Description of Event or Problem · 1
RPTR WRITES, "FOR MOST IMPORTANT ATTENTION, REVIEW ATTACHED LETTER TO & FROM ORTHOLOGIC INC CONCERNING BONE STIMULATION'S EFFECTIVENESS. AS YOU REVIEW THESE, ESPECIALLY LETTER BACK FROM ORTHOLOGIC, YOU WILL SEE THAT THEY HAVE EFFECTIVELY ADMITTED THAT THEIR UNIT HAS NO EFFECT ON "NON MAGNETIC" SUBSTANCES. HENCE, SINCE BONE TISSUE IS NON MAGNETIC, I URGE YOUR SCIENTISTS TO REVIEW CLAIMS THAT ORTHOLOGIC HAS MADE TO GAIN APPROVAL FOR THE USE OF THEIR DEVICE. UNIT DID NOT WORK AS PRESCRIBED. REVIEW LETTERS ALSO TO INSURANCE CO. I HAVE DISCUSSED THIS WITH MY PHYSICIANS, ONE M.D. GRADUATE & TWO ORTHOPEDIC SURGEONS. AFTER CONSIDERING "...ELECTROMAGNETIC STIMULATION" CLAIMS MADE BY ORTHOLOGIC, THEY ALL CONCUR THAT "...THERE APPEARS NOT TO BE MUCH SUPPORTING SCIENCE INVOLVED" WITH ORTHOLOGIC CLAIMS. ONE ELECTRICAL ENGINEER WORKING WITHIN MEDICAL FIELD, WHO I ASKED TO REVIEW THIS SCIENCE MADE COMMENT - "...THE ELECTROMAGNETIC CLAIMS FOR EFFECTIVE TREATMENT FOR BONE STIMULATION WOULD BE EQUIVALENT TO RUBBING GROUND UP TIGER CLAWS ON A BALD HEAD TO CURE BALDNESS"! I URGE FDA TO VIGOROUSLY REVIEW CLAIMS BY ORTHOLOGIC INC & SCIENTIFIC & MEDICAL VALUE OF "ELECTROMAGNETICS & BONE STIMULATION." THE PHYSICIANS THAT PRESCRIBE THIS EQUIPMENT HAVE TO RELY ON ADVERTISEMENTS, RARELY DO THEY EXAMINE SCIENCE OF THESE TYPE OF DEVICES, SINCE THEY ARE NOT TRAINED IN THIS SCIENCE DISCIPLINE - ELECTRICAL ENGINEERING. I HAVE HESITATED TO WRITE THIS LETTER DUE TO POSSIBLE INVOLVEMENT WITH ORTHOLOGIC'S LEGALS. HOWEVER I FEEL VERY STRONGLY THAT THIS TECHNOLOGY DOES NOT HAVE SOUND ENGINEERING SCIENCE TO SUPPORT PRODUCT. IN MY OPINION I BELIEVE THAT THIS IS A MEDICAL FRAUD, SINCE ELECTROMAGNETIC FLUX FIELDS DO NOT AFFECT NON-MAGNETIC MATTER. UNIT DID NOT WORK FOR US, HOW COULD IT! IT IS IMPOSSIBLE FOR IT TO HAVE ANY HEALING EFFECT OR STIMULATING VALUE TO NON-MAGNETIC BONE TISSUE. PLEASE DO NOT USE MY NAME IF YOU PURSUE THIS WITH ORTHOLOGIC. I ALSO KNOW THAT AT THE PRESENT TIME THAT YOU ARE REVIEWING THEIR APPLICATION FOR THEIR "SPINALLOGIC" UNIT. IF THESE UNITS DO NOT HAVE A SCIENCE TO SUPPORT & STIMULATE ACTUAL HEALING, THEN THEY SHOULD NOT BE ALLOWED TO BE ON MARKET. IT SIMPLY RUNS UP COSTS OF MEDICAL CARE FOR EVERYONE." RPTR WRITES TO MFR, "DR. (NAME WITHHELD) PRESCRIBED THIS TREATMENT, AS A RESULT OF OUR INSISTENCE. TREATMENT THAT WAS CONTINUED FOR APPROX (7) MONTHS WAS NOT SUCCESSFUL. THEREFORE WE MUST NOW UNDERGO SURGERY TO REJOIN NON-UNION FRACTURE. I SUBMIT FOR YOUR CONSIDERATION THAT WE, IN GOOD FAITH, USED ORTHOLOGIC BONE STIMULATOR, HOPING THAT IT WOULD PRODUCE CURE AS WAS STATED. ALSO WHEN WE PICKED UP STIMULATOR, YOUR REP ASSURED ME THAT ORTHOLOGIC WOULD SETTLE FOR AMOUNT THAT WAS CONTRACTED TO BE PAID BY MY HMO, WHICH WAS $2,240. UNIT WAS RETURNED IN PERFECT CONDITION AS WAS REC'D. WE NOW HAVE BEEN BILLED EXTRA $560. WE DO NOT AGREE, THAT SINCE UNIT FAILED TO PERFORM CURE AS WAS HOPED FROM PRESENTATION THAT WE SHOULD BE SUBJECT TO THIS EXTRA COST, BEING A COST THAT WE WILL HAVE DIFFICULTY. I BELIEVE THAT YOUR REP SHOULD HAVE LOOKED AT X-RAYS THAT SHOW LARGE STAINLESS STEEL PLATE COVERING AREA OF NON-UNION. ALSO HE SHOULD HAVE KNOWN THAT YOUR CO HAD IN YOUR 'R&D', READY FOR RELEASE SINGLE COIL UNIT, SPECIFICALLY DESIGNED FOR TREATMENT OF FRACTURES OF '...LONG BONE OF UPPER ARM, EXTENDING FROM SHOULDER TO ELBOW, & IS SUITABLE FOR TREATING NON-UNION FRACTURES IN MOST AREAS FOR LARGER INDIVIDUALS.' - AS STATED IN YOUR 'SEC 10-Q QUARTERLY REPORT.' IF HE HAD BEEN AWARE OF THIS, AS WELL AS DR, (NAME WITHHELD), IT IS VERY PROBABLE THAT THIS UNIT WOULD NOT HAVE BEEN PRESCRIBED, OR WOULD IT HAVE BEEN APPROVED. I, BEING AN ENGINEER ALSO UNDERSTAND SOMEWHAT, THE FIELD OF MAGNETICS, THE MICROWAVE FREQUENCY & ENERGY FIELD EFFECT AT THIS MICROWATT LEVEL. WE OFFER TO ORTHOLOGIC, ACCESS TO X-RAYS TO USE AS PART OF YOUR 'R&D', TO UNDERSTAND MORE ABOUT HOW STAINLESS STEEL ABSORBS, THIS MICROWATT ENERGY LEVEL AND PERHAPS AFFECTS STIMULATION OF BONE - AS INTENDED. TO ME, IT APPEARS THAT IT IS VERY IMPORTANT TO UNDERSTAND ENERGY LOSSES OF ABSORPTION INTO STAINLESS APPLIANCES AS A PART OF TOTAL ENERGY ABSORPTION. I WILL PERMIT TEMPORARY RELEASE OF RECENT SET OF X-RAYS, CALLED A TOMOGRAM THAT SHOW THAT NOTHING WHATSOEVER HAPPENED, USING ORTHOLOGIC UNIT. THE TREATMENT DID NOT WORK, PERHAPS BECAUSE IT WAS NOT EQUIPPED WITH SINGLE COIL UNIT THAT WAS RECENTLY RELEASED FROM YOUR 'R&D'. ORTHOLOGIC HAS COLLECTED $2,240, AS A RESULT OF OUR GOOD FAITH IN YOUR PRODUCTS HOPEFUL EFFECT ON THIS NON-UNION. I HAVE CALLED YOUR COLLECTION DEPARTMENT, TALKED TO A REP WITHOUT ANY RESPONSE, OTHER THAN SHE WAS MAKING NOTES OF MY REQUEST. I ASK YOU TO DO WHAT IS RIGHT & DIRECT CANCELLATION OF THIS $560 CHARGE AS YOUR PART OF GOOD FAITH WITH YOUR PATIENTS." MFR WRITES TO RPTR, "WE REFERRED YOUR QUESTIONS CONCERNING STEEL PLATE TO ENGINEERING. HE HAS CONCLUDED. "MOST FRACTURE FIXATION PLATES ARE MADE OF 316L STAINLESS STEEL. THIS TYPE OF STAINLESS STEEL IS NON-MAGNETIC & DOES NOT ABSORB NOR DISTORT MAGNETIC FIELDS. THERE ARE MAGNETIC STAINLESS STEEL, HOWEVER, THEY ARE NOT USED FOR IMPLANTATION BECAUSE THEIR CORROSION RESISTANCE IS NOT AS GOOD AS THAT OF 3166 STAINLESS. OTHER MATERIALS USED OCCASIONALLY FOR FRACTURE FIXATION IMPLANTS (TITANIUM ALLOY AND COBALT CHROME ALLOY) ARE ALSO NON-MAGNETIC." THE MAGNETIC FIELD AT FRACTURE SITE IS SAME FOR NEW SINGLE COIL AS IT WAS WITH ORIGINAL OL1000. YOUR INSURANCE APPROVED & SUBSEQUENTLY PAID $2,240.00. PER EXPLANATION FOR BENEFITS ENCLOSED, YOUR BALANCE IS $560.00. WE FEEL THAT WE PROVIDED A SVC FOR YOUR WIFE BASED ON MEDICAL NECESSITY FURNISHED FROM HER PHYSICIAN. WE SHOW THAT YOU SIGNED FOR FINANCIAL RESPONSIBILITY ON 11/21/97. AT THIS TIME, WE FEEL THE $560.00 BALANCE IS NOW YOUR RESPONSIBILITY. WE WOULD BE HAPPY TO SET UP PAYMENT ARRANGEMENTS FOR YOUR CONVENIENCE."