Home > Business of Medicine, Gynecology, Rants and Raves, Surgery > On the Surgical Consent Process

On the Surgical Consent Process

Today I saw a patient for a preoperative visit and went through the ritual of “informed consent” and the signing of the surgical permit.   We had decided to do a hysterectomy to treat her problematic fibroids, and she very much wanted to proceed.  Having discussed the alternatives, we now had to go through the legal ritual of the surgical consent.

As usual, I discussed what we could expect to gain from the hysterectomy.   There was a 100% chance that she would no longer have any bleeding, and a very strong chance that any pain that originated in her central pelvis would get entirely or mostly better.  Anemia that resulted from the bleeding would improve. Other symptoms, like urinary pressure and frequency, and lateralized pelvic pain, would likely improve though it is not as strong a likelihood as the other symptoms.

We also discussed the risks.   “You could have bleeding during the surgery, potentially enough to need a blood transfusion before or after surgery.  You could get a communicable disease from a blood transfusion.  You could develop a wound  infection or abscess, which sometimes is easy to treat and other times quite complicated.  Anything in the abdomen could be damaged during the surgery, such as the bowel, bladder, ureters (“which carry urine from the kidneys to the bladder” I always say), blood vessels, or other structures.  Anything damaged can be fixed at the time by myself or a consultant.  There is a possibility something could be damaged but we do not recognize it at the time, or that there is a delayed injury.  If this occurs you might need further surgery, antibiotics, or hospitalization.  Though extremely rare, you could die or be injured from an unforeseen surgical complication or complication of anesthesia.”

At this point she looked white as a sheet, as usual, and then I tempered with “but all of this is extremely unlikely, less than 1% of cases for major issues, and I have to explain it all for legal reasons.  I am well trained to do this surgery and will do my absolute best for you.”  I answered her questions, the consent is signed, and we had our pre-op.

While this consent process is quite standard, it just seems a little ridiculous to me.  Its a bit like asking your neighbor bring your son home from school, and having her say “we may get hit by another car, I might run a red light, we may run out of gas on a train track, there might be a meteor that hits the car and kills us all…. but don’t worry I am a good driver and your son will be fine.”

The fundamental reason we do these consents is that we believe that in some way they will protect us in a lawsuit if something bad happens.    For example, let’s say somehow I transect a ureter in my patient’s hysterectomy, I can say “See – I said this was a risk of the surgery… it wasn’t my fault!”

But isn’t that a bit ridiculous?  Is telling somebody that something bad could happen actually a defense if that bad thing does happen?  In some cases a problem is truly random, such as the development of a pelvic abscess after a hysterectomy, but in other cases it is not.  There is almost no situation in which I could cause a ureteral injury and have it not be a surgical error.  If it happens, I did it – and it was a mistake.  Ureters are damaged in about 1% of hysterectomies, but its not like they magically get injured in 1% of cases.  In 1% of cases the surgeon makes an error.

When I was a resident I worked with one attending that thought along these lines as well, and had a very different consent process.

“We are doing X surgery because of X.  I’m a good surgeon, and think I can do this surgery without a problem.  You need to sign this paper or the hospital won’t let me operate.  I think it will go well, but anything can happen, and if it does and you think its my fault you can still sue me.”

This all seemed very glib the first time I heard it, but I have to say I have always had a lot of respect for that attending’s honesty.  He was telling it like it really was, even though it wasn’t necessarily the smoothest way to go about it.   He was indeed a very good surgeon.  His partners thought he was a bit nuts, though.

The trouble with the standard consent process is that it doesn’t deal with the real issue; errors do occur, and physicians cannot be perfect.  By naming error-driven events as statistical occurrences, the process supports an expectation that surgeons will never make errors, and thus the corollary that any surgical error is a de facto breach of physician’s fiduciary duty.

Every time I do a standard consent process, I think about doing it differently.  Perhaps something like this:

“We are doing X surgery because of X problem.  I am well trained to do this surgery, and think I can give you a great chance at an good outcome.  Your surgery is something I know I can do well, but I cannot guarantee that you will not have a problem.  I can only guarantee that when I do your surgery I will be well rested and that my team and I will do our best.

