{"id":2186,"date":"2023-12-22T18:07:49","date_gmt":"2023-12-22T18:07:49","guid":{"rendered":"https:\/\/healthynewsusa.com\/?p=2186"},"modified":"2023-12-22T18:07:53","modified_gmt":"2023-12-22T18:07:53","slug":"agga-inventor-testifies-his-dental-device-was-not-meant-for-tmj-or-sleep-apnea","status":"publish","type":"post","link":"https:\/\/healthynewsusa.com\/?p=2186","title":{"rendered":"\u2018AGGA\u2019 Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea"},"content":{"rendered":"<div>\n<p>A Tennessee dentist who has been <a href=\"https:\/\/kffhealthnews.org\/news\/article\/dental-device-lawsuits-displaced-teeth-agga-steve-galella\/\">sued by multiple TMJ and sleep apnea patients<\/a> over an unproven dental device he invented has said under oath that he never taught dentists to use the device for those ailments \u2014 contradicting video footage of him telling dentists how to use it.<\/p>\n<p>Steve Galella, the inventor of the Anterior Growth Guidance Appliance, or \u201cAGGA,\u201d has said in court depositions that his device had been used on about 10,000 patients, and that he trained many dentists to use the AGGA in classes around the U.S. and overseas.<\/p>\n<p>At least 23 patients, some of whom described being desperate for relief from sleep apnea or temporomandibular joint disorder (TMJ), have sued Galella in recent years claiming that the AGGA damaged their mouths and, in some cases, caused tooth loss. Galella denied wrongdoing in those lawsuits and has settled almost all of them within the past few months.<\/p>\n<p>Galella was deposed before he settled the largest of those lawsuits. According to a <a href=\"https:\/\/www.documentcloud.org\/documents\/24203274-steve-galella-agga-lawsuit-july-deposition-transcript?responsive=1&amp;title=1\">deposition transcript<\/a> recently obtained by KFF Health News and CBS News, Galella said under oath that he had not represented that the AGGA could treat or cure TMJ or sleep apnea.<\/p>\n<p>Video footage tells a different story.<\/p>\n<p>Galella repeatedly references treating TMJ and sleep apnea patients with the AGGA, sometimes in conjunction with other devices, in footage from a training session he led with Australian dentists in 2017, which was produced in discovery in an AGGA lawsuit.<\/p>\n<p>At one point in the footage, Galella can be seen displaying two versions of the AGGA to the dentists, pointing to one he says is preferred by \u201cTMJ and sleep patients\u201d \u2014 and then saying, \u201cAnd I give it to them.\u201d<\/p>\n<p>\u201cCan you cure TMJ? Yes,\u201d Galella <a href=\"https:\/\/www.youtube.com\/watch?v=LseqCvMme0c\">told dentists as his 2017 training began<\/a>, according to the footage. \u201cCan you cure mild to moderate sleep apnea? Yes.\u201d<\/p>\n<figure class=\"wp-block-embed is-type-video is-provider-youtube wp-block-embed-youtube wp-embed-aspect-16-9 wp-has-aspect-ratio\">\n<p>\n<span class=\"embed-youtube\" style=\"text-align:center; display: block;\"><\/p>\n<div class=\"youtube-embed\" data-video_id=\"LseqCvMme0c\"><iframe loading=\"lazy\" title=\"A dental device was sold to fix jaws but some patients claim it wrecked their teeth\" width=\"696\" height=\"392\" src=\"https:\/\/www.youtube.com\/embed\/LseqCvMme0c?feature=oembed&#038;enablejsapi=1\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" allowfullscreen><\/iframe><\/div>\n<p><\/span>\n<\/p>\n<\/figure>\n<p>The AGGA, which Galella recently rebranded as the Osseo-Restoration Appliance, resembles a retainer and uses springs to apply pressure to the front teeth and upper palate, according to a patent application filed in 2021. This year, after a joint investigation by KFF Health News and CBS News reported allegations of patients harmed by the AGGA, the <a href=\"https:\/\/kffhealthnews.org\/news\/article\/fda-safety-concern-evaluation-agga-dental-device-investigation\/\">FDA <\/a>and the <a href=\"https:\/\/kffhealthnews.org\/news\/article\/agga-dental-device-federal-criminal-investigation\/\">Department of Justice<\/a> opened investigations into the device.