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SAFETY CWW Member Feature Outranks Convenience and Social Acceptability in Aesthetic Medicine

It has been said that the 21st century is the “Information Age” and the “Age of Information Overload.” How many times have you heard people say “just because you can find it on the Internet doesn’t make it true or credible?” Mass marketing and easy information accessibility provides consumers with countless medical choices, too many of which leads to confusion and potentially harm. “The naïve consumer fails to recognize that the majority of available information on the Internet seeks to manipulate, rather than educate.” (Kim, 2006)

As such, today’s consumer has a number of potential venues to obtain facial rejuvenation procedures: the traditional Medical Aesthetic Provider’s (MD, NP, RN, PA) office; Medi Spas; “Botox parties” (Perry, 2013); and “Pump parties” (procedures are performed at homes, malls, trade shows, etc.). The latter two options, namely, “Botox and Pump parties,” while growing in popularity, convenient, fun, socially acceptable, and potentially a lower cost option to obtain treatment, should cause Medial Aesthetic Providers and consumers to reflect on one of the central tenets of the medical profession: “do no harm.” The injection of neurotoxins (e.g., Botox, Dysport and Xeomin) and dermal fillers (e.g., Restylane Silk, Juvederm, Belotero, Voluma) is a medical procedure.

Medical procedures must be performed by trained and experienced Medical Aesthetic Providers equipped with the appropriate license, and the recipient must be fully informed of what the procedure involves and what potential side effects could develop post treatment. The vast majority of medical procedures are performed in a properly designed and equipped medical office for many good reasons; one of the most important is to ensure that proper equipment, instruments, sterility and medicaments are immediately available should something go wrong. While adverse events associated with cosmetic procedures are rare, they do occur. 

Being prepared is the best policy for ensuring safety and “do no harm” is top of mind whenever a facial rejuvenation procedure is performed. There are a number of checks and balances in place to ensure our clients are receiving their treatments as safely as possible. The Food and Drug Administration’s (FDA’s) role is to evaluate how robust the clinical evidence is in support of the efficacy and safety of a new medical device or indication. They also regulate the commercial distribution and marketing of medical devices and biologics but not the practice of medicine.

The medical device and biologic manufacturer’s role is to demonstrate their product is safe and effective and to provide this information to the Medical Aesthetic Provider. The Medical Aesthetic Provider’s role is to: educate their client; consider their client’s request and exercise good medical judgment on the appropriateness of fulfilling the request; utilize the appropriate product in a safe and effective manner; manage client expectations; and follow a code of ethical conduct including maintaining the confidentiality of their clients.

The client’s role is to be informed about the product and procedure they are about to experience, exercise their rights as a patient, and allocate the resources for the procedure and product they receive.  While getting together with a group of friends to receive neurotoxin treatments or dermal filler injections over a glass of wine may sound like a good time, it is important for the client to realize that there isn’t enough attention given to each recipient during ”Botox or Pump parties” as there is during a traditional medical appointment (i.e., thorough analysis includes medical history, medication use, risks, adverse events, etc.). Stepping outside the clinic increases the potential for a suboptimal outcome. Medical Aesthetic Providers have an ethical obligation to educate their clients on how to advocate for themselves when it comes to receiving facial rejuvenation treatments.  

The American Society for Aesthetic Plastic Surgery (ASAPS, 2008) advocates clients considering a non-invasive cosmetic procedure answer the following questions before receiving any treatment:

1. Have you been asked to provide a complete medical history?

A client should fully disclose any medical conditions and medications they are taking including vitamins and over-the-counter drugs. Medical Aesthetic Providers use this information to select the most effective procedure and product, and thereby, minimize the potential for side-effects. 

2. Have you been advised on alternative treatments?

Part of the purpose of a pre-treatment consultation is the thorough evaluation of each client for whatever treatment is being proposed. In the case of neurotoxins, not everyone is an appropriate candidate. For some clients, other treatments or even a surgical procedure may be more effective.

