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Research links rare cancer to breast implants, but Health Canada says no safety advisory is needed

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At age 44 and after two kids, Terri McGregor knew she wanted to give herself a gift.

“I simply wanted to restore my breasts to what they were before having children — that’s it,” said the North Bay, Ont., woman.

McGregor’s surgeon recommended a Biocell textured implant, made by Allergan, saying that the implant’s textured surface — similar to very fine sandpaper — better adheres to the chest tissue and increases stability.

For six years, McGregor lived what she calls her “honeymoon phase” with her implants. “I felt beautiful and I felt good — I had no problems,” she said.

Then in 2015, after she turned 50, McGregor went for her first routine mammogram. The examination caused both her implants to rupture.

She needed to undergo a replacement surgery.

“When they opened me up, the silicone gel was like Jello in my chest. It had to be mopped up, flushed out,” she recalled.

Her problems were just beginning.

Little-known cancer

During McGregor’s operation, the surgeon removed the ruptured implants and also her capsules, a layer of scar tissue that forms around an implant after it is placed.

One of those capsules had an unusual appearance.

“There were three tumours measuring about five centimetres each,” she said. “You could see the cancer with a naked eye.”

The remains of McGregor’s ruptured breast implants are shown after her replacement surgery in 2015. (Terri McGregor)

McGregor had developed a rare form of cancer known as breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.

Health Canada estimates that one in 12,000 women with textured implants will develop BIA-ALCL, noting an occurrence rate of one case per 24,177 textured implants. Other studies around the world vary, putting the occurrence rate at anywhere from one in 1,000 women to one in 30,000.

Globally, plastic surgeons have identified 615 cases of BIA-ALCL, including 16 deaths.

BIA-ALCL is not breast cancer, but rather a type of lymphoma that often appears as a build-up of fluid between the implant and the tissue that surrounds it.

McGregor’s diagnosis was bleak: The cancer had spread from her capsule to her lymph nodes and into her intestine and abdomen.

She ultimately underwent eight rounds of chemotherapy, but her cancer continued to grow.

Doctors told her she only had a few months to live.

“It was surreal; my breast implants were going to kill me,” she said. “I started putting my affairs in order, to prepare myself to die.”

Allergan acknowledges ‘inherent risks’

The U.S. Food and Drug Administration was the first agency in the world to identify a link between breast implants and cancer back in 2011. At the time, it said 34 cases had been recorded, with the first case dating back to 1997.

By 2015, when McGregor received her diagnosis, 140 cases had been identified worldwide, including a dozen in Canada. All of the Canadian cases were linked to the Biocell textured implants made by Allergan — the same type of implant McGregor had received.

But she said she was never told about the risk of developing BIA-ALCL.

“I drive a Chevy, and when my truck has some kind of warning or alert, I get a letter from General Motors that says: ‘Please take your vehicle to the dealership, you may have a problem,'” McGregor said.  

“So, why is it that General Motors will tell me if there’s a problem with my truck, but I’m not told if there’s a potential problem with a product that’s in my body?”

‘I started putting my affairs in order, to prepare myself to die,’ McGregor says of her feelings after she was told her cancer had spread from the scar tissue around her implant to her lymph nodes and into her intestine and abdomen. (Terri McGregor)

Last year, McGregor filed a civil lawsuit against Allergan, alleging that the manufacturer “did not fully and clearly” inform her of “all the dangers inherent in the use of its products that it knew or ought to have known.”

In the suit, McGregor also alleges that had she been made aware of the cancer risk after undergoing her breast augmentation, she would have “taken steps to have the implants removed.”

In a statement of defence, Allergan said that while breast implantation carries “certain inherent risks,” it was not negligent in the “manufacture, design, development, quality control or testing” of McGregor’s implants.

The lawsuit is still before the court, and none of the allegations have been proven. 

A poorly documented problem

On its website, Health Canada says only five Canadian cases of BIA-ALCL have been reported to the agency by manufacturers in the last 10 years.

