Columbia Urology Grand Rounds 2/17/16 - Hard Questions: Ethical Dilemmas in Penile Prosthesis Surgery

1. COLUMBIA UNIVERSITY DEPT. OF UROLOGY
GRAND ROUNDS
Hard Questions:
Ethical dilemmas in penile
prosthesis surgery

2. Overview
• Case
• Background on ED and penile implant surgery
• Ethics in urology
• Implants in special populations
• Conclusions

3. Overview
• Case
• Background on ED and penile implant surgery
• Ethics in urology
• Implants in special populations
• Conclusions

4. Case Presentation
• CC: erectile dysfunction
• HPI: 48 yo M h/o depression, obesity and erectile
dysfunction presents for evaluation at the VA.
Patient reports ED for the past 4 years with
difficulty achieving and maintaining erections.
SHIM=6. Able to achieve 2/10 erections
unassisted. He tried sildenafil 100mg with a poor
response of only 4/10 erection. He is extremely
distressed and is interested in prosthesis surgery.

5. Case Presentation
• PMH: obesity, insomnia, asthma
• Psych Hx: antisocial personality disorder,
depression, post-traumatic stress disorder
• PSH: Ex-lap 1991 after GSW; hernia repair 1982
• Meds: fluoxetine, trazodone, albuterol PRN
• All: NKDA
• FH: No GU hx

6. Case Presentation
• Social History:
• Army Veteran
• Released from prison 3 months ago after 11
year incarceration for rape in the third degree
• Currently unemployed
• In a committed relationship with girlfriend
• Denies tobacco, drugs, or alcohol

7. Physical Exam
• Vitals: 98.7 F, HR 76, BP 139/81, 99% on RA
• Gen: NAD, well appearing
• Lungs: breathing comfortably on RA
• Abd: obese, soft/NT/ND
• GU: circumcised phallus, testes descended
bilaterally, no penile plaques, no lesions

8. Labs
• CBC 5.7 > 14.9 / 44.8 < 151
• BMP 142 / 4.2 / 108 / 23 / 16 / 1.0 < 98
• PSA 0.34
• Testosterone 299
• HIV – negative
• Hep B/C – negative
• Drug screen – negative
• Urine culture – no growth

9. Case Presentation (Continued)
• Refilled sildenafil 100mg and instructed on proper
use. Poor response.
• Prescribed Muse (intraurethral alprostadil) with
poor response at home
• Given intracavernosal injection teaching with
20mcg Edex (injectable alprostadil) with fair
response (3/4 erection per training note)

10. Case Presentation (Continued)
• Poor response to all medications at home with
significant pain after ICI attempt
• Cleared for decision making capacity by VA
psychologist and psychiatrist
• Re-presented to clinic 2 weeks later adamantly
requesting penile prosthesis placement

11. Assessment
48 year old man with psychiatric history, felony sex
offense conviction, and erectile dysfunction
refractory to medical management who presents to
VA clinic requesting penile prosthesis placement.
Key Questions:
How should we proceed with this patient?
What are the ethical questions relevant to penile
prosthesis surgery?
What considerations do we need to take when treating
sexual dysfunction in special populations?

12. Overview
• Case
• Background on ED and penile implant surgery
• Ethics in urology
• Implants in special populations
• Conclusions

13. Physiology of Erections

14. Erectile Dysfunction (ED)
• Definition
• “Inability to attain and/or maintain penile erection sufficient
for satisfactory sexual performance” (AUA, 2005)
• Prevalence
• Overall ~17% of men (Massachusetts Male Aging Study, 2000.)
• Age 60-69 ~20-40%, age 70-79 ~50-75%
• Associated with many factors:
• Age, smoking, obesity diabetes, chronic diseases, CV
disease, prostate conditions, hormones, psych conditions,
and medications (especially SSRIs, antihypertensives)

16. Assessment of ED
• Medical, sexual and psychosocial history
• Comorbidities and risk factors
• Rapidity of onset and erectile reserve
• Sexual history (libido, premature ejaculation, Peyronie’s)
• Sexual Health Inventory for Men (SHIM or IIEF-5)
• Physical exam
• BMI, Peripheral pulses, hair pattern, gynecomastia, testicular size
• Penile stretch or plaques
• Diagnostic tests
• Hormonal testing (select patients)
• Penile doppler ultrasound