3. Have you been advised of the risks and given your informed consent?

A client should make sure the benefits and risks are fully explained during the pre-treatment aesthetic consultation (Brennan, 2012). Medical Aesthetic Providers use the consultation process to educate clients about the procedure under consideration. Every procedure has inherent risks and benefits; a signed informed consent ensures there is the understanding of risks and benefits, and realistic expectations. 

4. Is a qualified Medical Aesthetic Provider administering the treatment?

While clinical studies have demonstrated cosmetic use of a neurotoxin is both safe and effective, every medical procedure has risks and possible complications. It is imperative that neurotoxins be administered by an experienced Medical Aesthetic Provider who understands facial anatomy, proven injection techniques, and what to do if there is an adverse event. 

5. Is the physical setting appropriate for administering medical aesthetic treatments, including handling emergency situations?

Any aesthetic injectable should be administered in an appropriate setting using sterile instruments and appropriate technique. 

6. Do you know what you are being injected with?

Disturbing reports of clients being injected with everything from liquid silicone to baby oil and other unapproved products are appearing in the press on a regular basis. Similarly, “black market” aesthetic products are making their way into the United States. (Barakat, 2013; St. Louis Business Journal Staff, 2013) Make sure the client confirms that the Aesthetic Injectable products they receive are obtained from an approved distributor and are not a cheaper product claiming to be FDA approved.  

7. Are you willing and able to follow post-treatment instructions?

Neurotoxins and dermal filler treatments recommend the client limit physical activity for a period following the injections. Failure to follow post-treatment instructions can lead to adverse events. In a party atmosphere, clients may tend to forget these restrictions, particularly if alcohol is being served. Clients must also be aware that alcohol consumption will increase their chance of bleeding and bruising. (Brennan, 2013) 

8. Will you receive adequate follow-up care?

Neurotoxin and dermal filler treatments are temporary. Follow-up care is an important part of the Medical Aesthetic Provider-client relationship and should not be overlooked, even when treatment is administered outside of the usual medical setting. “Botox and pump parties,” tradeshows, group venues, etc., may offer a potentially fun and convenient social opportunity for treating many clients in a high throughput manner to reduce the cost of treatment for both client and Medical Aesthetic Provider alike.

But the risks can be high if Medical Aesthetic Providers aren’t at the forefront of client safety and education. Unless proper measures are in place to ensure both safety and effectiveness of treatments, I advise clients to enjoy the party and save their aesthetic facial injections for the Medical Aesthetic Provider’s office.

References

ASAPS. (2008, May 19). Botox “parties” not just fun and games, advises The American Society for Aesthetic Plastic Surgery (ASAPS).

www.surgery.org. Retrieved November 8, 2013 from www.surgery.org/media/news-releases/botox-parties-not-just-fun-and-games-advises-the-americansociety-

for-aesthetic-plastic-surgery#.Un0XLEAB6Tc.email

Barakat, M. (2013). Sales reps plead guilty in imported drugs case. Associated Press. Retrieved November 8, 2013 from http://abcnews.go.com/Business/

wireStory/sales-reps-plead-guilty-imported-drugs-case-20809077?singlePage=true

Brennan, C. (2012). Art of the aesthetic consultation. Plastic Surgery Nurse, 32(1), 12 – 16; quiz 17-18.

Brennan, C. (2013). Dermal fillers and volume enhancers for facial rejuvenation. Plastic Surgery Nurse, 33(3), 118 – 130.

Kim, H. (2006). Wine, cheese and a dash of poison in the forehead: Exploring the evolution of the injectable filler industry and the consequent

implications for regulatory action. Retrieved November 8, 2013 from http://dash.harvard.edu/bitstream/handle/1/9414576/KimA06.html?sequence=2

Perry, A. (2013). I’m having a Botox party! Mail Online. Retrieved November 8, 2013 from www.dailymail.co.uk/health/article-27199/lm-having-Botoxparty.

html?printingPage=true

St. Louis Business Journal Staff. (2013). Doctor gave patients Botox from unlicensed wholesaler, feds say. www.bizjournals.com.

Retrieved November 8, 2013 from http://www.bizjournals.com/stlouis/blog/2013/11/doctor-gave-patients-botox-from.html