MENTOR COHESIVE GEL SILICONE BREAST IMPLANT
Received Oct 16, 2018 · Event occurred Sep 6, 2018
Report MW5080605 · MDR key 7973536
Device
Generic name
Prosthesis, Breast, Non Inflatable, Internal Silicone
Manufacturer
MentorModel number
6736575-003Catalog number
18006368678
Lot number
259980
Product problems
- Patient-Device Incompatibility
Patient
28 YR
- Capsular Contracture
- Chest Pain
- Dyspnea
- Edema
- Fatigue
- Headache
- Heartburn/Indigestion
- Inflammation
- Pain
- Renal Failure
- Tachycardia
- Thrombus
- Vertigo
- Visual Disturbances
- Vomiting
- Tingling
- Dizziness
- Heart Failure
- Anxiety
- Arthralgia
- Depression
- Numbness
- Palpitations
- Shaking/Tremors
- Sleep Dysfunction
- Abdominal Distention
- Capsular Contracture
- Chest Pain
- Dyspnea
- Edema
- Fatigue
- Headache
- Heartburn/Indigestion
- Inflammation
- Pain
- Renal Failure
- Tachycardia
- Thrombus
- Vertigo
- Visual Disturbances
- Vomiting
- Tingling
- Dizziness
- Heart Failure
- Anxiety
- Arthralgia
- Depression
- Numbness
- Palpitations
- Shaking/Tremors
- Sleep Dysfunction
- Abdominal Distention
Narrative
Description of Event or Problem
IMPLANT RUPTURED TOTALLY LIQUID IN MY CHEST CAVITY. OTHER SIDE HAD GRADE 4 CAPSULAR CONTRACTURE. HAD ONLY BEEN IN 6 YRS. I'VE NOW HAD 3 SURGERIES. NOW GETTING A LIVER BIOPSY FOR AN UNSPECIFIED TUMOR. CANNOT WORK 40+ SYMPTOMS INCLUDING HEART FAILURE/TACHYCARDIA. LIVER TUMOR, H. PYLORI, TACHYCARDIA, HEART PALPITATION, CHRONIC FATIGUE, BRAIN FOG, DIZZINESS, FAINTING, TREMORS, DEPRESSION, AND PTSD, SUICIDAL THOUGHTS, ACID REFLUX, HEARTBURN, MIGRAINES CHEST PAIN, VOMITING BLACK STOOL, KIDNEY FAILURE, VISION PROBLEMS, ELECTRIC SHOCKS THROUGHOUT MY BRAIN, HIGH BLOOD PRESSURE, DYSPNEA, BLOATING, UPPER RIGHT ABDOMINAL PAIN, BREAST PAIN, BREAST NUMBNESS, BREAST TINGLING, ARMPIT PAIN, BACK PAIN, SHOULDER PAIN, LEG TREMORS, EDEMA, BLOOD CLOTS, JOINT PAIN, CHRONIC INFLAMMATION, ELEVATED WHITE BLOOD CELLS, HIGH SEDIMENTARY RATE, ELEVATED LIVER ENZYMES, INSOMNIA, ANXIETY, PAIN, FLUID RETENTION.