AGGA Dental Device: Mechanics, Controversies, and Safety Concerns

The Anterior Growth Guidance Appliance (AGGA) is a dental device that has come under intense scrutiny in recent years due to a growing number of lawsuits alleging it causes severe harm to patients. Invented in the 1990s by Tennessee dentist Dr. Steve Galella, the AGGA was marketed as a solution for various dental and jaw issues in adults, including temporomandibular joint disorders (TMJ), sleep apnea, and cosmetic concerns. However, the device’s safety and effectiveness have been called into question, with patients reporting devastating complications and experts criticizing its lack of scientific evidence.

How the AGGA Dental Device Works

The AGGA is a fixed palatal expansion device that consists of a metal wire framework attached to the teeth, along with a small disc designed to put pressure on the nasopalatine nerve. According to its proponents, this pressure is supposed to stimulate jaw growth or “remodeling” in adult patients, thereby improving conditions like TMJ, sleep apnea, and jaw alignment.

Patients are typically fitted with the AGGA by a dentist and instructed to wear it for several months. The device costs around $7,000 on average. Dr. Galella claims to have used the AGGA on over 600 of his own patients and has taught other dentists how to implement the device through training courses.

Claimed Benefits and Mechanism of Action

Proponents of the AGGA, primarily Dr. Galella and dentists trained by him, have made various claims about the device’s purported benefits. These include:

• Stimulating jaw growth and expansion in adults
• Improving or resolving TMJ symptoms
• Alleviating sleep apnea
• Enhancing facial aesthetics and jaw alignment
• Correcting crossbites and other bite issues

The claimed mechanism of action involves the AGGA’s pressure on the nasopalatine nerve, which is said to trigger bone remodeling and forward growth of the maxilla (upper jaw). Dr. Galella has described this process as “orthodontics for adults” and claimed it can achieve results that would otherwise require invasive jaw surgery.

However, these claims are not supported by peer-reviewed scientific evidence or clinical trials. Critics argue that the AGGA’s true effect is merely pushing the teeth outward without any actual jaw growth occurring.

AGGA vs Other Palatal Expansion Devices

While palatal expansion is a well-established orthodontic technique, it is typically used in children and adolescents whose jaws are still developing. Traditional palatal expanders are designed to widen the upper jaw by separating the palatal bones, which are not yet fused in young patients.

In contrast, the AGGA is marketed for use in adults, whose palatal bones have long since fused. Experts have expressed skepticism about the AGGA’s ability to achieve true skeletal changes in mature patients. Some have likened the device’s purported mechanism to attempting to expand a house by pushing on the windows, rather than altering the foundation.

Other adult palatal expansion devices, such as the MARPE (Microimplant-Assisted Rapid Palatal Expansion), rely on surgical anchorage to the palatal bones to achieve skeletal expansion. The AGGA, however, is a purely tooth-borne device and does not directly engage the palatal bones.

Controversies, Lawsuits, and Alleged Patient Harm

In recent years, a growing number of patients have come forward alleging severe injuries and complications from AGGA treatment. At least 20 lawsuits have been filed against Dr. Galella, the AGGA’s manufacturers, and the Las Vegas Institute (LVI) which taught dentists how to use the device.

Plaintiffs in these lawsuits claim the AGGA caused a range of devastating dental and skeletal damage, including:

• Tooth loss and mobility
• Gum recession and damage
• Alveolar bone loss (deterioration of the bone supporting the teeth)
• Nerve damage and chronic pain
• Bite misalignment and jaw dysfunction
• Facial disfigurement

Many patients report needing extensive corrective treatments, such as tooth extractions, bone grafts, and reconstructive jaw surgeries, to address the harm allegedly caused by the AGGA. Some, like former professional clarinetist Boja Kragulj, claim permanent disability and loss of livelihood due to their injuries.

Lawsuits allege that Dr. Galella and other AGGA proponents misled dentists and patients about the device’s safety and effectiveness, promoting unproven claims without adequate scientific backing. Plaintiffs argue they were not properly informed of the risks associated with the AGGA and that the device was inappropriately marketed for conditions like TMJ and sleep apnea.

Expert Opinions and Lack of Peer-Reviewed Evidence

Orthodontists, maxillofacial surgeons, and other dental experts have voiced strong criticism of the AGGA, questioning its purported mechanisms and highlighting the lack of peer-reviewed evidence supporting its use.

Dr. Kasey Li, a maxillofacial surgeon and sleep apnea specialist, has called the AGGA’s claimed ability to grow the adult jaw “hocus pocus.” He argues the device simply pushes teeth out of alignment without changing the underlying skeletal structure.

