Experts weigh in on consent

August 21, 2013

Informed consent is a critical element of a strong physician-patient relationship. It is both a legal requirement and an ethical obligation that supports the physician in the face of litigation and protects the patient's autonomy in the decision-making process. An expert panel discusses what specific items are on their consent forms and how often they have patients re-consent when returning for aesthetic fillers or neuromodulators.

This excerpt was part of a full panel discussion on best practices with injectables that took place during the 2013 Vegas Cosmetic Surgery and Aesthetic Dermatology meeting in Las Vegas.

Video courtesy of xMedica

Informed consent is a critical element of a strong physician-patient relationship. It is both a legal requirement and an ethical obligation that supports the physician in the face of litigation and protects the patient's autonomy in the decision-making process. It can, however, be challenging to manage due to time restraints and low patient information retention rates, among other issues. Studies have shown that patients forget as much as 75 percent of information disclosed. Poor recall increases the chance for litigation should complications arise. While consent itself is not absolute protection from litigation, there are best practices that can help to enhance patient care and reduce your risk of fighting a potentially losing legal battle.

Susan Weinkle, M.D., dermatologist, Bradenton, Fla.: 

What, specifically, is on your consent form? What do you think are the important, poignant aspects that patients coming in for aesthetic fillers or neuromodulators need to know? And, do you patients re-sign consent forms each time they return for a treatment?

Amy Taub, M.D., dermatologist, Chicago:         

I do have my patients renew a consent every six months. And on the consent form I have all the major things that can go wrong, although I am going to add blindness now. I think that to be honest, we don't really take the time to go over every single thing on the consent form. 

We talk about bruises, swelling, over-correction, asymmetry, and all the things that we can do to correct that. And I always have my initial patients - or in patients that we are injecting in a new area - come back in two weeks.

So I can't say no that I actually sit there and say, "There's a possible of occlusion of your artery in the middle of your face and you could have terrible pain for two days and we might need to do multiple laser treatments to keep you from having scarring." I think that that would be enough to scare me away. 

But on the other hand, I realize that for instance, when I had a colonoscopy, literally right before I fell asleep on the drugs my gastroenterologist said to me, "I just want you to know there is a 1 percent chance that we could perforate your colon. And I was like - that was really bad timing.  [laughter] I mean, I'm a physician so I know that, but I didn't think that was a good way to consent somebody. I think the best thing would be to really honestly go through every single thing and say, "This is exceedingly rare and we do everything we can to avoid this…"

 

Next: Michael Persky, M.D.: Anything you can conceive of should be on consent form

 

 

 

Michael Persky, M.D., plastic surgeon, Encino Calif.:

That was a great lead in Amy and I agree with everything you said. Practically, it's difficult to go over everything, every possible complication. I think that the medical consent form, no matter what procedure, treatment, or surgery that we do as physicians, is a medical legal document there to protect the physician. There's no worse feeling as a physician - and I'm sure all of us who have been practicing long enough have had some sort complication - where you want to go back to that consent form and make sure that it's written there and that the patient signed and dated it the consent.

I think everything you can possibly conceive of that could go wrong should be on that consent form. I think the injectable companies do a pretty good job of it and I don't know if blindness is on the company's form, but it's certainly on my form. 

Rebecca Fitzgerald, M.D., dermatologist, Los Angeles:      

Yeah I say blindness and death on my consent forms. But what I tell patients is that if I really thought they were going to go blind and die I wouldn't do this all day, every day, for a living right? And then I tell them that there's inherent risk in everything. It's a lot like driving a car. Everybody's going to eventually get in a fender bender, but there are very few head-on collisions. The fender benders are the obvious stuff and the head-on collisions are blindness and death that are very unlikely to happen. But it's a risk, and if they're not willing to take any risk whatsoever they shouldn't do it.

I say it like that just because: You know who 95 percent of the crazy people are the minute you get your hand off the doorknob. It's those 5 percent that get you. So if I say that in kind of a stern voice in their face, if I can see them sort of break then I don't really want to treat them. It's just another way to divide who are the safer or more reasonable patients?  They do have to know but, patients are in a highly suggestible state when they sign a consent form. So I'm not talking about just a little anxiety. It's normal for everybody to be a little anxious. But I'm talking about the person who reads it line by line, wants to discuss the whole piece of paper, is flipping the sheet. "What about this one here that says...?" That does us a favor, right? It's just a way to look at who might not be ready to do those procedures.

I think the length of time consent lasts varies from state to state. The staff watches that date, and whenever the date expires then we do it again. You can call your malpractice company and they'll tell you.

 

Next: Ben Bassichis, M.D.: We have separate forms and patients sign at every visit

 

 

 

Ben Bassichis, M.D., plastic surgeon, Dallas:   

We have separate consents for neurotoxins and HA (hyaluronic acid) fillers. And we have a separate consent for the other fillers we do. We have patients sign every time: If they're going to do one filler one time and they do a different filler the next visit, they're going to sign a new consent. It goes over what we’re going to do, and it offers documentation that, in the event there is a complication, there is a signed consent for that particular visit. I think it just gives one more level of defense. So if I inject three different products in one visit, we’ll circle which products we're injecting, where we're injecting. We have the complications in bold (print) that they have to initial, which includes blindness. And they also sign at the bottom of the form.  So they initial the section that has the complications in bold.

Welf Prager, M.D., dermatologist, Hamburg, Germany: 

Before the malpractice companies will insure a new procedure, they require from the doctors, who perform the procedure to supply the informed consents for these treatments. There are organizations in Germany that distribute these inform consents. They make sure that all new legal issues are within these informed consents. I only use them, because they cover all the important issues. In our informed consents, blindness is included and I think that's a really important point, and it should be on the informed consent. 

Derek Jones, M.D., dermatologist, Los Angeles:

We have patients re-sign their consent each time they come in. The company-provided informed consents that I've seen in the U.S. are generally not as comprehensive as I'd like to see them. Blindness has been reported frequently enough in the literature that it should be on there.

Just as a quick note about how blindness happens, because it's kind of a hot topic these days: It is probably caused by accidentally injecting under high pressure into arteries in the glabella region and into facial artery branches in and around the nasal sidewall and dorsal nose, which causes retrograde flow to the retinal artery. Products with a very high G-prime and particulate products may carry a greater risk. Preventative techniques include a slow injection speed and a masterful knowledge of facial arterial anatomy.

 

Next: Michael Kane, M.D.: Slow flow rates can reduce embolic phenomenon

 

 

  

Michael Kane, M.D., plastic surgeon, New York:   

I think embolic phenomenon theoretically can be greatly reduced, if not eliminated entirely, by slow flow rates. It's all about high flow rates when you’ve cannulated an artery. That being said, I've been in practice 22 years, and every consent that I’ve had has included blindness and death. But I think it's more of a moral issue than a legal issue. Even if you had that in your consent, if you inject someone and they go blind they're probably going to win. It doesn't matter if it's in your consent. It doesn't matter if you talked it over with them. They're probably going to be compensated. To me, it's more of a moral issue. I don't know if I could continue to practice if someone went blind. To me it's more about telling them that it's possible but extraordinarily unlikely. You've never had it your practice and you will do everything possible to make sure that doesn't happen.  

Susan Weinkle, M.D., Bradenton, Fla.: 

I think we could say unanimously that we all feel quite strongly that the issue of blindness does need to be included in the consent form. You need to check with your malpractice company to find out how often you need to re-consent even when you're doing the same procedure with that patient so that we all know that we're working within what our regional variations may be.