Description of Event or Problem · 0
ON (B)(6) 2025 I RECEIVED UROLIFT SURGICAL IMPLANTS TO PROVIDE RELIEF FROM EFFECTS OF BENIGN PROSTATIC HYPERPLASIA. ON (B)(6) 2025 I WAS AT A MEDICAL LABORATORY PROVIDING A URINE SPECIMEN ORDERED BY MY NEPHROLOGIST (UNRELATED). I VOIDED TO FILL THE SPECIMEN CUP, THEN REDIRECTED TO THE TOILET. I FELT SOMETHING MOVING IN THE URETHRA, AND DURING THE STREAM NOTICED A FLASH OF METAL FOLLOW THE STREAM INTO THE TOILET BOWL. I ASKED THE TECHNICIAN FOR A GLOVE AND CLEAN SPECIMEN JAR, DONNED THE GLOVE AND RETRIEVED THE METAL OBJECT AND PLACED IT INTO THE JAR. THE METAL OBJECT WAS APPROXIMATELY 8MM LONG, APPROXIMATELY 2MM WIDE, AND ABOUT .25MM THICK, WITH A TAPERED SLOT APPROXIMATELY .3MM WIDE AXIALLY DISPLACED FROM ONE END APPROXIMATELY 4MM LONG. THE MATERIAL APPEARED TO BE SOME SORT OF ELECTROPOLISHED STAINLESS STEEL ALLOY (POSSIBLY AUSTENITIC), TITANIUM, OR NITINOL. THERE WAS NO VISIBLE EVIDENCE OF ANY OTHER REMNANT OF THE SUTURE ATTACHED TO THE OBJECT. I TOOK CELLPHONE PICTURES OF THE OBJECT IN THE TOILET BOWL AND THRU THE BOTTOM OF THE TRANSPARENT JAR. HAVING REVIEWED THE UROLIFT BROCHURE PROVIDED BY MY UROLOGIST PRIOR TO THE PROCEDURE, THE OBJECT WAS RECOGNIZABLE AS AN ANCHOR (TERMINAL HARDWARE OF THE UROLIFT IMPLANT) THAT SHOULD EXIST IN THE URETHRA AGAINST THE URETHRA WALL ATTACHED TO THE POLYMER SUTURE HOLDING THE URETHRA OPEN AGAINST THE PROSTATE SHELL. THERE WERE NO OTHER OBJECTS VISIBLE IN THE STREAM, IN THE SPECIMEN CUP, IN THE TOILET BOWL, OR IN THE JAR. AS I WAS LESS THAN THIRTY MINUTES FROM THE UROLOGIST'S OFFICE, I CALLED AND DESCRIBED MY FINDINGS. 1 ASKED TO TALK WITH THE DOCTOR, WAS DIRECTED TO THE OFFICE MANAGER AND AGAIN DESCRIBED FINDINGS. THE OFFICE MANAGER RELATED THAT, "WE SEE THIS OCCASIONALLY" AND "L TALKED WITH THE DR. AND YOU HAVE NOTHING TO WORRY ABOUT, HE SAYS HE PUT EXTRAS IN." I DETERMINED TO SEE THE DR. AND SAID I WOULD BE AT THE OFFICE WITHIN THIRTY MINUTES FOR SUCH A DISCUSSION. ARRIVING AT THE OFFICE, CHECKIN DIRECTED ME TO WAIT FOR THE OFFICE MANAGER. I PRESENTED THE JAR CONTAINING ANCHOR AND ASKED IF THE REMNANT BROKEN IMPLANT WAS GOING TO BE A PROBLEM, WORK LOOSE UNCONTAINED IN MY ABDOMINAL CAVITY, CAUSE AN INFECTION, PIERCE BLADDER OR BOWEL. ALL ANSWERS WERE "NO." SHE SAID THE DR. WOULD CALL ME LATER IN THE AFTERNOON TO DISCUSS. THE OFFICE MANAGER CALLED LATER IN THE AFTERNOON REITERATING THE SAME ANSWERS. I HAD ALREADY SCHEDULED A 6-WEEK FOLLOW UP OFFICE VISIT FOR (B)(6), AND SO CONCEDED TO MAKE FIRST DIRECT CONTACT WITH THE DR. THEN. THE OFFICE MANAGER SAID SHE WOULD GIVE THE JAR/ANCHOR TO THE DOCTOR. ON (B)(6) 2025 I HAD SURGICAL FOLLOWUP AT THE UROLOGIST'S OFFICE AND INCLUDED MY WIFE IN THE VISIT. I ASKED ALL OF THE SAME QUESTIONS, WITH APPROXIMATELY SIMILAR ANSWERS. HOWEVER, DISCUSSION OF EXPERIENCE RATE OF THIS FAILURE BY THE DR. WAS SIGNIFICANTLY DIFFERENT, WHEREIN HE STATED THAT I WAS, "ONE IN A MILLION" AND THE OFFICE HAD NEVER SEEN THIS FAILURE AND