Posts tagged with "FDA"

LISTERIA OUTBREAK

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If you are a frequent buyer of bagged salad or vegetable greens items, you will want to proceed with caution during consumption for the next few weeks.

Dole Fresh Vegetables announced on December 23, 2021, that there would be a recall of 180 different packaged salads due to probable contamination with Listeria monocytogenes. The recall affects nine different brands, including Dole-branded salads, Ahold, Lidl, Kroger, Little Salad Bar, Marketside, Naturally Better, Nature’s Promise and Simply Nature. 180 products were spread through 25 states in total.

The Centers for Disease Control and Prevention (CDC) issued an announcement stating there is an investigation underway to examine the listeria outbreak that connects to two separate packaged salads produced by Dole. Research is ongoing to determine if more products may be affected.

The recall is directly linked to Dole’s Bessemer City, North Carolina, and Yuma, Arizona, production facilities. Listeria monocytogenes were discovered in a Dole-branded Garden Salad package at the site in North Carolina, as well as a package of shredded iceberg lettuce from the Yuma location, via the US Food and Drug Administration (FDA).

Operations at both spots have been halted to ensure cleaning and sanitation procedures are followed through.

Products in the recall lot

Packaged products consisting of mixed greens, garden salads, Caesar kits and varying types of salads in bags or clamshells
“Best if used by” dates from November 30, 2021, to January 8, 2022
Product lot code begins with the letter “N” or “Y” found in the upper-right corner of packages

A full list of recalled products can be found HERE.

To stay safe…

Dispose of recalled packaged salads and follow cleaning procedures to ensure your space is clean.

Call your healthcare provider if you experience any of the following symptoms following the consumption of packaged salads:

Pregnant individuals encountering fever, fatigue and muscle aches. Listeria can result in pregnancy loss or premature birth, as well as serious illness or death in newborns.
Non-pregnant individuals may suffer headache, stiff neck, confusion, loss of balance and convulsions, paired with fever and muscle aches.

Ten Benefits of Ultrasound Technology

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The medical field is always advancing. Scientists constantly search for new ways to diagnose and prevent illnesses, especially with the latest technology.

Ultrasound machinery was an incredible advancement that continues to help patients and doctors. It has improved over the years and expanded to many uses. These are the 10 main benefits of the technology that anyone can appreciate.

1. It’s Safe Diagnostic Imaging

Many people are hesitant to test for illnesses because they don’t want to risk the side effects of certain machinery or new medications. Ultrasound imaging is different. Doctors recommend it for most patients because it rarely has any downsides.

The U.S. Food and Drug Administration (FDA) considers non-ionizing radiation in ultrasounds safe because it has an excellent 20-year track record. It won’t affect the patient like X-ray systems or other technology that uses ionizing radiation.

2. It Doesn’t Take Long

Depending on the exam, an ultrasound appointment is relatively quick. It produces images upon contact with the patient. No one has to wait to see results. They are clear right away and found by people who are experienced in reading whatever might appear on the screen.

Without the need for third-party labs, patients and doctors can find the best diagnosis and treatment plan right away. The streamlined process produces quick results and minimizes how many costly steps might wait between a patient and their life-changing diagnosis.

3. It Has Soft-Tissue Visualization

One of the benefits of ultrasound technology is soft-tissue visualization. Doctors can see contrast without harmful radiation to identify and diagnose issues throughout the body. It’s a significant medical advantage for humans and animals, so the tech is multipurpose across medical fields.

The soft-tissue visualization can also focus on blood flow. The imaging identifies veins and muscle tissue to easily identify potential problems with blood flow like clotting or swelling. It can provide more specific answers than other testing like an ankle-brachial index (ABI). There’s also no need for iodine dyes like those used for a computed tomography angiograph (CT) or magnetic resonance angiograph (MRA).

4. It’s a Noninvasive Option

Many modern testing options require invasive procedures or dyes. It can be too intensive for some patients or time-consuming for others. Ultrasound noninvasively visualizes, monitors and performs measurements in the human body. The treatment’s easy to perform for everyone involved, making it an excellent resource for medical professionals.

5. It Doesn’t Risk Allergic Reactions

Some treatments aren’t available to patients with specific allergies. They may not respond well to dyes or have a bad reaction to medications that make procedures possible. Ultrasounds don’t pose a severe health risk in the same way.

The ultrasound wand doesn’t contain ingredients that trigger allergies. Even if used within body cavities, patients have little to no risk of encountering a severe reaction. The only potential danger is the gel used to make the imaging clearer. One study found that an older man with contact dermatitis developed a purpuric cutaneous presentation where his skin contacted the gel. However, the case didn’t influence the safety for general clinical use.

6. It’s Relatively Inexpensive for Clinics

Because ultrasounds have been around for so long, they’re relatively inexpensive compared to other machinery used in doctors’ offices and clinics. Medical facilities can easily afford them even if the ultrasound is brand new because the technology is easily accessible.

The only time they will become more costly is if a clinic needs its ultrasound machine to have more high-tech features for specialized exams. More advanced software with additional features will cost more for clinics and their patients.

7. It’s Insurance-Provided Care

Most insurance providers cover ultrasound testing. They’re medically necessary for achieving the correct diagnosis and maintaining a patient’s overall health. Insurance often covers unique ultrasound features as well, like keepsake sonograms for pregnant patients who are prescribed a sonogram.

Insurance providers rarely leave ultrasound fees entirely to the patient. Contact your insurance company if you’re unsure about how much you will need to pay for an upcoming exam. It can ask questions that rule out the rare cases where your exam will be out-of-pocket and give you a better idea of how much your appointment will cost.

8. It Can Locate Numerous Diseases

People often think of pregnancy when they imagine conditions that require ultrasound imaging, but that isn’t the only time it might be necessary. Ultrasound machinery can also diagnose symptoms related to conditions like:

Gallstones
Cysts
Abnormal growths

The transducer wand can press against different organs to capture clear images, so they help spot anything that’s causing pain or unordinary lumps.

