Wishing to have perfect smiles is not a sin. Are you planning to remodel your jawline to get a perfect smile? Make sure the methods your dentist adopts are apt.
Otherwise, you will face a similar destiny to that of Plaintiff Boja Kragulj, a famous clarinetist. The Anterior Growth Guidance Appliance (AGGA), which her dentist used for her to grow her jawbone, made her lose four teeth.
The appliance pushed her teeth forward and destroyed her smile as well as her profession. She lost her job as a clarinetist as she couldn’t play her instrument efficiently.
Her AGGA appliance lawsuit alleged that she had to endure severe pain and undergo many dental surgeries.
Before plunging deep into the AGGA complications and the resulting lawsuits, let’s know some basic information about AGGA.
Table of Contents
What is AGGA?
AGGA is an Anterior Growth Guidance Appliance. It’s a device used in orthodontics to promote the growth of the premaxilla and maxilla forward and make room for the upper dental arch.
The majority of it is wire, with a little acrylic oval that rests below the front teeth and mildly presses on the upper palate. (See the picture for more insights)
(Picture courtesy: Galella patent application)
AGGA was developed by Dr. Steve Galella, DDS. He found the Controlled Arch system, which includes the AGGA and Controlled Arch braces (CAB), to aid in promoting natural bone growth to extend the jaw bones.
With a background in facial trauma surgery, Dr. Galella is currently regarded as an expert in facial beauty and facial growth modification after creating the Controlled Arch System. He is the co-founder of OrthoMatrix Inc., the clinical director of the Face Beauty Institute, and he lectures and instructs other dentists all over the world on how to use his product.
Another version of the device named ‘FAGGA’ from Dr. Galella is also in the market, and it is a fixed version usually cemented to the teeth.
The Anterior Growth Guidance Appliance (AGGA) is now manufactured by the Johns Dental Laboratories.
The manufacturer claims that AGGA can be beneficial in the following ways:
- Alters the nasomaxillary complex of adults in three dimensions, including growing, advancing, or modifying the maxilla to advance horizontally over time by as much as or more than 10 mm
- Makes these nasomaxillary changes in adults through a process of mechanical force and new bone deposition as a result of stimulation of a nerve in the palate;
- Attaches bite plates to the lower molars, the lower jaw moves forward as the upper jaw moves forward, including in adults
- The movement of the jaws has the effect of opening the airway and moving the jaws into a position that is more conducive to breathing;
- AGGA is generally safe for installation into dental patients’ mouths, including in adults;
- It can be used as an alternative to jaw surgery, including in adults.
Patients pay about $7,000 for the gadget, which is normally worn for several months, as advised by the dentists.
Joint Investigation by KHN and CBS News
The Kaiser Health News (KHN) and the Columbia Broadcasting System (CBS) News interviewed around 11 people who have undergone adverse impacts after using Anterior Growth Guidance Appliance. Out of the 11 people, eight are pursuing lawsuits against the inventor and the dentists.
They have also interviewed many attorneys handling similar cases of more than 20 other victims.
In their lawsuits or the interviews they have given, the plaintiffs stated that they were persuaded by the claim that the device would enlarge their jaws without surgery and enhance their breathing. They believed that AGGA would not be available for purchase until it was proven safe and effective.
Some even claimed the equipment damaged the patients’ mouths severely, so they had to spend tens of thousands of dollars to fix the issues.
Patients like Kragulj must now anticipate more involved procedures to try to repair the harm done to their teeth.
Many victims informed that they had come to know of the device through the Facebook page of the Las Vegas Institute for Advanced Dental Studies, which provided training for dentists to use the device.
Even the dentist defendants got training from the Las Vegas Institute.
Though AGGA is sold to dentists, and many dentists have used them on their patients, it is not yet submitted either to the FDA or any governmental agency for approval to be used, reveals the investigation.
Eight specialists examined the dental images from users using the defective device. The scans revealed “symptoms of the AGGA shifting teeth instead than widening the jaw,” the scientists told KHN and CBS News.
In one of the videos released by CBS news, Dr. Galella was found saying about his device, “It’s predictable, it’s reliable, and it’s safe.”
Galella stated in his deposition that he has personally used the AGGA on over 600 patients and has spent years training other dentists on how to use the device.
He added that his osseo-restore device puts “pressure on the nasopalatine nerve” to make the jaw bone remodel itself.
Galella claimed in one of the training sessions’ video footage, which was produced in discovery in an AGGA lawsuit that the device puts pressure on a patient’s palate and causes an adult’s jaw to “remodel” forward. It will make them look more attractive and cure ailments like sleep apnea and TMJ (temporomandibular joint disorder).
In one of the videos obtained from a lawsuit, Dr. Galella was telling to the dentists during the training, “It’s OK to make a crapload of money,”. “You’re not ripping anybody off. You’re curing them. You’re helping them. You’re making their life totally beautiful forever and ever.”
Dr. Kasey Li, a California maxillofacial surgeon who had examined many of the AGGA device users, stated that it was a medieval device. His article notes that “Significant mobility of the anterior maxillary teeth due to vertical and horizontal bone loss was noted in the five patients” whom he had examined.
He added that “It doesn’t grow the jaw. It doesn’t widen the jaw. It just pushes the teeth out of their original position.”
When the CBS News national correspondent Anna Werner interviewed Cara Tenenbaum, the FDA’s former policy advisor, she stated that it was surprising why the device was not submitted to the FDA for approval.
She believes that the FDA has the authority to regulate the device. Since it was not registered with the FDA, no adverse report was yet reported to it.
As a positive outcome of the investigation, around 11 dentists have removed the information about the AGGA appliance from their websites, says the CBS News. Plaintiff Kragulj welcomed this information and said it was good to hear that.
