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FDA Evaluates Dental Device ‘Safety Issues’ Featured in KHN-CBS Investigation



Following an investigation by KHN-CBS News, the Food and Drug Administration (FDA) on Thursday said it was “evaluating safety concerns” for the use of a dental appliance that multiple lawsuits allege caused grievous harm. patients.

The federal agency told the public in a “safety announcement” posted on his website that he is reviewing not only this product, the Anterior Tooth Growth Control Device, or AGGA, but other similar dental devices, including the Anterior Tooth Remodeling Device, or ARA, mentioned in a recent KHN and CBS News article.

The FDA said it was “aware of reports of serious complications with the use of these devices” and asked patients and healthcare providers to report any complications associated with them to the agency.

The agency stated that it is aware that these devices have been used to treat conditions including sleep apnea and temporomandibular joint disorder, also known as TMJ or TMJ, but noted that “the safety and efficacy of these devices intended for these uses, have not been established.”

According to court records, the AGGA device alone has been installed by more than 10,000 dental patients.

The AGGA investigation by KHN-CBS News included interviews with 11 patients who said they were harmed by the device, attorneys who said they represented or represented at least 23 other patients, and dental professionals who said they were examining patients who had experienced serious complications while using AGGA. The investigation found no records of AGGA registration with the FDA, despite the agency’s role in the regulation of medical and dental devices. On Thursday, the FDA confirmed that the devices are “not approved or approved by the FDA.”

Inventor of AGGA, Tennessee dentist Dr. Steve Galella said at sworn testimony that AGGA has never presented itself to the FDA, which it believes has no jurisdiction over it.

At least 20 AGGA patients have filed lawsuits against Galella and other defendants over the past three years, alleging that AGGA does not and cannot work. The plaintiffs allege that instead of expanding their jawbones, AGGA left them with damaged gums, loose teeth and shattered bone.

Additionally, KHN and CBS News reported that the Las Vegas Institute, a company that previously trained dentists in the use of the AGGA, is now training dentists in the use of a different device, which its CEO described as “almost exactly the same device.” This is called Anterior Remodeling Appliance, or ARA.

KHN and CBS News contacted attorneys for Galella, the Las Vegas Institute, and makers AGGA and ARA on Thursday, but received no immediate response.

Galella declined to be interviewed by KHN and CBS News. His attorney, Alan Fumuzo, previously said in a written statement that AGGA is “safe and can produce positive results.”

All AGGA lawsuits are ongoing. Galella and other defendants denied responsibility in court documents. Kara Tenenbaum, a former senior policy adviser at the FDA’s device center, said reports of complications related to these devices are critical and could be submitted through the FDA MedWatch Portal.

“Whether it’s a dentist, orthodontist, surgeon, patient, family member, or caregiver,” Tenenbaum said in a recent interview, “anyone can and should submit these reports so the FDA has a better understanding of what’s going on.”

In court, Galella said he had personally used AGGA on over 600 patients and had taught other dentists how to use it for years. In videos of one workout during the AGGA trial, Galella said the device puts pressure on a patient’s palate and causes an adult’s jaw to “realign” forward, making them more attractive and “curing” common ailments such as sleep apnea and TMJ.

“It’s okay to make a ton of money,” Galella told the dentists in the video. You don’t rob anyone, you heal them. You help them. You make your life beautiful forever and ever.”

In a statement Thursday, the FDA said it is aware the devices have been used “for jaw reconstruction in adults” but indicated that devices such as “fixed (non-removable) palatal expanders” are commonly used in children and adolescents. “In which the bones of the upper jaw have not yet fused.” In contrast, the FDA stated that “the adult maxillary bones are fused and when the fixed palate expansion device applies force, the palate resists expansion. If improper force is applied to the teeth, serious complications can occur, including chronic pain, misaligned teeth, swollen teeth, misaligned bites, difficulty eating, damaged gums, exposed roots, bone erosion, and tooth loss.”

Patients interviewed by KHN and CBS News said they experience many of these problems. One patient who filed a lawsuit, former professional clarinetist Boya Kragul, said that specialists later had to remove four of her front teeth. Now she wears false teeth.

Kragulj said Thursday: “While it is too late for me and many others, there is some consolation that the FDA is investigating the AGGA/ARA/ORA product and its claims. I hope other patients are spared the trauma and wasted years that so many of us are now experiencing.”

