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Informed consent for penile prosthesis

International Journal of Impotence Research volume 21, pages 37–50 (2009)Cite this article

When most urologists begin talking to their patients about the possibility of a penile prosthesis, they focus on the medical aspects of the procedure: is the patient a candidate for the surgery? Will the patient respond well to this treatment? What type of prosthesis should be used? How will the patient's anatomy affect the course of the surgery and the ultimate recovery? How can infection be kept at bay? What most urologists do not focus on—but should—are the legal aspects of the procedure. Physicians who perform penile prosthesis surgery must be aware of the legal concept of informed consent and, just as importantly, how they can make sure that they obtain informed consent from their patients before the surgery takes place. The purpose of this paper is to provide an overview of the legal doctrine of informed consent and to provide practical advice for making sure that informed consent is obtained prior to the performance of penile prosthesis surgery.

As one legal commentator has noted, the legal doctrine of ‘informed consent’ is not a static, carved-in-stone legal principle. Rather, it is a fluid principle undergoing continuous refinement and definition; it is forever evolving and changing as new laws and new cases further shape the parameters and content of what constitutes ‘informed consent’.1 To understand informed consent today, it is helpful to review where the concept came from.

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References

  1. George F. Evans, Jr., “Informed Consent: The Third Generation”, p. 5 (Texas Medical Liability Trust 2004).

  2. Id.

  3. Pratt v. Davis, 79 N.E.2d 562 (Ill. 1906).

  4. Schloendorff v. Society of New York Hospital, 211 N.Y. 125 (1914).

  5. Moss v. Rishworth, 222 S.W.2d 225 (1920).

  6. Evans, supra, note 1, p. 6.

  7. Id.

  8. Id.

  9. Salgo v. Leland Stanford, Jr. University Board of Trustees, 317 P.2d 170 (Cal. App. 1957).

  10. Evans, supra, note 1, p. 6. See, e.g., Wilkinson v. Vesey, 295 A.2d 676 (R.I. 1972); Gerety v. Demers, 589 P.2d 180, 190 (N.M. 1978).

  11. Hills v. State of Florida, 706 So.2d 103 (1st Dist. 1998).

  12. Wilson v. Merritt, 142 Cal.App.4th 1125 (Cal. App. 2006).

  13. Id.

  14. Truman v. Thomas, 611 P.2d 902 (1980).

  15. Peterson v. Shields, 652 S.W.2d 929 (Tex. 1983).

  16. Barclay v. Campbell, 704 S.W.2d 8 (Tex. 1986).

  17. Evans, supra note 1, p. 10.

  18. Daum v. SpineCare Medical Group, Inc., 52 Cal.App.4th 1285 (1997); Peterson, supra note 14.

  19. Id.

  20. Cobbs v. Grant, 502 P.2d 1 (1972); Schiff v. Prados, 92 Cal.App.4th 692 (Cal. App. 2001); Estate of Allen v. Rockford Health Systems, 848 N.E.2d 202 (2nd Dist. 2006).

  21. Schiff v. Prados, 92 Cal.App.4th 692 (Cal. App. 2001).

  22. Id. at p. 178.

  23. Betterton v. Leichtling, 101 Cal.App.4th 749 (Cal. App. 2002).

  24. Id.; Halley v. Birbiglia, 458 N.E.2d 710 (Mass. 1983).

  25. Only those doctors who have actively managed the plaintiff's care are held to be the ones with whom a duty rests to disclose information about necessary medical procedures. Townsend v. Turk, 218 Cal.App.3d 278 (Cal. App. 1990).

