PENUMA
Report
- Report Number
- 3010606546-2022-00003
- Event Type
- Injury
- Date Received
- August 2, 2022
- Date of Event
- June 21, 2021
- Report Date
- August 2, 2022
- Manufacturer
- INTERNATIONAL MEDICAL DEVIES
- Product Code
- MIB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
PATIENTS ARE INSTRUCTED TO AVOID ANY SEXUAL STIMULATION FOR SEVERAL WEEKS FOLLOWING THE IMPLANTATION UNTIL CLEARED BY THE SURGEON. THE INCLUSION OF THE EXTERNAL 1-CM-WIDE POLYESTER MESH IS INCLUDED IN THE INSTRUCTIONS FOR USE. THE PATIENT IS REQUIRED TO SIGN A CONSENT FORM THAT STATES THEY UNDERSTAND THAT A SOFT MESH LAYER WILL BE ADDED TO THE DISTAL TIP OF THE IMPLANT DURING THE PROCEDURE, AND THAT THEY UNDERSTAND THE POTENTIAL RISKS, COMPLICATIONS, AND BENEFITS OF THE USE OF THIS SOFT MESH. A SERIOUS INJURY REQUIRES A REMOVAL TO PREVENT AN INJURY OR ILLNESS THAT IS LIFE-THREATENING, RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, OR NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. RISK OF MIGRATION, EROSION AND PAIN ARE RISKS ASSOCIATED WITH EVERY SURGICAL PROCEDURE INVOLVING PLACEMENT OF A SYNTHETIC IMPLANT MATERIAL FOR COSMETIC PURPOSES. A RETROSPECTIVE REVIEW WAS PERFORMED OF THE CHARTS FOR ALL PATIENTS WHO RECEIVED A CURVILINEAR SILICONE BLOCK FOR THE TREATMENT OF SOFT TISSUE DEFORMITIES OF THE PENIS BEGINNING IN (B)(6) 2013. FROM THAT DATE, 100 SUCCESSIVE PATIENT CHARTS WERE REVIEWED, COVERING A PERIOD THROUGH (B)(6) 2014. IN OTHER WORDS, ALL PATIENTS WHO RECEIVED A CURVILINEAR SILICONE BLOCK FOR THE TREATMENT OF SOFT TISSUE DEFORMITIES OF THE PENIS IN THE CLINIC OF DR. (B)(6) UNDER THE PRACTICE OF MEDICINE BETWEEN (B)(6) 2013 AND (B)(6) 2014 WERE INCLUDED IN THIS REVIEW. BY REVIEWING PATIENTS WHOSE DATE OF SURGERY WAS IN (B)(6) 2013 THROUGH (B)(6) 2014, SUFFICIENT TIME ELAPSED FOR A COMPLETE REVIEW OF PATIENT FOLLOW-UP SESSIONS FOR AT LEAST ONE YEAR AFTER THE DATE OF SURGERY. PER THE CLINIC'S SURGICAL PROTOCOL, BEFORE EACH PROCEDURE, PATIENTS ARE REQUIRED TO SIGN AN INFORMED CONSENT DOCUMENT THAT, AMONG OTHER THINGS, STATES THAT THEIR DE-IDENTIFIED DATA MAY BE SHARED WITH GOVERNMENT AGENCIES (E.G., THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)). AFTER EACH SURGICAL PROCEDURE, THE CLINIC COLLECTS FOLLOW-UP DATA ON ALL PATIENTS FOR THREE SUCCESSIVE DAYS FOLLOWING THE PROCEDURE, AND AT TWO WEEKS, ONE MONTH, THREE MONTHS, SIX MONTHS, AND TWELVE MONTHS FOLLOWING EACH PROCEDURE. AT EACH FOLLOW-UP SESSION, THE SURGEON ASKS