The Food and Drug Administration said it plans to “investigate possible violations” in connection with the use of the devices, and that it “is identifying and contacting those responsible to inform [its] concern.”

The American Dental Association, which has a membership of 159,000 dentists, said it “will keep dentists informed about the FDA evaluation and will continue to monitor FDA updates regarding these devices and concerns.”

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Healing begins in the lobby of Barrington Hospital, where volunteer musicians play their passion – Chicago Tribune



If you happen to walk through the front doors of Barrington’s Advocate Good Shepherd Hospital and think you’re hearing Windows launch music or Universal Studios or Warner Bros. themes played on the piano, don’t hesitate. This is most likely Guido Calcagno, a registered nurse, playing tunes for patients, staff and visitors.

Calcagno is one of the volunteer musicians who play live music for patrons in the Good Shepherd lobby Monday through Saturday.

When volunteer pianist René Mullany plays 88 keys in the lobby, she usually keeps her eyes on the entrance. If she spots a child going to the hospital, she can turn on a Disney song or “Twinkle Twinkle Little Star”. If a veteran enters, she will play a patriotic song. Her reasoning is that hospitals can be scary and intimidating, and if people recognize a familiar song in the air, maybe that little thing will put them at ease.

“Because we’re in the front, I feel like the pianists are kind of ambassadors for creating a positive tone for Advocate Good Shepherd, and sometimes we can be the face of the hospital,” said Mullany, a Cary resident who has volunteered for her musical talent for four years old. “Let’s face it, when you’re in the hospital, the happiest thing is the kids. Otherwise, you are there to visit someone who is sick, or you are there for a test. … Every time I go to play, at least three or four people pass by, and you can see them snapping their fingers to the beat of the music. People stop by and thank us for our efforts — for being there and bringing a bit of comfort to what might otherwise have been a stressful situation.”

Calcagno, 23, understands. On weekends he plays the small Kawai piano. Piano-trained since the age of 4, the Deerfield resident began working at Good Shepherd in August 2021, and by October he was entertaining passers-by with popular music and compositions he composed. It all started when he heard volunteer pianist Sue Schurr play while walking to the cafeteria. He introduced himself, played some music for Schurr, and she referred him to the hospital’s volunteer services coordinator, Lynette Ig, a clarinetist who auditions for musical volunteers. The rest is history.

“When I play, I can play about eight different songs,” Calcagno said. “I play from a wide variety of music. I have my own compositions… about 10 different pieces that I can play from memory or improvise. I like to think that the music I created really evokes emotions or feelings. In my piano folder, I have music from TV shows, be it Korean dramas, anime, Golden Girls intros, songs from films like Interstellar, Inception, and more modern classical music, pop songs. It also depends on how I feel that day. Music is as therapeutic as it is for my listeners. It helps me relax and reflect and think about what might have happened the day before at work, helps me digest.”

Calcagno, who attends to a wide variety of patients during his 12-hour work day, says he always has time for music and would like to help out with film scores one day.

Eeg said that there are currently 10 volunteer musicians, including a flutist, who play in 90-minute shifts. High school students who have reached the age of 16 can also become volunteers. Interested persons can fill out an application. Magda Scanlan, Good Shepherd’s director of volunteer services, said the office makes sure volunteer roles are aligned with their needs and passions.

Schurr brought a friend from Mullany’s book club into the ranks, and she eventually brought her mother, a piano teacher, to duet with her in the lobby. Schurr, a retired English and drama teacher, laughs as she recalls how she came to play Good Shepherd in 2016.

“My husband had knee surgery and I was getting a little bored so I started walking and checking the hospital and going to the dining area, I was like, ‘Wow! Piano! It’s amazing!” – she said. She sat down and started playing. Schurr asked the staff if she could volunteer, and Eeg said the vacancy had been created.

“We created this position because we now had this beautiful piano that people wanted to play,” said Eeg. She and Schurr agreed that none of this would have happened if the donated piano had been small enough to fit through the conference room door as planned. When the piano did not fit, it settled at the main entrance to the hospital.

“It was a wonderful mistake,” Schurr said. “It was a blessing.”

She plays late morning/early afternoon on Thursdays. She said that playing the piano on Good Shepherd is good for her brain because she tries to learn two new pieces a week. At the request of patients, she learned to play Coldplay and the Ukrainian national anthem. She plays hymns, songs of the season. She even made friends along the way.

