Informed consent ensures patients understand risks, benefits of permanent fillers

Clinicians who are using permanent fillers in their practice should take a more exhaustive approach to the informed consent process with their patients, according to a member of the Ontario council for the Canadian Medical Protective Association.

"Physicians should approach them (fillers) with a higher degree of caution if there is a permanent implant element to the material, simply because the remedy for an outcome that is less than satisfactory can be extremely difficult," says Bryan Callaghan, M.D., F.R.C.S.C. (Fellow of the Royal College of Surgeons of Canada), a plastic surgeon with Callaghan Plastic Surgery in Ottawa, Ontario. Dr. Callaghan spoke at the Aesthetic Plastic Surgery Symposium in Toronto in April.

"Any implant fillers that contain a permanent result need to be approached with a higher degree of caution, and perhaps would entail a more elaborate form of informed consent," Dr. Callaghan says. "We need to set the bar higher and need to have a far more detailed discussion with the patient in terms of informed consent."

TAKING PROPER CARE According to Trevor Born, M.D., F.R.C.S.C., a plastic surgeon with offices in Toronto and New York, "Injectable substances have a high degree of safety, but much harm can come if proper care and consultation are not performed."

Dr. Born urges physicians to buy products from a direct representative of a company that manufactures or distributes the product, rather than purchasing products from a third party or online retailer, to avoid purchasing counterfeit injectable products. Additionally, patients can take steps to make sure they are being administered real products.

"Patients should ask to see the packaging, expiry and labels/stickers on the vials and syringes," Dr. Born says. Moreover, "All products must be FDA (Food and Drug Administration)-approved. Both the physicians and patients put their insurance at risk if they do not follow the proper guidelines," he says.

MONITORING RESULTS Injectables and fillers — in fact, noninvasive medicine in general — is becoming a larger element of aesthetic medicine because of several factors, such as the fact that they pose less disruption to lifestyle, are more accessible and are attractive in terms of their price point, Dr. Callaghan says. As the use of injectables will increase, it stands to reason that there will be a spectrum of results from their use, he says. As a matter of course, clinicians should attempt to be more systematic in the measurement of their results, both short-term and long-term, to monitor outcomes with their patients.

"We are more and more convinced we can learn a great deal if we can track our outcomes over a certain amount of time, and thereby, we can inform the manufacturers and patients if the product is delivering what it is professed to deliver," Dr. Callaghan says. "Unless we measure the outcomes over the passage of time, we don't learn as much as we could about the performance of some of the products, like injectables and fillers."

While Dr. Callaghan did not propose a specific timetable for following up on patients who have undergone injections with filling agents, he suggests that patients be monitored for their progress at three months, six months, one year and then at two years.

In addition, clinicians should set a "very realistic range of expectations" so that patients appreciate what is and what is not attainable with aesthetic medicine. "A physician has to be an educator, and I think the role of the physician is to keep the expectations of patients within a realistic range," Dr. Callaghan says. "You have to be really forthright about what these products can do and cannot do."

Patients can opt to either complain to regulatory bodies if they are dissatisfied with the results of aesthetic procedures, or make a legal claim to seek financial redress through civil litigation, Dr. Callaghan says.

The Physicians Coalition for Injectable Safety (Garden Grove, Calif.), an organization dedicated to informing the public about injectable cosmetic treatments, encourages patients to report any perceived symptoms, beyond a few days' post-injection, to their treating physician.

OFF-LABEL, SAFETY ISSUES There is no doubt that off-label use of products — such as products being injected in sites other than the face when the FDA-approved use is for injection in the face — is practiced in aesthetic medicine. Dr. Callaghan says even when aesthetic medicine products are employed in an off-label fashion, they have likely moved into the realm of a safe, acceptable level of care, despite not yet being met with regulatory approval.

"I think a jury of expert peers would determine what is an acceptable standard of care," Dr. Callaghan says. "In the event of a complaint or issue, I think that is ultimately how off-label use would be judged. I think they would measure what is safe and acceptable for a colleague with the same training faced with the same circumstances and same conditions."