If you are not aware, there are several lawsuits pending regarding Anterior Growth Guidance Appliance (AGGA), also referred to as Oseo Restoration Appliance. On March 2, CBS News and Kaiser Health News aired a damning investigation about the device and the physical, emotional, and financial damage it has caused to a number of patients.
The inventor of the AGGA device promoted it as a cure for sleep apnea. This device is not cleared or approved by the FDA to treat or cure sleep apnea. If you have provided this device to patients, we recommend you contact your patients to assess any side effects they may be experiencing.
We recognize that some patients may assume that the AGGA device is an oral appliance for sleep-related breathing disorders or become skeptical about oral appliances for sleep-related breathing disorders as a result of this news. The AADSM is working closely with its public relations firm, KNB Communications, to ensure you, your patients, the general public, and the media are aware of the differences between AGGA and oral appliances for sleep-related breathing disorders. It is critical to have comprehensive and conclusive messaging, so the AADSM Board of Directors is making itself available for any media requests for interviews or comment.
This situation serves as a poignant reminder of the AADSM's standards for practice and statement of ethics that every member is expected to uphold and adhere to. As a reminder, the AADSM:
- Develops peer-reviewed standards of practice and published treatment protocols for oral appliance therapy to help members provide optimal patient care.
- Recommends that members only provide devices that are FDA-cleared and meet the AADSM's definition of an effective oral appliance to treat sleep apnea.
- Cautions members to not suggest or claim a device can cure sleep apnea.
- Encourages members to deliver care to patients in a manner that demonstrates competence and is within the clinical expertise of the dentist.
- Reminds members that the state licensing laws prohibit dentists from advertising or marketing their services utilizing untruthful tactics or misleading claims.
In addition, AADSM expects all members to adhere to the principles outlined in the American Dental Association's Principles of Ethics and Code of Professional Conduct.
Members who are found to be in violation of these standards and codes of ethics may be subject to disciplinary action as outlined in the AADSM bylaws. |
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