jueves, 28 de mayo de 2015

FDA MedWatch - Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury

AUDIENCE: Dermotology, Surgery, Neurology, Patient
ISSUE: The FDA has reviewed information that suggests unintentional injection of soft tissue fillers into blood vessels in the face can result in rare, but serious side effects. Unintentional injection can block blood vessels and restrict blood supply to tissues. Sometimes this can result in embolization. This means the filler material has traveled to other parts of the body. This can cause vision impairment, blindness, stroke and damage and/or death of the skin (necrosis) and underlying facial structures.
While unintentional injections into blood vessels may occur with injection sites anywhere on the face, the FDA’s review of literature and adverse event reports submitted to the FDA identifies certain injection locations where blood vessel blockage have been reported more often. These sites include the skin between the eyebrows and nose (glabella), in and around the nose, forehead, and around the eyes (periorbital region).
FDA is working with manufacturers to update their labeling. The requests asks that the labeling include additional warnings, precautions, and other statements about the risk of unintentional injection into blood vessels, consistent with the recommendations in this communication, so that both health care providers and patients would have a better understanding of the risks.
BACKGROUND: Soft tissue fillers, also called dermal fillers, injectable facial implants, or wrinkle fillers, can create a smoother or fuller appearance of the face. They are FDA-approved to reduce the appearance of wrinkles or to augment lips or cheeks.
RECOMMENDATIONS:
  • Do not inject soft tissue fillers if you do not have the appropriate training or experience.
  • Make sure that you are familiar with the anatomy at and around the site of injection, keeping in mind that blood vessel anatomy  can vary among patients.
  • Before injection, thoroughly inform the patient of all risks of the procedure and the specific product you intend to use.
  • Note that the approved indications for use of soft tissue fillers vary depending on the product. The FDA may not have reviewed use of soft tissue fillers in some locations in the body.
  • Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary.
  • Know the signs and symptoms  associated with injection into blood vessels, and have an updated plan detailing how you plan to treat the patient if this should this occur. This may include on-site treatment and/or immediate referral to another health care provider for treatment.
  • Immediately stop the injection if a patient exhibits any signs or symptoms associated with injection into a blood vessel, such as changes in vision, signs of a stroke, white appearance (or blanching) of the skin, or unusual pain during or shortly after the procedure.
  • Tell patients that they should seek immediate medical attention after the procedure if they experience signs and symptoms associated with injection into a blood vessel.
  • Educate health care facility employees on how to quickly assist patients that report signs and symptoms of filler complications. They must understand how to instruct the patient to receive appropriate medical care.
  • Report to the FDA and the manufacturer if you become aware of a patient experiencing an adverse event associated with unintentional injection of soft tissue filler into a blood vessel.
For a complete list of recommendations for healthcare professionals and patients, see the FDA Safety Communication
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
  • Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Read the MedWatch safety alert, including a link to the FDA Safety Communication, at:

A patient’s budding cortex — in a dish?

A patient’s budding cortex — in a dish?



National Institutes of Health (NIH) - Turning Discovery Into Health



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Jules Asher
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A patient’s budding cortex — in a dish?

Networking neurons thrive in 3-D human “organoid”
A patient tormented by suicidal thoughts gives his psychiatrist a few strands of his hair. She derives stem cells from them to grow budding brain tissue harboring the secrets of his unique illness in a petri dish. She uses the information to genetically engineer a personalized treatment to correct his brain circuit functioning. Just Sci-fi? Yes, but...
Image of budding brain-like structures
Budding brain-like “human cortical spheroids” growing in a petri dish. Source: Sergiu Pasca, M.D., Stanford University
An evolving “disease-in-a-dish” technology, funded by the National Institutes of Health (NIH), is bringing closer the day when such a seemingly futuristic personalized medicine scenario might not seem so far-fetched. Scientists have perfected mini cultured 3-D structures that grow and function much like the outer mantle – the key working tissue, or cortex — of the brain of the person from whom they were derived. Strikingly, these “organoids” buzz with neuronal network activity. Cells talk with each other in circuits, much as they do in our brains.
Sergiu Pasca, M.D. External Web Site Policy, of Stanford University, Palo Alto, CA, and colleagues, debut what they call “human cortical spheroids,” May 25, 2015 online in the journal Nature Methods.
“There’s been amazing progress in this field over the past few years,” said Thomas R. Insel, M.D., Director of the NIH’s National Institute of Mental Health, which provided most of the funding for the study. “The cortex spheroids grow to a state in which they express functional connectivity, allowing for modeling and understanding of mental illnesses. They do not even begin to approach the complexity of a whole human brain. But that is not exactly what we need to study disorders of brain circuitry. As we seek advances that promise enormous potential benefits to patients, we are ever mindful of the ethical issues they present.”
Prior to the new study, scientists had developed a way to study neurons differentiated from stem cells derived from patients’ skin cells — using a technology called induced pluripotent stem cells (iPSCs). They had even produced primitive organoids by coaxing neurons and support cells to organize themselves, mimicking the brain’s own architecture. But these lacked the complex circuitry required to even begin to mimic the workings of our brains.
Image of cross section of spheroids
Neurons and supporting cells in the spheroids form layers and organize themselves according to the architecture of the developing human brain and network with each other. Source: Sergiu Pasca, M.D., Stanford University
Based on an improved, streamlined method for producing iPSCs, Pasca’s team’s cortex-like spheroids harbor healthier neurons supported by a more naturalistic network of supporting glial cells, resulting in more functional neural connections and circuitry. Like the developing brain, the neurons form layers and talk with each other via neural networks. The spheroid technology is more consistent than earlier organoids in generating the same kinds of cortex-like structures in repeated experiments.
The budding cortex also lends itself to analysis using conventional brain slice methods. So, in a sci-fi future, it might potentially reveal what circuits went awry in the developing cortex of a particular individual with a brain disorder.
“While the technology is still maturing, there is great potential for using these assays to more accurately develop, test safety and effectiveness of new treatments before they are used in individuals with a mental illness,” said David Panchision, Ph.D., NIMH program director for stem cell research.
What’s next? Perhaps development of multiple neuron subtypes that normally populate the cortex, as well as long-distance connections between this cortex-like structure and other -- yet to be developed – organoid structures.
Grants: MH100900, MH099555, MH060233, MH106261, MH094714, MH099797, GM007365, NS075252, NS092474
The mission of the NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For more information, visit the http://www.nimh.nih.gov.
The NINDS is the nation’s leading funder of research on the brain and nervous system. The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIH...Turning Discovery Into Health®