9. It Travels Easily

Some medical technology is too bulky or heavy to lift. Dialysis machines and ventilators must stay within the same building, while laboratory equipment that makes testing possible should remain in a single room. Ultrasound machines are much easier to move because they have a simple shape and come on wheels.

That mobility makes ultrasounds a crucial resource for facilities, hospitals and mobile clinics. Depending on where medical professionals need to see their patients, ultrasound machines can easily be transported between rooms or locations.

10. It’s Easy to Learn

Ultrasound techniques aren’t something you can learn by picking up the wand and giving it a try. Medical professionals have to take courses and practice imaging before ever helping their patients. Although the class may take weeks or months, it’s relatively easy to add to someone’s professional abilities.

People in different medical fields can take classes at any point in their careers to update their procedural knowledge or add ultrasound imaging to their skillset. Courses are also available to anyone in retirement who wants to work with nonprofit clinics as an ultrasound technician.

Discover the Benefits of Ultrasound Technology

Ultrasound technology delivers many benefits for patients and doctors alike. Consider these examples as you decide the best course of treatment for your health concerns. Ultrasound imaging can be an excellent resource if everyone understands its many purposes and gets the most out of this testing.

Understanding Physical Limitations

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Five Things Non-Disabled People Should Understand About Those With Physical Limitations

By: Julie Morin, Co-Founder, Envol

Chronic illness has continued to grow in the past decades with six in ten Americans living with at least one chronic disease today, according to the CDC.

Having at least one chronic symptom is considered normal in the modern world of today – and let me tell you, that’s a scary realization. Such symptoms can look and feel different for everyone, ranging from mild occasional discomfort to being physically limited in our ability to participate to everyday activities.

Yet non-disabled people dominate the population and culture in the US, which means our understanding of normal is wholly based around the perimeters for non-disabled ideas and activities.

This is something I know all too well. Two weeks after taking ciprofloxacin – a commonly prescribed antibiotic – for a UTI, I was practicing yoga and, out of nowhere, my leg muscles went into painful paralysis. I couldn’t walk or even move my legs anymore. I had to call for help – it was terrifying – and I was rushed to the hospital in the neurology department. All the tests came back negative, and no one knew what was wrong with me. After two weeks, they said it was probably all just in my head and sent me home.

I spent the next four years in a wheelchair, and after multiple misdiagnoses and unsuccessful medical treatments, I turned to holistic healing. I began working with a French naturopathic physician who informed me that my symptoms aligned with fluoroquinolone toxicity, which is currently not recognized as a diagnosis yet. Still, many cases of fluoroquinolone-associated disability are being reported, and doctors continue to prescribe them today despite the FDA advising against it.

Under the guidance of my naturopathic physician, I created a wellness routine that incorporated a healthy, plant-based diet, meditation, therapeutic movement, rest, and gratitude, and I am now 75% healed and can walk short distances again.

Going from a healthy, vibrant young lady to a handicapped 25 years old just by taking a few pills has not been easy. But what was even harder was how people treated me during this time.

And what I learned during this time is knowledge I feel is essential to share with others:

Illness isn’t always visible.

It’s always wise to be careful with assumptions and presuming someone is healthy just because they don’t look sick. There is a lot that can be invisible to the eye and coming from a place of empathy when we simply don’t know enough about a situation or a person, is always a good idea.

Dare to talk about it.

Avoiding complex topics because they might be awkward or uncomfortable can make a person living with a chronic illness feel even more lonely and unheard. Talk about what they’re going through, the struggles, the hardship, but also the joy and the little things that they feel grateful for.

Not having a diagnosis doesn’t mean nothing is wrong.

So many people go mis- or undiagnosed by the medical profession and many assume that it must mean that there is nothing wrong with them and that they should simply resume their life. Yet the daily struggles and limitations are still there, and they can be very real. Continuing to offer your support and trust even when a clear diagnosis isn’t identified is one of the best way you can support someone you love who is going through a difficult time with their health. This type of support can greatly contribute to our recovery.

Avoid suggesting that someone is lucky that they can’t work.

Being unable to work isn’t a privilege – it’s a consequence of chronic illness or physical limitations. Rather, helping that person find their mission and a passion in which they can contribute to the world can often shift their perspective and help them boost their self-esteem.

People with physical limitations of disabilities are reminded every day of how life is different for them.

Be the person who finds and enhances similarities and makes them feel like they belong to the same group as healthy and non-disabled people. Invite them to parties, include them in group conversations, activities, etc. In the end, our cells listen to every one of our thoughts and so why not see life as everybody else should: full of possibilities, feeling confident, strong, and powerful beings.

And let’s not forget the power of love and positivity and the positive effects they can have on our health & well-being.

Being in a state of love and gratitude is in fact so important that it is a nourishment in the healing app Envol that my partner and I have created after my recovery.

Envol app is a holistic healing tool with a unique health-score tracking concept + algorithm, backed by science and doctors, that combines all the necessary tools to improve health no matter where people start–whether they’re recovering from a chronic illness or need some extra guidance when dealing with stress or anxiety.

I hope that people never stop believing in the incredible powers of their body. We are more powerful than we think. There is pure magic in us, and if we create the right conditions in our life to let that magic express itself, miracles can happen. Our cells respond to each of our thoughts and beliefs – and it starts with changing ‘I can’t’ into ‘I can.’

About The Author

As someone who’s spent years battling chronic illness, Julie Morin, co-founder of Envol, knows how difficult and pricey it can be to get our health back. She started to wonder about what would happen to our bodies should we give them the opportunity to heal from within. Julie explored that question and when she started walking again after 4 years in a wheelchair, Envol was born: an easy-to-use mobile app to guide and empower people to take control of their health and start feeling better.

DELTA VARIANT PUTS NORMAL BACK-TO-SCHOOL SEASON AT RISK

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By: Clara Guthrie

There was a period in the late spring and early summer of this past year in which it seemed America’s COVID-19 struggles were nearing some long-awaited conclusion: the last few moments of breathlessness before a collective sigh of relief. At that time, students and their parents looked forward to a seemingly normal back-to-school season. Yet, the recent rise in the Delta variant has introduced a new wave of doubt.

