Risk is something we are all aware of and manage every day, even though we may not be explicitly aware of it. Did you drive your car to work today? If so, then you accepted the risk of an accident. Further, you accepted the risk of death! However, I bet you did not really consider that risk consciously at the time. Nonetheless, you accepted and then managed the risk by following the road rules and being alert to potential problems.
Everyone else usually does the same, but as we see on the news every night, accidents—and, yes, deaths—occur on the road.
The same issue of risk management arises every time we see a patient, or at least every time we do something to them. There are rules to follow, and we are alert to potential problems, but still, problems arise. You probably have heard the patient say, “If I knew this was going to happen, I would never have had it done.” That well may be so, but if we knew it was going to happen, we would not have done it in the first place. No physician knowingly sets out to harm a patient.
I had an interesting experience recently when presenting a long-lasting filler substance to Canadian and US plastic surgeons and dermatologists. They had no experience with the product, and they raised concerns about its safety. This, of course, is not an unreasonable reaction at all.
However, the nature of the reactions to the safety issue was very enlightening.
Risk Management 101
- An injury that doesn’t happen needs no treatment. An emergency that doesn’t occur requires no response. Avoiding patient complications and injury requires planning, training, leadership, good judgment, and acceptance of responsibility.
- Risk management is so much a part of our lives that often we hardly notice we are doing it.
- Consider all the available information about the technique and technology used in a particular procedure, and then make decisions that keep risks at acceptable levels.
- You cannot eliminate risk completely, but you can manage risk by identifying its sources, understanding its boundaries, and tailoring your behavior to minimize exposure of your patients to danger.
- A critical aspect of risk management is to let your colleagues, mentors, and other professionals know when you are having difficulties or are aware of a concern that might affect you or your patients. You must overcome any natural tendency to keep things to yourself.
- Risk management is not built on a list of rules, but rather on good judgment and a willingness to accept responsibility for one’s own safety and that of others.
EDUCATION AND TRAINING
One response from an Italian surgeon friend and colleague was that he did not feel this product should be made available because he was concerned that doctors would not appreciate its potential for problems. In addition, he was concerned that physicians might start using the product widely before they had opportunities to get proper training in its use. Worse still, there might be some physicians who would simply ignore the training opportunities.
Using a potentially difficult product the same way as other fillers, without appreciating the need to be discerning about patient selection and technique, is not any way to manage risk. In fact, it is a recipe for disaster.
This is a very valid response in this situation, and it reflects a caring appraisal of the risk to patients. This risk issues can be managed by education and training.
For example, being somewhat restrictive about the supply of the filler preparation in question, as well as ensuring both proper education in patient selection and techniques of use, can help to manage risk in this case.
However, I must reinforce the fact that there is always a risk.
The second reaction was more commercially based. A physician was concerned that the long-lasting product would cannibalize his current filler practice and reduce his return rate of patients. Therefore, he felt that the filler product should not be made available to anyone, because even if he did not use it then others might. Again, it might adversely affect his practice.
This is also a very understandable objection to this new product, albeit reflective of self-interest rather than any patient considerations. I have used this product in my practice for 10 years and have not found it detrimental to my practice economics. In many ways, it is a practice builder.
Patients will always search out a new product if they feel it offers them a better outcome. They will come looking, and that can’t be stopped. As their physician, you might see them less often for their filler needs, but if you treat them well they will come see you for other things, as well.
As new products come online, it behooves us all to understand them and their particular place, as well as the nuances of their uses. It is imperative for us all to advise our patients properly about the risk involved in addition to the potential advantages.
A third objection relates to adverse events and how they are managed. With this particular product, the reaction rate in patients is similar to other fillers, including the so-called “safe” hyaluronic acid. When they occur, severe adverse events are more difficult to treat.
Again, it is imperative for all physicians to be able to manage adverse events with whatever treatment they are administering. If some events are outside their experience, then they must have a support network of colleagues to whom they can turn for assistance. One physician who objected suggested he would not provide any assistance to a colleague using this product. What about your professional duty to the patient to assist them in their time of distress?
The final objection was, indeed, objectionable. This particular doctor suggested—no, demanded—that the product be banned “permanently; everywhere.” His reasoning was astonishing: “We should never do anything to our patients that might give them a risk of a permanent reaction… To do so would be a complete absence of ethics.”
While this might be a noble ideal, it is an impossibility. For starters, it would mean that for this plastic surgeon to follow his own dictum he would have to stop doing any surgery at all. What surgery do you know of has no risk attached?
To Prevent Patient Injuries
- Follow their patients complaints to full diagnosis;
- Prepare themselves mentally before procedures; and
- Know when it’s time to consult with a colleague or make a referral.
We know from all of the patient information brochures and informed consent forms of the risks of poor scarring, keloid scars, wound infections, etc. For example, with blepharoplasty there are risks of lag ophthalmos, scleral show, and ectropion. With facelifts, there are risks of facial nerve damage. Abdominoplasty carries a risk of wound dehiscence, severe infection, and necrotising fasciitis. Any general anaesthetic carries a risk of death. How many deaths have there been in the United States from liposuction?
No deaths have been caused by this particular filler, but to suggest it be banned is only valid if the physician who objected applies the same test to every other procedure.
While all the other objections had at least some element of sense or logic, this last one was pompous and nonsensical. How very disappointing that such hypocrisy is dressed up as concern for patients.
When assessing any procedure for a patient, new product, or old and established technique, there are rules to follow in order to minimize risk. Risk is always a factor. There is a clear imperative to properly inform patients of risk and to ensure that plastic and cosmetic surgeons are properly trained in any procedurewe perform.
In addition, we need to take responsibility when things do go wrong—and they will, sooner or later. We must have expertise in managing adverse events or at least have a supportive network of colleagues to assist us and our patients. We need to be prepared to support our colleagues and their patients when things go wrong. To do otherwise is to just throw them both to the wolves. And that is hypocritical, not Hippocratic.
John Flynn, MBBS, Dip RACOG, FRACGP, FACCS, is a past president of the Australian College of Cosmetic Surgery and a current fellow of the College. He is a board-certified member of the American Board of Laser Surgery and a member of the International Society of Laser Cosmetic Surgeons. He can be reached at