<\/p>\n<p>Dentists across the country have promoted the AGGA on their websites, often claiming it can \u201cgrow,\u201d \u201cremodel,\u201d or \u201cexpand\u201d an adult\u2019s jaw without surgery, sometimes saying it has the potential to make patients more attractive and to treat common ailments like TMJ and sleep apnea, which afflict millions of Americans. Galella has said in depositions and video footage that the AGGA causes the bones in an adult\u2019s jaw to \u201cremodel\u201d forward, reshaping their face.<\/p>\n<p>The 2017 video footage contains other examples of Galella teaching dentists to treat TMJ and sleep apnea patients with the AGGA, which he sometimes calls a \u201cgrowth appliance.\u201d In one segment, he describes using a growth appliance on \u201cnine out of 10\u201d of his TMJ patients. In another instance, Galella presents photos of what he says is a TMJ patient, then proceeds to describe how he treated them with an AGGA while showing photos of the patient\u2019s device and saying: \u201cIt\u2019s easy with this appliance.\u201d The footage also shows Galella calling a growth appliance \u201cthe cure\u201d for sleep apnea, and he later says in reference to sleep apnea that \u201cwith a growth appliance, yeah, you can fix it.\u201d<\/p>\n<div class=\"wp-block block--newsletter  \" data-type=\"kaiser-health-news\/newsletter\" data-align=\"center\" style=\"\">\n<h4 class=\"newsletter__title\">\n\t\t<a href=\"https:\/\/kffhealthnews.org\/email\/\"><br \/>\n\t\t\tEmail Sign-Up\t\t<\/a><br \/>\n\t<\/h4>\n<p class=\"newsletter__description\">\n\t\tSubscribe to KFF Health News&#8217; free Morning Briefing.\t<\/p>\n<\/div>\n<p>When Galella was confronted with this video footage during his recent deposition, he said his statements had been taken \u201cout of context,\u201d according to the deposition transcript.<\/p>\n<p>The AGGA plaintiffs alleged in their lawsuits not that Galella treated them directly but instead that he or his company consulted with their dentists and prepared AGGA \u201ctreatment plans\u201d for each patient.<\/p>\n<p>Galella said during his deposition he had reviewed more than 12,000 treatment plans but said he\u2019d never seen one that used the AGGA to treat TMJ or sleep apnea, according to the transcript. In the AGGA lawsuits, about a <a href=\"https:\/\/www.documentcloud.org\/documents\/24204025-agga-lawsuits-indiana-defendant-treatment-plans?responsive=1&amp;title=1\">dozen treatment plans<\/a><a href=\"https:\/\/www.documentcloud.org\/documents\/24204025-agga-lawsuits-indiana-defendant-treatment-plans?responsive=1&amp;title=1\"> are filed as exhibits<\/a>, and some of those plans list the patient\u2019s \u201cchief complaint\u201d as TMJ or sleep apnea.<\/p>\n<p>Galella\u2019s attorneys did not respond to multiple recent requests for comment, and Galella declined to be interviewed when approached in person in February. One of Galella\u2019s attorneys, Alan Fumuso, said in a written statement in February that the AGGA \u201cis safe and can achieve beneficial results\u201d when used properly.<\/p>\n<p>The KFF Health News-CBS News investigation of the AGGA was based on interviews with 11 people who said they were hurt by the device and dental specialists who said they\u2019d witnessed severe complications in AGGA patients. The investigation found no record of the AGGA being registered with the FDA and no peer-reviewed evidence showing the device \u201cexpands\u201d or \u201cremodels\u201d the jaw as Galella and other dentists have claimed.<\/p>\n<p>\u201cThe entire concept of this device, of this treatment, makes zero sense,\u201d said Kasey Li, a maxillofacial surgeon and sleep apnea specialist who has <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/36704948\/\">published research on AGGA patients<\/a>. \u201cIt doesn\u2019t grow the jaw. It doesn\u2019t widen the jaw. It just pushes the teeth out of their original position.