MAUDE Adverse Event Report: MENTOR SMOOTH ROUND HIGH PROFILE GEL

Model Number REF 350-3254BC

Device Problems Material Disintegration (1177); Migration or Expulsion of Device (1395)

Patient Problems Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 05/24/2017

Event Type  Injury  

Event Description

My right mentor high profile silicone breast implant shell has completely disintegrated, implanted in 2012.Have heavy metal toxicity and silicone has been found in my lymphnodes of my left armpit and chest wall.No tear or rupture was noted over the years so doctors did not know was diagnosed with lupus in 2015 and have been on thousands of dollars worth of medication the whole time.I asked doctors if it could be my implant and they told me, "no.The fda say they are safe." waiting for scheduled explant and lymphadenotomy when i will be hospitalized.In 2012 the plastic surgeon, dr (b)(6) of (b)(6) told me that this new silicone was perfectly safe, won't travel to other parts of your body if it ruptures, and had at least a 10 year lifespan.Only need to get an mri if you suspect a rupture or feel contracture.I'm disappointed that the fda allowed mentor to complete their own studies and so easily allowed them back on the market after only 3 years so that this implant company and plastic surgeons could make money.This is five years of my life i can't get back.Five years of being sick.Five years of medicating my body when it was trying to say please get these out of me.Please take these off the market.At least make every day doctors like rheumatologists aware that this is happening, and what can happen if they don't treat it right away.I know many, many(over (b)(6)) women suffering with this same situation.

• Brand Name: SMOOTH ROUND HIGH PROFILE GEL
• Type of Device: SMOOTH ROUND HIGH PROFILE GEL
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6607484
• MDR Text Key: 76662528
• Report Number: MW5070143
• 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: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: REF 350-3254BC
• Device Lot Number: 6496948
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 39 YR
• Patient Weight: 62