However, in the U.S., where medical device reports are made public, a database lists 20 cases of BIA-ALCL reported in Canada.

The discrepancy suggests that Allergan reports the Canadian cases to the FDA in the U.S., but that same information does not reach Health Canada.

In a brief statement to CBC News, Allergan said the safety of its products is supported by a large number of studies and more than a decade of clinical use in the United States and Canada. Allergan also said patient safety is a priority for the company.

Two Canadian plastic surgeons — Peter Lennox and Mitchell Brown — have also been compiling data from colleagues across the country and have identified 25 women in Canada with BIA-ALCL. Of those 25 confirmed cases, they found 23 had Biocell implants.

When asked about the differences in these numbers, Health Canada said it was made aware of the 25 surgeon-identified cases this past summer, and it is reviewing each case. The agency said it will publish an update once that review is complete.

A wedding and an experimental treatment

Just a few weeks after being told she was going to die, Terri decided to get married.

“I look back at my wedding photos today, and I just think, ‘What a shame that these photos have so much sadness attached to them.'”

Shortly after her wedding, McGregor’s doctors managed to get her access to an experimental drug called Brentuximab, a treatment only available to those whose chemotherapy has failed.

‘I look back at my wedding photos today, and I just think: What a shame that these photos have so much sadness attached to them,’ McGregor says. She married just weeks after she got her cancer diagnosis. (Terri McGregor)

After four doses of the drug, McGregor’s cancer is today completely gone.

Earlier this month, Brentuximab was approved by the FDA as a first-line treatment for anaplastic large cell lymphoma.

For the past two years, McGregor has been urging Health Canada to require manufacturers to send safety advisories to all women with textured breast implants, in order to better inform them of the cancer risk.

“Women with textured implants in Canada deserve a letter — not to alarm them, but to tell them they need to be on the lookout for symptoms of cancer,” she said.

Health Canada told Radio-Canada it currently has no plans to require such an advisory, saying it believes there is enough safety information about the risk of BIA-ALCL on its website and in the documentation provided by implant manufacturers.

“Health Canada representatives have told me that they cannot tell manufacturers what to do. I say to them, ‘Why not? You approved their products … Why can’t you tell them what to do? You’re the regulator,'” said McGregor.

Earlier this week, France became the first country to advise its physicians to switch to smooth-surfaced breast implants rather than the textured implants.

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Sweet! Here are 7 reasons to eat sweet potatoes

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(Natural News) Sweet potatoes may not be as popular as regular potatoes, which is too bad — since they’re packed with vitamins and minerals. One cup of sweet potatoes can provide more than 100 percent of the daily value of vitamin A. It’s also rich in vitamin C, dietary fiber, and manganese. Both purple and orange varieties contain antioxidants that can protect the body from damage caused by free radicals.

Eating sweet potatoes is beneficial for your health

Sweet potatoes are brimming with micronutrients and antioxidants —  making them useful to your health. Below is a list of reasons why you should incorporate sweet potatoes into your diet.

They improve brain function

The purple variety of sweet potato contains anthocyanins. Anthocyanins are known for their anti-inflammatory properties. Studies have revealed that anthocyanins are effective at improving cognitive function. Moreover, the results suggest that purple yams can help protect against memory loss. Antioxidants from the purple variety safeguard the brain against damage from free radicals and inflammation.

They aid digestion

Sweet potatoes are rich in dietary fiber. This macronutrient prevents constipation, diarrhea, and bloating by adding bulk and drawing water to the stool. In addition, fiber keeps a healthy balance in the gut by promoting the growth of good bacteria.

They slow down aging

The beta-carotene in orange sweet potatoes can help reduce damage caused by prolonged sun exposure. This is especially true for people diagnosed with erythropoietic protoporphyria and other photosensitive diseases. Sweet potatoes also contain antioxidants that protect against free radical damage. Free radicals are not only linked to diseases but also premature aging.

