MAUDE Adverse Event Report: SIENTRA SIENTRA BREAST IMPLANTS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Hair Loss (1877); Memory Loss/Impairment (1958); Blurred Vision (2137); Complaint, Ill-Defined (2331); Joint Disorder (2373); Sleep Dysfunction (2517); Cognitive Changes (2551)

Event Date 09/01/2016

Event Type  Injury  

Event Description

Breast implants, sientra making me ill.Hair loss, fatigue, memory loss, brain fog, blurry vision, joint pain, and sleep disturbance.

• Brand Name: SIENTRA BREAST IMPLANTS
• Type of Device: SIENTRA BREAST IMPLANTS
• Manufacturer (Section D): SIENTRA
• MDR Report Key: 6232513
• MDR Text Key: 64262860
• Report Number: MW5067097
• 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: 01/05/2017
• 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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 34 YR
• Patient Weight: 54