\u201d<\/p>\n<p>In the wake of the KFF Health News-CBS News investigation, the FDA announced it was \u201c<a href=\"https:\/\/www.fda.gov\/medical-devices\/safety-communications\/evaluation-safety-concerns-certain-dental-devices-used-adults-fda-safety-communication\">evaluating safety concerns<\/a>\u201d about the AGGA and a similar device, the Anterior Remodeling Appliance. The agency said the devices had been used to treat TMJ and sleep apnea even though they were not cleared by the FDA and their safety and effectiveness had not been established.<\/p>\n<p>Weeks later, the criminal investigation into the AGGA was disclosed in court filings by Galella and device manufacturer Johns Dental Laboratories, who said the U.S. attorney\u2019s office in Memphis, Tennessee, was \u201c<a href=\"https:\/\/kffhealthnews.org\/wp-content\/uploads\/sites\/2\/2023\/04\/AGGA-Lawsuit-Motion-for-Stay-Because-of-Criminal-Probe.pdf\">potentially bringing criminal charges<\/a>\u201d against them. In another court filing, Johns Dental provided a copy of a grand jury subpoena seeking a wide variety of AGGA documents, including \u201cany complaints received from any source whatsoever regarding the AGGA.\u201d<\/p>\n<p>Since then, Galella has resolved lawsuits from at least 19 AGGA plaintiffs through out-of-court settlements without any public admission of fault. Additional AGGA lawsuits were filed in Indiana, Pennsylvania, and Washington, with all plaintiffs alleging they were harmed while being treated for TMJ or sleep apnea.<\/p>\n<p>Alice Runion, a 30-year-old IT consultant living outside Indianapolis, alleged in one of those lawsuits that wearing an AGGA as part of her TMJ treatment resulted in \u201cpermanent impairment and disfigurement\u201d and \u201ccaused severe damage to the roots of [her] teeth.\u201d<\/p>\n<p>In an interview, Runion added that the AGGA caused lingering migraines that have left her unable to work on a computer for long stretches, forcing her out of her job. Runion said that even after corrective jaw surgery that cost tens of thousands of dollars, some of her teeth may still be at risk.<\/p>\n<p>\u201cMy surgeon and my health care providers have told me that it is possible that I could lose teeth in the future still because of the treatment I received,\u201d Runion said.<\/p>\n<figure class=\"wp-block-image size-full\"><figcaption class=\"wp-element-caption\">This Anterior Growth Guidance Appliance, or \u201cAGGA\u201d device, was purchased by orthodontists Neal Kravitz and Jeffrey Miller as part of their ongoing research into the device and its complications. <span class=\"photo-credit\">(Claire Miclat)<\/span><\/figcaption><\/figure>\n<p>The AGGA is also being studied by orthodontists Neal Kravitz and Jeffrey Miller, who said they intend to publish a research paper next year on how the device hurts patients. Miller, who has been a paid consultant for some AGGA plaintiffs, said he has examined dental scans from at least 30 patients who were \u201cdamaged\u201d by the AGGA.<\/p>\n<p>\u201cIt\u2019s not difficult to see the pattern,\u201d Miller said. \u201cThe patients lose bone that supports the housing of their teeth.\u201d<\/p>\n<p>Miller and Kravitz said that they bought an AGGA in May for their research and that the Department of Justice sent an official to photograph the unboxing of the device for the criminal investigation.<\/p>\n<p>Miller and Kravitz added that Johns Dental was willing to sell them the AGGA only if they did not refer to the device by name while purchasing it. They provided KFF Health News and CBS News with a copy of an email in which a Johns Dental employee writes: \u201cTo order the growth appliances from here on out, you\u2019ll need to avoid using the names of those appliances or Dr. Galella\u2019s name.