They boost the immune system

Orange and purple sweet potatoes are loaded with a good number of antioxidants that help protect the body from harmful molecules that cause inflammation and damage DNA. This, in turn, protects the body from chronic diseases like cancer and heart disease.

They can prevent cancer

Eating sweet potatoes can help protect against various types of cancers. The compounds in sweet potatoes restrict the development of cancer cells. Test tube studies have shown that anthocyanins can prevent cancers in the bladder, breast, colon, and stomach.

They lower blood sugar

Despite its relatively high glycemic index, studies have shown that the regular intake of sweet potatoes can help lower blood sugar, thanks to the presence of dietary fiber. While fiber falls under carbohydrates, it is digested differently, compared to starchy and sugary forms of carbohydrates. Interestingly, insulin doesn’t process fiber (unlike other types which get turned into glucose), and it only passes through the digestive tract.

They promote healthy vision

Orange sweet potatoes are rich in a compound called beta-carotene, an antioxidant which transforms into vitamin A in the body. Adequate intake of vitamin A promotes eye health. Conversely, deficiencies in vitamin A have been linked to a particular type of blindness called xerophthalmia.

Sweet potatoes are easy to incorporate into your everyday meals. They are best prepared boiled but can also be baked, roasted, or steamed — they can even replace other carbohydrates such as rice, potatoes, and toast. (Related: Understanding the phytochemical and nutrient content of sweet potato flours from Vietnam.)

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Frostbite: What it is and how to identify, treat it

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Manitoba’s temperature has plummeted to its coldest level this season, triggering warnings about the extreme risk of frostbite.

Oh, we know it’s cold. We can feel Jack Frost nipping at our noses. But what about when he gnaws a little harder — what exactly does “frostbite” mean?

People tend to underestimate the potential for severe injuries in the cold, says the Winnipeg Regional Health Authority. We laugh off the sting of the deep freeze, rub our hands back from the brink of numbness and wear our survival proudly like a badge.

That’s because, in most cases, frostbite can be treated fairly easily, with no long-term effects.

But it can also lead to serious injury, including permanent numbness or tingling, joint stiffness, or muscle weakness. In extreme cases, it can lead to amputation.

Bitter cold can cause frostbite in just minutes. Here’s how to recognize the warning signs and treat them. 0:59

Here’s a guide to identifying the first signs, how to treat them, and when to seek medical help.

What is frostbite and frostnip?

Frostbite is defined as bodily injury caused by freezing that results in loss of feeling and colour in affected areas. It most often affects the nose, ears, cheeks, chin, fingers or toes — those areas most often exposed to the air.

Cooling of the body causes a narrowing of the blood vessels, slowing blood flow. In temperatures below –4 C, ice crystals can form in the skin and the tissue just below it.

Frostnip most commonly affects the hands and feet. It initially causes cold, burning pain, with the area affected becoming blanched. It is easy to treat and with rewarming, the area becomes reddened.

Frostbite is the acute version of frostnip, when the soft tissue actually freezes. The risk is particularly dangerous on days with a high wind chill factor. If not quickly and properly treated, it can lead to the loss of tissues or even limbs. 

Signs of frostbite

Health officials call them the four P’s:

  • Pink: Skin appears reddish in colour, and this is usually the first sign.
  • Pain: The cold becomes painful on skin.
  • Patches: White, waxy-feeling patches show when skin is dying.
  • Prickles: Affected areas feel numb or have reduced sensation.

Symptoms can also include:

  • Reduced body temperature.
  • Swelling.
  • Blisters.
  • Areas that are initially cold, hard to the touch.

Take quick action

If you do get frostbite, it is important to take quick action.