On August 8 alone, The New York Times reported 36,068 new Covid-19 cases and a seven-day average of 110,360 total cases in the United States. Covid-related deaths are also on the rise, with a seven-day average of 516 deaths. This figure has risen from a weekly average of 188 deaths only one month prior, on July 6. Experts attribute these rising numbers to the highly contagious Delta variant overlaid with low vaccination rates in certain areas across the country. When asked about these trends in mid-July, Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC), said, “This is becoming a pandemic of the unvaccinated. We are seeing outbreaks of cases in parts of the country that have low vaccination coverage because unvaccinated people are at risk.”

Unfortunately, as the Delta variant continues to run rampant throughout unvaccinated communities, people who are fully vaccinated are also being infected. Although, it is far rarer. These “break-through” cases speak mainly to the wild infectiousness of the Delta variant, coupled with the facts that no vaccine is 100% effective and that our knowledge of how long immunity lasts after vaccination is still quite murky. According to CNBC, however, “break-through” cases still represent fewer than 0.08% of those who have been fully vaccinated in the United States since the start of the year.

With that being said, the Delta variant is impacting the hopes of a normal back-to-school season in two distinct ways. The first, perhaps more obvious way, is that parents and teachers are fearing for students’ health. This fear suggests a potential return to online learning and more strict social distancing and mask mandates enforced within schools.

It is important to note that COVID-19 poses a far lesser threat to young children than to adults; the risk of becoming severely ill from the virus increases for those over the age of 50 and only grows with age. According to the CDC, the risk of serious illness or complications from COVID-19 for children is actually lower than that from the flu. However, children under the age of 12 are not yet eligible for any form of vaccination. This restriction is raising concerns about how susceptible younger age groups are to becoming sick, even if that sickness does not lead to any serious complications.

Thus, many parents and school districts are pursuing a range COVID-19 precautions to ensure the safety of students. Time Magazine shared a story last week of a school board in Des Moines, Iowa that has already decided to offer a virtual learning option for elementary school students. The ability to transition to in-person learning is available whenever the family feels comfortable enough to do so. This move was, in part, forced by the recent ruling of eight states, including Iowa, to ban schools from being able to require masks – despite the CDC’s recommendation that all students should wear masks inside schools, regardless of whether or not they are vaccinated. “Had we been able to follow the CDC recommendations that everyone in school is masked, regardless of their vaccine status—if we were able to mandate that, then I think we’d be having a different conversation here,” Phil Roeder, a spokesperson for Des Moines’ Polk County public schools, said.

Other counties are having similar struggles, even without the imposition from state governments to ban mask mandates within schools. For example, New York City Mayor Bill de Blasio announced in May that all online learning would be eliminated come fall, a decision that he has not yet reversed. But many parents are now petitioning for online options for their children as safety concerns continue to rise. One parent, Farah Despeignes, who is the president of the Bronx Parent Leaders Advocacy Group and has two middle-school-aged sons, said, “When you think about the conditions of the schools with old buildings, with not enough ventilation, that are co-located, that are overcrowded—for us, in the Bronx, in underserved communities, it’s not as simple as, ‘Well, let’s just get back to school.’”

In California, options for students are equally limited. According to The Los Angeles Times, the state has done away with “hybrid learning, ”a combination of in-person and online learning. As a result of such, Los Angeles County parents had until August 6 to choose between either solely in-person or online learning for their children. The latter option is expected to take the form of an independent study, rather than the supportive online learning of last school year. On August 6th, L.A. Unified School District reported that only 10,280 of their almost 665,000 students opted for the online option.

The second prominent way in which the Delta variant is affecting back-to-school season is through the shopping behavior of students and their families. Back when the hopes of a normal school year were still high, The National Retail Federation predicted that consumers with children K-12 would spend a record-breaking 37.1 billion dollars this year. Furthermore, it was predicted that back-to-college spending would reach 71 billion dollars. These predictions were due to the excitement associated with a long-awaited return to the classroom after over a year away, when items like lunchboxes and backpacks seemed superfluous.

However, according to a recent poll by First Insight, many consumers are feeling anxious about returning to stores, trying on clothing in dressing rooms and making big purchases due to the risk of the Delta variant. In fact, 56% of respondents said they are actively cutting back their spending at retailers. The CEO of Bath Bed & Beyond, Mark Tritton, told CNBC that their stores have observed people delaying their back-to-school investments, and that peak spending may extend further into September than usual.

As many students return to their classrooms and the Food and Drug Administration continues to work on improving vaccines for individuals under the age of 12, it will become more and more clear how great of a mark Covid-19 has left on the American schooling system and the children within it.

UNVACCINATED AMERICANS AT RISK OF NEW VARIANT

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By: Clara Guthrie

In December of 2020, the beginning of the end of the pandemic was set into motion as the first COVID-19 vaccines were administered in the United States to frontline workers. Sandra Lindsay, an ICU nurse from the Long Island Jewish Medical Center, was the very first individual to receive the Pfizer-BioNTech vaccine. The momentous occasion was filmed and live streamed on New York Governor Andrew Cuomo’s Twitter feed. At the time, Lindsay proudly stated, “I want to instill public confidence that the vaccine is safe. We’re in a pandemic and so we all need to do our part.”

Yet, in the six months following Lindsay’s statement of comfort and inspiration, it can be argued that the totality of the American people has not, in fact, done their part. According to data collected by the CDC, 45.1% of the total US population have been fully vaccinated, a number that only increases across age demographics: 77.2% of the population that is 65 years and older have been vaccinated. Additionally, 53.3% of the total population have received at least one dose of the vaccine. However, the rate of vaccination wildly varies when broken down state by state. According to CNN, states like Vermont and Connecticut have vaccination rates that exceed 80%. Meanwhile, other states—a majority of which are in the South—have vaccination rates below 35%.

According to Becker’s Hospital Review, Mississippi currently has the lowest vaccination rate in the country with only 28.86% of their population being fully vaccinated. The CDC reports that fewer than one million residents have received both doses of the Moderna and Pfizer-BioNTech vaccines or one dose of the Johnson and Johnson vaccine, making them fully vaccinated. For reference, their total population is approximately three million people, based on data from the United States Census Bureau in 2019. Following Mississippi for the lowest vaccination rates are Alabama and Arkansas, with 31.86% and 33.3% of their respective populations being fully vaccinated. (As an interesting side note, these three states were also among the first to lift their mask mandates; Mississippi on March 2, Alabama on April 9 and Arkansas on March 30.)