Orthodontists Dr. Neal Kravitz and Dr. Jeffrey Miller are currently studying the AGGA and intend to publish a research paper on how the device harms patients. Dr. Miller, who has served as a paid consultant for AGGA plaintiffs, says he has examined dental scans from at least 30 patients “damaged” by the device, all showing a clear pattern of bone loss around the teeth.

To date, there have been no controlled clinical trials or peer-reviewed studies demonstrating the AGGA’s safety and efficacy for its claimed indications. Critics argue that the anecdotal evidence cited by AGGA proponents, such as Dr. Galella’s own patient cases, is insufficient to establish the device’s legitimacy, especially in light of the mounting patient complaints and lawsuits.

FDA Scrutiny and Criminal Investigation

The AGGA controversy has also attracted the attention of regulators and law enforcement. In March 2023, the U.S. Food and Drug Administration (FDA) announced it was evaluating safety concerns about the AGGA and similar devices, like the Anterior Remodeling Appliance (ARA). The FDA noted it was aware of reports of serious complications associated with these appliances and that their safety and effectiveness for uses like treating TMJ and sleep apnea had not been established.

Notably, the AGGA was never submitted to the FDA for clearance or approval. Dr. Galella has claimed the device did not fall under the agency’s jurisdiction, a position the FDA disputes. The lack of FDA oversight meant that patient complaints and adverse event reports related to the AGGA went largely unchecked for years.

In a significant development, court filings in 2023 revealed that the U.S. Attorney’s Office in Memphis, Tennessee, was conducting a criminal investigation into the AGGA and its makers for “potentially bringing criminal charges.” A federal grand jury subpoena was issued seeking a wide range of documents related to the device, including patient complaints.

While the outcomes of the FDA’s evaluation and the criminal probe remain to be seen, the scrutiny underscores the seriousness of the concerns surrounding the AGGA and the potential for legal and regulatory repercussions for those involved in its promotion and use.

Conclusion

The controversy surrounding the AGGA dental device raises alarming questions about the safety, effectiveness, and marketing of unproven medical treatments. As patient lawsuits mount and experts voice their critiques, the case of the AGGA underscores the importance of rigorous scientific evidence, regulatory oversight, and informed consent in patient care.

For individuals considering any dental or orthodontic treatment, it is crucial to thoroughly research the proposed intervention, discuss the risks and benefits with a trusted healthcare provider, and seek out credible, peer-reviewed information before proceeding. The AGGA saga serves as a cautionary tale about the potential harms of insufficiently vetted medical devices and the need for greater accountability in the healthcare marketplace.

As the legal and regulatory investigations into the AGGA continue to unfold, it is hoped that the lessons learned from this controversy will lead to improved patient safeguards, more robust evidence-based practices, and a heightened commitment to prioritizing patient safety and well-being in dental and medical care.

Frequently Asked Questions

Is the AGGA FDA approved?

No, the AGGA has never been cleared or approved by the FDA. The device’s inventor, Dr. Steve Galella, has claimed it does not fall under the agency’s jurisdiction, but the FDA disputes this and is currently evaluating safety concerns related to the AGGA.

Can the AGGA cause permanent damage?

Many patients have reported severe and sometimes permanent injuries allegedly caused by the AGGA, including tooth loss, bone deterioration, nerve damage, and facial disfigurement. Some patients have required extensive corrective surgeries to address these complications.

Is there scientific evidence supporting the AGGA’s claimed benefits?

Currently, there are no peer-reviewed studies or controlled clinical trials demonstrating the AGGA’s safety and efficacy for its promoted uses, such as treating TMJ or sleep apnea in adults. Critics argue that the anecdotal evidence cited by AGGA proponents is insufficient to establish the device’s legitimacy, especially given the numerous patient complaints and lawsuits.

Are there any ongoing investigations into the AGGA?

Yes, the FDA announced in March 2023 that it is evaluating safety concerns related to the AGGA and similar devices. Additionally, court filings have revealed an ongoing criminal investigation by the U.S. Attorney’s Office in Memphis, Tennessee, into the AGGA and its makers for potential criminal charges.

What should patients consider before undergoing any dental or orthodontic treatment?

Patients should thoroughly research any proposed treatment, discuss the risks and benefits with a trusted healthcare provider, and seek out credible, peer-reviewed information before proceeding. It is essential to prioritize treatments with demonstrated safety and efficacy based on rigorous scientific evidence and to be fully informed about potential complications before consenting to any intervention.