17. Management of ED
• Identification and management of organic
comorbidities and psychosexual dysfunctions
• Pharmacologic treatment options
• Apply in a stepwise fashion with dose titration and increasing
invasiveness
• Oral PDE5 inhibitors > intra-urethral alprostadil or intra-cavernosal
injections (+/- vacuum device)
• Surgical therapy
• Penile arterial reconstruction (select patients)
• Penile prosthesis implantation
AUA guideline: Management of Erectile Dysfunction 2005

18. Evolution of the Penile Prosthesis
• 1936 – Borgoraz uses rib cartilage as penile implant
Le and Burnett. Evolution of penile prosthetic devices. Korean J Urol. 2015
Martinez, et al. Evolution and Utility for the Small Carrion Prosthesis. J Sex Med 2015

19. Evolution of the Penile Prosthesis
Le and Burnett. Evolution of penile prosthetic devices. Korean J Urol. 2015
Martinez, et al. Evolution and Utility for the Small Carrion Prosthesis. J Sex Med 2015
• 1936 – Borgoraz uses rib cartilage as penile implant
• 1952 – Goodwin and Scott use acrylic prosthesis

20. Evolution of the Penile Prosthesis
• 1936 – Borgoraz uses rib cartilage as penile implant
• 1952 – Goodwin and Scott use acrylic prosthesis
• 1967 – Pearman describes placement of rod implant
Le and Burnett. Evolution of penile prosthetic devices. Korean J Urol. 2015
Martinez, et al. Evolution and Utility for the Small Carrion Prosthesis. J Sex Med 2015

21. Evolution of the Penile Prosthesis
• 1936 – Borgoraz uses rib cartilage as penile implant
• 1952 – Goodwin and Scott use acrylic prosthesis
• 1967 – Pearman describes placement of rod implant
• 1973 – Scott, Tim and Bradley invent inflatable prosthesis
Le and Burnett. Evolution of penile prosthetic devices. Korean J Urol. 2015
Martinez, et al. Evolution and Utility for the Small Carrion Prosthesis. J Sex Med 2015

22. Evolution of the Penile Prosthesis
• 1936 – Borgoraz uses rib cartilage as penile implant
• 1952 – Goodwin and Scott use acrylic prosthesis
• 1967 – Pearman describes placement of rod implant
• 1973 – Scott, Tim and Bradley invent inflatable prosthesis
• 1974 – Small and Carrion design silicone flexible implant
Le and Burnett. Evolution of penile prosthetic devices. Korean J Urol. 2015
Martinez, et al. Evolution and Utility for the Small Carrion Prosthesis. J Sex Med 2015
Modern malleable implant

23. Evolution of the Penile Prosthesis
• 1936 – Borgoraz uses rib cartilage as penile implant
• 1952 – Goodwin and Scott use acrylic prosthesis
• 1967 – Pearman describes placement of rod implant
• 1973 – Scott, Tim and Bradley invent inflatable prosthesis
• 1974 – Small and Carrion design silicone penile implant
• 1983 – 3-piece inflatable implant (Mentor)
Le and Burnett. Evolution of penile prosthetic devices. Korean J Urol. 2015
Martinez, et al. Evolution and Utility for the Small Carrion Prosthesis. J Sex Med 2015

24. Evolution of the Penile Prosthesis
• 1936 – Borgoraz uses rib cartilage as penile implant
• 1952 – Goodwin and Scott use acrylic prosthesis
• 1967 – Pearman describes placement of rod implant
• 1973 – Scott, Tim and Bradley invent inflatable prosthesis
• 1974 – Small and Carrion design silicone penile implant
• 1983 – 3-piece inflatable implant (Mentor)
• 1998 – Viagra (sildenafil) released
Le and Burnett. Evolution of penile prosthetic devices. Korean J Urol. 2015
Martinez, et al. Evolution and Utility for the Small Carrion Prosthesis. J Sex Med 2015