These stark discrepancies in vaccination rates pose legitimate and pressing problems for states and counties that are struggling to vaccinate their citizens. Most concerning in these areas is the increased spread of more contagious strains of COVID-19, specifically the Delta variant. As the World Health Organization explains, the more a virus spreads, “the more opportunities it has to undergo changes.” These changes can directly alter both spreadability and severity of the virus. Earlier this year, the UK variant (or the Alpha variant) gained international attention because it was more transmissible than earlier COVID-19 strains. The Delta variant—which experts are now predicting will become the dominant strain in the United States—is even easier to spread between individuals. Moreover, the Delta variant is more unpredictable in how it affects individuals, in comparison to other strains. Steve Edwards, the CEO of CoxHealth, spoke on the variant and said, “We can’t tell why one patient is doing poorly and one is doing well. There’s just something different about how this variant is affecting the immune system of our patients.”

Due to this new Delta strain, doctors are doubling down on their insistence that citizens must get vaccinated to protect themselves and others. Dr. Rochelle Walensky, director of the CDC, said, “After two doses—reminding you, get your second dose—after two doses, you are protected from that Delta variant.” Dr. Paul Offit, a pediatrician who specializes in infectious diseases and vaccines, added, “Unless we vaccinate a significant percentage of the population before winter hits, you’re going to see more spread and the creation of more variants, which will only make this task [of ending the pandemic] more difficult.” These claims are backed by a recent study conducted by Public Health England that found that the Pfizer-BioNTech vaccine is 96% effective against hospitalization caused by the Delta variant after two doses.

Therefore, in states like Mississippi, Alabama and Arkansas, there have been significant upsurges in cases of this new Delta variant, according to the aforementioned CNN article. Like what the country experienced when COVID-19 cases swelled during the winter months of late 2020 and early 2021, hospitals are again filling up in these lesser vaccinated states. According to the CDC, as of June 17, 2021, Mississippi was averaging 119 new cases of COVID-19 every seven days. Similarly, Alabama was averaging 190 new cases, and Arkansas was averaging 247 new cases every seven days. Meanwhile, Vermont was averaging only six new cases each week. It is important to note that, although slow and incomplete, some progress has been made in these southern states; Mississippi’s average weekly cases peaked in early January at around 2,324 new cases. But this progress is far from over and not yet something to celebrate.

Doctors and legislators now need to turn their attention towards pushing the vaccine into communities that are currently resistant to its presence or that are being faced with systemic barriers blocking them from receiving it. Scott Gottlieb, former commissioner of the FDA, said, “Now we need to think about trying to push out the vaccine into community sites where people could get it delivered to them through a trusted intermediary, that’s going to mean doctors’ offices, schools, places of employment.”

This continued effort to vaccinate American citizens becomes increasingly important when one considers that the pandemic is disproportionately affecting racial and ethnic minorities. America has continually fallen short of health equity, the concept that all citizens have equal opportunity for fair treatment and being healthy, and it has been brought to the forefront during the pandemic. Factors including discrimination, access to healthcare, employment as essential workers and housing conditions all pose challenges to achieving health equity. Thus, American Indian citizens and Alaska Natives represented 1,216.1 COVID-related hospitalizations per 100,000 people in America from March 1, 2020 to June 5, 2021. Black citizens represented 997.8 COVID-related hospitalizations, and Hispanic and Latinx citizens represented 993.5 hospitalizations. White Americans represented only 354.7 COVID-related hospitalizations across that same timespan.

Moreover, vaccination rates sorted by race also point towards immense health inequity. Only 1.0% of the American Indian and Alaska Native population, 9.1% of the Black population, and 15.1% of the Hispanic and Latinx population have received at least one dose of the vaccine. In stark contrast, 60.2% of the white population have received their first dose.

To stop the spread of the Delta variant, reduce the further mutation of the COVID-19 virus and protect the American population, vaccinations remain of the utmost importance, per the repeated recommendations of the CDC and other medical professionals.

STRUCTURED BREAST IMPLANTS OUTPERFORM SILICONE GEL IMPLANTS

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Ten-Year Data Shows Lower Risk of Rupture than Silicone Gel Implants as Surgeons Nationwide Report Higher Demand for IDEAL IMPLANT Structured Breast Implants

IDEAL IMPLANT Incorporated today announced the release of its ten-year FDA Core Clinical Trial Data, indicating that the Structured Implant presents a substantially lower risk of two major breast implant complications compared to the silicone gel implants. While silicone gel implants have dominated the industry since they were allowed back on the market in 2006, technological advances over the past decade are now eliminating the need for accepting certain risks associated with silicone gel.

The cumulative risk of implant rupture or deflation with IDEAL IMPLANT over ten years after primary breast augmentation was only 3.7% in comparison to clinical trial data on silicone gel implants from Allergan (9.3%), Mentor (24.2%) and Sientra (8.7%) that had to use MRI scans to detect rupture. When a Structured Implant ruptures, a woman can easily detect partial deflation simply by looking in the mirror, and the multi-chamber design makes full deflation unlikely. Unlike silicone gel, any leaked saline is harmlessly absorbed by the body, and no MRI or ultrasound scan is necessary to detect a rupture.

“This data emphasizes a clear advance in breast implant technology where the old question to patients of ‘do you want saline or silicone gel?’ has become a false choice, since the original, unstructured saline implant does not offer natural results” reports Dr. Larry Nichter, a board-certified plastic surgeon in Southern California and an FDA investigator for the Structured Implant. “We moved toward silicone gel implants after 2006 because they offered a better cosmetic result over the original, unstructured saline implants. Now we have the Structured Implant technology that offers the similar natural look and feel as silicone gel and doesn’t require MRI or ultrasound scans to detect rupture. It eliminates the concern of silent rupture and offers a significantly lower rupture risk, where the saline filler is safely absorbed by the body if there is a leak. In light of this ten-year clinical performance data, the question surgeons should now be asking patients today is, ‘do you want Structured or silicone gel?'”

