MAUDE Adverse Event Report: SIENTRA, INC. SIENTRA SILICONE GEL IMPLANTS

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Bacterial Infection (1735); Fatigue (1849); Feeding Problem (1850); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Pain (1994); Raynauds Phenomenon (2034); Scleroderma (2062); Vertigo (2134); Visual Disturbances (2140); Tingling (2171); Arthralgia (2355); Numbness (2415); No Code Available (3191)

Event Date 02/19/2014

Event Type  Injury  

Event Description

Sientra implants on (b)(6) 2014.Since implants i have had biotoxin illness symptoms including but not limited to visual disturbances, vertigo, hair loss, nutritional deficiencies, memory loss, brain fog, pain in joints, migraines, fatigue, reynards syndrome, low ferritin levels, immune system lowered, increase food allergies, scleredema, candida overgrowth, bacterial infections in vagina, cold hands and feet, numb and tingling hands and feet, pain in shoulders, inability to concentrate.

• Brand Name: SIENTRA SILICONE GEL IMPLANTS
• Type of Device: SIENTRA SILICONE GEL IMPLANTS
• Manufacturer (Section D): SIENTRA, INC.
• MDR Report Key: 5445160
• MDR Text Key: 38539559
• Report Number: MW5060252
• Device Sequence Number: 1
• 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: 02/15/2016
• 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?: No
• Device Operator: Health Professional
• Other Device ID Number: 20621-485MP
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 34 YR
• Patient Weight: 63