MENTOR GUMMY BREAST IMPLANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-13 for MENTOR GUMMY BREAST IMPLANT manufactured by Mentor.

Event Text Entries

[136807215] I am a breast cancer survivor. I have had 2 exchange surgeries and many issues over the last 9 years. In april i will be having these implants removed and do a flap procedure for my reconstruction. This has been an emotional choice to make as it is like having a mastectomy for the second time. I did well for a while after my expanders were removed and the saline implant put in. Two years later we found a lump and went in to look at it. During the surgery we went to the mentor gummy implant. In just a few months my energy started to diminish, i went from being able to climb 3 flights of stairs with camera gear and school books in toe, to not being able to climb 3 flights of stairs without anything. My joints started to ache like never before, leading to a knee surgery and months of walking with a cane. I have had zaps in my brain, dizzy spells and horrible issues thinking and doing even the smallest tasks. These issues have led to brain scans, tests with contrast and a lot of stress on my already exhausted body. In 2015, we found a rupture of the left implant. I have spent the last 3 years fighting with insurance, out of pocket and doctors not thinking it is a big deal to get this defective implant out of me. I have pain and swelling around to left (ruptured) implant that has made it so i wear compression garments or a large ace wrap most of the time. I have no energy. I went from a woman who could take care of a family of 5 or more to not being able to care for just me. Shopping for the basic needs has become exhausting for me. My vision is deteriorating at a fast pace. I had 20/20 before implants. I have days when i can't get out of bed for the pain and pure exhaustion i feel. I am having issues with my kidneys, bladder and digestive track. Again lots of test and no answers. Everything i am experiencing is inflammatory or autoimmune. And since the rupture my symptoms have escalated. Including trips to the er for chest and breathing issues. I am to the point that i feel like the money is wasted. My primary doctor is holding further testing until we get the implants out and can fully assess the impact on my life.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5084042
• MDR Report Key: 8339462
• Date Received: 2019-02-13
• Date of Report: 2019-02-12
• Date Added to Maude: 2019-02-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: MENTOR GUMMY BREAST IMPLANT
• Generic Name: SIZER, MAMMARY, BREAST IMPLANT
• Product Code: MRD
• Date Received: 2019-02-13
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MENTOR

Device Sequence Number: 2

• Brand Name: MENTOR GUMMY BREAST IMPLANT
• Generic Name: SIZER, MAMMARY, BREAST IMPLANT
• Product Code: MRD
• Date Received: 2019-02-13
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MENTOR

Device Sequence Number: 3

• Brand Name: EXPANDERS
• Generic Name: EXPANDER, SKIN, INFLATABLE
• Product Code: LCJ
• Date Received: 2019-02-13
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: UNKNOWN

Device Sequence Number: 4

• Brand Name: EXPANDERS
• Generic Name: EXPANDER, SKIN, INFLATABLE
• Product Code: LCJ
• Date Received: 2019-02-13
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: UNKNOWN

Device Sequence Number: 5

• Brand Name: SALINE IMPLANTS
• Generic Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Product Code: FWM
• Date Received: 2019-02-13
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: UNKNOWN

Device Sequence Number: 6

• Brand Name: SALINE IMPLANTS
• Generic Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Product Code: FWM
• Date Received: 2019-02-13
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: UNKNOWN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Deathisabilit	2019-02-13