“Women seeking breast augmentation increasingly are demanding options that don’t require silicone gel to be placed in their bodies, and they have less patience for the risk of silent rupture,” reports Dr. Vivian Ting, a board-certified plastic surgeon in Northern California who presented survey data on women’s implant preferences at the ASPS Aesthetica Super Symposium in 2018. “Too many surgeons—who are predominantly male in this industry—dismiss this trend simply because they are content with the options of the past. Hopefully this data will drive home that they will have fewer ruptures, better outcomes and happier patients, when they stay current with the technology and patient preferences.”

The IDEAL IMPLANT Structured Breast Implant also outperformed silicone gel implants over ten years in a second major breast implant complication: capsular contracture. After augmentation, the body may form scar tissue around the implant, which can deform the look of the breast and cause pain and firmness. Capsular contracture generally requires revision surgery to remove and replace the implant and scar tissue. IDEAL IMPLANT rates of Baker class III/IV capsular contracture over ten years after primary augmentation were only 6.6%, compared to silicone gel implants from Allergan (18.9%), Mentor (12.1%) and Sientra (12.9%).

“No woman wants to deal with breast implant complications, and this very low rate of capsular contracture directly translates to a lower risk of surgical revisions—and the expense and time associated with that,” explains Dr. Elizabeth Kerner, a board-certified plastic surgeon in the Dallas Fort Worth Metroplex. “A year after surgery, I have to check a patient’s chart to see whether they had silicone gel or the IDEAL IMPLANT, and in my experience, the look and feel is practically identical. While different implants are appropriate for different body types, IDEAL IMPLANT has now demonstrated a superior safety profile while offering the same look and feel as gel. I think we are already seeing this trend follow science as more women demand this choice.”

Dr. Constance Barone, a renowned board-certified plastic surgeon with a busy practice in San Antonio, Texas, confirms this trend. “Demand for the IDEAL IMPLANT is high and growing quickly as women are more educated about the clinical performance data. I ensure all my patients see and feel each one of the current implant options and, almost exclusively these days, they pick the IDEAL IMPLANT.”

The IDEAL IMPLANT Structured Breast Implant began FDA clinical trials in 2009, and received FDA and Health Canada approval for public use in 2014. The company also offers a first-of-its-kind optional Premium Protection Plan, which provides limited financial protection for certain complications related to the procedure and/or the implant, and is renewable for life for greater peace of mind. For more information, click HERE.

Best CBD Salves

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Best CBD Salves: Top Brands in 2021

At some point in their lives everyone deals with sore muscles, achy joints, and dry, chapped skin. However, finding relief can sometimes be a challenge. Harsh ingredients irritate the skin, and watery formulas have no effect.

People are looking for a solution. They want a product that works with the body’s natural defenses to reduce pain and inflammation while also nursing the skin. Products made with CBD targets problem areas by penetrating the skin’s layers for healing and relief.

But, finding the best CBD salve isn’t always easy because not all CBD salves are created equal. Several companies manufacture CBD products that contain very little CBD, or the CBD is low-quality and combined with harmful ingredients.

This article looks at the different CBD salves on the market, and determines what makes one CBD topical salve better than others. The objective of this article is to educate readers on how to choose a high-quality salve, explain what is in a salve, and determine if a salve is the right choice for their type of pain. Additionally, this piece will explain the benefits and side effects of CBD topicals.

Keep reading to discover our top picks for the best CBD salves and learn how we chose them.

What Are CBD Salves and Topicals?

Many people are already familiar with CBD that can be taken orally: such as tinctures, gummies, or vape cartridges. CBD topicals are products that contain CBD for application to the skin. Topicals come in many forms, such as creams, lotions, balms, and salves.

Creams and lotions combine oil and water, along with an emulsifier. Creams have a higher ratio of oil to water, whereas the ratio is vice versa for lotions. Manufacturers formulate lotions and creams to absorb quickly into the skin.

In contrast, salves and balms typically contain CBD, herbal remedies, and some type of wax–such as beeswax. Salves usually have a softer consistency than balms.

When Looking for a High-Quality CBD Salve?

Here are things to consider when choosing high-quality CBD salve for you:

The type of CBD

Previously, we discussed the difference between full spectrum, broad spectrum, and CBD isolate. Many people prefer full spectrum CBD because they are getting all the beneficial chemical compounds found in the hemp plant, including minute traces of THC. For people who want their products to contain only the CBD from the hemp plant and no other cannabinoids, CBD isolate is their preference.

The amount of CBD

CBD topicals come in varying strengths. The more CBD a product contains, the more potency it has. For first-time CBD users, it’s always best to start with the lowest strength and increase dosage until reaching the desired effect. Since many companies offer money-back guarantees, it’s easy finding the CBD strength that’s right for you.

Desired outcome

The primary purpose of using a CBD salve is to provide relief from pain. However, other benefits depend on the other added ingredients. Some people prefer a heating or cooling sensation, or alternate between both. Yet, others enjoy a calming scent that will help them to calm their minds and relieve stress. Many users of CBD topicals like to have their skin feel nourished and moisturized.

Price

CBD Salves tend to be more expensive than other topicals that are mass-produced and found in large box stores. The best CBD companies use high-quality hemp and organic ingredients to make their salves. They also do a considerable amount of research and testing to produce a CBD salve that’s safe and effective. If a store is advertising the “cheapest CBD products in town,” the product likely contains little CBD and inferior ingredients.

Our Criteria for Choosing The Best CBD Salves In 2021

In recent years, several CBD companies have come onto the market. Knowing what to look for can seem like a daunting task. It may seem easy to choose the first item during a web search or to stop by a nearby corner advertising CBD products. However, to make sure you’re purchasing a high-quality CBD salve, you will want to consider the following:

Where Does the Company Get its Hemp?

The 2018 Farm Bill made the cultivation of industrial hemp legal in the United States. It states that farmers can apply for a license to grow hemp and that the hemp can’t have THC levels above 0.3%. The Department of Agriculture regulates the industrial hemp industry, so all hemp produced in the US must meet USDA standards.

