MAUDE Adverse Event Report: SIENTRA BREAST IMPLANTS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Capsular Contracture (1761); Rash (2033); Depression (2361); Skin Inflammation (2443); Cognitive Changes (2551); No Code Available (3191)

Event Type  Injury  

Event Description

Breast implants, capsule contracture, fluid in breasts, rashes, brain fog, depression.I have had depression since the implants and very bad eczema, dry hair and skin and other health symptoms.

• Brand Name: BREAST IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): SIENTRA
• MDR Report Key: 6972064
• MDR Text Key: 90170096
• Report Number: MW5072916
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/22/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 54 YR
• Patient Weight: 64