25. Evolution of the Penile Prosthesis
• 1936 – Borgoraz uses rib cartilage as penile implant
• 1952 – Goodwin and Scott use acrylic prosthesis
• 1967 – Pearman describes placement of rod implant
• 1973 – Scott, Tim and Bradley invent inflatable prosthesis
• 1974 – Small and Carrion design silicone penile implant
• 1983 – 3-piece inflatable implant (Mentor)
• 1998 – Viagra (sildenafil) released
• 2001-present –antibiotic coatings, materials changes,
design modifications
Le and Burnett. Evolution of penile prosthetic devices. Korean J Urol. 2015
Martinez, et al. Evolution and Utility for the Small Carrion Prosthesis. J Sex Med 2015

26. Three-Piece Inflatable Penile Prosthesis

27. Risks of Penile Implants
• Anesthetic risks
• Penile shortening
• Hematoma
• Infection (1-3% of first time surgery)
• Perforation / erosion (1-11%)
• SST deformity (1-10%)
• Device malfunction (5-20% failure at 5 years)
• Reservoir migration (<1%)
Sadeghi-Nejad. Penile Prosthesis Surgery: Review J Sex Med. 2007

28. Economics of ED and Penile Implants
• Economic trends in ED treatment (Wessells. J Urol. 2007)
• Annual US expenditures for ED treatment increased from $185M in
1994 to $330M in 2000
• VA patients receiving prescriptions for ED increased 9x from 1999
to 2003 (1 out of every 20 patients)
• Implant Cost
• $10,000 to $20,000+
• Covered by Medicare and many insurance companies
• Medicare data 2001-2010 (Lee. J Sex Med. 2015)
• 1,763,260 men diagnosed with ED
• 53,180 implants performed (3% of men; ~5,000 per year)

29. Trends in implant surgery
• Case log data from AUA 2003-2012
• 6,615 urologists placed 9,558
penile prosthesis implants
• 75% completed ≤4 implants per
year
• 59% of implants performed in 10
states with highest volume

30. • "We provide drugs through Medicare and Medicaid that
are lifesaving drugs; we don't pay for lifestyle drugs. [It
is wrong] to take the money you earned on overtime to
pay for Grandpa's Viagra.”
- Representative Steve King (R-Iowa) 2005

31. • On July 1, 2015 Medicare stopped paying for vacuum
assist devices for erectile dysfunction

32. Overview
• Case
• Background on ED and penile implant surgery
• Ethics in urology
• Implants in special populations
• Conclusions

33. Principles of Biomedical Ethics
Autonomy Justice
Beneficence
Non-
maleficence

34. Autonomy
• Patients are individuals with preferences that should be
honored. They have the right to refuse or choose their
treatment free of coercion.
• Basis for informed consent and advanced directives

35. Beneficence
• Duty to act in the patient’s best interest
• Demands providers develop and maintain skills and
knowledge
• Must consider individual circumstances of all patients and
strive for benefit
• *May conflict with autonomy*
“The well being of the patient is the most important law”

36. Nonmaleficence
• “First, do no harm” (primum non nocere)
• Procedures must not hurt the patient or others in society
• Balance risks (nonmaleficence) vs. benefits (benefice)
• “Double effect” – interventions have positive outcome
while also potentially doing harm

37. Justice
• Treat patients fairly
• Concerns distribution of scare resources, competing
needs, rights/obligations and potential conflicts with
established legislation

38. Surgical Ethics
• Informed consent
• Professionalism
• Disclosure
• Conflicts of interest
• Elective procedures
• Innovation and research
• Futility
• End of life care

39. AUA Code of Ethics

40. AUA Code of Ethics
• “Pursue the practice of urology with honesty and place the
welfare and rights of my patients above all else...”
• Continuing medical education
• Professional competence, impairment, and abuse
• Designating responsibility to qualified providers
• Reimbursement
• Advertising and disclosures
• Expert testimony
• Research
• Informed consent
• Law
Full document available at
www.auanet.org/myAUA/code-of-ethics.cfm

41. AUA Ethics Curriculum
• 18 modules available online at AUAnet.org
• Designed to develop knowledge base of ethical principles
and highlight current ethical issues in urology
• Modules include:
• Codes of conduct -Resolving Dilemmas -Confidentiality
• Disclosing errors -Informed consent -Surrogate decision
• Peds patients -Competent care -Advanced directives
• Terminal illness -Transplant ethics -Research ethics

