Beyond Informed Consent: Breast Implant Patient Decision Aid
Recently, the Food and Drug Administration announced that patients considering breast implants receive more detailed information about potential complications and rare health risks that can occur. The new breast implant guidelines would require that standardized patient decision materials called a Patient Decision Aid or PDA (downloadable here) be reviewed with women to help ensure they understand the involved risks and benefits. This applies for all breast implant procedures, whether for reconstructive surgery after a mastectomy or purely cosmetic.
My first reaction on seeing this was that we have been doing a comprehensive informed consent process for years already! We have always believed that our patients should be thoroughly educated about their choices and potential risks of any surgery. That’s just good medical practice. So why the new tightened focus on breast implants?
What the regulators want is a switch from traditional informed consent checklists, which are seen as too are focused on disclosure and not enough on patient understanding. Informed consent checklists are viewed as having too much emphasis on one-way communication, and often simply a ritualistic formality rather than something truly interactive. They are looking for something that helps to elicit patient goals and informed preferences, and assesses comprehension. (Oh and by the way the guidelines include a checklist of what the PDA is supposed to include, but not a decision aid to ensure that it is used optimally …)
The forgetting curve
I have no doubts that this effort is well intentioned, and that a lot of work based on the latest principles has gone into it. One thing I’ve learned is that a big limitation on the potential inadequacy of checklist-type informed consent is how easy it is for people to forget the important points. Studies show that if new information isn’t applied, about 75% of it is forgotten within a week. I believe that our process is better than whatever these studies were based on, but it’s not like we give our patients a pop quiz before going into the operating room, so who knows.
However well-designed the new breast implant PDA is, it is important to recognize that it too has limitations. For one, the explanation of concepts about various techniques may not align with each surgeon’s approach. I personally feel that the information about under muscle vs over is misleading, at least in the illustration in this particular FDA-sanctioned PDA. And will patients retain the information better? Research indicates that they will, and if so that is a good thing, but it will still rely to a degree on the effectiveness of the communication between surgeon, their staff, and the patient. So pardon me if I don’t show any Public Displays of Affection for this new decree, but know that we will do our best to implement it.