Anterior Growth Guidance Appliance (AGGA) Lawsuits Claim Dental Device Destroyed Teeth, Caused Other Permanent Damage
A growing number of lawsuits have been filed over the past few years, each raising similar allegations that a dental device known as an Anterior Growth Guidance Appliance, or AGGA, destroyed teeth, disfigured their face and caused other serious health problems.
The Anterior Growth Guidance Appliance (AGGA) is a metal, wire insert placed between a patient’s teeth, which is supposed to help remodel or expand an adult’s jaw without the need of surgery. However, over the past three years, at least 20 patients have filed APPA lawsuits against the manufacturers and designers, including Steve Galella, D.D.S, OtrhoMatrix Corp, and John’s Dental Laboratory, Inc.
The dental device is supposed to cause three-dimensional changes in adult jaws, which can move the maxilla forward horizontally over time as much as 10 mm or more. However, plaintiffs indicate that, instead, the device pushes the upper teeth out of their housings, resulting in serious and painful injuries.
The lawsuits date back to at least 2000, indicating that the AGGA device was originally designed for children, who are still growing naturally, but alleging that it is unreasonably dangerous for adults, whose bone growth has stopped.
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AGGA Device Lawsuits
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One of the most recent lawsuits was filed on March 3, when Michael Haile and Melanie Pappalardi filed a complaint (PDF) in the U.S. District Court for the Southern District of Indiana.
Haile, of New York, indicates that he was prescribed an AGGA in May 2019, due to problems with his airway and open bite. The device was removed and replaced in February 2021. However, even a year before that, in February 2020, Haile began to suspect the device was causing damage, but was reassured by his provider that his discomfort was a normal part of the procedure.
The lawsuit indicates that use of the AGGA caused significant dental damage, including loosening of anterior maxillary teeth; pain; flaring of the front teeth; gum recession; probably root resorption and alveolar bone loss.
The other plaintiff, Pappalardi, received her AGGA device in August 2020, but began to suffer tooth sensitivity and loosening, and had the device removed in August 2021. She indicates the device caused her front upper teeth to be pushed out of the alveolar bone, and also caused her to suffer nerve damage, extreme tooth sensitivity, and will probably lose teeth because of the device’s side effects.
AGGA Lawsuit Indicates Device Insufficiently Tested on Adults
According to allegations raised in the AGGA lawsuit, the manufacturers for not sufficiently testing the design on adults, and did not considering the difference between adult and child bone growth.
“Dr. Galella and OrthoMatrix, knew or should have known that, while the representations may have been true in regard to the use of AGGA by children (who are still growing naturally), the representations as to adults were unproven, not supported by medical knowledge or science, and were false and materially misleading,” the lawsuit states. “AGGA is unreasonably dangerous to adult patients in whom it is installed, and is not reasonably safe for use by such patients; and, AGGA is not a substitute for jaw surgery for adults.”
The lawsuit presents claims of negligence, breach of warranty, violation of the Indiana Product Liability Act and the Indiana Deceptive Consumer Sales Act.
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