EXOGEN 4000 SYSTEM

Description of Event or Problem

FDA: THE EXOGEN BONE HEALING DEVICE WAS APPROVED BY THE FDA. THE COMPANY ADVERTISE AS IT HAVING NO SIDE EFFECTS. IN MY CASE (AND PROBABLY OTHERS), THIS WAS NOT TRUE. WHEN SPEAKING WITH SOMEONE IN THEIR HEADQUARTERS - THE ONE QUESTION SHE ASKED WAS "HOW MUCH METAL DO YOU HAVE IN YOU" - (I HAVE A QUITE A BIT). I THINK THERE SHOULD BE A WARNING FOR PEOPLE LIKE ME SINCE THIS IS A VERY EXPENSIVE PIECE OF EQUIPMENT. NO WAY WOULD I HAVE INVESTED HAD THIS WARNING BEEN POSTED. BIOVENTURES: TO SAY THE EXOGEN DEVICE HAS NO SIDE EFFECTS IS CERTAINLY NOT TRUE. I EXPERIENCED THE SAME SIDE EFFECTS WITH THE REPLACEMENT AS I DID WITH THE ORIGINAL. ONE MUST TAKE IN THE FACTS OF CHEMISTRY, NERVOUS SYSTEM AND ABOVE ALL, I BELIEVE - THE AMOUNT OF HARD-WARE IN THE BREAK. IN MY CASE, I HAVE A LARGE BOLT-FACER SCREWS AND A ROD UP THE FEMUR. I DESPERATELY WANTED TO USE THE DEVICE AND I TRIED EVERYTHING! LESS TIMING - VARIOUS TIMES OF DAY, ETC. NO MATTER WHAT I TRIED AND I GOT THE SAME RESULTS. LOTS OF PAIN AND A BURNING IN MY WHOLE LEG. SINCE NOT USING IT, I HAVE NOT EXPERIENCED ANY OF THE PAIN. YOU SHOULD WARN BEFORE YOU SELL SUCH AN EXPENSIVE DEVICE.