  • Most cases of frostbite can be treated by heating the exposed area in warm (not hot) water.
  • Immersion in warm water should continue for 20-30 minutes until the exposed area starts to turn pink, indicating the return of blood circulation.
  • Use a warm, wet washcloth on frostbitten nose or earlobes.
  • If you don’t have access to warm water, underarms are a good place to warm frostbitten fingers. For feet, put them against a warm person’s skin.
  • Drink hot fluids such as hot chocolate, coffee or tea when warming.
  • Rest affected limbs and avoid irritation to the skin.
  • E​levate the affected limb once it is rewarmed.

Rewarming can take up to an hour and can be painful, especially near the end of the process as circulation returns. Acetaminophen or ibuprofen may help with the discomfort.

Do not …

There are a number of things you should avoid:

  • Do not warm the area with dry heat, such as a heating pad, heat lamp or electric heater, because frostbitten skin is easily burned.
  • Do not rub or massage affected areas. This can cause more damage.
  • Do not drink alcohol.
  • Do not walk on your feet or toes if they are frozen.
  • Do not break blisters.

Seek immediate medical attention

While you can treat frostbite yourself if the symptoms are minor — the skin is red, there is tingling — you should seek immediate medical attention at an emergency department if:

  • The exposed skin is blackened.
  • You see white-coloured or grey-coloured patches.
  • There is severe pain or the area is completely numb.
  • The skin feels unusually firm and is not sensitive to touch after one hour of rewarming.
  • There are large areas of blistering.
  • There is a bluish discolouration that does not resolve with rewarming.

Be prepared

The best way to avoid frostbite is to be prepared for the weather in the first place.

Wear several loose layers of clothing rather than a single, thick layer to provide good insulation and keep moisture away from your skin.

The outer garment should breathe but be waterproof and windproof, with an inner thermal layer. Retain body heat with a hat and scarf. Mittens are warmer than gloves because they keep the fingers together.

Be sure your clothing protects your head, ears, nose, hands and feet, especially for children.

Wind chill and frostbite rates

Wind chill: 0 to –9.
Frostbite risk: Low.

Wind chill: –28 to –39.
Frostbite risk: Moderate.

Exposed skin can freeze in 10-30 minutes

Wind chill: –40 to –47.
Frostbite risk: High.

Exposed skin can freeze in five to 10 minutes.

Wind chill: –48 to –54.
Frostbite risk: Very High.

Exposed skin can freeze in two to five minutes.

Wind chill: –55 and lower.
Frostbite risk: Extremely High.

Exposed skin can freeze in less than two minutes.
 

NOTE: In sustained winds over 50 km/h, frostbite can occur faster than indicated.

Source: Environment Canada

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Awkward Flu Jabs Attempted at Golden Globes

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In what can only be described as a new level of propaganda, hosts Andy Samberg and Sandra Oh featured a flu shot stunt during the 76th Golden Globe Awards ceremony. They told the audience to roll up their sleeves, as they would all be getting flu shots, while people in white coats stormed down the aisles, syringes in hand.

Most of the audience looked thoroughly uneasy at the prospect of having a stranger stick them with a needle in the middle of an awards show. But perhaps the worst part of the scene was when Samberg added that anti-vaxxers could put a napkin over their head if they wanted to be skipped, basically suggesting that anyone opposed to a flu shot deserved to be branded with a proverbial scarlet letter.

The flu shots, for the record, were reportedly fake,1 nothing more than a bizarre gag that left many people stunned by the Globe’s poor taste in turning a serious medical choice into a publicity gimmick.