Several companies import their hemp from China, Canada, and the EU.[1] Many foreign countries do not have the same regulations and oversight as hemp grown in the United States. The hemp in their products might contain heavy metals, pesticides, or toxins.

How Does the Company Extract the CBD From the Hemp?

There are several methods for extracting CBD oil from the hemp plant and some of those ways are less expensive than others. These methods usually involve using a solvent, such as ethanol or isopropanol. The problem with these extraction methods is that they destroy the hemp plant, and the solvents tend to bind to some of the plant’s components. What is left is a product that may be lacking in potency and purity.[2]

Alternatively, CO2 extraction is more expensive. It uses pressurized carbon dioxide to isolate and extract the beneficial cannabinoids from the hemp, without damaging the plant. The result is a high-yield, high-quality CBD oil that is pure and potent.

Does the Company Do Third-Party Testing?

CBD companies don’t have the same types of regulations under the FDA as drugs, and some brands make misstatements on their products. Legitimate CBD companies have their products tested by a third-party independent lab. These labs test the products for potency, ensure the THC level is below 0.3%, and checks for heavy metals, chemicals, and pesticides. Look for the company’s Certificate of Analysis (COA) on its website.

What Other Ingredients Are in The Salve?

Many brands of CBD salves contain other ingredients to enhance its effects. Look for products that contain organic and natural ingredients, such as botanicals and essential oils, and try to stay away from brands that contain chemicals and synthetic additives

What are Other People’s Opinions?

While it’s a good idea to read the reviews on a company’s website, it’s also essential to search the web for independent reviews. See what other people say about the company, the product, and the customer service.

However, keep in mind that a product that works for someone else may not work for you. You may have to try a couple of different brands before finding the product that is effective for your issues.

Best CBD Salve Brands in 2021: Our Top Picks

We considered all the previous factors, along with others, and compiled our list of the five best CBD salve brands on the market. These products come from reputable CBD companies and have been shown to be effective in treating pain relief. These CBD Salves have received favorable reviews from users of all ages. They’re used by athletes, office workers, outdoor enthusiasts, and knitters. These are our top choices.

Fab CBD

Fab CBD offers a full spectrum body salve. It comes in a roll-on, so it is easy to target sore muscles. While many other salves provide cooling or heating, Fab CBD Salve offers both. It contains Menthol Crystals for cooling and Cinnamomum Camphora Oil for heating. It also includes other organic essential oils and terpenes to soothe aching muscles and relax the body and mind.

Available in 1000mg and 3000mg full spectrum CBD
Convenient to carry in a backpack or gym bag
Great for weekend warriors or to relieve everyday aches and pains
It contains Rosemary, Ginger, Lavender, Eucalyptus, Organic Peppermint, Organic Tea Tree, and Organic Lemon Grass Oils to soothe skin and reduce inflammation
CBD extracted from hemp organically grown in Colorado
Roll-on applicator means less mess

Joy Organics

Joy Organics CBD salve combines broad-spectrum, premium-grade CBD with organic beeswax and essential oils. It absorbs quickly into the skin to relieve aching muscles, while the scent of lavender and eucalyptus promotes a feeling of relaxation.

CBD salve comes in strengths of 500mg and 1000mg
All of Joy Organics hemp is grown in the United States and is USDA Certified Organic
Joy Organics offers free shipping on all orders
All the ingredients in Joy Organics CBD Salve are organic
Joy Organics CBD Salve is high quality but is less expensive than many other competitors

CBDistillery

CBDistillery has all-natural ingredients in its CBD Relief Salve. Full-spectrum CBD absorbs quickly into the skin for incredible pain relief. Olive, Coconut, and Jojoba oils combine with Vitamin E to moisturize the skin.

Customers can choose from three strengths: 500mg, 1000mg, and 2000mg
CBD extracted from hemp grown organically in Colorado
The direct use of an essential skin care component like Vitamin E makes this cream a must have
Hemp is non-GMO and contains no animal by-products
CBDistillery offers free shipping

What Are CBD Salves Generally Made From?

The main ingredient in CBD Salves is Cannabidiol (CBD) from hemp. CBD is one of over 100 chemical compounds in the cannabis plant. There are three different types of CBD that companies use in their products.

Full Spectrum

Full spectrum CBD is the least processed of all the extraction types. It contains all the cannabinoids, terpenes, and flavonoids from the hemp plant. It may also trace amounts of THC, the chemical compound found in cannabis with psychoactive properties. However, that trace amount is below 0.3% and is not enough to give users a feeling of being high. Full spectrum CBD allows for the entourage effect, that is, all parts of the hemp plant working together for maximum benefit.

Broad Spectrum

Broad spectrum CBD is very similar to full spectrum. However, it goes a little further in the extraction process to remove all traces of THC. Users can experience all the other beneficial components of the hemp plant without worrying about having any THC in their system.

CBD isolate

CBD isolate is the most processed of three types of extraction. CBD isolate is as the name suggests. All the other cannabinoids, including THC, along with the terpenes and flavonoids are entirely removed, leaving only the CBD.

Next, the company may combine natural botanicals with the CBD. These are essential oils from plants that people have been using for centuries for their therapeutic properties, such as Lavender, Rosemary, or Eucalyptus. Mixing the botanicals with CBD provides added relief and calming.

Some essential oils are potent and may be irritating to the skin in pure form. Therefore, manufacturers add carrier oils to the CBD. Jojoba oil, sweet almond oil, olive oil, or coconut oils are typically used as carrier oils, though there are several other choices.

Last, salves contain some type of wax, usually beeswax. The beeswax gives the salve its firmness. The wax’s primary purpose is to provide a skin barrier to allow the CBD and botanicals to absorb into the skin.

How to Apply CBD Salve, Lotion, And Cream?

There are several application methods for applying CBD salves, lotions, and creams. Some CBD topicals come as a roll-on, allowing the user to roll the salve onto the affected body part with no mess. This method is ideal for people traveling or on a hike or bike and need quick relief.

