FDA Adverse Event Injury Summary report: N

SALINE IMPLANTS

MDR report key: 1950773 · Received December 31, 2010

Report

Report Number
MW5018797
Event Type
Injury
Date Received
December 31, 2010
Date of Event
July 1, 2005
Report Date
December 31, 2010
Product Code
FWM
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MA, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

BEGAN TO DEVELOP EXTREME CHRONIC FATIGUE, EXTREME ANXIETY, BRAIN FOG, JOINT PAIN, BIZARRE MUSCLE ACHES/PAIN WHICH WERE UNEXPLAINED AND UNABLE TO BE DIAGNOSED BY MY PHYSICIAN, DEPRESSION, NECK/BACK/CHEST PAIN, SORES IN MY MOUTH, BURNING OF LIPS, INTRACTABLE MIGRAINES. I'M NOT SURE WHAT TYPE OF IMPLANTS OTHER THAN SALINE IMPLANTS WHICH WERE IMPLANTED ON (B)(6) 2004 AND SHORTLY THEREAFTER, I DEVELOPED STRANGE PAIN JUST UNDER THE DELTOID WHICH FELT LIKE TIGHT RUBBER BANDS. AFTER APPROXIMATELY 6 MOS TO 1 YR., I DEVELOPED CHRONIC FATIGUE, MEMORY LOSS, INABILITY TO RECALL WORDS, "BRAIN FOG" AND EXTREME DEPRESSION/ANXIETY. THEREAFTER, MY SYMPTOMS WORSENED AND I DEVELOPED SENSITIVITY TO LIGHT, CONSTANT/DAILY MIGRAINES, SEVERE JOINT PAIN FINGERS/TOES, BACK PAIN/NECK AND CHEST PAIN. BASICALLY, MY LIFE TURNED INTO A LIVING HELL. NO TESTS CAME BACK TO INDICATE ANY DIAGNOSABLE PROBLEM OTHER THAN "CHRONIC FATIGUE" AND AN MRI INDICATED C2-C7 SPINAL CURVATURE AND SOME NERVE IMPINGEMENT. I KNEW, WITHOUT A DOUBT, MY IMPLANTS WERE MAKING ME SICK. I WENT BACK TO MY PS WHO TOLD ME "NO WAY". NO OTHER DOCTOR ACKNOWLEDGES THIS EITHER, BUT THE SXS ARE PRETTY STRANGE AND MY CAREER/LIFE HAS BEEN DEVASTATED. YOU PEOPLE NEED TO KNOW AND ACKNOWLEDGE THESE THINGS ARE CAUSING ILLNESS IN A CERTAIN PROPORTION OF WOMEN. (B)(6). DATES OF USE: (B)(6) 2004 -- (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: BREAST DEFLATION/PTOSIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SALINE IMPLANTS FWM UNK

Patients

Seq Age Sex Outcome Treatment
1 40 YR Other| S