42. AUA Ethics Curriculum
Module 3: Resolving Dilemmas
1. Clarify the facts (biography, patient preferences,
diagnosis, options, chronology, setting)
2. Identify ethical issues
3. Frame the ethical issues (biomedical good, broader
interests of patient, interests relevant other parties)
4. Contextualize the issues (parallel or preceding cases)
5. Evaluate alternative courses
6. Make a decision and take action
7. Evaluate the decision prospectively and retrospectively

43. Overview
• Case
• Background on ED and penile implant surgery
• Ethics in urology
• Implants in special populations
• Conclusions

44. Sex offenders
• Definition: Person convicted of a sexual offense (rape,
assault, child abuse, statutory rape, etc.)
• Public registry databases
• ~700,000 registered sex offenders in USA
• 1560 registered offenders in New York County and 2267 in Bronx
County (http://www.criminaljustice.ny.gov/nsor/)
• Recidivism
• DOJ report: among 9,691 offenders 15 states released in 1994 5.3%
rearrested after 3 years of release from prison
• Increased rates of re-offense rate for child molesters ( up to 23%)
• Sexual dysfunction
• ~20+% experience sexual dysfunction
• Can have legally imposed restrictions on sex enhancing drugs during
probation
• Not required to specifically disclose history to doctors
US DOJ Bureau of Justice Statistics. Recidivism of Sex offenders released from prison in 1994. Nov 2003.

45. • Goal: Determine incidence and characteristics of sex
offenders seeking treatment in a urology clinic
• Methods: Offenders identified from new patient
screening, ICI teaching sessions or IPP placement and
cross referenced with US DOJ National Sex Offender
Registry
• Results: 1597 men screened and 18 sex offenders
identified

46. Table 2 (continued)

47. • Conclusions
• Registered sex offenders are in fact seeking and receiving
treatment for sexual dysfunction
• No cases in which physician was accused of aiding a crime by
treating a sex offenders sexual dysfunction.
• Commentary (Paul Fedorff, forensic psychiatrist)
• If the intended sex partner is a non-consensual victim, treatment of
ED is unethical
• In the case of sex offenders with legal and consenting partners who
would like to include intercourse in their sexual relations, treatment
of ED is both ethical and recommended

48. IPP in sex offenders
• Ethical issues
• Nonmaleficience (for patient and society)
• Justice (distribution of scarce resources; conflicts with established
legislation)
• Risk of recidivism and physician liability
• Judgment/capacity issues with co-existing mental illness
• Physician bias
• More…
• Resolving conflicts
• Identification of criminal hx (screening before IPP)
• Assessment by psychiatrist or psychologist
• Ultimately, individual urologist must decide to treat or not

49. ED and Infectious diseases
• No reliable data on effects of ED treatment and
transmission of sexually transmitted diseases
• Increased rates of ED in men with HIV and Hep C
• Ethical issues:
• Professional responsibility to treat patient’s primary concern vs.
responsibility to partner / society at risk for sexually transmitted
diseases
• Restricting autonomy may be ethically justified when it threatens to
cause harm to others
• In some states it is illegal to knowingly expose another person to a
communicable disease
• Counseling of safe sex practices is essential

50. Implants in the Elderly
• Increased surgical risk in elderly
• Age independently associated with increased morbidity (wound,
renal, cardiac, respiratory complications) and mortality (Turrentine.
JACS. 2006)
• High satisfaction rates for penile implants
• In 35 patients ≥70 years old, 83% satisfied and 73% using
prosthesis (Al-Najar. BJUI. 2009.)
• In 30 patients ≥75 years old, 5% revised at 2 years and 93%
satisfied (same as younger group) (Chung. World J Urol. 2013.)
• Ethical Issues
• Beneficence vs. nonmaleficence
• Informed consent
• Distribution of scare resources

51. Overview
• Case
• Background on ED and penile
implant surgery
• Ethics in urology
• Implants in special populations
• Conclusions