“I play Hanukkah and Christmas music. … I try to keep inclusivity in mind,” Schurr said. “You look around and see who’s there and try to play for those people. I listen to Pandora. I listen to the radio and if I like a song I download it and play it. I don’t want to get bored with my own music. I’m definitely trying to spice it up and make people have fun.”

Scanlan said that the live music “feels like you’re entering a really healing space.”

“It’s a beautiful campus, but when you hear music, it just speaks to your other senses,” she said.

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Does Honor Among Thieves have a post-credits scene?



action adventure Dungeon & Dragons: Honor Among Thieves brings the high fantasy escapism of the hugely popular Dungeons & Dragons tabletop RPG to the big screen.

The film follows the lovable villain Egin Darvis, played by Chris Pine, and his ragtag team of magical misfits, including the barbarian Holga (Michelle Rodriguez), the paladin Xenka (Rege-Jean Paige), and the sorcerer Simon (Justice Smith), who must take on the adventurer. turned tyrant, Forge Fitzwilliam (Hugh Grant).

This is not Paramount’s first attempt at adapting D&D; there was a trilogy of films in the early 2000s that are probably best forgotten, but the script and ensemble played Honor among thieves garnering far more rave reviews and leading viewers to speculate that this could be the first installment in a new series of stories set in the fantasy world of D&D.


And if we’ve learned anything from the Marvel Cinematic Universe, it’s that a surefire way to get viewers talking about potential installations in the future is to tease them a bit with a post-credits scene.

Is there a post-credits scene in Dungeons & Dragons: Honor Among Thieves?

After Chris Pine and Co. Defeated the bad guy and saved the day, all that’s left is for the music to play and the credits to rollbut you won’t want to leave the theater right away, because yes, Dungeons & Dragons: Honor Among Thieves includes a post-credits scene.

Or more specifically, the mid-credits scene: after the initial animated credits sequence, the characters reappear. However, this is not intended to leave the door open for future adventures, but rather a reference to one of the film’s early comics. We won’t spoil it for you here, just stay where you are and enjoy.

Philip Ellis is a freelance writer and journalist based in the United Kingdom covering pop culture, relationships and LGBTQ+ issues. His work has appeared in GQ, Teen Vogue, Man Repeller and MTV.

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Cancer tumors in mice shrank thanks to oxygen-sucking battery



Mouse breast tumor tomography


Implanting an oxygen-consuming battery into mice with cancer caused their tumors to shrink or disappear in two weeks when used in conjunction with an experimental class of anti-cancer drugs.

As most tumors grow, they consume oxygen from the non-cancerous tissues surrounding them, so that the tumor cells become anoxic or hypoxic. One class of drugs, called hypoxia-activated prodrugs (HAPs), aims to exploit this feature by killing only those cells that exhibit hypoxia so that healthy cells are less affected, reducing the side effects of the treatment. But no HAPs have been approved for clinical use due to limited evidence for their effectiveness.

Now, Fang Zhang at Fudan University in Shanghai, China, and colleagues have developed a self-charging implanted battery that is powered by salt water injected around it, causing the battery to generate very low voltage electricity and consume oxygen. By creating a hypoxic environment, the battery must optimize the action of the HAP.

“The battery can cover the tumor and continuously consume the oxygen it contains for more than 14 days, which is much longer than previous agents. [that worked for] usually no more than two days,” Zhang says.

Zhang and his team implanted the battery in the armpits of 25 mice with breast cancer. Five received a healthy battery and HAP treatment. The rest of the mice were divided into groups in which they either received no treatment or received only HAP preparations, or an implanted battery that did not work, or only a working battery that can last up to 500 hours in mouse tissues.

Fourteen days later, the tumors were reduced by an average of 90% in the five mice that received the working battery and HAP treatment, and in four of these mice they completely disappeared. Tumors remained the same size or grew in other groups of mice.

While the battery hasn’t caused any safety issues when used in mice, the safety bar is higher in humans, so further research is needed to make sure it’s compatible with human tissue before being tested in humans, Zhang says.

Randall Johnson at the University of Cambridge they say that inducing hypoxia in tumors may have negative effects, such as an increased tendency for the cancer to spread to other parts of the body. While this hasn’t happened in mice, the costs and benefits of using a battery in humans should be evaluated before any human treatment, he says.


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