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

Model Number	0721-565HP
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Codes	Bacterial Infection (1735); Purulent Discharge (1812); Pain (1994)
Date of Event	10/18/2015
Type of Reportable Event	Serious Injury
Event or Problem 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.

• Brand Name: SIENTRA
• Common Device Name: SIENTRA STYLE 107 BREAST IMPLANT
• Manufacturer (Section D): SIENTRA; santa barbara CA 93117
• MDR Report Key: 5462933
• Report Number: MW5060524
• Device Sequence Number: 10057808
• Product Code: FTR
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2016
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0721-565HP
• Device Catalogue Number: 0721-565HP
• Device Lot Number: 5803231
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 56