Sometimes when bad things happen during or after surgery it is a random event.  There are certain things we can do to reduce these events, and we will do those things.  Another kind problem can be because  a member of my team or I makes a technical error.  While I do my best to operate perfectly, it is possible that I could make a mistake.  I have occasionally done so in the past, and will no doubt do so again in the future.  As I have always learned a great deal from these rare mistakes,  I hope to think I will never make the same error twice.  Fortunately, almost every error is recoverable, and I know how to make those recoveries.  If we have a problem, I will be there to fix that problem and help you through whatever recovery is necessary.  I will explain the problem to you, and if I know, I will explain how it happened.

(now sign this paper or the hospital won’t let me operate :) )”

I often wonder if the common legalese consent process we go through actually protects us.   Ultimately, we are bound to meet the goal of “The Standard of Care”, and we don’t get to define that standard on our consent form.  Lawyers love to say that this standard is readily viewable in any textbook, but in reality its pretty grey.  The exact definition changes from state to state, but usually is defined as what another reasonably practicing physician of similar training and situation would have done in the same situation.  Fortunately, reasonably practicing physicians of similar training and situation also make mistakes from time to time, and usually lawyers and juries recognize that.  As long as one recognizes the mistake and does the right thing from there forward, usually one has a reasonable defense.

So let’s just say that up front.  We are well trained, and we do our best.  If we screw up, we’ll let you know that, and we’ll fix it.   Now sign here.

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  1. kc
    June 20, 2011 at 2:10 pm

    (Qualification: I’m not an MD… but rather one of those ‘fake’ doctors – PhD in molecular biology)
    I think that most people (the general publich) not only aren’t trained to know what possibly could happen if something goes wrong in a surgery, but in fact also usually think that doctors (especially surgeons!) are ‘gods.’ I think it’s important to be upfront about all the possible things that could go wrong (for whatever reason) because how else is someone supposed to understand that there is risk involved? It’s not like they’ve had training in risks and complications of hysterectomy. It’s quite a bit different than the analogy of a neighbor driving your child home from school – risks of driving a car are common knowledge, however the risks of a hysterectomy surgery… yeah, most people off the street probably don’t even know what a hysterectomy is.

  2. Beagirl
    June 20, 2011 at 2:31 pm

    If the reason you’re doing consents is to protect yourself from a lawsuit (as you state in your piece), you are missing the point of consents entirely and it explains why informed consent is a sad, sad joke in OB/GYN. The point of a consent is to tell me what my options are and help me understand my risks, so that *I* can make the best decision for myself. But look at VBAC. Women are told that they are not “allowed” that it’s “illegal” or that, sure, they can *try* if they want a dead baby. Similar horror stories around first deliveries. “I’ll have to break his collarbone to get him out, he’s so big.” “Your placenta is getting old and your baby will die silently in utero if you don’t consent to an induction.” In my own case, I nearly had an unconsented episiotomy – the doctor didn’t even bother to inform me of her intent to cut.

    Bottom line: if your intent is not meaningful, none of your conversations around consent will feel meaningful either.

    • June 20, 2011 at 2:52 pm

      I appreciate the comment, but I think we’re having a bit of ‘lost in translation’ here. There are really two different concepts going on here. You’re talking about the concept of going over the risks and benefits of the various options and having a conversation of what the best course of action is. This process is a core part of medical care, but isn’t really what I’m talking about. This is ‘informed consent’, but isn’t the same as the formalized ritual of signing the surgical consent, which is what I’m talking about.

      Admittedly, my post is a little inside baseball for the non-docs. What’s I’m talking about isn’t really about doctoring – its about medicolegal risk. If it wasn’t, there would be no need to write it down. We don’t even get to what I’m talking about until we have decided what we’re going to do.

      • Gene Rosov
        July 6, 2011 at 3:21 am

        Dear Dr. Fogelson: I’d like to send you a PowerPoint about a telephonic informed consent system that has been in use in ob/gyn for nearly five years. It effectively provides for bi-directional information; drives good patient-physician interaction on the key areas of concern, and provides a legally secure and appropriate document which proves the details of patient understanding, interaction and acceptance. If you like, I will happily forward it to you (or anyone else). It is currently used extensively by a professional medical liability insurer, and an major hospital. And…best… it is extremely inexpensive, and saves an estimated 100-200 hours annually of physician time. Sincerely, Gene Rosov, CEO – Obstetricians & Gynecologists National Association. 305 666-6703 ext. 1#; erosov@gmail.com

  3. June 20, 2011 at 3:15 pm

    My understanding, as a lawyer, is the reason the law started requiring “informed consent” was the “problem” of paternalistic doctors (I have problem in quotation marks because I have no opinion on whether this was an actual problem or merely a claim some clever lawyer snookered an appellate court into accepting). Such doctors would assume they knew what was best for the patient and therefore would downplay risks associated with the recommended course of treatment. Informed consent is designed to prevent such paternalism.