  26. Ritter v. Delaney, 790 S.W.2d 29 (Tex. App. 1990).

  27. See e.g., Mahannah v. Hirsch, 191 Cal.App.3d 1520 (Cal. App. 1987).

  28. See e.g., Lenahan v. University of Chicago, 808 N.E.2d 1078 (1st Dist. 2004).

  29. Id. at p. 1086.

  30. Evans, supra note 1, p. 9.

  31. Id. at p. 11.

  32. Ramirez v. Plough, Inc., 863 P.2d 167 (Cal. App. 1993).

  33. Quintanilla v. Dunkelman, 133 Cal.App.4th 95 (Cal. App. 2005).

  34. Id. at p. 115.

  35. Evans, supra note 1, pp. 12–13.

  36. Id. at p. 13.

  37. Evans, supra note 1, p. 13.

  38. Id.

  39. Id.

  40. Id. at p. 14.

  41. Id. at p. 16.

  42. Id. at pp. 20–21.

  43. Id. at p. 21.

  44. Hernandez v. Schittek, 713 N.E.2d 203 (1st Dist. 1999); Estate of Allen v. Rockford Health Systems, Inc., 848 N.E.2d 202 (2nd Dist. 2006).

  45. Ashcraft v. King, 228 Cal.App.3d 604 (Cal. App. 1991).

  46. See e.g., Hartfiel v. Owen, 618 S.W.2d 902 (Tex. App. 1981); Trabal v. Queens Surgi-Center, 8 A.D.3d 555 (N.Y. 2004); Mills v. Pate, 225 S.W.3d 277 (Tex. App. 2006).

  47. Richard A. Santucci, MD, “Penile Prosthesis Implantation”, http://www.emedicine.com/med/topic3047.htm.

  48. Id.

  49. Id.

  50. Id.

  51. Id.

  52. Id.

  53. Id.

  54. Id.

  55. Id.

  56. East v. United States, 629 F.Supp. 682 (E.D. Mo. 1986).

  57. Id. at p. 687.

  58. Wenger v. Oregon Urology Clinic, 102 Or.App. 665, 796 P.2d 376 (Or. App. 1990).

  59. Id. at p. 669–670.

  60. Montgomery v. Bazaz-Sehgal, 568 Pa. 574, 798 A.2d 742 (Pa. 2002).

  61. Id. at p. 584.

  62. Id.

  63. Id. at pp. 589–590.

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  1. Williams Montgomery & John Ltd, Chicago, IL, USA

    B C Nahrstadt

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  1. B C Nahrstadt
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Correspondence to B C Nahrstadt.

Appendix A

Appendix A

Penile prosthesis informed consent

You have elected to undergo placement of a penile prosthesis. Several devices are currently available in the marketplace including those which are non-inflatable versus two or three piece inflatable prostheses. All of these devices have the capacity to give you the opportunity to have a rigid penis on demand and to be used as frequently and as long as you would like. There are, therefore, many advantages to the use of the prosthesis which you have already discussed with your physician. The goal of this informed consent form is to identify the potential problems that have been recognized to occur with penile prosthesis placement and that you understand the risks of undergoing prosthesis placement. It is important to recognize that as a result of improvements in design as well as better surgical technique, that all of the risks listed below are less than they were even 10 years ago. It is also important to recognize that most of the available studies report on historical data for devices which are now either not manufactured or have undergone structural improvements to reduce those side effects. The complications are simply noted in random order and do not reflect their frequency.

(1) Prosthesis mechanical failure occurs as a result of leakage of fluid from the inflatable types of devices. This typically occurs as a result of a fracture in the tubing, most commonly as it emerges out of the scrotal pump, but it can also be due to a leak from the erectile cylinders in the penis. It is felt that this occurs as a result of repetitive mechanical trauma which weakens the tubing which causes it to crack. When the fluid leaks, it is not something you would be aware of. It does not cause pain. The fluid contained within the device is typically a sterile saline solution, which will simply be reabsorbed by the body. What you will recognize is that when you squeeze the pump, there will be no transfer of fluid and no rigidity or inadequate rigidity. The most recent long-term data looking at 5–10 year success reports mechanical failure in the 5–10% range over that period of time. Looked at another way, 90–95% of men will have a functional prosthesis in 10 years. These devices are designed to be used for life. Each company has its own warranty, which you should discuss with your physician.

