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Complications With AGGA and Similar Appliances Draw FDA Safety Evaluation The FDA is asking anyone who has experienced complications with AGGA or similar dental devices to report those problems to the agency. March 31, 2023 Irvin Jackson Add Your Comments The U.S. Food and Drug Administration (FDA) confirmed this week that it has launched a safety investigation to evaluate recent reports of complications with the Anterior Growth Guidance Appliance (AGGA) and similar dental appliances, which were never officially approved by the agency and have been linked to reports of tooth damage, bone loss and other problems. The FDA safety communication about the AGGA appliance was issued on March 30, confirming recent reports that the federal regulators were evaluating the device. In addition to reviewing reports of complications with AGGA, the agency also indicates that it is evaluating similar devices, including the Fixed Anterior Growth Guidance Appliance (FAGGA), the Anterior Remodeling Appliance (ARA), the Fixed Anterior Remodeling Appliance (FARA), the Osseo-Restoration Appliance (ORA) and Fixed Osseo-Restoration Appliance (FORA). AGGA Appliance Complications The AGGA appliance involves 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 an AGGA lawsuit against the manufacturers and designers, including Steve Galella, D.D.S, OrthroMatrix Corp, and John’s Dental Laboratory, Inc. Although the dental appliance 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, plaintiffs indicate it actually pushed the upper teeth out of their housings, resulting in serious and painful injuries. AGGA LAWSUITS Have you experienced problems with an AGGA dental device? Problems with the AGGA dental device have caused severe teeth damage and disfiguring injuries. Financial compensation may be available through an AGGA lawsuit. Learn More SEE IF YOU QUALIFY FOR COMPENSATION AGGA LAWSUITS Have you experienced problems with an AGGA dental device? Problems with the AGGA dental device have caused severe teeth damage and disfiguring injuries. Financial compensation may be available through an AGGA lawsuit. Learn More SEE IF YOU QUALIFY FOR COMPENSATION The AGGA was designed by a dentist, Steve Galella, and OrthoMatrix Corp., Inc., in order to correct dental, facial and airway abnormalities instead of using complex jaw surgery. However, individuals who have experienced complications from AGGA appliances allege in lawsuits that the device is not safe for use among adults. While it was originally designed for children’s teeth and jaws, which are still growing, lawsuits over AGGA indicate the appliance can cause catastrophic injuries and dental complications for adults. “The FDA is aware of these devices being used to treat conditions such as obstructive sleep apnea (OSA) and temporomandibular joint disorder (TMD) of the jaw, and to remodel the jaw in adults,” the FDA safety communication states. “However, the safety and effectiveness of these devices intended for these uses have not been established, and these devices are not cleared or approved by the FDA.” The agency issued a list of recommendations for patients, caregivers and health care providers while the AGGA safety evaluation is underway. It called for them to be aware the devices are not proven or approved by the agency, and called for them to consult with a dental professional for problems or concerns with the dental devices, warning that the devices under investigation may result in serious complications, including Chronic pain Tooth dislocation Flared teeth Uneven bite Difficulty eating Damaged gums Exposed roots Bone erosion Tooth loss The FDA is also calling on any patients or healthcare professionals who experience complications with AGGA or other appliances to file a report through its MedWatch adverse event reporting system. Written by: Irvin Jackson Senior Legal Journalist & Contributing Editor Irvin Jackson is a senior investigative reporter at AboutLawsuits.com with more than 30 years of experience covering mass tort litigation, environmental policy, and consumer safety. He previously served as Associate Editor at Inside the EPA and contributes original reporting on product liability lawsuits, regulatory failures, and nationwide litigation trends. Tags: AGGA, Dental Appliance, Tooth Damage More AGGA Lawsuit Stories AGGA Lawsuit Alleges “Unreasonably Dangerous” Appliance Caused Permanent Dental Side Effects October 8, 2024 Lawsuit Claims AGGA Device Damaged Teeth, Resulting in Disfiguring Injury July 19, 2024 AGGA Lawsuits Allege Appliance Caused Permanent Dental Injury, Bone Loss and Nerve Damage May 8, 2024 0 Comments LinkedInThis field is for validation purposes and should be left unchanged.Share Your CommentsFirst Name*Last NameEmail* Shared Comments*This field is hidden when viewing the formI authorize the above comments be posted on this page Yes No Post Comment I authorize the above comments be posted on this page Weekly Digest Opt-In Yes, send me a weekly email with the latest lawsuits, recalls and warnings. Want your comments reviewed by a lawyer?To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.Contact Phone #Alt Phone #Private CommentsNOTE: Providing information for review by an attorney does not form an attorney-client relationship.CAPTCHAGA SourceGA CampaignGA MediumGA ContentGA Term Δ MORE TOP STORIES Three Talcum Powder Cancer Trials Set To Begin in California State Court (Posted: today) California state court will host three talcum powder bellwether trials beginning in November, with each trial involving claims of ovarian cancer injuries. 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AGGA Lawsuit Alleges “Unreasonably Dangerous” Appliance Caused Permanent Dental Side Effects October 8, 2024
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