The Risks of Offering Botox in Dentistry: A Legal Perspective

In the increasingly competitive profession of dentistry, dentists search for an edge to set them apart. Botulinum Toxin, or Botox, is marketed as a way to increase patient traffic to the dental office by providing them with additional aesthetic and therapeutic dental treatment options. However, the use of Botox in dentistry carries additional risks that are unknown to many dentists. Dentists should be aware of the unique risks with Botox use in dentistry.

The Risks

As a preliminary matter, the use of Botox in dentistry is subject to compliance with the definition of dentistry found in Section 6601 of the New York State Education Law. Section 6601 defines the practice of the profession of dentistry as diagnosing, treating, operating or prescribing for any disease, pain, injury, deformity or physical condition of the oral and maxillofacial area related to restoring and maintaining dental health. The practice of dentistry includes the prescribing and fabrication of dental prostheses and appliances and may include performing physical evaluations in conjunction with the provision of dental treatment.

Further clarification of the use of Botox in dentistry can be found in written opinion from the New York State Board of Dentistry. In that written opinion the Board essentially provides three basic pieces of guidance on the use of Botox in dentistry:

• The Education Law does not prohibit a New York State licensed dentist from using Botox and collagen in the oral and maxillofacial area, consistent with Section 6601, as long as it is related to restoring and maintaining dental health.
• The dentist must be competent to provide such services.
• A dentist’s use of Botox solely for cosmetic purposes or beyond the scope of competence can constitute professional misconduct and subject the dentist to licensure proceedings as well as the imposition of fines.

Contrary to popular belief, the FDA has not approved Botox for specific uses in dentistry. Its use in dental treatment is off label. Some of the accepted uses of Botox as part of a restorative or maintenance related dental treatment plan include:

• Bruxism
• Temporomandibular Joint Disorder
• Orofacial Myofunctional Disorders
• Sialorrhea (excessive salivation/drooling)
• Facial pain and trigeminal neuralgia
• Oral and maxillofacial trauma
• Denture wearers (Botox can be used in such patients struggling with getting used to a new set of dentures due to irregular and uncoordinated muscle activity) 

There is no exclusive list of accepted therapeutic or cosmetic uses for Botox in dentistry. This, plus the lack of FDA approval specifically for dental applications, makes its use subject to regulatory compliance issues and increases the risk of professional misconduct charges and malpractice allegations.

Some of the specific malpractice allegations that a dentist may face include:

• Claims of incompetence in using Botox due to the dentist’s lack of training, incorrect dosing or improper injection site.
• Lack of informed consent because of a failure to disclose information like side effects, possible adverse reactions that could be permanent, as well as its non-FDA approved status for dental treatments.
• Advertising liability in the case of marketing that included guarantees, statistics or success claims.

Lastly, allegations related to the use of Botox may fall outside the scope of professional liability insurance coverage, including allegations related to the use of Botox outside the definition of dentistry or in the case of guarantees made to patients.

General Conclusions

As part of a restorative or maintenance-related dental plan, dentists can use Botox to treat dental patients. However, dentists cannot use Botox solely as a cosmetic treatment of patients. In addition, even when properly used by dentists, Botox poses increased risks related to competence, informed consent and advertising liability. Dentists need to be aware of these risks and should talk to their professional liability insurer before beginning to offer Botox treatments.

For more, read a case study on the use of Botox in dentistry. Stay tuned for a forthcoming and in-depth claim analysis involving the use of Botox in a non-FDA approved setting.

Got questions about Botox in dentistry? Policyholders can contact our team of risk management professionals 24/7 at no additional cost by calling (844) 667-5291 or emailing hotline@tmglawny.com. For more resources for dentists, visit the MLMIC Dental blog, The Scope: Dental Edition, Dental Impressions and our Twitter and LinkedIn pages.

Photo by Diana Polekhina.