MAUDE Adverse Event Report: ALLERGAN NATRELLE SMOOTH IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Erythema (1840); Hair Loss (1877); Itching Sensation (1943); Pain (1994); Rash (2033); Burning Sensation (2146); Swelling/ Edema (4577)

Event Date 12/09/2015

Event Type  Injury  

Event Description

I had my first breast implants placed approximately 20+ years ago.I have had them replaced over the years due to various reasons.I was diagnosed in (b)(6) 2015 with dcis on the right breast and underwent a right mastectomy with allograft and an allergan tissue expander placed.In 2016, approximately six months later, i had the tissue expander removed and a mentor smooth style ultra high profile implant placed.The mentor implant was not esthetic and i decided to go back to my original plastic surgeon that placed my implants before my cancer diagnosis.We came up with a plan and in 2017 i had the mentor implant removed with fat grafting and a natrelle smooth implant placed.In 2019, i developed pain and severe itching on my right breast, axillary, arm and flank area.The symptoms went away then would come/go with random itching over different areas of my body.The pain continued and i started experiencing severe sweating during the day but especially at night.This was contributed to me getting closer to menopause and thyroid problems.The symptoms continued with what i thought was some hair loss that was contributed to my hypothyroidism.In 2020, a bilateral ultrasound was performed and nothing was noted on the right breast.In (b)(6) 2021, i developed severe midline chest pain with continued right pain in my breast and areas listed above.I went to my internal medicine doctor that ordered a chest x-ray, blood work and referral to a cardiologist.Then i had a nuclear stress test and ultrasound of my heart.All of these tests came back good.The end of (b)(6) 2021, i developed severe burning in my right breast along with redness, a rash, on/off swelling and increased firmness.I went to my plastic surgeon that ordered an mri.The mri came back with nothing suspicious or abnormal noted.Fda safety report id# (b)(4).

• Brand Name: NATRELLE SMOOTH IMPLANT
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 13151858
• MDR Text Key: 283399641
• Report Number: MW5106428
• Device Sequence Number: 3
• Product Code: LCJ
• Combination Product (y/n): N
• 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: 12/30/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: ALLOGRAFT ; LEVOTHYROXINE; MULTI VITAMIN
• Patient Outcome(s): Disability
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White