Description of Event or Problem · 0
I AM SUBMITTING THIS REPORT TO DOCUMENT SERIOUS COMPLICATIONS AND POTENTIAL DESIGN AND MARKETING DEFECTS ASSOCIATED WITH THE PENUMA PENILE IMPLANT MANUFACTURED BY INTERNATIONAL MEDICAL DEVICES AND IMPLANTED BY DR. (B)(6). I FIRST RECEIVED THE PENUMA IMPLANT IN (B)(6) 2020. SHORTLY AFTER SURGERY, ALL SUTURES ANCHORING THE DEVICE TO MY PENIS RUPTURED. ONE YEAR LATER, AT DR. (B)(6) INSISTENCE, HE PERFORMED A REPLACEMENT PROCEDURE. FOLLOWING THAT SECOND IMPLANT, I DEVELOPED SEVERE CAPSULAR CONTRACTURE, A CONDITION DR. (B)(6) HAD PREVIOUSLY STATED WAS NOT POSSIBLE WITH THIS DEVICE BECAUSE, IN HIS WORDS, "THE PENIS IS A DYNAMIC ORGAN THAT MOVES CONSTANTLY." MARKETING MATERIALS AT THE TIME ALSO DESCRIBED THE PENUMA AS "COMPLETELY REVERSIBLE." SINCE THEN, THAT LANGUAGE HAS BEEN CHANGED TO "REMOVABLE," AN IMPORTANT DISTINCTION. I RELIED ON THOSE ORIGINAL REPRESENTATIONS, ALONG WITH DR. (B)(6) SELF-PUBLISHED RESEARCH AND STATEMENTS CLAIMING SAFETY, REVERSIBILITY, AND MINIMAL PHYSIOLOGICAL IMPACT. AFTER THE SECOND IMPLANT, THE CAPSULAR CONTRACTURE CAUSED DEBILITATING DEFORMITY, AND I HAVE SINCE UNDERGONE SEVEN ADDITIONAL SURGERIES. THE SCARRING AND TISSUE DAMAGE APPEAR PERMANENT; NORMAL FUNCTION MAY NEVER RETURN. THE IMPLANT CAUSES EXTENSIVE FIBROSIS THAT SHORTENS AND CURVES THE PENIS, CONTRADICTING ANY ASSERTION THAT OUTCOMES ARE "REVERSIBLE." THE MODEL I RECEIVED ALSO APPEARED INHERENTLY FLAWED IN DESIGN, REQUIRING A MESH EXTENSION TO BE MANUALLY ATTACHED AFTER MANUFACTURING TO ENABLE FIXATION--SUGGESTING AN IMPROVISED RATHER THAN ENGINEERED SOLUTION. THE DEVICE'S FDA CLEARANCE COVERS USE FOR CORRECTION OF SOFT-TISSUE DEFORMITIES OF THE PENIS; I HAD NO SUCH DEFORMITY PRIOR TO IMPLANTATION. DR. (B)(6) CONTINUES TO PROMOTE AND IMPLANT THIS DEVICE PRIMARILY FOR COSMETIC ENLARGEMENT, BEYOND THE SCOPE OF THAT CLEARANCE. IN ADDITION, BASED ON TWO (B)(6) MEDICAL BOARD DISCIPLINARY ACTIONS, DR. (B)(6) HAS BEEN FOUND TO USE PRE-WRITTEN OPERATIVE REPORTS THAT CREATE THE APPEARANCE THAT EACH CASE MEETS FDA-CLEARED INDICATIONS. THESE TEMPLATE DOCUMENTS MISREPRESENT PATIENT CONDITIONS AND, IN MY OPINION, CROSS INTO FALSIFICATION OF MEDICAL RECORDS. IN SUMMARY, THE PENUMA DEVICE IS BEING MARKETED AND IMPLANTED FOR UNAPPROVED COSMETIC PURPOSES, IS NOT REVERSIBLE AS CLAIMED, AND CAUSES SEVERE CAPSULAR CONTRACTURE AND PERMANENT DEFORMITY. ITS ATTACHMENT DESIGN IS DEFECTIVE, AND THE SURGEON RESPONSIBLE FOR ITS INVENTION AND PROMOTION HAS A DOCUMENTED HISTORY OF NEGLIGENT PRACTICE. I URGE THE FDA TO INVESTIGATE BOTH THE DEVICE DESIGN AND ITS ONGOING OFF-LABEL MARKETING. ALL MEDICAL RECORDS FROM MULTIPLE TREATING PHYSICIANS, AS WELL AS WRITTEN CORRESPONDENCE TO THE IMPLANTING DOCTOR, ARE AVAILABLE FOR REVIEW.