    Of course the end result is we now have prescription drug commercials that spend more time listing the potential adverse side effects (“erections lasting more than four hours!!!!”) than they spend explaining what the drug actually does. Further, since most patients lack the ability to understand fine distinctions in probability (tending to discount higher probability risks that are in their control to prevent while overvaluing low probability risks that are out of their control) they tend to do whatever their doctors recommend anyway.

  4. June 20, 2011 at 3:40 pm

    I must say, Gregory, those pharmaceutical commercials are hilarious! With the small print at the bottom, and the smooth-talking guy talking at break neck speed about all the possible consequences (“heart attacks, strokes, excessive bleeding” and yes,even “erections lasting more than four hours!!!”), I’m terrified just listening to all the possibilities. I don’t even know what the medication is called nor will I, or my husband, ever take it! It’s almost like a “Saturday Night Live” commercial.
    Anyway, about informed consent, as a patient, if I was that 1% that did suffer from an error or, “well, this just happens sometimes,” at least I would know that I was warned. I really do appreciate being informed of the risks. I’m just a little weird like that. (And I get a hoot out of those commercials, too!)

  5. mamasnail
    June 20, 2011 at 4:30 pm

    Dr. Fogelson, I appreciate your honesty. I agree that in my personal experience, at the point in which it was necessary for me to sign a surgical consent form for my laparoscopic BTL, the standard process of reciting all possible complications was ridiculous. My youngest child was 14 months of age, and I’d given myself plenty of time to consider all of my options. After meeting with three surgeons, I’d chosen the one with whom I felt most comfortable. My decisions were already made. Signing a form was a mere formality.

  6. June 21, 2011 at 10:49 pm

    I always assumed the informed consent was also at least partly about just plain old informing the patient. That’s why it bothers me that epidural consents are usually done with the mom writhing around on the bed, not listening to a single word that’s said. (I once saw a mother snatch the consent out of the doctor’s hands and sign it while he was in the middle of his spiel, because she was in no state to listen to him, then the interpreter, recite the risks.) Then when I see someone in postpartum who can’t sit up for an epidural headache, they say “I had no idea that could happen”. I think if you went over the risk of epidural headache with those moms and they clearly understood the risk, 99.9% would still get an epidural just as readily, and that’s fine. But if it does happen, I think it helps them cope that it’s not totally out of the blue. I think there’s value in the informed consent beyond the legal niceties, if done correctly, for the people who do have complications.

  7. Susan Peterson
    June 22, 2011 at 5:50 pm

    When I worked as a nurse, doctors routinely had us get the patient to sign the consent, rather than doing it themselves. We were told in nursing school that this was wrong, but it was common practice. Mostly they signed without reading the form. Mostly this was for procedures like a colonoscopy under conscious sedation, not for a surgery, but sometimes it was for amputations of a foot or lower leg which had to go due to diabetic ulcers which had become gangrenous, or led to osteomyelitis. For the amputations the patients would ask a lot of questions they hadn’t asked the doctor when he stopped by to see them, not all of which we knew the answers to. We also had to deal with the patients’ fear and grief, which I suppose is one of the jobs of nurses, but we always suspected the doctors didn’t hang around to answer questions because they didn’t want to deal with the patient’s emotions.

    Then there were the situations where doctors came and performed minor procedures and then told us to get the consent for them. As in “Here’s some synovial fluid from 304’s knee; it has to go to the lab right away, And here’s the consent for him to sign.” (I was particularly pissed with this doctor because he was forcing his vial and his paper on me, while I was dealing with a confused elderly woman who had come to the door of the room naked and was in danger of slipping in her own pee and falling, and he acted as if I should let go of her to attend to his consent and his vial.)

    All I can say is that if you, the doctor, spend the time with the patient, explaining, listening, answering questions, and even in some cases dealing with his-or her- feelings about the operation. your chances of being sued are reduced by much more than just the signature on the form.

    Susan Peterson

    • June 23, 2011 at 2:19 am

      Well said.

