FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries
Kaiser Health News » Patient Safety
by Daniel Chang and Holly K. Hacker
1M ago
A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA’s most serious recall, the agency announced Monday. Related Article Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk? The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4,500 reports in which the medical device may have caused or contributed to a patient’s death. Read More The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by T ..read more
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‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea
Kaiser Health News » Patient Safety
by Brett Kelman and Anna Werner, CBS News
5M ago
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 — contradicting video footage of him telling dentists how to use it. Related Articles This Dental Device Was Sold to Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth. Mar 1, 2023 Watch: Dental Device at Center of Lawsuits Was Used on Patients Without FDA Review Mar 2, 2023 Feds Launch Criminal Investigation Into ‘AGGA’ Dental Device and Its Inventor Apr 12, 2023 Steve Galella ..read more
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Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk?
Kaiser Health News » Patient Safety
by Daniel Chang and Holly K. Hacker
5M ago
Too old and too sick for a heart transplant, Arvid Herrman was given a choice: Have a mechanical pump implanted in his heart, potentially keeping him alive for several years, or do nothing and almost certainly die within a year. The 68-year-old Wisconsin farmer chose the pump, called a HeartMate 3 — currently the only FDA-approved device of its kind in use. Instead of extending his life, though, the device led to his death, according to a lawsuit filed in December 2020 by his daughter Jamie Edwards. The lawsuit alleged that Herrman died because a defect in the locking mechanism of the HeartMat ..read more
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Patients Expected Profemur Artificial Hips to Last. Then They Snapped in Half.
Kaiser Health News » Patient Safety
by Brett Kelman and Anna Werner, CBS News
5M ago
Bradley Little, a physical education teacher in Arizona, was leading his class through a school hallway in 2017 when he collapsed. Little feared he was having a stroke. Or, in a sign of the times, that he’d been shot. He tried to stand, but his leg wouldn’t move. A student ran for help. Firefighters arrived and hoisted Little onto a gurney. At the hospital, an X-ray revealed that the artificial hip implant in Little’s right leg had “suddenly and catastrophically structurally failed,” according to a lawsuit Little would later file in federal court. The implant severed at its “neck” — a 2-inch-l ..read more
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Journalists Cover Air Quality, Tick Risks, and … Brazilian Butt Lifts?
Kaiser Health News » Patient Safety
by
1y ago
KFF Health News senior fellow and editor-at-large for public health Céline Gounder discussed health concerns from hazardous air quality on CBS’ “CBS Mornings” on June 8. And on May 29, she dug into the number of tick-borne disease cases on the rise in the U.S. Click here to watch Gounder on “CBS Mornings” Click here to watch Gounder on “CBS Mornings” KFF Health News Florida correspondent Daniel Chang discussed the draw and dangers of Brazilian butt lifts in Miami on Al Jazeera’s “Fault Lines” on June 7. Click here to watch Chang on “Fault Lines” Read Chang’s “Shaved Costs, High Risk, Maximu ..read more
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Alto riesgo y máximas ganancias: reguladores se preocupan por el auge del levantamiento de glúteos en Florida
Kaiser Health News » Patient Safety
by Daniel Chang
1y ago
MIAMI, FL – En retrospectiva, debería haber reconocido las señales de alarma, dijo Nikki Ruston. El consultorio de Miami donde programó lo que se conoce como levantamiento (lifting) de glúteos brasileño había cerrado y transferido sus registros a un centro diferente, explicó. El precio que le ofrecieron, y que pagó por adelantado, aumentó el día de la intervención, y no conoció a su cirujano hasta poco antes de recibir anestesia general. “Estaba lista para irme”, afirmó Ruston, de 44 años, de Lake Alfred, en Florida Central. “Pero ya había pagado todo”. Pocos días después de la intervención, q ..read more
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Shaved Costs, High Risk, Maximum Profits: Regulators Worry About Florida’s Butt Lift Boom
Kaiser Health News » Patient Safety
by Daniel Chang
1y ago
MIAMI — In hindsight, Nikki Ruston said, she should have recognized the red flags. The office in Miami where she scheduled what’s known as a Brazilian butt lift had closed and transferred her records to a different facility, she said. The price she was quoted — and paid upfront — increased the day of the procedure, and she said she did not meet her surgeon until she was about to be placed under general anesthesia. “I was ready to walk out,” said Ruston, 44, of Lake Alfred in Central Florida. “But I had paid everything.” A few days after the July procedure, Ruston was hospitalized due to infect ..read more
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Sick Profit: Investigating Private Equity’s Stealthy Takeover of Health Care Across Cities and Specialties
Kaiser Health News » Patient Safety
by Fred Schulte, KFF Health News
1y ago
Two-year-old Zion Gastelum died just days after dentists performed root canals and put crowns on six baby teeth at a clinic affiliated with a private equity firm. His parents sued the Kool Smiles dental clinic in Yuma, Arizona, and its private equity investor, FFL Partners. They argued the procedures were done needlessly, in keeping with a corporate strategy to maximize profits by overtreating kids from lower-income families enrolled in Medicaid. Zion died after being diagnosed with “brain damage caused by a lack of oxygen,” according to the lawsuit. Kool Smiles “overtreats, underperforms and ..read more
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¿No has visto a tu médico en años? Es posible que tengas que buscar un nuevo doctor
Kaiser Health News » Patient Safety
by Michelle Andrews
1y ago
Cuando Claudia Siegel sufrió un virus estomacal a principios de este año, contactó a su médico de atención primaria para que le recetara algo para aliviar la diarrea. La residente de Philadelphia se sorprendió cuando recibió un mensaje en línea informándole que debido a que no había visitado a su médico en más de tres años, ya no era una paciente. Y como no estaba aceptando nuevos pacientes, tendría que encontrar otro médico de atención primaria. “Creo que es inconcebible”, dijo Siegel, observando que muchos pacientes no fueron al médico en los últimos años por la pandemia de covid. “No hubo n ..read more
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At US Hospitals, a Drug Mix-Up Is Just a Few Keystrokes Away
Kaiser Health News » Patient Safety
by Brett Kelman
1y ago
More than four years ago, Tennessee nurse RaDonda Vaught typed two letters into a hospital’s computerized medication cabinet, selected the wrong drug from the search results, and gave a patient a fatal dose. Vaught was prosecuted this year in an extremely rare criminal trial for a medical mistake, but the drug mix-up at the center of her case is anything but rare. Computerized cabinets have become nearly ubiquitous in modern health care, and the technological vulnerability that made Vaught’s error possible persists in many U.S. hospitals. Since Vaught’s arrest in 2019, there have been at least ..read more
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