Reference

Functional cortical neurons and astrocytes from human pluripotent stem cells in 3D culture. Pasca AM, Sloan SA, Clarke LE, Tian Y, Makinson CD, Huber N, Kim CH, Park JY, O'Rourke NA, Nguyen KD, Smith SJ, Huguenard JR, Geschwind DH, Barres BA, Pasca SP. Nat Methods. 2015 May 25. doi: 10.1038/nmeth.3415. [Epub ahead of print PMID:26005811

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Consumer Information | Federal Trade Commission

Consumer Information | Federal Trade Commission



Donaciones a organizaciones cartitativas: sepa cómo reportar estafas

La Comisión Federal de Comercio (FTC, sigla en inglés) presentó cargos el 19 de mayo contra cuatro organizaciones de caridad falsas que prometían destinar donaciones a pacientes con cáncer, pero estafaron a los donantes y usaron los fondos para gastos personales.
Las organizaciones demandadas son Cancer Fund of America, Inc. (CFA), Cancer Support Services Inc. (CSS), Children’s Cancer Fund of America Inc. (CCFOA) y The Breast Cancer Society Inc. (BCS). Entre 2008 y 2012 estas organizaciones recaudaron más de $187 millones, pero de esa suma solo entre el 2.4 y 3.4 por ciento se usó en obras de caridad. 
Si usted cree que puede haber sido afectado, presente una queja en inglés o en español con elAsistente de Quejas de la FTC  o llame al 1-877-FTC-HELP (1-877-382-4357). La FTC ingresa las quejas presentadas a una base de datos segura llamada Red Centinela del Consumidor (Consumer Sentinel), la cual es utilizada por más de 2,000 agencias de cumplimiento de las leyes civiles y penales en los Estados Unidos y el extranjero.
Antes de hacer una donación a una organización de caridad, visite el portal de la FTC sobreestafas de caridad para prevenir fraudes y engaños.

Public Comment on Draft Research Plan: Screening for Cervical Cancer

Public Comment on Draft Research Plan: Screening for Cervical Cancer

U.S. Preventive Services Task Force banner

The U.S. Preventive Services Task Force posted today a draft research plan on screening for cervical cancer. The draft research plan is available for review and public comment from May 28 through June 24, 2015. To review the draft research plan and submit comments, go to http://www.uspreventiveservicestaskforce.org/Page/Name/us-preventive-services-task-force-opportunities-for-public-comment.

CDC Updates Intimate Partner Violence Uniform Definitions and Recommended Data Elements for Improved Data Collection

Centers for Disease Control and Prevention. Your online source for credible health information.

CDC Updates Intimate Partner Violence Uniform Definitions and Recommended Data Elements for Improved Data Collection
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CDC’s Injury Center has released Intimate Partner Violence Surveillance: Uniform Definitions and Recommended Data Elements, Version 2.0. This publication is designed to promote consistency in the use of terminology and data collection across organizations that work to prevent intimate partner violence (IPV).
IPV is a profound social and public health problem in the U.S., with broad affects for males and females across the lifespan.
Changes that impact data collection and IPV prevention have occurred since the original document was published 16 years ago. The updated document addresses those changes by adding stalking as an explicit form of IPV victimization, describing the use of technology to perpetrate stalking and noncontact forms of sexual violence (e.g. use of GPS for tracking, or sexually explicit text messages), and considering psychological aggression as a form of IPV, regardless of whether physical violence was experienced. (Psychological aggression, called “psychological abuse” in the first publication, was only included as a form of IPV if physical violence was also experienced in the same relationship.) Additional recommended data elements are also presented.
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  • CDC’s updated definitions of intimate partner violence can help gather data, inform research, and guide prevention. Check them out. #VetoViolence http://go.usa.gov/3knYR.
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  • Updated @CDCInjury definitions of intimate partner violence released. Use them to improve data, research, & prevention. go.usa.gov/3knYR.
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Mediterranean Diet Tied to Lower Odds of Uterine Cancer: MedlinePlus

