MAUDE Adverse Event Report: SIENTRA SILICONE BREAST IMPLANTS

Model Number 10621-385MP

Device Problem Insufficient Information (3190)

Patient Problems Capsular Contracture (1761); Chest Pain (1776); Fatigue (1849); Headache (1880); Muscle Spasm(s) (1966); Muscle Weakness (1967); Pain (1994); Red Eye(s) (2038); Swelling (2091); Swollen Lymph Nodes (2093); Burning Sensation (2146); Anxiety (2328); Toxicity (2333); Neck Pain (2433)

Event Date 01/22/2015

Event Type  Injury  

Event Description

I had sientra implants on (b)(6) 2015.After getting my implants in, the next day my face was swollen.I had real bad thrush.I couldn't even swallow.It burned all the way down my throat.My iron was really low.I had chest pains shooting to my back on my left side for the whole time period i had my implants in which was 10.5 months.As the weeks went by, i had upper back pain.After two months, i began having capsular contracture on both boobs especially my left.By the third month my surgeon said yes i did have capsular contracture.I had grade iv capsular contracture by the fifth month of having my implants in.I was sent to the emergency room for sharp intense pain in my mid level back, which they took ct scan.They said they didn't see anything and kept me in the hospital over night.I have been to e.R.Several times over sharp pains in my back i have had fatigue, exhaustion, anxiety, sore muscles, weak muscles, joint pains, tension headaches, locked up arm on my left side, muscle cramps throughout my body, red painful eyes, muscle burning on my ankle and wrist, neck pain.I was told by my primary doctor i had chronic pain all over my body, fibromyalgia, unusual large lymph nodes under my arm pits, which were very tender, my chest felt heavy, hard to breathe.

• Brand Name: SILICONE BREAST IMPLANTS
• Type of Device: SILICONE BREAST IMPLANTS
• Manufacturer (Section D): SIENTRA
• MDR Report Key: 5396776
• MDR Text Key: 37083858
• Report Number: MW5059723
• 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: 01/21/2016
• 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
• Device Model Number: 10621-385MP
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 40 YR
• Patient Weight: 61