52. Case evaluation
1. Clarify the facts
• 48 year old man with psychiatric history, felony sex offense conviction,
and erectile dysfunction refractory to medical management who
presents to VA clinic requesting penile prosthesis placement
2. Identify ethical issues
• Beneficience vs. nonmaleficence; judgement/capacity evaluation;
patient autonomy vs. justified paternalism
3. Frame the ethical issues
• Patient benefit vs. potential societal harm; Legal repercussions
4. Contextualize the issues
5. Evaluate alternative courses
• Further medical management +/- sex therapy
6. Make a decision and take action
7. Evaluate the decision prospectively and retrospectively

53. Conclusions
• Knowledge of the physiology of ED, evaluation, medical
treatment pathways, and surgical options provides us with
many solutions for patients
• Core ethical principles and codes of ethics (AUA) provide
a framework to evaluate dilemmas
• Ethical dilemmas should be handled in a case by case
basis
• Education and communication are vital within the
physician patient relationship
• When in doubt, consult with colleagues or hospital ethicist

54. “A man’s penis often
fails to rise to the occasion
simply because it is a bad idea.”
Bernie Zilbergard, psychologist, 1939-2002
Author of Male Sexuality (1978)

55. Questions? Comments?
Fernando Botero. Adam (1990)
• Thanks to Dr. Harris, Dr. Stahl,
Dr. Valenzuela, and Dr. Prager
for feedback and comments on
this case and presentation

56. References
• Campbell MF, Wein AJ, Kavoussi LR. Campbell-Walsh Urology. 9th ed. Philadelphia: W.B. Saunders; 2007.
• National Ethics Teleconference: Ethical Considerations When Treating Erectile Dysfunction in Patients with Sexually Transmissible
Diseases. National Center for Ethics in Health Care 10E. May 2004.
• Al-Najar, A., et al. (2009). Should being aged over 70 years hinder penile prosthesis implantation? BJU International, 104(6), 834–
837. http://doi.org/10.1111/j.1464-410X.2009.08502.x
• Chung, E., et al. (2013). Clinical outcomes and patient satisfaction rates among elderly male aged ≥75 years with inflatable penile
prosthesis implant for medically refractory erectile dysfunction. World Journal of Urology, 32(1), 173–177.
http://doi.org/10.1007/s00345-013-1102-7
• Heyns, C. F., et al. (2013). Urological aspects of HIV and AIDS. Nature Reviews. Urology, 10(12), 713–722.
http://doi.org/10.1038/nrurol.2013.230
• Jiann, B.-P., et al. (2004). Impact of introduction of sildenafil on other treatment modalities for erectile dysfunction: a study of
nationwide and local hospital sales. International Journal of Impotence Research, 16(6), 527–530.
http://doi.org/10.1038/sj.ijir.3901259
• Le, B., et al. (2015). Evolution of penile prosthetic devices. Korean Journal of Urology, 56(3), 179.
http://doi.org/10.4111/kju.2015.56.3.179
• Lee, D. J., et al. (2015). Trends in the Utilization of Penile Prostheses in the Treatment of Erectile Dysfunction in the United States.
The Journal of Sexual Medicine, 12(7), 1638–1645. http://doi.org/10.1111/jsm.12921
• Nejad, H. S. (2004). Round Table: The Ethics of Treating Sexual Dysfunction in Patients Who Have STD: L19: Perspectives on the
Medical, Legal, and Ethical Considerations in the Management of Erectile Dysfunction in HIV‐positive Patients and those with
Sexually Transmissible Diseases. Journal of Investigative Dermatology, 1(Supplement 1), 22. http://doi.org/10.1111/j.1743-
6109.2004.04051_19.x
• Oberlin, D. T., et al. (9999). Sexual Function/InfertilityNational Practice Patterns of Treatment of Erectile Dysfunction with Penile
Prosthesis Implantation. Journal of Urology, 193(6), 2040–2044. http://doi.org/10.1016/j.juro.2014.11.095
• Phillips, E. A., et al. (2015). Sex Offenders Seeking Treatment for Sexual Dysfunction—Ethics, Medicine, and the Law. The Journal
of Sexual Medicine, 12(7), 1591–1600. http://doi.org/10.1111/jsm.12920
• Segal, R. L., et al. (2014). Modern utilization of penile prosthesis surgery: a national claim registry analysis. International Journal of
Impotence Research, 26(5), 167–171. http://doi.org/10.1038/ijir.2014.11