FDA Adverse Event Injury Summary report: N

TEXTURED SALINE (SILICONE SHELL BREAST IMPLANTS)

MDR report key: 8510977 · Received April 11, 2019

Report

Report Number
MW5085831
Event Type
Injury
Date Received
April 11, 2019
Date of Event
January 1, 1995
Report Date
April 9, 2019
Manufacturer
MCGHAN MEDICAL CORPORATION / ALLERGAN
Product Code
FTR
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
RI, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

FOUND OUT THAT MY BREAST IMPLANTS WERE LINKED TO A RISK OF: BREAST IMPLANT ASSOCIATED - ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL) AND CHRONIC SYMPTOMS OF BREAST IMPLANT ILLNESS (BII) - BREAST PAIN. BREAST AUGMENT 1995 WITH MCGHAN TEXTURED IMPLANTS (BIA-ALCL RISK). I HAVE SEVERE PAIN ACROSS UNDER IMPLANTS ESP., RIGHT, JUST BEGINNING IN LEFT. ALSO, SHARP PAIN IN RIGHT NIPPLE. THESE IMPLANTS SOMETIMES GET A BURNING PAIN AND FEEL HOT. AUTO IMMUNE INFLAMMATION ISSUES? TESTING? ARMPIT PAIN ESP, RIGHT SIDE BUT, LESS OFTEN AND PAINFUL ON LEFT SIDE. IT IS A HARD STRONG TIGHT PAIN IN ARMPIT, CUT OFF CIRCULATION? RADIATES INTO SHOULDER AND DOWN RIGHT ARM WITH NUMBNESS, TINGLING AND PAIN DOWN ARM TO WRIST AND HANDS. MY HAND STAYS COLD FOR HOURS (NOW SOMETIMES MY RIGHT FOOT TOO). PHYSICAL THERAPY MANY TIMES, BUT UNRESOLVED. NUMBNESS TINGLING DOWN BOTH LEGS TO FEET ESP., RIGHT SIDE; JUST BEGINNING ON LEFT SIDE. MY FEET STAY BURNING COLD EVEN WITH HEAT. HAND PAIN I HAVE TO STRETCH THEM HARD AND HOLD THE STRETCH, VERY MINIMAL RELIEF, SWOLLEN LYMPH NODE-GROIN (13 SIZE BY ULTRASOUND) RASH. FROM (B)(6) 2019 - PRESENT, NUMBNESS, TINGLING, ESP., RIGHT SIDE. STOMACH PAIN LOWER BELOW NAVEL AND ESP., UPPER W/ NAUSEA (HAND WIDE BAND UNDER CHEST, ABOVE WAIST). STOPPED WEARING JEANS BELTED PAINTS BUT PAIN CONTINUES. SKIN CYSTS (WOULD LIKE THEM TESTED FOR ALCL). SKIN BURNING, ITCHING AND CRAWLING. RED BLOOD SPOTS- TELANGIECTASIAS ON MY BREASTS, TORSO BELLY RAYNAUD'S- WOULD LIKE TESTING. OSTEOPOROSIS SEVERE EARLY ONSET, CHRONIC INFLAMMATION MY "Z" SCORE OF -2.2 IS EARLY ONSET (OUTSIDE THE NORM OF OTHER WOMEN MY AGE). FURTHER TESTING IS WARRANTED. FATIGUE INCAPACITATING SUDDEN, RANDOMLY DURING THE DAY OVERTAKEN AND NEED TO FALL INTO DEEPEST SLEEP, "FALL TO DEATH", HAIR LOSS, VERTIGO - SEVERE BOUT IN 2012 SENT ME TO THE EYE DR, UNRESOLVED. MILD BOUTS CONTINUING ALLERGIC REACTIONS, RANDOM, ITCHY EYES, LIDS SKIN. SWOLLEN LIPS, TONGUE AT WORST THROAT CLOSES UP AND CHEST PAIN, BACK PAIN - CENTER BETWEEN SHOULDER BLADES AND LOWER BACK MUSCLE PAIN, JOINT PAIN, LEGS, ESP., FRONT OF THIGHS CALVES AND ANKLES AND FEET (MASSAGE HELPS SOME). I USUALLY HAVE TO GO TO BED JUST BECAUSE OF LEG PAIN (USE HEATING BLANKET). NECK PAIN, VISION LOSS, BLURRY DOUBLE VISION, DULL GRAY BLOODSHOT EYES, HEARING LOSS, TESTED / DR (B)(6), TINNITUS, SEVERE BOUTS- VERY LOUD; DIFFICULTY SWALLOWING, FEELS LIKE SLUGGISH, PARALYZED "SWALLOWER", FOOT GETS STUCK. SOMETIMES EVEN A SMALL MEAL SEEMS TO "BACK UP" CAN'T ENTER MY STOMACH, COUGH UNUSUAL, RANDOM COUGH NOT CONNECTED TO COLD ETC., ALSO OFTEN UNUSUAL BOUT OF COUGH AFTER EATING. HEARTBURN, OCCASIONAL BOUTS WITH REGURGITATION, LOW VITAMIN D (EVEN THOUGH IT CAME UP IN SUMMER AND I EAT A VERY HEALTHY DIET, LOW ALKALINE PHOSPHATE (WOULD LIKE FURTHER TESTING - CELIAC?), LOW B12, LOW ZINC, CELIAC SYMPTOMS, ENDOCRINOLOGIST - TESTING, KIDNEY CYSTS, PAIN W/ BOUTS OF FREQUENT URINATION (5 TIMES DURING SLEEP). FURTHER TESTING? LIVER CYSTS; HEMANGIOMA, ARTERIOVENOUS MALFORMATION, HEADACHES 3 DAY, HEADACHES (MINIMAL HELP FROM MEDICAL MARIJUANA, HEAT PAD AND TYLENOL) COGNITIVE, MEMORY LOSS; DISABILITY, LOSS OF CONCENTRATION, NUMBERS, CONNECTING THOUGHTS SINCE 2002. PREMATURE AGING, SEVERE LOSS OF COLLAGEN IN SKIN, SEVER DRY SKIN ESP., THIGHS DECREASED LIBIDO, IRRITABLE BOWEL SYNDROME, TEETH UNUSUALLY SOFT AND WORN DOWN. PAIN, LOSS, CROWDING ((B)(6) ORTHODONTIST, UNUSUAL TEETH - NEVER SEEN TEETH AS WORN DOWN AS MINE; EVEN IN MEN WITH GRINDING ISSUES). PALPITATIONS, CHEST PAIN, ANXIETY, SHORTNESS OF BREATH, INSOMNIA, DIFFICULT BOUTS. FDA SAFETY REPORT ID# (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
300559 TEXTURED SALINE (SILICONE SHELL BREAST IMPLANTS) PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR MCGHAN MEDICAL CORPORATION / ALLERGAN HA9381/2
300560 TEXTURED SALINE (SILICONE SHELL BREAST IMPLANTS) PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR MCGHAN MEDICAL CORPORATION / ALLERGAN

Patients

Seq Age Sex Outcome Treatment
1 60 YR Life Threatening| R| S