MAUDE Adverse Event Report: SIENTRA IMPLANTS; BREAST IMPLANT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Capsular Contracture (1761); Chest Pain (1776); Dyspnea (1816); Erythema (1840); Extreme Exhaustion (1843); Fatigue (1849); Inflammation (1932); Pain (1994); Rash (2033); Red Eye(s) (2038); Swelling (2091); Weakness (2145); Burning Sensation (2146); Phototoxicity (2165); Myalgia (2238); Arthralgia (2355); Deformity/ Disfigurement (2360); Disability (2371); Sore Throat (2396); Fungal Infection (2419); Neck Pain (2433)

Event Date 12/17/2015

Event Type  Injury  

Event Description

After implants in (b)(6) 2015 my health started going downhill.Right after implants i had severe thrush, throat burned very bad.I could not eat without having very bad pain in throat.I had very bad, sharp, shooting pains in my left side of chest which shot to my back side immediately after implants put in.The sharp pains did not go away.Face swollen the very next day after implants put in.Immediately had back, spine pain, lower back pain, shoulder pain, upper back pain after implants put in, in (b)(6) of 2015.Two months after implants put in i had capsular contractions in both breasts from implants.Still sharp pains shooting from left breast to my left side of back.Upper back pains even more at this time, "misformed" shaped breast.Now was getting neck pains.Three and a half months after implants i now have eye pains in both eyes, breast getting more uneven shaped.Six months after implants in, very hard to breathe at times.I now have joint and muscle pains throughout my body, in my feet, calves, hands, back, neck, shoulders, inflamed lymph nodes under my armpits.Still shooting pains from left breast to my left back.By nine months out, i am very weak, fatigued, exhausted, can barely work at my job.At 10 months i am now getting burning, inflamed, red spots/patches throughout body, so painful it feels like i had sprained a body part.Eyes blood shot red and in pain and very sensitive to light.

• Brand Name: IMPLANTS
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): SIENTRA
• MDR Report Key: 5319715
• MDR Text Key: 34239661
• Report Number: MW5058657
• 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: 12/17/2015
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 40 YR
• Patient Weight: 60