A SERIES OF QUESTIONS TO DETERMINE IF ANY ADVERSE EVENT(S) HAS OCCURRED, THE RELATED SYMPTOMS OF THE ADVERSE EVENT(S), THE SEVERITY OF THE ADVERSE EVENT(S), AND THE POSSIBLE CAUSE(S) OF THE ADVERSE EVENT(S). WITH THIS INFORMATION, THE SURGEON DETERMINES THE APPROPRIATE TREATMENT COURSE FOR EACH ADVERSE EVENT, A PREVENTION COURSE TO AVOID FUTURE ONSET, AND CONDUCTS SUBSEQUENT FOLLOW-UP SESSIONS TO DETERMINE THE EFFECTIVENESS OF THE RECOMMENDED TREATMENT COURSE AND MONITOR FUTURE OCCURRENCE. IN THIS GROUP OF PATIENTS, THERE WERE 3 CASES OF EROSION. THIS ADVERSE EVENT WAS OBSERVED BY THE CLINIC ON AVERAGE 8 MONTHS AFTER THE PATIENT'S PROCEDURE WITH A MINIMUM OF 6 MONTHS AND A MAXIMUM OF 10 MONTHS. 1 PATIENT EXPERIENCED STRETCHING/EXTENSION OF THE PENILE SKIN OVER THE PENILE GLANS (APPROXIMATELY 2 TO 3 MM), AND 2 PATIENTS EXPERIENCED PROMINENT WRINKLING AND BULGING OF THE PENILE SKIN OVER THE SHAFT. IN ALL CASES, THE CAUSE OF THE EROSION WAS THE PATIENT'S USE OF EXTERNAL DEVICES FOR THE STRETCHING AND EXPANSION OF THE PENILE SKIN, WHICH WAS DONE BY THE PATIENT HIMSELF AND AGAINST MEDICAL ADVICE, INCLUDING SURGEON INSTRUCTIONS AND PRECAUTIONS. THE TREATMENT WAS A SUBSEQUENT PROCEDURE WHEREBY THE IMPLANT WAS REMOVED AND REPLACED. THE 3 PATIENTS WHOSE IMPLANTS WERE REMOVED AND REPLACED WERE SUBSEQUENTLY OBSERVED USING THE CLINIC'S SURGICAL PROTOCOL FOR NEW IMPLANT PATIENTS (I.E., THE CLINIC COLLECTED FOLLOW-UP DATA ON THE PATIENTS FOR THREE SUCCESSIVE DAYS FOLLOWING THE PROCEDURE, AND AT TWO WEEKS, ONE MONTH, THREE MONTHS, SIX MONTHS, AND TWELVE MONTHS FOLLOWING EACH PROCEDURE). NO SUBSEQUENT ADVERSE EVENTS WERE OBSERVED IN THESE 3 PATIENTS WITH THE EXCEPTION OF MILD PAIN. IMD BELIEVES THAT THE UNIQUE ANATOMY, PHYSIOLOGY AND FUNCTION OF THE PENIS DOES NOT INCREASE THE OVERALL POTENTIAL RISKS COMPARED TO THE PREDICATE DEVICES. CLINICAL EVIDENCE DEMONSTRATES THAT RATES OF PAIN, EROSION, AND MIGRATION ARE COMPARATIVELY LOW AND MIGHT BE FURTHER MITIGATED BY PRE-OPERATIVE EDUCATION. AS THIS COMPLAINT WAS COMMUNICATED VIA A REVIEW OF THE MAUDE DATABASE, WITH INFORMATION REGARDING THE EXACT PRODUCT, LOT NUMBER, PATIENT, AND PHYSICIAN LEFT AS CONFIDENTIAL, IT IS NOT POSSIBLE TO REVIEW LOT RECORDS FOR THIS COMPLAINT. AN ARTICLE WAS PUBLISHED IN THE INTERNATIONAL JOURNAL OF IMPOTENCE RESEARCH (IJIR) TITLED UPDATE ON THE PENUMA AN FDA - CLEARED PENILE IMPLANT FOR AESTHETIC ENHANCEMENT OF THE FLACCID PENIS. THE ARTICLE DISCUSSES THE REMOVAL OF PENUMA