MAUDE MDR 8339462

MDR report key
8339462
Report number
MW5084042
Event key
0
Event type
3
Date received
2019-02-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MENTOR GUMMY BREAST IMPLANTSIZER, MAMMARY, BREAST IMPLANTMENTORMRDI Y
2MENTOR GUMMY BREAST IMPLANTSIZER, MAMMARY, BREAST IMPLANTMENTORMRDI Y
3EXPANDERSEXPANDER, SKIN, INFLATABLEUNKNOWNLCJI Y
4EXPANDERSEXPANDER, SKIN, INFLATABLEUNKNOWNLCJI Y
5SALINE IMPLANTSPROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINEUNKNOWNFWMI Y
6SALINE IMPLANTSPROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINEUNKNOWNFWMI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-02-1301. H; 2. O; 3. S

Event Narratives#

D

Patient 1

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.