Description of Event or Problem · 0
ON (B)(6) 2024, I HAD THE OPTILUME PROCEDURE FOR BPH AT (B)(6). THE OPTILUME PROCEDURE FOR BPH WAS APPROVED BY THE FDA THE PREVIOUS OCTOBER. THE ADVERTISEMENT CLAIMED THE PROCEDURE WAS SAFE AND HAD FEW. IF ANY, SIDE EFFECTS, AND THAT HALF OF THE PATIENTS RETURNED TO WORK THE NEXT DAY. NOTHING COULD BE FURTHER FROM THE TRUTH. THE EFFECTS FROM THE PROCEDURE WERE NOTHING SHORT OF A NIGHTMARE. I COULD NOT HAVE RETURNED TO WORK FOR ALMOST SIX MONTHS DUE TO BLEEDING, SEVERE PAIN, LEAKING, AND INABILITY TO VOID. I HAD THE PROCEDURE TO CURE BPH AND GET OFF OF FLOWMAX, BUT THE PROCEDURE HAS NOT EVEN SOLVED THE UNDERLYING ISSUE. I HAD A DOCTOR AT THE (B)(6) DO A CYSTOSCOPY THIS LAST MONDAY, AND SHE FOUND THAT THE OPTILUME PROCEDURE DID NOTHING TO CURE MY BPH. SHE WILL DO A LASER TURP (TRANSURETHRAL RESECTION OF THE PROSTRATE) PROCEDURE ON THE 26TH TO CURE THAT AND THE DAMAGE FROM THE OPTILUME PROCEDURE. WE COULD NOT DO THIS NEW CYSCOSPY UNTIL LAST MONDAY BECAUSE THE PAIN IN MY PROSTATE WAS SO EXTREME FOR HALF A YEAR. THE DOCTORS FELT IT WAS TOO DANGEROUS TO DO THE PROCEDURE DUE TO THE DAMAGE FROM THE OPTILUME PROCEDURE UNTIL THE DAMAGE HAD CALMED DOWN. THIS TOOK HALF A YEAR. THE FDA SHOULD CONSIDER REVOKING THE APPROVAL FOR OPTILUME FOR BPH AS IT IS, IN MY OPINION. EXTREMELY UNSAFE AND DANGEROUS AND DOES NOT CURE OR TREAT THE PROBLEM. IT ALSO CREATES MANY OTHER MEDICAL ISSUES THAT DID NOT EXIST IN THE FIRST PLACE. I WILL BE HAPPY TO DISCUSS THIS WITH YOU AND SHARE ANY AND ALL MEDICAL RECORDS YOU MAY NEED. I DO NOT THINK ANYONE ELSE SHOULD BE SUBJECTED TO THIS DANGEROUS PROCEDURE. YOU SHOULD CONSIDER STOPPING THESE PROCEDURES IN THE U.S. UNTIL FURTHER STUDY IS DONE ON THE SAFETY OF THIS PROCEDURE.