MAUDE Adverse Event Report: MENTOR SILICONE IMPLANT

Device Problem Burst Container or Vessel (1074)

Patient Problems Rash (2033); Complaint, Ill-Defined (2331); Foreign Body In Patient (2687); Cancer (3262)

Event Date 05/20/2005

Event Type  Injury  

Event Description

I had 220 cc silicone breast implants and their capsule, which were implanted in 1987, burst during a routine mammogram.I had informed the technician that i had them.Within 3 hours of the mammogram i felt very ill, and had hives on my torso.I went to the er, where they weren't sure what was wrong and gave me antibiotics, which had no effect.I was acutely ill for several months, until the physician who had ordered the mammogram phoned me that something was peculiar on the mammogram film.I hadn't been contacted for several months because the breast tissue itself looked normal.The mammogram film showed the bursting of the implant.I contacted a plastic surgeon at (b)(6), and scheduled an explant.At this point, it had been about 9 months of sustained acute illness.The plastic surgeon at (b)(6), removed the implant material by opening up what was left of the capsules rather than using the en bloc method, which is now standard.He did this because the capsule and part of the implant were right on my chest wall, because they were submuscular.I did not get well after the surgery, although he was able to take out 130 ccs of material on one side and 210 ccs on the other.I finally found a surgeon who could explain why i was still acutely ill, and she was able to remove the remaining capsule and silicone, which she was able to find.Most of the missing silicone was never accounted for, though.I started to feel better after that surgery.It has been a year of feeling acutely ill.Then in 2011, i was diagnosed with a rare blood cancer.Polycythemia vera rubra.I am being treated for this currently.

• Brand Name: SILICONE IMPLANT
• Type of Device: SILICONE IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6435876
• MDR Text Key: 71032344
• Report Number: MW5068667
• Device Sequence Number: 2
• 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: 03/23/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81 MG DAILY; COQ10; FISH OIL; OTC MEDS: PROBIOTICS; RX MEDS: PEGASYS 45 MCG/WEEKLY; VITAMIN D
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 56 YR
• Patient Weight: 55