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Received Sep 22, 2003 · Event occurred Apr 1, 1990
Report MW1029803 · MDR key 490703
Device
Product problems
- Explanted
Patient
24 YR
- Fatigue
- Muscle Weakness/Atrophy
- Myalgia
- Disability
- Treatment with medication(s)
Narrative
Description of Event or Problem
PT RECEIVED A SILICONE TESTICULAR DEVICE AFTER APPARENTLY SUCCESSFUL REMOVAL OF A TESTICULAR TUMOR. A YEAR LATER THEY BEGAN TO HAVE MYALGIAS AND TRANSIENT MUSCULAR WEAKNESS BOTH OF WHICH HAVE CONTINUED TO DATE AND WHICH BECAME WORSE AND MORE WIDESPREAD, TO THE POINT OF HAVING TO GIVE UP THEIR GOAL OF LONG DISTANCE RUNNING. THERE IS NO FAMILY HISTORY OF MUSCLE DISEASE. THE DEVICE WAS REMOVED IN 1994 WITH ONLY TEMPORARY RELIEF OF THEIR PROGRESSIVE DISABILITY. THE DIAGNOSIS OF ERYTHROMELALGIA WAS CONSIDERED (ARCH.DERMATOL, 136:330-336, 2000] IN ADDITION TO SILICONE TOXICITY [J.NUTRI.ENVIRON.MED.12:101-106,2002]. PT HAS RESPONDED TEMPORARILY TO HIGH DOSES OF INOSITOL AND SHORT TERM COURSES OF HYDROXY-CHLOROQUINE, THE LATTER POSSIBLY BUT NOT YET PROVEN TO HAVE BEEN THE REASON FOR A SKIN RASH IN JUNE 2003, PROMPTING STOPPING THE DRUG. SEVERE FATIGUE PERSISTS.