Another method preferred by many is to use a spatula to scoop out a small amount and apply it to the skin in a thin layer. However, most people use their fingers to apply the salve and massage it in.

No matter what the application method is, users should use the following steps in applying a CBD salve, lotion, or cream.

The first step is always to wash your hands to prevent any germs or bacteria from transferring from your hands to the CBD topical.

Next, wash and dry the affected body part. Using an applicator, clean spatula, or your fingers, take a small amount of salve and apply it where needed. Always start with a small amount and add more if it’s needed. Slowly and gently, rub it in so it can permeate the skin.

Wash your hands (and spatula) and wait a few minutes. Pain relief should happen in a short amount of time. Re-apply a few times throughout the day, as needed.

What Are The Benefits Of Applying CBD Salves?

Many people are curious why applying salve containing CBD is more beneficial than other mass-market-produced topicals, especially if they aren’t sure what CBD is and how it works.

To understand how CBD works, a person needs to know about the body’s Endocannabinoid System (ECS). Three components form the ECS.

There are receptors on the surface of the cells throughout the body. They monitor the body’s functions and keep alert for any changes in condition. The two types of receptors are the CB1 receptors in the central nervous system and the CB2 receptors in the peripheral nervous system.

When the receptors sense that a condition has changed in the body, they send out a message. At that point, endocannabinoids will come and bind to the receptors and work to bring the affected area back into homeostasis. Once the endocannabinoid’s job is complete, the enzymes break them down.

Researchers believe that the CBD works with the ECS to prevent the enzymes from breaking down the endocannabinoids, allowing them to work longer.

The skin is the body’s largest organ with a large concentration of CB2 receptors. When someone applies CBD topicals to the affected body part, the CBD can go directly to those receptors and provide fast relief.

Do Salve CBD Products Have Side Effects?

There are no known side effects from using products containing CBD. Additionally, there is little to no THC in CBD products, so people using CBD don’t need to worry about any psychoactive effects.

However, everyone has a different skin type. Some types are more sensitive to specific ingredients that might be in the salve, or there may be an allergic reaction. People with allergies should also check the label before using a salve for the first time. Furthermore, those with sensitive skin types should consult their physician before trying a CBD salve.

Last, whenever using a product for the first time, it’s essential to use only a small amount and test it on a small part of the body. If there is irritation or a rash, stop using the product immediately.

Is CBD Salve Right for You And Your Pain?

CBD Salve is ideal for short-term localized pain. It’s perfect for aching muscles from over-exertion or the joint pain associated with arthritis. Salves usually contain various other herbal remedies that have been proven to have therapeutic healing properties.

Many people prefer not to treat pain with pain relievers such as aspirin or ibuprofen and consider all-natural products to be better alternatives.

For anyone suffering from chronic pain or pain throughout the body, it’s always best to consult a physician as it may be a sign of a more severe condition. Furthermore, most instruction labels will state not to use CBD Salves on any open wounds or cuts.

The Bottom Line

People have been hearing a lot about CBD over the last few years. Research is still in the early stages, but scientists are excited about all the potential ways that CBD can benefit humans. CBD companies are working hard to find new ways for people to add CBD to their lives.

While CBD tinctures and edibles are a great way to achieve overall wellness, many people are discovering that CBD salves, lotions, and creams are the ideal solution for treating specific body parts with CBD.

CBD Salves are the perfect solution for providing quick relief from pain and can be re-applied several times throughout the day to stay pain-free. Essential oils enhance the effects of the CBD for added comfort.

There are many options to choose from when shopping for CBD salves. It’s important to note that the FDA doesn’t provide regulation on the safety or effectiveness of CBD products. Therefore, customers need to educate themselves on what to look for before purchasing any CBD Salves.

Last, this article is for informational purposes and instructs consumers on choosing the best, high-quality CBD salve. It’s always important to discuss any changes in medical conditions with a health provider.

Antibody Cocktail May Prevent Symptomatic COVID-19 Infections

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An antibody cocktail being tested at UVA Health and other sites was able to block 100% of symptomatic COVID-19 infections among people exposed to the virus, early results from the clinical trial suggest.

In addition, those who developed asymptomatic infections accumulated far less virus in their bodies than usual and saw their infections resolve within a week, according to interim data released by the cocktail’s manufacturer, Regeneron Pharmaceuticals.

“This is the first treatment shown to prevent COVID-19 after a known exposure, and offers protection for unvaccinated individuals caring for a family member with COVID-19,” said UVA Health’s William Petri Jr., MD, PhD, one of the leaders of the trial at UVA. “We expect that Regeneron will file for Emergency Use Authorization from the FDA so that this drug can be used outside of the context of a clinical trial.”

Antibodies for COVID-19

The phase 3 clinical trial aims to determine if the antibodies will prevent COVID-19 infection in people who have been exposed but not yet developed the disease. This is known as “passive immunization.”

Regeneron’s new analysis, which has not yet been published in a scientific journal, looked at outcomes in approximately 400 trial participants. Of 186 people who received the antibodies, none developed symptomatic COVID-19. Of the 223 who received a placebo, eight developed symptomatic COVID-19, the company reports.

Asymptomatic infections occurred in 15 of the antibody recipients and in 23 of the placebo recipients. Overall rates of infection, including both symptomatic and asymptomatic infections, were approximately 50% lower in the antibody group.

Among those who developed infections, placebo recipients had, on average, a peak viral load (the amount of virus in the body) that was more than 100 times greater than antibody recipients. The antibody group also recovered more quickly–all the infections resolved within seven days, while 40 percent of infections in the placebo group lasted three to four weeks, Regeneron said.

The cocktail also appears to shorten the duration of viral shedding, the time when the virus is being manufactured in the body. The viral shedding period was nine weeks among antibody recipients and 44 weeks among the placebo recipients. While people with COVID-19 are not infectious for this entire time, reducing the duration of viral shedding may shorten the period when they can spread the disease.

There were more adverse events reported among placebo recipients than among antibody recipients – 18 percent and 12 percent, respectively. Regeneron attributed this to the larger number of COVID-19 infections in the placebo group.