      • July 3, 2011 at 5:23 am

        Susan, I agree with Dr. Fogelson. Your last paragraph says it all. Its called the doctor-patient relationship and used to be the foundation of good medicine ala Marcus Welby for those of us old enough to remember. Kindness and honesty not only protect against a law suit but provide the patient with a sense of trust and safety that help in the healing process. Maintaining a personal relationship has become much harder with the managed care model, the use of hospitalists who don;t know you, the creation of shift based medicine and all the micromanaging from the administrative and regulatory side. Likely the next phase in the depersonalization of medicine and the informed consent process will be preformatted computerized modules and lengthy checklists complete with links that patients will have to complete before even the simplest of procedures. Sigh!

  8. Marianne
    June 23, 2011 at 9:27 am

    I think your point might have been lost to us interested outsiders… While I understand the comparison with having an accident while taking the neightbour’s kid… yes, in that case it is common knowledge that that can happen. In medical procedures, however, all needs to be said, and it needs to be in writing so some doctors won’t abuse it.
    While I easily get lost in medical jargon I am intelligent enough to understand statistics and I don’t appreciate fluffing over dangers. I’m happy to assume the risks for a good reason (doing stuff but running the risk of a car accident) but if I had the money I know some one I’d sue for a D&C I probably didn’t need, and which caused me great anxiety afterwards. Even if I lost it’d be worth it to give that doctor a bit of a fright and make her think a bit more how she handles these things. And no, I’m not normally vindictive and I’d never sue about a normal, understandable error. But after that I’m reading everything I can get my hands on so doctors like her won’t do stuff to me unaware of the potential risks and benefits. I shouldn’t have to mistrust them but that’s how it goes… :(

    • June 23, 2011 at 3:32 pm

      The point is not to fluff over dangers. One discusses them when one discusses what one is going to do. The signing of the formal consent after this discussion already happened is what I am talking about. This process isn’t really part of the decision making process, it happens after the decision has already been made. It is a legal ritual designed to document that the doctor has written evidence that the patient understands the risks of surgery.

      Sorry you had a bad experience with your doctor.

  9. Marianne
    June 23, 2011 at 10:33 pm

    Fair enough… any ideas how that may best be done, taking into account not all discussions may be extensive enough? I’m still not sure I get your point.

    Thanks for the sympathy about my *ex*-doctor ;)

  10. June 28, 2011 at 3:36 am

    An absolute pleasure to read. A nice blend of real life healthcare with an intellectual twist.

    I just wanted to add that avoiding lawsuits no doubt is helped by carefully explaining options, risks, etc. before getting signed consent. But equally important is the relationship factor. As one nurse pointed out in her comment, if a doctor takes the time to connect with the patient and show empathy and explain “stuff”….that will go a long way in protecting the doctor. Even if something goes wrong, the patient might just say “how can I sue that nice doctor…it clearly was an unintentional accident, etc.”

    May all your surgeries go smoothly!

  11. Kristy
    June 30, 2011 at 7:48 am

    That type of honesty and integrity are *exactly* what I’m looking for in a surgeon (in particular, and in a health care provider, in general). Tell me what could happen randomly and tell me what could happen if you make a mistake that you can’t recover from. I’m a big girl and I understand mistakes happen. Don’t sweep that stuff under the rug as if it’s a random event.

    Too bad “you” (collectively) can’t be so forthcoming, and “we” (again, collectively) are looked at as if we’ve got three heads when we try to solicit such a response. Sad, sad state of affairs.

  12. August 11, 2011 at 2:58 pm

    wow, your attending during your resident was truly an honest man … and brave too.. never heard a surgeon saying like that.. from the patient point of view , it gave them a lot more comfort , respect and confidence to the doctor… hope there is a lot of surgeon like that now….

  13. November 15, 2011 at 3:31 pm

    I am new to reading your blog, but really enjoying it! The issue of “informed consent” is really an issue here, in the United States. I’ve worked in Russian hospitals (as a midwifery apprentice and as an anthropologist) and in Canadian hospitals (as a doula) and their approaches were so very different in tone and feeling! There was no informed consent process in the Russian hospitals (in 2000-2001) and the process in Canada felt much more like what you describe at the end of your post: a friendly chat.

    I can’t wait to read more of what you’ve written and I’m so grateful that you are taking the time to share your experiences with those of us who are so, so curious to read about them.

    I am posting a much longer response to this at my blog: http://www.thebirthmuse.wordpress.com

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