(2) Infection is a disastrous complication which usually requires the removal of the prosthesis as it is rare to be able to clear infection so long as the prosthesis is within the body. Occasionally, the infected prosthesis can be removed, the location of the device can be washed out vigorously with a special antibiotic salvage procedure and then a new device may be able to be immediately placed. When this is not possible, the infected device is removed and then a period of healing will follow where the device can be replaced after a period of healing (6 weeks to 6 months). Delayed replacement of a prosthesis after initial removal is a more complicated operation associated with the potential for not being able to replace the device because of scarring but other problems such as shortening of the penis, change in sensation and shape may also occur.

As a result of improved surgical technique and device design, infection rates are now markedly reduced, typically being reported in the <1–2% range for new prosthesis placements and up to 3% when the prosthesis is uninfected and has mechanically failed.

(3) Bleeding and hematoma are rarely a problem. There is likely to be localized swelling as well as ‘black and blue’ of the penis, groin area and scrotal sack. These will resolve without treatment over 1–3 weeks. Rarely a scrotal hematoma (collection of blood) will develop which can be treated with rest and it will reabsorb with time or if it is growing in size or painful, it may need to be evacuated surgically (opened up and washed out). The risk of needing a blood transfusion after penile prosthesis placement is extremely rare to nonexistent.

(4) Post-operative pain is variable and can be minimal, but in most men it is quite significant. Your physician will provide you with adequate pain medication to help control the pain, but not necessarily eliminate it entirely. As the prosthesis heals, there will be complete resolution of the pain such that you will typically not even be aware that the prosthesis is within your body unless you were to touch it directly. Complete pain resolution will most commonly occur within 4–12 weeks postoperatively. Post-operative pain is typically managed with oral narcotic agents. You should be aware that these drugs can cause constipation as well as sleepiness and you therefore should not be in any position where you might need to make important decisions or drive until the pain is under better control without the need for narcotic pain-killers. It is recommended that during the first several days after the operation, you spend as little time as possible on your feet as this will encourage healing, reduce swelling and result in more rapid resolution of pain.

(5) Loss of length—Penile shortening is probably the reason that most men are disappointed with the outcome from their prosthesis surgery. Studies have shown that when the flaccid penile stretched length is measured preoperatively, that the actual loss of length following placement of the prosthesis is on average no more than one centimeter (1/3 inch). To reduce the likelihood of loss of length, the surgeon will do his best to place the proper size device that fits your penis. You can expect that the length of your penis will be much like what you see when you grab the head of the penis and pull it straight out away from your body. Many men who believe they have lost length in their penis following prosthesis surgery in fact did not really lose length because of the surgery, but rather because they have not had a full erection for some time during which there may be some loss of tissue elasticity and thereby shortening of the penis. In addition, they may have gained some weight in the pubic area which will cover the penis and make it look shorter. Lastly, they may be expecting that the postoperative result will be like the erections they had when they were a much younger man. Although the goal is to make the penis as long as possible, one can expect that the rigidity of the penis will be much like the erections obtained as a younger man.

(6) Decreased girth—Girth is typically not substantially changed as most cylinders can expand and fill the penis satisfactorily, but if there has been scarring within the tissues of the penis, this can prevent expansion and result in a narrower appearing penis. The surgeon will do his best to put the largest cylinder in the penis, but there are limitations to which the tissues can expand. Decreased girth is not a common complaint.

(7) Sensory loss—By and large the surgical techniques being used avoid injury to the sensory nerves of the penis. Therefore there is rarely any significant change in the sexual sensation of the penis. Some men find that it takes longer for them to experience orgasm. This may occur because they can simply inflate the penis without any sexual arousal, and then it will seem to take longer for them to become aroused, resulting in the prolonged time to orgasm. Therefore, proper sexual stimulation is important to enjoy the entire sexual experience with a prosthesis.

