health and wellness
FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance
Last Updated on June 30, 2024 by Daily News Staff
Today, the U.S. Food and Drug Administration issued a draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits and risks of LASIK devices.
“It is important to provide patients with comprehensive labeling that clearly describes the risks involved with LASIK surgery, including potential adverse effects such as dry eye, pain and discomfort, and visual symptoms,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “These proposed labeling recommendations, based on extensive consultation with stakeholders and patients, are intended to present information about LASIK in language that is easy to read and understand and include images that convey visual symptoms that could occur following LASIK. The draft guidance is designed to support discussions that patients should have with their eye care providers about the benefits and risks of LASIK to help them make informed decisions before proceeding with the surgery.”
LASIK is an outpatient surgical procedure that permanently reshapes the cornea to change the way the eye focuses light rays onto the retina at the back of the eye. LASIK surgery is intended to correct common vision problems such as nearsightedness, farsightedness, and astigmatism and to reduce a person’s dependency on eyeglasses and contact lenses.
The draft guidance “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations,” details the FDA’s proposed recommendations for the content and format of patient labeling for LASIK devices, including general information about the surgical procedure; indications for use; benefits; procedure alternatives; contraindications, warnings and precautions; risks; what to expect before, during and after surgery; clinical study information; and manufacturer contact information. In addition, the draft guidance proposes the inclusion of a patient decision checklist as part of the patient labeling information that physicians provide to their patients prior to the procedure. To ensure the patient decision checklist is clearly understood by patients, the proposed checklist includes, among other information, who is a good candidate for LASIK, what to expect after surgery, and a summary of long-term risks of the procedure. It also proposes that the patient and physician sign the checklist to acknowledge it was read and discussed.
The FDA collaborated with external experts on research efforts that informed the recommendations in the draft guidance. The agency, in collaboration with the National Eye Institute and the Department of Defense, conducted research as part of the LASIK Quality of Life Collaboration Project to help better understand the potential risk of problems that can occur after LASIK. This project led to the development of the Patient-Reported Outcomes with LASIK PROWL Symptoms and Satisfaction (PROWL-SS)External Link Disclaimer, questionnaire, qualified through the FDA’s Medical Device Development Tools (MDDT) program.
By issuing draft guidance for public comment, the FDA is encouraging feedback on the proposed labeling recommendations from patients, health care providers and stakeholders. The FDA will continue to monitor the latest scientific data related to LASIK and work with professional medical societies and patient advocacy groups to help ensure that risk information about LASIK devices is disseminated to patients, as new information becomes available.
Related Information
- Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations
- LASIK
- Medical Device Development Tools (MDDT) Program
Source: FDA
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Health and Life Insurance
Lessons in Life Insurance: 4 Reasons Getting It May Be Easier Than You Think
Life is the most valuable thing you have – and like all valuable things, it should be insured. Even thinking about life insurance can be stressful, so it’s one of those things that’s easy to put off and tell yourself you’ll do another day. Consider these four ways to make getting life insurance simpler than you thought.
Lessons in Life Insurance: 4 Reasons Getting It May Be Easier Than You Think
(Feature Impact) Life is the most valuable thing you have – and like all valuable things, it should be insured. Even thinking about life insurance can be stressful, so it’s one of those things that’s easy to put off and tell yourself you’ll do another day.
If that’s how you feel, you aren’t alone. According to the 2026 Life Happens Life Insurance Survey, nearly half (46%) of U.S. adults have getting life insurance on their to-do list but plan to deal with it later or not at all. Confusion, procrastination and cost concerns are among the main reasons people kick this can down the road, according to 45% of respondents.
Yet the survey also uncovered an interesting disconnect: 69% of Americans said they personally know someone who had life insurance or whose family used a life insurance policy, most often a parent or parent figure (33%), but still haven’t made getting coverage a priority.
“Life insurance isn’t unfamiliar to most Americans,” Life Happens Executive Director Brian Steiner said. “The challenge is turning that awareness into action. People may think life insurance is something they can deal with later, but waiting can leave the people they love financially vulnerable. Getting started doesn’t have to be complicated, and professional guidance can help you find protection that fits your needs and budget.”
Consider these four ways to make getting life insurance simpler than you thought.
Watch this video to learn more
1. Find a policy that’s a fit.
Roughly 4 in 10 survey respondents reported feeling overwhelmed, anxious or some combination of both about planning for life insurance, with 12% citing thinking it’ll be too expensive as a reason they’ve delayed looking into, buying or updating life insurance.
The good news: There’s a policy that’s right for your current needs. It may be term life insurance, which provides protection for a specific period of time, like to cover a mortgage or tuition for children. There’s also permanent life insurance, which offers lifelong protection, as long as you pay the premiums.
2. Take advantage of digital tools
One-quarter of respondents said they’d be more likely to look into life insurance if they learned it was easier to get than they thought, and digital tools can help make that demand a reality.
It can take as little as two minutes to find out how much you need, for example, with the life insurance needs calculator from the nonprofit Life Happens. Just answer a few simple questions to estimate the amount of life insurance coverage you may need to take care of your family.
3. It’s about protection, not perfection.
Part of the anxiety around life insurance may be the perception that it should be perfect. For more than 1 in 5 survey participants, the plan is to seriously look at it when they feel more financially stable, and another 12% simply said they’ll do it when they’re older.
However, life insurance doesn’t have to check all the boxes for every stage of your life – you can find what works for your family right now then adjust as things change over time.
4. Professional help is available.
Perhaps the biggest hurdle to tackling life insurance is the feeling that you’re in it alone. Overall, 55% of respondents said if they learned life insurance may be easier to get than they expected, they’d be more likely to start the process.
