inforMED
InjuryFAF

*

Received Sep 22, 2003 · Event occurred Apr 1, 1990

Report MW1029803 · MDR key 490703

Device

Generic name

Solid Silicone Testicular Device

Manufacturer

Mentor

Model number

*

Catalog number

*

Lot number

*

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.