(8) Change in shape—The overall shape or configuration of the penis is rarely altered as a result of placement of any type of prosthesis, but if there is some unidentified scarring involving the penis such as that which occurs with Peyronie's disease, some curvature or indentations including hourglass narrowing can be identified along the shaft. Typically, in the postoperative period, the prosthesis will cause an internal tissue expansion which will correct these deformities. This may take 6–9 months to occur.

(9) Erosion or cylinder extrusion—If the tissues in the tip of the penis are weakened either by previous internal penile disease or as a result of the surgery, the prosthetic cylinder may migrate distally into the head of the penis and may appear to be ready to poke through the skin or into the urethra. By all means, if such an irregularity is seen, you should address it with your doctor before the prosthesis is exposed so that it can be corrected without developing infection. This problem occurs in <1% of cases.

(10) Pump problems—These include difficulty in activating or deactivating the pump as well as change of pump location due to migration or fixation of the pump to the scrotal skin. These problems are also quite unusual but can happen as a result of an altered healing process or a malposition of the pump by the implanting surgeon. If the pump were to migrate or become fixed or difficult to manipulate because of its position, a simple outpatient scrotal procedure can be performed to reposition the pump which is almost universally successful. This procedure is performed in no more than 1% of cases.

(11) Prosthesis care—In the postoperative period, it is best to take the antibiotics prescribed by your physician, reduce your physical activity to reduce swelling and enhance healing, take pain medicine for your comfort, and avoid submerging the incision during bathing for a minimum of 1–4 weeks. Specific bathing instructions will be issued by your physician. It is not uncommon to have an inflatable prosthesis partially fill during the postoperative period involuntarily. This is called ‘auto-inflation.’ To prevent this problem, it is important that once the prosthesis is activated, which is typically 4–6 weeks after surgery that you perform what is known as ‘cycling’ of the device. Cycling means complete inflation and then complete deflation of the penile cylinders twice per day for one month. In doing this, the tissues around the prosthesis are softened and stretched allowing complete deflation of the device into the reservoir. It also will allow you to become more familiar with operating the device and make it easier for you to activate it quickly and inconspicuously when you want to engage in sexual relations. If you have an inflatable device with a scrotal pump, it is best to inflate it without twisting it. The repetitive twisting of the pump can weaken the connections between the tubing and the pump and is the most common cause for mechanical failure of the prosthesis.

(12) No erection if device is removed—If your penile prosthesis is removed, for whatever reason, you will not be able to sustain an erection.

(13) Possibility of revision surgery—You may have to undergo additional surgeries if the first surgery is not successful or if there are major complications. Those complications could include infection, tissue problems, erosion or cylinder extrusion or malfunctioning of the device itself.

It is hoped that this review will inform you of the potential problems associated with your prosthesis and as a result, will make for more realistic expectations regarding the outcome.

I acknowledge that:

The doctor has explained my medical condition, the proposed procedure and the risks associated with this procedure, including the risks outlined above. I understand the risks of the procedure, including risks that are specific to me, and the likely outcomes.

The doctor has explained other relevant treatment options and their associated risks. The doctor has explained my prognosis and the risks of not having the procedure.

I have fully read and understand the information contained in this informed consent form.

I was able to ask questions and raise concerns with the doctor about my condition, the procedure and its risks, and my treatment options. My questions and concerns have been discussed and answered to my satisfaction.

The doctor has explained to me that if immediate life-threatening events happen during the procedure, they will be treated accordingly.

I understand that no guarantee has been made that the procedure will improve my condition and that the procedure may make my condition worse.

On the basis of the above statements,

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Nahrstadt, B. Informed consent for penile prosthesis. Int J Impot Res 21, 37–50 (2009). https://doi.org/10.1038/ijir.2008.63

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