DESCRIBED MY STATISTICAL PROBABILITY OF THIS FAILURE AS "99.99 PERCENT." THE DR. STATED THEY INFORMED THE MANUFACTURER AND THREW THE ANCHOR IN THE TRASH. SYMPTOMS AT WRITING ARE: SOMEWHAT A REVERSION OF FIFTH WEEK GREATLY IMPROVED TO SINGLE NIGHTIME URINATION TO NOW TWO TO FOUR PER NIGHT; SENSATION ON URINATION THAT I HAVE TO PUSH TO EMPTY THE BLADDER FROM MID-RECOVERY FEELING OF ONE-TIME TO EMPTY. I AM CONSTANTLY REMINDED OF THE POSSIBILITY OF FAILURE OF THE REMAINING THREE SUPPOSEDLY INTACT IMPLANTS, AND ON FIRST NIGHT WAKENING TO URINATE CANNOT THEN RETURN TO A SOUND SLEEP. I SUFFER FROM PSORIATIC ARTHRITIS AND HAVE BEEN ON MANY BIOLOGICS FOR THE PAST FIFTEEN YEARS. THE POSSIBILITY OF AN IMMUNOSUPPRESSED SYSTEM BESET BY REMNANT IMPLANT-CAUSED INFECTION TERRIFIES ME. I WORRY THAT SUCH AN EVENT MIGHT EXACERBATE THE PROSTATE CANCER AND MIGHT CAUSE SECONDARY INFECTION IN BILATERAL KNEE REPLACEMENTS AND CERVICAL FUSION HARDWARE. THE DOCTORS AT THE UROLOGY GROUP HAVE GIVEN ME THE BEST OF CARE FOR THIRTY YEARS. AT ONSET OF FINDING THIS FAILURE, I IMMEDIATELY IMAGINED A REVISION SURGERY, POSSIBLE REMOVAL OF THE REMNANT ANCHOR ASSEMBLY, REPEAT OF RECOVERY AND ATTENDANT AGONY, AND POTENTIAL LONG-LASTING EFFECTS. I WAS A BIT FRUSTRATED AT WHAT I PERCEIVED TO BE A NONCHALANT MISCOMMUNICATION BETWEEN PROVIDERS ('ONE IN A MILLION' VERSUS 'WE SEE THIS OCCASIONALLY'), AND I WENT ON TO DESCRIBE TO THE DR. MY POSITION THAT I WAS IN A BUSINESS WITH SIMILAR IMPLICATIONS RELATIVE TO PRODUCT RELIABILITY, ENGINEERING PRODUCTS AND PROCESSES FOR AIRCRAFT ENGINES WITH FAILURE RATE LIMITS TARGETING SINGLE DEFECT PER MILLION OPPORTUNITIES ((B)(4) RATE). I ASKED THE DR. RATHER BLUNTLY, "GIVEN THE SIMPLICITY OF THE IMPLANT CONSTRUCTION, HOW IN THE WORLD DID WE "PROFANITY" THIS UP?" THERE WAS NO SPECIFIC ANSWER GIVEN. ON RETURN HOME, I RESEARCHED DEVICE FAILURE RATES FOR UROLIFT. I SEE A STUDY WHERE 2 PERCENT FAILURE IN THE IMPLANT WAS RECORDED FROM REPORTED INCIDENTS. IN THE CIRCUMSTANCES OF MY PASSING AND FINDING THE ANCHOR IN MY URINE STREAM, I CAN ONLY IMAGINE HOW ANYONE WITH SIMILAR FAILURE COULD EVEN DETECT SAID ANCHOR IN THE STREAM UNLESS THEY WERE SPECIFICALLY GIVING A URINE SPECIMEN. I HOPE BY INITIATING THIS REPORT ANY RELEVANT MANUFACTURER, USER, SURGEON, CAREGIVER AND PATIENT MIGHT BE MORE AWARE OF A POTENTIAL MODE OF FAILURE THAT IS STATISTICALLY IMPOSSIBLE TO DETECT, MAYBE SAVING THEM FROM FURTHER INJURY. IN REVIEW OF APPROXIMATELY TWENTY PATENTS FOR UROLIFT IMPLANT AND APPLICATOR I FIND VERY SPARSE REFERENCE TO THE ADJUSTMENT OF TENSION IN THE UW ANCHOR FILAMENT, POSITIVE RETENTION OF THE UW ANCHOR ON THE FILAMENT, AND ONLY IN THE APPLICATOR USER INSTRUCTION A REFERENCE TO CUTTING OF THE FILAMENT AFTER THE IMPLANT IS POSITIONED. IT WOULD SEEM THAT THERE IS SOME PROCESS CONTROL OR MONITORING LACKING IN MANUFACTURE OF THE IMPLANT ASSEMBLY OR ITS COMPONENTS, OR IN RELIABILITY OF THE APPLICATOR DEVICE AND IMPLANT MECHANICAL CYCLE DURING SURGERY.