Description of Event or Problem · 0
I HAD RECEIVED THE PENUMA IMPLANT FROM DR. (B)(6) ON (B)(6) 2021. I HAD A HEALTHY AND NORMAL SELF-ESTEEM AND HAD A PHYSIOLOGICALLY NORMAL AND HEALTHY PENIS PRIOR TO THE SURGERY AND IMPLANT. IN THEIR MARKETING MATERIAL AND PUBLICATIONS, THEY CLAIMED PRIOR TO THE TIME OF THE SURGICAL CONSULTATION THAT THE PENUMA WAS "THE FIRST FDA-CLEARED PENILE IMPLANT FOR COSMETIC ENHANCEMENT." IT WAS ALSO CLAIMED THAT THE PENUMA IMPLANT WAS COMPLETELY REVERSIBLE. IT WAS ALSO CLAIMED THAT THE INVENTOR OF THE PENUMA, DR. (B)(6), WAS A BOARD CERTIFIED UROLOGIST. I HAVE SEARCHED FOR HIS NAME ON ONLINE MEDICAL SPECIALIST DATABASES AND I HAVE NEVER FOUND HIS NAME. I ALSO LEARNED AFTER THE IMPLANT SURGERY THAT DR. (B)(6) PLACES DACRON MESH AROUND THE PENUMA AT THE TIME OF SURGERY, TO ENCOURAGE THE FORMATION OF A FIBROUS SCAR TISSUE AROUND THE IMPLANT. THESE ARE JUST A SMALL LIST OF THINGS THAT WERE NEVER SHARED WITH ME PRIOR TO SURGERY. IF ANY OF THE CLAIMS WERE TRUTHFUL, IT WOULD NOT CAUSE THIS LEVEL OF DAMAGE TO ME, AS WELL AS COUNTLESS OTHERS. POST SURGERY, I WAS INSTRUCTED TO CONTACT THE OFFICE FOR 8 WEEKS. AFTER 8 WEEKS, DR. (B)(6) NOR THE MANUFACTURER DOES NOTHING TO FOLLOW UP OR TRACK ANY ISSUES. ANY ISSUES THAT ARE BROUGHT UP WITHIN THAT TIMEFRAME ARE DISMISSED AND DISCOUNTED. THERE IS NO TRACKING OF ANY ISSUES, NOR DOES DR. (B)(6) OR THE MANUFACTURER OF PENUMA RECORD OR RELAY ANY ISSUES, NOR DO THEY PROVIDE ANY ISSUE TRACKER OR PATHWAY TO RELAY ISSUES TO THE FDA, OTHER THAN WHEN A PATIENT TAKES IT UPON THEMSELVES TO VOLUNTARILY SEARCH AND RELAY ISSUES ABOUT THE PENUMA SUCH AS THIS. I CONTINUED FOLLOWING THE POST-SURGICAL PROTOCOL AS WELL AS CONTACTING DR. (B)(6) MEDICAL ASSISTANTS, WHO STATED THAT I SHOULD CONTINUE FOLLOWING PROTOCOL AND WAIT FOR THE 'PSEUDO CAPSULE' TO CONTINUE TO FORM. BASED ON THE NATURAL INFLATION AND DEFLATION OF BLOOD IN THE PENIS, THE PENUMA IMPLANT ALSO BEGAN TO SHIFT CAUSING THE PENUMA TO BE MISALIGNED AND NO LONGER IN PLACE WITH THE BASE PRESSED AGAINST MY PELVIC BONE. THIS IN TURN CAUSE MY PENIS TO POINT AT AN ANGLE AS THE PENUMA WAS AT AN ANGLE. I CONTINUALLY STATED MY CONCERNS TO DR. (B)(6) ASSISTANTS AND OFFICE REGARDING THE SEVERE DISCOMFORT AND FAILURES OF THE CLAIMS OF DR. (B)(6) AND MANUFACTURER THAT IT WOULD FEEL NATURAL. THE DEVICE NEVER FELT OR LOOKED NATURAL. THE MORE ERECTIONS I HAD THROUGHOUT EACH CONTINUING DAY SHOWED THE FAULTS OF THE IMPLANT AND THE LACK OF VERACITY BEHIND THE MANUFACTURER'S AND DR. (B)(6) CLAIMS. THE PENUMA DEVICE CAUSES PAIN AND DISCOMFORT AS THE ISSUE MADE IT SO MY PENIS COULD NOT EXTEND IN A NORMAL ERECT FASHION. DR. (B)(6) ASSISTANTS, OFFICE, AND DR. (B)(6) ALL DISMISSED AND DISCOUNTED MY CONCERNS FOR APPROXIMATELY ONE MONTH BEFORE TAKING ANY ACTION TO SEE ME AND ASSESS THE ISSUE. I CONTINUALLY STATED MY CONCERNS TO THE DOCTOR'S ASSISTANTS AND OFFICE STATED THAT THE IMPLANT WAS NOT CORRECTLY IN PLACE AND THAT DISCHARGE FROM THE INCISION SITE CONCERNED ME THAT THERE COULD BE INFECTION, AND THAT IT WAS IMPERATIVE I HAVE A HEALTHCARE PROVIDER EXAMINE THE CONDITION OF MY PENIS. ONCE AGAIN, DR. (B)(6) ASSISTANTS, OFFICE, AND DR. (B)(6) ALL DISMISSED AND DISCOUNTED MY CONCERNS AND INSTEAD MERELY SENT ME A PRESCRIPTION FOR ANTIBIOTICS. IN THE INTEREST OF MY HEALTH, I REQUESTED AND SCHEDULED A DATE FOR THE PENUMA IMPLANT TO BE FIXED ON (B)(6) 2022. I WAS EXAMINED BY DR. (B)(6), WHO WAS STILL DISMISSIVE AND DEFENSIVE OF ALL THE ISSUES I SHARED. I WAS TOLD BY DR. (B)(6) THAT I NEEDED TO HAVE THE IMPLANT ADJUSTED AND ON (B)(6) 2022, I UNDERWENT A PROCEDURE TO DO THAT WHICH RESULTED IN DR. (B)(6) REMOVING THE IMPLANT CITING SIGNS OF INFECTED TISSUE WHICH I HAD VOICED CONCERN FOR NEARLY TWO MONTHS PRIOR TO THIS. I RECEIVED NO FOLLOW UP FROM THE IMPLANT REMOVAL EXCEPT FOR A PAPER WITH REHABILITATION INSTRUCTIONS. FDA SAFETY REPORT ID # (B)(4).