Among the many responsibilities of PAs and NPs (in fact, most healthcare professionals), there will come a point in their patient engagement to address the topic of informed consent. Every patient has the right to get information and ask questions before undergoing invasive treatments and procedures. Regardless of how common, all procedures of a surgical nature have certain risks or benefits and a patient must clearly understand them. Basically, the informed consent is the process of educating the patient concerning your proposed treatment plan. The patient has the right to make an intelligent decision about their health and medical condition after being given the appropriate information.
An informed consent is a written explicit consent and has four principles:
- The capacity of the patient to make a decision. In cases where the patient lacks capacity, the consent can be signed by a family member or custodian or legal guardian.
- A coherent explanation of the expected risks and benefits of the procedure.
- Comprehension, by asking questions and an understanding of the proposed procedure. When possible, the patient should be given a handout that explains any additional information.
- The patient must voluntarily grant consent without coercion or duress. This is sometimes a factor in certain procedures performed by a plastic surgeon or aesthetic provider for treatments such as liposuction, breast augmentation, Botox or intradermal face fillers Considering the highly subjective nature of aesthetic treatments, providers of these elective procedures must be very careful in explaining and not selling by enticement.
The Joint Commission requires documentation of all the elements of informed consent in a form or progress notes. Exemptions to these four principles are emergency care to prevent irreversible harm as well as the aforementioned mental competence of the patient.
It is a well-known fact that patients who are informed and involved regarding treatments have better outcomes.
A Christmas Present or a Sack of Coal
In the last two months, there have been additional guidelines imposed upon surgeons who perform the most popular procedure: breast augmentation. I have spent forty years of my life in surgical practice including full-time office and surgery responsibilities partnering with plastic surgeons. Needless to say, I have seen the good, the bad, and the ugly. The often-used comment by some physicians is “I have never had a complication.” The general response to that statement (offered by other surgeons) is that to make a such a pronouncement is tantamount to having never performed any surgery. ALL procedures have risks for a patient and it is our duty as medical professionals to ensure that the patient is aware of them, no matter how slight.
How should a patient approach surgery? First, they should do some of their own research on the proposed procedure so that they understand its terminology and goals. The patient should research the surgeon, including medical education, fellowships, board certifications and ratings on internet sites. Do not just believe what you hear: research, research, research. Research the facility where the procedure will be performed. The absolute safest is a hospital where there is accreditation from the Joint Commission. Second to the hospital is a certified surgi-center which meets standards on a state and national level and charges less than a hospital for their services. Lastly is a surgeon’s office. This remains the third choice because of conditions of sterility, excess supplies, emergency equipment and medications for rare reactions such as a nightmare called malignant hyperthermia. Ice is one of the essentials in the treatment of MH. When I asked the surgeon about a ready supply of ice in his office, said that he could send out his office secretary to purchase it at 7-11 if necessary. I immediately refused to assist him and left his office quickly. Another extremely important question is, who will be administering anesthesia: a board-certified anesthesiologist – or a CRNA or PA anesthetist? Both require extensive additional education in anesthesia. And, finally (as I have seen this happen) does their office have back-up implants in case one is contaminated, dropped, or damaged?
Why would a patient seek this surgery? The purpose of augmentation is to increase the breast mass, to alter the shape of the breast, to make them more symmetrical. This procedure, for comfort, requires a general anesthetic of between one to two hours. This is not an inexpensive procedure between the hospital, anesthesia, and surgeon’s fees and somewhere in the price is the cost of the prosthesis. Ask who is paying for the implant. Also, there are no guarantees with any surgery but if you are told that you would not be charged anything should a re-do be necessary, get it in writing.
This procedure has temporary side effects and potentially, permanent complications. The temporary side effects, as with most surgery, is some degree of discomfort from swelling and bruising of the tissue dissections. There can be a tightness in the breast and, depending on the site of the incision, a thick scar can develop. Ask the surgeon if the incision will be sub-mammary or peri-areola. What are some of the more permanent problems that require additional surgery? Capsular contracture, implant ruptures. I had a patient call from her honeymoon stating that one breast deflated. This was not a happy bride. There can be silicone granulomas, noticeable creases, rotation of the implant from heavy manipulation which can make a hi-profile implant reverse itself, nerve damage to the sensitive areola, making it more sensitive to the point of being uncomfortable, less sensation from 10% to 100%, infection, requiring removal of the implant, rippling, breast feeding issues, and, lastly, in a very small percentage of patients, anaplastic large cell lymphoma.
The types of implants are silicone which cause less wrinkling but can rupture which means additional surgery to remove the gel and place a new implant. The FDA recommends MRI to search for implant rupture at three years post-operative and then every two years thereafter. Screening MRI is not usually covered by insurance and the lifespan of the implants are ten to fifteen years. Saline implants are also available, but do not feel as natural, tend to look rounded and have more wrinkling, folding and contracture and can totally deflate. The FDA added a Black Box Warning to all implants in the last two months and demand a standardized risk list for all patients to receive.
The reason I chose to highlight this procedure, aside from its popularity, is to underline the critical need for informed consent. If you are a patient with limited financial resources, you could find yourself saddled with additional debt from future procedures; and if you had not been fully informed, you might choose to become a litigant – and sue. Which brings me to my final point. Does your surgeon, physician or current healthcare employer maintain malpractice insurance? If they work in a hospital or a licensed surgi-center, they are compelled to have this insurance but, if they are working in a solo office, they might choose to take the risk of not having an active policy.
Should you as a PA or NP own your own malpractice policy? Do you examine patients? Do you recommend treatment or therapy? Do you perform office surgical procedures such as suturing, pain control, prescribing medications, performing I&D’s, performing excisions of lesions both malignant and nonmalignant? Do you perform invasive procedures in any field including interventional radiology, dermatology, aesthetic treatments such as Botox and fillers? All medical care includes (you) a provider and (they) a patient. So, are you in compliance with the rules of informed consent? If not, investigate your options and seriously consider buying your own quality malpractice protection. Choose a company who specializes in medical malpractice, with top-rated underwriting credentials and customer service.
By: Bob Blumm, PA-C Emeritus, DFAAPA
PA Advisor to CM&F