Critics are slamming the federal Food and Drug Administration for dropping the ball in informing the U.S. officials who run the Medicare, Medicaid, and veterans’ health programs about crucial regulatory decisions, leading the federal government apparently to pay hundreds of millions of dollars for patients to get a defective heart device and potentially to pay….
Continue ReadingMedical Device Safety
Biden nominates Robert Califf to reprise his Obama-era role as FDA chief
Robert Califf, a cardiologist and President Biden’s “new” nominee to head the federal Food and Drug Administration, is a familiar face around the agency and Washington, D.C. Califf served as the FDA commissioner before — winning U.S. Senate confirmation and holding the important post for the last year of the Obama presidency. He is 70….
Continue ReadingWomen will receive more disclosures about risks of breast implants
Federal regulators have toughened the requirements for surgeons and medical device makers to inform women in detail about rising risks associated with breast implants, which also now will carry the government’s sternest warning — a “black box” label cautioning about the products’ potential harms. The implant alarms, announced after years of complaints by patients, include….
Continue ReadingFDA advances plan for cheaper, easier, more convenient hearing aids
Millions of Americans soon may be able to buy much cheaper devices to help them with their mild to moderate hearing loss and avoid costly hearing aids prescribed by specialists. It took far too long for this big step to occur, and consumers won’t see its full benefits for a bit still. But the Food….
Continue ReadingFDA gives Big Tobacco a big win — approval for e-cigarette for vaping
The federal Food and Drug Administration has infuriated health and anti-smoking advocates by handing Big Tobacco a major first — the agency’s seal of approval for an e-cigarette as a way for consumers to reduce or stop harmful use of burning tobacco cigarettes. The decision allowing RJ Reynold’s Vuse product (shown, left) to stay on….
Continue ReadingAching backs lead to dubious surgeries and billion$ in revenue$
As the nation rapidly grays, not only are middle-aged and older patients undergoing increasing numbers of knee, hip, ankle, and shoulder surgeries, back operations also have spiked — and a significant number of these procedures may be unwarranted and harmful. Spinal surgery is a booming business for orthopedic surgeons and hospitals, with Wall Street analysts….
Continue ReadingExperts call for end to a race-based adjustment in a key kidney function test
Medical specialists and researchers have taken a big step in recognizing that how they diagnose black patients with kidney disease may be racially biased and harmful to a group that already and disproportionately suffers the illness’s harms. Doctors now should jettison race-based adjustments in equations used in a crucial and fundamental test to assess kidney….
Continue ReadingA million bucks of surgical machinery? It’s not proven better — at least for patients
If big hospitals really want to keep surgeons happy and provide them with greater comfort during procedures, why not build giant, sanitary glass garages next to operating rooms and let docs park their Bentleys, Lamborghinis, and Bugattis there for ogling and maybe even to take a break under the vehicles’ hoods? Okay, maybe we’re being….
Continue ReadingMillions stuck in nightmarish recalls of sleep apnea breathing devices
Millions of patients with serious, diagnosed sleep disorders now are wrestling with a daytime nightmare: Medical devices designed to help them avoid damage from their conditions have been recalled for major and concerning defects. But consumers complain that they’re getting poor and too little information about their health options until the device maker more fully….
Continue ReadingQuestions grow about billions flowing to specialists over medical hardware
Patients, regulators, hospitals, and doctors themselves need to open their eyes and ask tougher questions about the eyebrow-raising trend occurring among a specialized set of “sawboneses” — orthopedists and neurosurgeons. Hundreds of them are profiting handsomely, not on their medical skills but rather their investments in and relationships with surgical hardware. The specialists also are….
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