Flu Shot Stunt Reeks of Desperation

Whoever came up with the idea to turn the Golden Globes into a platform for a public health message probably thought it was ingenious, but the stunt only serves as a seemingly desperate attempt to make flu shots relevant and in vogue. During the 2017 to 2018 flu season, only 37 percent of U.S. adults received a flu shot, a 6 percent drop from the prior season.2

“To improve flu vaccination coverage for the 2018-19 flu season, health care providers are encouraged to strongly recommend and offer flu vaccination to all of their patients,” the U.S. Centers for Disease Control and Prevention (CDC) wrote. “People not visiting a provider during the flu season have many convenient places they can go for a flu vaccination.”3

Yet, perhaps the decline in people choosing to get vaccinated has nothing to do with convenience and everything to do with their dismal rates of efficacy. In the decade between 2005 and 2015, the influenza vaccine was less than 50 percent effective more than half of the time.4

The 2017/2018 flu vaccine was a perfect example of this trend. The overall adjusted vaccine effectiveness against influenza A and B virus infection was just 36 percent.5

Health officials blamed the flu season’s severity on the dip in vaccination rates, but as Dr. Paul Auwaerter, clinical director of the division of infectious diseases at Johns Hopkins University School of Medicine, told USA Today, “[I]t is also true that the vaccine was not as well matched against the strains that circulated.”6

But bringing flu shots to the Golden Globes, and calling out “anti-vaxxers,” is nothing more than “medical care, by shame,” noted Dr. Don Harte, a chiropractic activist in California. “But it was entertaining, in a very weird way, including the shock and disgust of some of the intended victims, notably [Willem Dafoe],” he said, adding:7

“This Hollywood publicity stunt for the flu vaccine is one of the stupidest things I’ve ever seen from celebrities. But it does go with the flu shot itself, which is, perhaps, the stupidest of all the vaccines available.”

Did 80,000 People Really Die From the Flu Last Year?

The CDC reported that 79,400 people died from influenza during the 2017/2018 season, which they said “serves as a reminder of how severe seasonal influenza can be.”8 It’s important to remember, however, that the 80,000 deaths figure being widely reported in the media is not actually all “flu deaths.”

According to the CDC, “We look at death certificates that have pneumonia or influenza causes (P&I), other respiratory and circulatory causes (R&C), or other nonrespiratory, noncirculatory causes of death, because deaths related to flu may not have influenza listed as a cause of death.”9

As for why the CDC doesn’t base flu mortality estimates only on death certificates that list influenza, they noted, “Seasonal influenza may lead to death from other causes, such as pneumonia, congestive heart failure or chronic obstructive pulmonary disease … Additionally, some deaths — particularly among the elderly — are associated with secondary complications of seasonal influenza (including bacterial pneumonias).”10

In other words, “flu deaths” are not just deaths directly caused by the influenza virus, but also secondary infections such as pneumonia and other respiratory diseases, as well as sepsis.11

According to the CDC, most of the deaths occurred among those aged 65 years and over, a population that may already have preexisting conditions that makes them more susceptible to infectious diseases. As Harte said of annual flu deaths, “[M]ost if not all, I would assume, are of people who are already in very bad shape.12

CDC Claims Flu Vaccine Reduces Flu Deaths in the Elderly — But Does It?

Since people aged 65 and over are those most at risk from flu complications and death, the CDC has been vocal in their claims that the flu shot significantly reduces flu-related deaths among this population. The research, however, says otherwise.

Research published in 2005 found no correlation between increased vaccination rates among the elderly and reduced mortality. According to the authors, “Because fewer than 10 percent of all winter deaths were attributable to influenza in any season, we conclude that observational studies substantially overestimate vaccination benefit.”13

A 2006 study also showed that even though seniors vaccinated against influenza had a 44 percent reduced risk of dying during flu season than unvaccinated seniors, those who were vaccinated were also 61 percent less like to die before the flu season ever started.14

This finding has since been attributed to a “healthy user effect,” which suggests that older people who get vaccinated against influenza are already healthier and, therefore, less likely to die anyway, whereas those who do not get the shot have suffered a decline in health in recent months.

Journalist Jeremy Hammond summed up the CDC’s continued spreading of misinformation regarding the flu vaccine’s effectiveness in the elderly, as they continue to claim it’s the best way to prevent the flu:15

[T]here is no good scientific evidence to support the CDC’s claim that the influenza vaccine reduces hospitalizations or deaths among the elderly.