\u201d<\/p>\n<p>A Johns Dental facility was inspected by the FDA in July, according to online inspection records. Those records show the company was <a href=\"https:\/\/datadashboard.fda.gov\/ora\/firmprofile.htm?FEIi=3014680794&amp;\/identity\/3014680794\">issued seven citations<\/a> pertaining to medical devices, but do not specifically mention the AGGA or any specific device. One citation was for an unspecified device whose \u201cdesign history file does not demonstrate that the design was developed following the requirements\u201d of federal law. Johns Dental declined to comment through its attorney, Jeffrey Oberlies.<\/p>\n<p>Ten days after that FDA inspection, Johns Dental owner Jerry Neuenschwander was deposed in an AGGA lawsuit, court records show. He pleaded the Fifth in response to every question, according to a <a href=\"https:\/\/www.documentcloud.org\/documents\/24203275-jerry-nueunschwander-agga-lawsuit-july-deposition\">deposition transcript<\/a> obtained by KFF Health News and CBS News.<\/p>\n<p>Spokespeople for the Justice Department and the FDA declined to comment on the AGGA. Attorneys for Neuenschwander did not respond to requests for comment.<\/p>\n<p><em>CBS News producer Nicole Keller contributed to this report.<\/em><\/p>\n<aside class=\"meta-authors meta\">\n<p>\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"author-name\">Brett Kelman: <\/span><br \/>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/kffhealthnews.org\/news\/article\/agga-inventor-testifies-dental-device-not-designed-for-tmj-or-sleep-apnea\/mailto:bkelman@kff.org\">bkelman@kff.org<\/a>,\t\t\t\t\t\t\t\t\t\t\t<a href=\"http:\/\/twitter.com\/BrettKelman\" target=\"_blank\" rel=\"noopener\"><br \/>\n\t\t\t\t\t\t\t@BrettKelman<\/a>\n\t\t\t\t\t\t\t\t\t<\/p>\n<\/aside>\n<section class=\"block--category-tag-list \">\n<div class=\"category-tag-list__content-wrapper\">\n<h3 class=\"block--category-tag-list__title\">\n\t\t\t\tRelated Topics\t\t\t<\/h3>\n<p>\t\t\t\t<a class=\"category-tag-list__contact-link\" href=\"https:\/\/kffhealthnews.org\/contact-us\/\"><br \/>\n\t\t\tContact Us\t\t<\/a><br \/>\n\t\t<a class=\"category-tag-list__tip-link\" href=\"https:\/\/kffhealthnews.org\/tips\/\"><br \/>\n\t\t\tSubmit a Story Tip\t\t<\/a>\n\t<\/div>\n<\/section><\/div>\n<p><script async src=\"\/\/platform.twitter.com\/widgets.js\" charset=\"utf-8\"><\/script><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Tennessee dentist who has been sued by multiple TMJ and sleep apnea patients over an unproven dental device he invented has said under oath that he never taught dentists to use the device for those ailments \u2014 contradicting video footage of him telling dentists how to use it. Steve Galella, the inventor of the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2187,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-2186","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health-industry"],"_links":{"self":[{"href":"https:\/\/healthynewsusa.com\/index.php?rest_route=\/wp\/v2\/posts\/2186","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/healthynewsusa.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/healthynewsusa.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/healthynewsusa.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/healthynewsusa.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2186"}],"version-history":[{"count":1,"href":"https:\/\/healthynewsusa.com\/index.php?rest_route=\/wp\/v2\/posts\/2186\/revisions"}],"predecessor-version":[{"id":2188,"href":"https:\/\/healthynewsusa.com\/index.php?rest_route=\/wp\/v2\/posts\/2186\/revisions\/2188"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/healthynewsusa.com\/index.php?rest_route=\/wp\/v2\/media\/2187"}],"wp:attachment":[{"href":"https:\/\/healthynewsusa.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2186"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/healthynewsusa.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2186"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/healthynewsusa.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2186"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}