Mediterranean Diet Tied to Lower Odds of Uterine Cancer: MedlinePlus

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Mediterranean Diet Tied to Lower Odds of Uterine Cancer

Women who followed it most closely saw significant reduction in risk, study suggests
     
By Robert Preidt
Wednesday, May 27, 2015
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WEDNESDAY, May 27, 2015 (HealthDay News) -- Adhering to a Mediterranean diet may significantly reduce a woman's risk of uterine cancer, a new study suggests.
"Our research shows the impact a healthy, balanced diet could have on a woman's risk of developing womb [uterine] cancer. This adds more weight to our understanding of how our everyday choices, like what we eat and how active we are, affect our risk of cancer," study author Cristina Bosetti, of the IRCCS-Istituto di Ricerche Farmacologiche in Milan, Italy, said in a Cancer Research UK news release.
Bosetti's team analyzed the diets of more than 5,000 Italian women to determine how well they followed the Mediterranean diet. In general, the diet emphasizes eating vegetables, fruits, nuts, cereals, potatoes, fish and monounsaturated fats, along with moderate alcohol intake, and cutting back on meat and dairy products.
Women who followed seven of the nine components of the Mediterranean diet had a 57 percent reduced risk of uterine cancer, the investigators found.
Those who followed six components of the diet had a 46 percent reduced risk, and those who followed five components had a 34 percent reduced risk, the findings showed.
Women who followed fewer than five components did not have a significantly lower risk of uterine cancer, according to the study published in the May 27 issue of the British Journal of Cancer.
Although the study found an association between adherence to the Mediterranean diet and a reduced risk of uterine cancer, it did not prove a cause-and-effect relationship between the two.
"While we know that getting older and being overweight both increase a woman's risk of womb [uterine] cancer, the idea that a Mediterranean diet could help reduce the risk needs more research. This is partly because this study was based on people remembering what they had eaten in the past," Julie Sharp, Cancer Research UK's head of health information, said in the news release.
"Cancer risk is affected by our age and our genes, but a healthy lifestyle can also play a part in reducing the risk of some cancers," Sharp added. "Not smoking, keeping a healthy weight, being active, eating healthily and cutting down on alcohol helps to stack the odds in your favor."
SOURCE: Cancer Research UK, news release, May 27, 2015
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Gene Testing Can Be Flawed, Study Finds: MedlinePlus

Gene Testing Can Be Flawed, Study Finds: MedlinePlus

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Gene Testing Can Be Flawed, Study Finds

Labs interpret findings differently, perhaps leading to inappropriate 'treatment'
     
By Margaret Farley Steele
Wednesday, May 27, 2015
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WEDNESDAY, May 27, 2015 (HealthDay News) -- Gene tests that claim to predict your risk for certain diseases are often inaccurate, a large, new study finds.
Errors in testing or interpretation are serious, possibly leading to unneeded treatment or deterring someone from a life-saving therapy, according to the first report from a public-private consortium overseeing pooled gene data.
"In the past few years, it has become clear that many genetic variants that have been reported in the literature to cause disease have been misinterpreted," said the authors of the study, published online May 27 in the New England Journal of Medicine and also released at a conference in Washington, D.C.
"The magnitude of this problem is bigger than most people thought," one of the study's authors, Michael Watson, executive director of the American College of Medical Genetics and Genomics, told the Associated Press.
Watson is a partner in a gene data-pooling project called ClinVar, which U.S. health officials helped form and fund a few years ago. The database contains confidential gene findings from more than 300 labs as well as private companies, according to the AP.
Of more than 80 million genetic variants known to exist, the group's scientists have only tracked a fraction -- about 172,000 variants in nearly 23,000 genes. Many of these variants influence the risk for a disease, and more than 10 percent have been analyzed by multiple labs in an attempt to compare results.
In 17 percent of the cases, the researchers said, results were interpreted differently at separate labs -- either overstating the risk of disease, understating it or saying the gene variation had unknown significance or no significance. "At least one interpretation must be wrong and could therefore lead to inappropriate medical intervention," the study authors wrote.
Doctors and online testing companies differ in their practices, the study authors discovered. "Patients need to choose labs that are sharing their data" with other investigators, study leader Heidi Rehm, genetics lab chief at Brigham and Women's Hospital in Boston, told the AP. This is how scientists learn and improve their accuracy, she explained.
"Healthy competition among isolated entities is no longer sufficient to drive our understanding of human variation, and patient care may be compromised when data are not shared," the study authors wrote.
SOURCE: May 27, 2015, New England Journal of Medicine, online; Associated Press
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