MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

Device Problem Material Rupture (1546)

Patient Problems Arthritis (1723); Inflammation (1932); Lupus (1956); Pain (1994); Complaint, Ill-Defined (2331); Disability (2371); Ambulation Difficulties (2544)

Event Date 11/05/2015

Event Type  Injury  

Event Description

Had mammogram at (b)(6) hospital and became very ill within 3 weeks.I had silicone breast implants and had no idea they both got ruptured.I started in (b)(6) going to doctor.Unable to walk.Severe pain in feet.Many test to follow.Was sent to podiatrist and rheumatologist.Was immediately put on meloxicam for inflammation.Tested positive ana for possible lupus.Had many blood test and i have all of the results.As of(b)(6) i no longer was able to work.Diagnosed with mid foot osteoarthritis and surgery was suggested.I was also diagnosed with lower back osteoarthritis and in (b)(6) with fibro.I applied for social security disability and as approved.I did not correlate the breast implants till approx (b)(6).I requested an mri and it was shown both implants were ruptured.Then upon investigating, i found that all of my symptoms were related to silicone poisoning due to ruptured implants.I got so sick so fast and did not know why.Since the removal of the implants, i have had 2 add'l reconstruction surgeries including a latissimus flap.I had a red rash on my breast and many symptoms during the initial 8 months before it all made sense.I have pictures, notes and many bills.The hospital has denied the mammogram caused the rupture but both at the same time is so obvious.The implants were silicone made by mentor 600cc.

• Brand Name: BREAST IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7002916
• MDR Text Key: 91213350
• Report Number: MW5073144
• Device Sequence Number: 3
• Product Code: FTR
• 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: 11/02/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Weight: 61