text Key: 71067494
• Report Number: MW5068663
• Device Sequence Number: 2
• Product Code: FTR
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 20621-285MP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BUPROPION; COCONUT OIL; CYTOMIL; OTC MEDS: FISH OIL; PROBIOTIC; RX MEDS: SYNTHROID
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 90