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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIENTRA SIENTRA SIENTRA STYLE 107 BREAST IMPLANT

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SIENTRA SIENTRA SIENTRA STYLE 107 BREAST IMPLANT Back to Search Results
Model Number 0721-565HP
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Pain (1994)
Event Date 10/18/2015
Event Type  Injury  
Event Description
On (b)(6) 2015, sientra, a mfr of breast implants, notified (b)(6) plastic surgery ((b)(6)) that breast implants from one of their factories could be contaminated. Those breast implants were only sold in europe, and did not impact the u. S. Supply. We alerted our pts of this issue, but were not concerned because our sientra rep, (b)(6) told us that only the european supply had potential problems. After being informed of the sientra issue, one of our pts elected to continue with her breast augmentation with sientra implants (style 107) on (b)(6) 2015. Dr. (b)(6) performed the breast augmentation surgery using sientra style 107 gel implants. Two days later on (b)(6) 2015, sientra voluntarily stopped selling implants in the u. S. Our pt seemed to be doing fine the first week, but then had issues with the implant. She had developed increasing symptoms of pain and tenderness in her chest and breasts. On (b)(6) 2015, dr. (b)(6) removed both implants. He saw creamy yellow pus on each breast side, removed both implants, and had cultures tested. (b)(6) surgery center submitted a product complaint report form to sientra on 10/20/2015. (b)(6) plastic surgery reported the incident to the sientra rep. On 11/05/2015, the epic lab confirmed that the pt had developed bilateral polymicrobial infections. (b)(6) of sientra sent (b)(6) an explant kit on 10/20/2015 to retrieve the implants for sientra testing. The implants were sent back to sientra for their own testing. At an (b)(6) 2015 office visit, the pt was feeling much better and was continuing to improve. Sientra was supposed to report this infection to the fda. (b)(6) followed the proper channels in notifying sientra and providing pt care. As of 02/23/2016, sientra denies any bacterial infection from any implants in the u. S. This is incorrect, as this case demonstrates. (b)(6) is notifying the fda of our instance of bacterial infection from sientra breast implants.
 
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Brand NameSIENTRA
Type of DeviceSIENTRA STYLE 107 BREAST IMPLANT
Manufacturer (Section D)
SIENTRA
santa barbara CA 93117
MDR Report Key5462933
MDR Text Key39327968
Report NumberMW5060524
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 02/23/2016
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0721-565HP
Device Catalogue Number0721-565HP
Device Lot Number5803231
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/23/2016 Patient Sequence Number: 1
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