There was one death and one COVID-19-related hospitalization in the placebo group and none in the antibody group. Injection-site reactions were reported among 2 percent of both groups.

“We are profoundly grateful to the nurses and staff of the UVA COVID-19 clinic, led by Dr. Debbie-Anne Shirley,” Petri said. “Their day-to-day support made our participation in this trial possible.”

About the Clinical Trial

Phase 3 clinical trials, such as the one under way at UVA, examine the safety and effectiveness of new drugs and treatments in large numbers of people. Positive results in the phase 3 trial could spur the federal Food and Drug Administration to make the antibody cocktail available for post-exposure COVID-19 prevention.

The antibody cocktail is not a vaccine and is not expected to provide permanent immunity to COVID-19.

The team conducting the study at UVA is led by Petri and Shirley and includes Gregory Madden, MD; Chelsea Marie, PhD; Jennifer Sasson, MD; Jae Shin, MD; Cirle Warren, MD; Clinical Research Coordinator Igor Shumilin; assistant Rebecca Carpenter; and COVID-19 Clinic nurses Michelle Sutton, Elizabeth Brooks, Danielle Donigan, Cynthia Edwards, Jennifer Pinnata, Samantha Simmons and Rebecca Wade.

To keep up with the latest medical research news from UVA, subscribe to the Making of Medicine blog.

Pfizer × BioNTech near historic vaccine

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By Althea Champion

Pfizer and BioNTech announced on Monday that their COVID-19 vaccine is more than 90 percent effective. If approved, it could potentially be available to the public by early December, according to Dr. Anthony Fauci.

The results came out of Pfizer’s Phase 3 trial, which involved 40,000 individuals. Of those participating, 94 contracted COVID-19. These results, like much of 2020, are historic. Vaccines have never been developed on such a fast-moving timeline. The last vaccine that was developed in such considerable haste was for mumps, and it took four years.

Pfizer says that they plan to ask the Federal Drug Administration for emergency use by the end of the month. The vaccine will require two doses administered three weeks apart. The company hopes to have enough doses for 25 million people by the end of the year, and 650 million people in 2021.

In the case that the vaccine supply is limited, the C.D.C. will first vaccinate healthcare personnel, essential workers, people who are at high risk for severe COVID-19 illness due to underlying medical conditions, as well as those 65 years and older.

An expedited timeline does not mean drug companies are cutting corners. Fauci, like many of his colleagues in Washington, assures that manufacturers will stick to a process of vaccine development that ensures the safety of patients. The FDA will still make the final call.

“Today is a great day for science and humanity,” said Dr. Albert Bourla, Pfizer Chairman and CEO, in Pfizer’s press release. “The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19.”

However, a few questions remain unanswered.

“Historically, important scientific announcements about vaccines are made through peer-reviewed medical research papers that have undergone extensive scrutiny about study design, results and assumptions,” writes Arthur Allen in the Opinion section of the NYT. “Not through company press releases.”

According to Allen, it is unclear from the press release how long Pfizer’s vaccine will keep patients protected, if it is safe for high-risk populations like the elderly, or if rare side effects can arise in patients who are vaccinated. He notes that the Novavax and Sanofi Pasteur vaccines may be safer for older patients.

Novavax and Sanofi Pasteur are subunit vaccines, like the hepatitis B vaccine. They deliver only the essential antigens of the virus to the immune system, so it learns how to attack it. Because it is only a part, or a subunit, of the virus, fewer side effects are likely.

Pfizer’s is a nucleic acid vaccine that uses RNA. According to the Washington Post, “this type of vaccine contains a strip of genetic material within a fat bubble” that enters the cell. Once inside, “the RNA generates a protein found on the surface of the virus.” It can then familiarize itself with the virus and learn how to fight it.

Moderna’s vaccine is also an RNA vaccine in Phase 3 trials. Pfizer’s success bodes very well for Moderna, according to a statement Fauci made to CNN.

Furthermore, because the vaccine must be stored in extremely low temperatures—on dry ice at negative 100 degrees Fahrenheit according to the Washington Post—its roll-out becomes complicated. If left out in the sun, or just at room temperature, or even at just below freezing, the mRNA self-destructs and the vaccine becomes useless.

Shortly after Pfizer’s announcement, President-elect Joe Biden addressed the nation, warned of the “dark winter” ahead, and urged Americans, regardless of party affiliation, to wear a mask until the vaccine is available.

The head of the C.D.C. warned this fall, that “for the foreseeable future, a mask remains the most potent weapon against the virus,” he said from the podium. “Today’s news does not change that urgent reality.”

Elyptol Sanitizers Clean × Heal

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Elyptol is the first Type 1 eco-certified and professionally registered hand sanitizer. It harnesses the healing properties of eucalyptus oil and naturally-sourced pure ethanol to bring you a product that sanitizes in a healthy and eco-friendly way. Despite its gentle feel, make no mistake that this hand sanitizer is FDA listed and hospital grade.

To Kill Germs Gently, Think Naturally with Elyptol

The sanitizer kills 99.99997% of germs with 70% alcohol. It contains eucalyptus oil and pure ethanol derived from sugar cane to eliminate germs gently and safely. And, it uses botanical food grade ethanol and eucalyptus ingredients that are known for soothing and healing aching bones and irritated skin.

Not only is Elyptol antibacterial, but it is antimicrobial as well. For this reason, it kills a wider range of germs.

“The perfect synergy of science and nature,” notes the company on their front page. “Elyptol harnesses nature’s strengths to create skincare and hard surface hygiene products that effectively kill germs harmful to your health.”

About Elyptol:

The USA/Australian company takes its natural inspiration from those putting their lives on the line for us every day. Elyptol founder Tim O’Connor recognized just how much health care workers used sanitizers when his daughter was born. These hospital grade formulas wreaked havoc on their hands. With years of extensive research and development using green chemistry, Elyptol became the first Type 1 eco-certified and professionally registered hand sanitizer. It expertly pairs eucalyptus oil, known for its healing properties, and natural sanitizing ingredient pure ethanol, derived from sugarcane and corn. The result is an efficient formula that eliminates germs, yet it’s gentle enough on skin and safe for the environment.