IMPLANTS AND THAT ANY ADVERSE EVENTS FOLLOWING REMOVAL TEND TO SUBSIDE. A CLINICAL INVESTIGATION WAS IRB-APPROVED IN 2015, CLINICAL INVESTIGATION REPORT: RETROSPECTIVE ANALYSIS OF THE SAFETY AND EFFECTIVENESS OF THE SILICONE BLOCK IN PENILE SURGERY. THE 400 CONSENTED MEN AVERAGED 35.5 YEARS OF AGE WITH A MEAN BMI OF 25.4, JUST SLIGHTLY ABOVE THE NORMAL RANGE, AND WERE ALL CIRCUMCISED. 12/400 PATIENTS (3%) EXPERIENCED SERIOUS ADVERSE DEVICE EFFECTS NECESSITATING DEVICE REMOVAL. THE CAUSES INCLUDED IMPLANT BREAKAGE WITH IMPLANT PERFORATION AND INFECTION (4/400 PATIENTS (1%)); IMPLANT INFECTION (4/400 PATIENTS (1%)); SUTURE DETACHMENT (2/400 PATIENTS (0.5%)); IMPLANT BREAKAGE (1/400 (0.25%)); AND HEMATOMA (1/400(0.25%)). THE SELF-CONFIDENCE OPTIONS RANGED FROM 1 (LOW) TO 4 (VERY HIGH). POST-SURGERY, 83.5% OF RESPONDENTS (334/400) REPORTED AT LEAST A 2 CATEGORY IMPROVEMENT IN SELF-CONFIDENCE, AND LONG-TERM, 72.6% (223/307) REPORTED AT LEAST A 2 CATEGORY IMPROVEMENT IN SELF-CONFIDENCE (P <0.001 FOR BOTH). EIGHT-ONE PERCENT (81.0%) OF THE SUBJECTS REPORTED HIGH OR VERY HIGH LEVELS OF LONG-TERM SATISFACTION. RETROSPECTIVE ANALYSIS OF 400 SUBJECTS ELECTING SURGICAL CORRECTION OF PENILE DEFORMITIES DEMONSTRATED THE SAFETY AND EFFECTIVENESS OF SILICONE BLOCK. DEVICE REMOVALS ATTRIBUTED TO AN ADVERSE EVENT WERE RARE, AND SUBJECTS REPORTED IMPROVED SELF-CONFIDENCE AND HIGH LEVELS OF LONG-TERM SATISFACTION. THIS STUDY DEMONSTRATED THE SAFETY OF THE SILICONE BLOCK FOR ITS INTENDED USE.
EVENT WAS DISCOVERED THROUGH A REVIEW OF THE MAUDE DATABASE, SEE REPORT NUMBER MW5110238. PATIENT STATED THEY RECEIVED THE PENUMA IMPLANT IN 2021. PATIENT CLAIMS TO HAVE FOLLOWED ALL 'PROPER PROTOCOL' BUT STILL EXPERIENCED SKIN EROSION. PATIENT CLAIMS THAT MANUFACTURER MADE CLAIMS THE DEVICE FEELS NATURAL BUT HE DID NOT EXPERIENCE THIS. PATIENT CLAIMS THE EXTERNAL MESH CREATES VARIOUS PROBLEMS WITH BLOOD CIRCULATION AND NERVES. PATIENT CLAIMS 3 MONTHS AFTER FOLLOWING THE 'PROPER PROTOCOL' THE EDGE OF THE DEVICE BEGAN TO CUT THROUGH THE SKIN AND HE HAD THE PENUMA IMPLANT REMOVED. PATIENT CLAIMS THAT EIGHT MONTHS AFTER REMOVAL, HE HAS NERVE DAMAGE THAT CAUSES OCCASIONAL PAIN AND SENSITIVITY LOSS. ALL ALLEGED COMPLICATIONS ARE KNOWN AND REQUIRE PATIENT INFORMED CONSENT IN ADVANCE OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2161988 | PENUMA | PRE-FORMED PENILE SILICONE BLOCK | MIB | INTERNATIONAL MEDICAL DEVIES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |