Description of Event or Problem · 1
RE: RESTORE MEDICAL'S PILLAR PROCEDURE. THIS IS AN FDA-APPROVED PROCEDURE USING PLASTIC IMPLANTS TO TREAT OBSTRUCTIVE SLEEP APNEA. I WAS EXAMINED BY AN ENT (WHO WAS RECOMMENDED BY RESTORE MEDICAL) FOR SUITABILITY FOR THIS PROCEDURE. THE ENT AND I BOTH SEPARATELY SPOKE TO RESTORE MEDICAL TO MAKE SURE THIS PROCEDURE WAS SUITABLE FOR SOMEONE WITH MARFAN'S SYNDROME (I HAVE A CONNECTIVE TISSUE DISORDER THAT IS EITHER MARFAN'S SYNDROME OR IS CLOSELY RELATED TO IT...DIFFICULT TO DIAGNOSE). SO, JUST TO BE ON THE SAFE SIDE, WE WANTED TO MAKE SURE THE PROCEDURE WAS SUITABLE FOR MARFANS PTS.- RESTORE MEDICAL SAID YES, THE PROCEDURE WAS SUITABLE. I WAS PERSONALLY ASSURED OVER THE PHONE BY RESTORE MEDICAL'S DIRECTOR OF CLINICAL REGULATIONS. HE TOOK DOWN MY DR'S NAME AND ADDRESS IN ORDER TO SEND HIM A LETTER STATING THIS FACT. MEANWHILE, MY DR (THE ENT) WAS MAKING SIMILAR INQUIRIES OF HIS RESTORE MEDICAL SALES REP. ALL MARFAN'S SYNDROME PATIENTS HAVE HIGH, NARROW ARCHED PALETTES AND "TOO STRETCHY" CONNECTIVE TISSUES. RESTORE MEDICAL NEVER RESPONDED WITH ANY INFORMATION THAT WOULD INDICATE LOWERED EXPECTATIONS OF SUCCESS. THEIR ATTITUDE AND RESPONSES WERE, "NO PROBLEM." MY HEALTH INSURANCE DOES NOT COVER THIS PROCEDURE. I PREPAID OF MY OWN MONEY. OF THE THREE IMPLANTS: ONE IS IN PROPER POSITION. ONE PROTRUDED, HAD TO BE REMOVED AND REINSERTED A WEEK LATER. IT CONTINUES "BUMPING" THE ROOF OF MY MOUTH, NOT QUITE PROTRUDING. THE SITE CAN BE DESCRIBED AS ULCERATED. SOME DAYS, IT SEEMS CLOSER TO A TRUE EXTRUSION AND SOME DAYS, IT SEEMS TO BE GOING BACK IN. CLEARLY, IT IS NOT "SETTLED." THE THIRD INSERT HAS MIGRATED DOWNWARD TO JUST BESIDE MY UVULA. I CANNOT DISCUSS THIS WITH RESTORE MEDICAL BECAUSE I CAN'T GET ANYONE BUT MARKETING PEOPLE ON THE PHONE. THEY HAVE ONE DR WHO IS ONLY IN THE OFFICE ONE DAY A WEEK AND WHO HAS HIS OWN CASELOADS TO DEAL WITH. HE HAS NOT CALLED ME BACK. MY OWN ENT HAS NO IDEA IF THE MIGRATED IMPLANT IS PROBLEMATIC OR NOT. I AM ONLY HIS SECOND PILLAR PROCEDURE PT. MY SLEEP APNEA HAS NOT ABATED ANY AT ALL. I CANNOT HELP BUT THINK THAT IMPLANT THAT IS NOW DOWN BY MY UVULA MUST BE COMPLETELY USELESS; HOW CAN MY SLEEP APNEA BE RESOLVED IF THE IMPLANT IS NOT EVEN IN THE PROPER LOCATION? I CAN'T GET ANYONE TO TELL ME IF THAT IMPLANT SHOULD BE REMOVED. I HATE TO KEEP STARTING THIS PROCESS OVER AGAIN. I GUESS THERE'S A POSSIBILITY