With professional help only a few clicks away, you can rest assured you’re on the path to a life insurance fit that’s right for you by visiting findapro.lifehappens.org.
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Child Health
Changing the Landscape of Childhood Cancer Survivorship
Childhood Cancer: hile “cancer” is a term no family wants to hear, especially when it comes to their children, there is reason for hope. Today, 85% of children diagnosed with cancer survive at least five years. Survival is only part of the journey, however.
Changing the Landscape of Childhood Cancer Survivorship
(Feature Impact) While “cancer” is a term no family wants to hear, especially when it comes to their children, there is reason for hope. Today, 85% of children diagnosed with cancer survive at least five years, according to the National Cancer Institute, up from 75% three decades ago.
Watch this video to learn more
“This progress is driven in large part by dedicated research,” Hyundai Hope on Wheels Board Member Kevin Reilly said. “Over the last 28 years, Hyundai Hope on Wheels has committed over $300 million in pediatric cancer research and program grants, awarding more than 1,600 grants to 210 medical institutions nationwide, impacting thousands of young lives each year.”
Survival is only part of the journey, however. Nearly half (46%) of U.S. adults believe a child ringing the hospital bell after cancer treatment means the child is cancer-free and their medical journey is largely over, according to a survey conducted by Atomik Research on behalf of Hyundai Hope on Wheels. For the children and families living through a diagnosis, the reality is far more complex.
“The reality is that healing continues long after treatment, which is why sustained investment in survivorship care is a priority for us,” said John Guastaferro, executive director of Hyundai Hope on Wheels.
Isabella Franco-Capps, 11, understands that journey firsthand. Diagnosed with B-cell acute lymphoblastic leukemia at age 5, her journey took two years before she could say she’s “a cancer survivor.”
“I was diagnosed with b-cell acute lymphoblastic leukemia,” she said. “This began my two-year-long journey of scans, pokes, chemotherapy and hospital stays. And now I’m a cancer survivor.”
Fellow Hyundai Hope on Wheels National Youth Ambassador, Jackson Trihn, 12, is using his voice to call for continued research and to bring hope to others.
“The role … is being able to share my story,” he said. “Not just to spread awareness but to spread hope to kids that need it. And awareness is so important because people don’t understand how hard pediatric cancer can be.”
Continued progress can help ensure more children ring the bell and receive the care and support they need long after they’ve had the opportunity to do so. To learn more about these efforts and how you can help, visit HyundaiHopeOnWheels.org.
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(Feature Impact) Driven by rising rates of obesity, diabetes, high blood pressure and other risk factors,cardiovascular disease has surpassed cancer as the leading cause of death among Hispanic adults in the United States.
Hispanic people represent nearly 1 in 5 of the U.S. population and are the nation’s largest ethnic minority group, yet many continue to face barriers to achieving heart health and accessing high-quality healthcare. A new scientific statement published in the American Heart Association’s flagship journal, “Circulation,” revealed how social, economic, cultural and environmental factors contribute to persistent disparities in cardiovascular health, calling for culturally tailored prevention strategies, equitable access to care and greater representation of Hispanic populations in cardiovascular research.
“Hispanic populations in the U.S. are incredibly diverse even within their own communities with differences in genetic ancestry, language, cultural traditions and social experiences that can significantly influence cardiovascular health,” said Johanna Contreras, M.D., M.Sc., FAHA, director of the Division of Heart Failure and medical director of the Hispanic Heart Center within the Mount Sinai Health System. “Yet Hispanic people remain underrepresented overall in the research that guides prevention and treatment strategies… Without better representation and more detailed data, we risk overlooking important differences that can help us improve care and save lives.”
Hispanic Cardiovascular Health by the Numbers
Cardiovascular risk factors – obesity (nearly 46%), type 2 diabetes (15.5%) and high blood pressure (approximately 44%) – are prevalent among Hispanic adults and often emerge at younger ages and occur more frequently among Hispanic adults compared with white adults.
According to the report, only about 1 in 5 Hispanic adults achieves ideal cardiovascular health as defined by the American Heart Association’s original Life’s Simple 7 metrics. Updated analyses using the Life’s Essential 8 framework demonstrated persistent disparities for heart and brain health, as well as suboptimal dietary quality, sleep patterns and levels of physical activity.
Social and Economic Barriers Matter
Biology alone does not explain cardiovascular health disparities. The environments where people live, work and age, along with social and economic challenges, impact heart health. In fact, approximately 17% of Hispanics live below the federal poverty threshold, compared with 8.2% of white adults.
“Many Hispanic adults face obstacles that extend far beyond the doctor’s office,” Contreras said. “Limited health insurance coverage, language differences, food insecurity, environmental exposures and concerns related to immigration status can make it more difficult to prevent disease, manage chronic conditions and receive timely treatment.”
Contreras emphasized the cultural values and practices of Hispanic people also influence how they perceive their health and healthcare options.
“Family plays a central role in many Hispanic communities and can be an extraordinary source of strength, support and resilience,” Contreras said. “At the same time, family members are often called upon to translate medical information, navigate health systems and help make healthcare decisions for loved ones. Those responsibilities can shape how health information is understood and acted upon.”
An Action Plan for Improving Hispanic Health
There are practical opportunities to achieve equitable cardiovascular health and reduce disparities through community engagement, culturally responsive care, inclusive research and policies that address the underlying drivers of health.
“Reducing cardiovascular disease among Hispanic populations demands action at every level,” Contreras said, “from improving access to culturally responsive care and expanding research participation to addressing the social and environmental conditions that shape health.”
By addressing both medical risk factors and the social conditions that shape health, experts believe there is an important opportunity to reduce disparities and help more people live longer, healthier lives. Learn more at Heart.org.
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