The AGGA is an unproven and unregulated dental device that faces multiple lawsuits alleging it has wrecked patients’ teeth. @annawerner and I investigated the AGGA for months. Here’s what we found, in this story and thread. https://t.co/dQdNDu4Tzb
— Brett Kelman (@BrettKelman) March 1, 2023
The FDA Turns its Attention to the AGGA Appliance Issues
Tenenbaum informed that the FDA officials have started looking into the matter and analyzing under which legal authority it could regulate the AGGA appliance. However, the FDA did not respond to its evaluation of the device when contacted by CBS News.
Two weeks ago, @annawerner and I told you about the AGGA, a dental device that multiple lawsuits allege causes terrible harm to users’ teeth. Today, a follow-up: The FDA is on the case and “very concerned.” @KHNews @CBSMornings https://t.co/VodvLz3NNX
— Brett Kelman (@BrettKelman) March 15, 2023
AGGA Appliance lawsuits
Baja Kargulj was a professional clarinetist who performed with the Philadelphia Orchestra, the Orpheus Chamber Orchestra, and various other orchestras and groups.
Plaintiff underwent a number of dental procedures/orthodontic treatments as a kid to repair a problematic bite relationship between her upper and lower teeth, including the use of an orthodontic expander, braces, and the excision of four bicuspid teeth.
Following the aforementioned procedures/techniques, the plaintiff acquired breathing and postural problems for which she has been seeking answers ever since.
She had undergone many procedures then, to rectify her issues under doctors like Dr. Ira Shapira and Dr. Michael Gunson.
Since she wished to avoid the maxilla-mandibular advancement surgery, she contacted Martha Cortes, D.D.S., who used devices like DNA and ALF to correct her jawline and breathing issues. Dr. Cortes then installed the AGGA device twice, which caused many issues for Kragulj.
Her AGGA appliance lawsuit was filed on the following grounds:
- Dental malpractice (negligence)
- Lack of informed consent
- Product liability (negligence, failure to warn, breach of warranty, strict liability)
- Consumer protection (NY 1 p. 2 General Business Law §349)
She claimed the damages listed below:
- Significant and permanent injury and damage
- Degradation and loss of alveolar bone
- Gum recession
- Exposure of the tooth roots
- Future loss of at least four to six upper anterior teeth
- Future need for bone grafts to support four to six anterior dental implants and two posterior implants for the space created by the AGGA
- Emotional distress
- Interference with her advancement as a professional clarinetist
Michael Haile and Melanie Pappalardi
Michael Haile and Melanie Pappalardi filed their lawsuit on March 3, 2023.
Haile of New York reports that he was prescribed an AGGA in May 2019 due to airway and open bite issues. In February 2021, the gadget was removed and replaced.
However, Haile began to think the gadget was causing damage a year earlier, in February 2020, but was persuaded by his provider that his suffering was a natural part of the therapy.
According to his AGGA appliance lawsuit, the AGGA caused considerable dental damage, including anterior maxillary tooth loosening, discomfort, front tooth flaring, gum recession, root resorption, and alveolar bone loss.
Pappalardi, the other plaintiff, received her AGGA device in August 2020, but after experiencing tooth sensitivity and loosening, she had the device removed in August 2021. She claims the device caused her front upper teeth to be pushed out of the alveolar bone, as well as nerve damage, excessive tooth sensitivity, and the likelihood of tooth loss as a result of the gadget’s negative effects.
Dave Hornblower, an Ontario resident, filed his AGGA lawsuit against the inventor, manufacturer, and others on December 10, 2021.
In 2019, his dentist Dr. Terzis prescribed an AGGA device for Mr. Hornblower to treat sleep disruption, the sensation that his tongue did not fit in his mouth, ear congestion, grogginess in the morning, waking up frightened from choking, clicking, and popping of the jaw, and narrow and constricted arches.
His dentist claimed to be trained at the Las Vegas Institute for fixing this device for curing ailments and remodeling the jaw.
Ms. Thompson sought treatment from Dr. Smith for sleep apnea. He prescribed treatment with an AGGA device instead of jaw surgery to cure sleep apnea and to get a more pleasing physical appearance.
The outcome of the Legal Battle
As per the court documents, approximately 10,000 dental patients got the AGGA device fixed in their mouths. It shows that many more lawsuits can be expected in the coming months.
The lawsuits filed earlier alleged that the AGGA device left them with flared teeth, damaged gums, exposed roots, or erosion of the bone that holds teeth in place. In all cases, the device can only be removed by a medical professional.
However, Galella and his company, the Face Beauty Institute, have denied liability during one of the lawsuit proceedings.
Johns Dental Labs resolved one claim for an undisclosed sum but is still fighting allegations in the remaining cases.
The Las Vegas Institute, which previously hosted AGGA workshops for dentists and promoted the device on Facebook, has disputed liability in court and has a request to dismiss claims in another lawsuit, which is pending.
The investigation by CBS News and KHN began creating awareness among the people who used the device and encouraged the victims to come forward with their tales of woes and file lawsuits.
Visit medlegal360.com to get periodic updates on AGGA appliance lawsuits.
If you are one of the victims affected by the AGGA appliance, contact an experienced lawyer to embattle your claim.
To wind up
The booming AGGA appliance lawsuits unearth many shocking revelations regarding the damage the AGGA device had done to the victims. From Dr. Galella’s own words, we can be sure that he and the manufacturer Johns Dental Laboratories, have compromised the health of the victims over money.
Let’s hope the evolution of AGGA appliance lawsuits and the investigations prompt the FDA to take stringent action on the inventor and the manufacturer and seize the remaining devices from the market.
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