THAT THE ENT COULD BE INSTALLING THE IMPLANT INCORRECTLY BUT THERE'S NO ONE AT RESTORE MEDICAL WHO WILL HELP ME FIGURE THIS OUT. I THINK RESTORE MEDICAL HAS A "HELLUVA" MARKETING EFFORT WITHOUT THE MEDICAL SUPPORT ITS PTS NEED. I WONDER IF DIR OF CLINICAL REGULATIONS WHO PERSONALLY TOLD ME THAT THIS PROCEDURE WAS SUITABLE FOR MARFAN'S SYNDROME PTS, EVEN KNOWS WHAT MARFAN'S SYNDROME IS OR HOW IT COULD POSSIBLY AFFECT THE DESIRED OUTCOME OF THE PROCEDURE. THIS PROCEDURE IS MARKETED AS A ONE-TIME OFFICE VISIT. I MUST DRIVE 5 HOURS ROUND-TRIP FOR EACH OFFICE VISIT. I HAVE BEEN TO THE ENT'S OFFICE 5 TIMES SO FAR: EVAL -12/05-, PROCEDURE 2006-, REMOVAL OF PROTRUDING IMPLANT -2006-, INSERTION OF REPLACEMENT IMPLANT -2006-, AND FOLLOW-UP TO CHECK ON STATUS OF MIGRATED IMPLANT AND ULCERATED SITE OF REPLACEMENT IMPLANT AND AN ULCERATED SITE 2006-. YET I STILL HAVE NO SIGN OF ABATEMENT IN SLEEP APNEA. I STILL HAVE A MIGRATED IMPLANT AND AN ULCERATED SITE. I'M GETTING NOWWHERE. OF COURSE, YOU HAVE TO SIGN A FORM THAT STATES THAT EVERTYHING IN THE WORLD CAN GO WRONG AND I QUESS THIS LEGALLY LETS RESTORE MEDICAL OFF THE HOOK. BUT I AM AMAZED THAT THE MFR OF A HIGHLY TOUTED MEDICAL DEVICE DOES NOT HAVE ANY TRAINED MEDICAL PERSONNEL ON STAFF TO ANSWER PT QUESTIONS, AND I AM HORRIFIED TO THINK THAT I WAS ASSURED BY SOMEONE WHOM I THOUGHT WAS MEDICALLY KNOWLEDGEABLE. (IT WAS TRANSFERRED TO THEM WHEN I CALLED RESTORE MEDICAL AND ASKED TO SPEAK TO SOMEONE WHO COULD ANSWER MEDICAL QUESTIONS ABOUT THE PROCEDURE) AND WAS ASSURED BY THIS INDIVIDUAL THAT MARFAN'S SYNDROME WAS NOT A CONCERN. YET IT MAY VERY WELL BE THE EXACT REASON WHY THIS PROCEDURE HAS BEEN NOTHING BUT A FAILURE FOR ME. AN HONEST AND KNOWLEDGEABLE ANSWER TO MY PRE-PROCEDURE QUESTION COULD HAVE SAVED ME THE MONEY, 25 HRS OF DRIVING -GAS MONEY!- AS WELL AS TIME SPENT AT APPOINTMENTS, NOT TO MENTION SOME PERSONAL PAIN AND DISCOMFORT. I COULD HAVE FOREGONE HAVING THE PILLAR PROCEDURE DONE...MY SLEEP APNEA REMAINS UNCHANGED, ANYWAY. SOMEONE NEEDS TO BE AWARE OF RESTORE MEDICAL'S UNETHICAL CONDUCT. I THINK THEY DID NOT HELP EVALUATE MY CASE USING MEDICALLY SOUND INFORMATION; I THINK THEY WERE JUST GREEDY AND MADE ANOTHER SALE. THE TRUTH NEEDS TO BE KNOWN ABOUT THIS BIG MARKETING PLOY WITH LITTLE OR NO MEDICAL SUPPORT FOR ITS PTS AND THE LACK OF THE SOUND INFORMATION FOR PROSPECTIVE PTS WHO WANT TO MAKE AN INFORMED DECISION.