The types of studies the CDC has relied on to support this claim have been thoroughly discredited due to their systemic ‘healthy user’ selection bias, and the mortality rate has observably increased along with the increase in vaccine uptake — which the CDC has encouraged with its unevidenced claims about the vaccine’s benefits, downplaying of its risks, and a marketing strategy of trying to frighten people into getting the flu shot for themselves and their family.”

Death of Vaccinated Child Blamed on Not Getting Second Dose

In January 2019, the state of Colorado reported the first child flu death of the 2018/2019 flu season — a child who had received influenza vaccination. But instead of highlighting the vaccine’s failure and clear limitations, the Colorado Department of Public Health and Environment blamed the death on the child being only “partially vaccinated.”

“It’s an unfortunate but important reminder of the importance of two doses of influenza vaccine for young children who are receiving influenza vaccine for the first time,” Dr. Rachel Herlihy, who is the state communicable disease epidemiologist, said in a news release.16 For those who aren’t aware, the CDC notes that one dose of flu shot may not be enough to protect against the flu. Instead, they state:17

“Children 6 months through 8 years getting vaccinated for the first time, and those who have only previously gotten one dose of vaccine, should get two doses of vaccine this season …

The first dose ‘primes’ the immune system; the second dose provides immune protection. Children who only get one dose but need two doses can have reduced or no protection from a single dose of flu vaccine.”

Not only may the flu vaccine fail to provide protection against the flu, but many people are not aware that other types of viruses are responsible for about 80 percent of all respiratory infections during any given flu season.18 The flu vaccine does not protect against or prevent any of these other types of respiratory infections causing influenza-like illness (ILI) symptoms.

The chance of contracting actual type A or B influenza, caused by one of the three or four influenza virus strains included in the vaccine, is much lower compared to getting sick with another type of viral or bacterial infection during the flu season.

Does Flu Vaccine Increase the Risk of Influenza Infection, Contribute to Vaccine Shedding?

There are serious adverse effects that can come along with annual flu vaccination, including potentially lifelong side effects such as Guillain Barré syndrome and chronic shoulder injury related to vaccine administration (SIRVA). They may also increase your risk of contracting more serious flu infections, as research suggests those who have been vaccinated annually may be less protected than those with no prior flu vaccination history.19

Research presented at the 105th International Conference of the American Thoracic Society in San Diego also revealed that children who get seasonal flu shots are more at risk of hospitalization than children who do not. Children who had received the flu vaccine had three times the risk of hospitalization as children who had not. Among children with asthma, the risk was even higher.20

There’s also the potential for vaccine shedding, which has taken on renewed importance with the reintroduction of the live virus vaccine FluMist during the 2018/2019 season. While the CDC states that the live flu virus in FluMist is too weak to actually give recipients the flu, research has raised some serious doubts that this is the case.

One recent study revealed not only that influenza virus may be spread via simple breathing (i.e., no sneezing or coughing required) but also that repeated vaccination increases the amount of virus released into the air.21

MedImmune, the company that developed FluMist, is aware that the vaccine sheds vaccine-strain virus. In its prescribing information, they describe a study on the transmission of vaccine-strain viruses from vaccinated children to nonvaccinated children in a day care setting.

In 80 percent of the FluMist recipients, at least one vaccine-strain virus was isolated anywhere from one to 21 days following vaccination. They further noted, “One placebo subject had mild symptomatic Type B virus infection confirmed as a transmitted vaccine virus by a FluMist recipient in the same playgroup.”22

Are There Other Ways to Stay Healthy During Flu Season?

Contrary to the CDC’s and Golden Globe’s claims that flu vaccinations are a great way to prevent flu, other methods exist to help you stay healthy during the flu season and all year, and they’re far safer than annual flu vaccination. Vitamin D testing and optimization have been shown to cut your risk of respiratory infections, including colds and flu, in half if you are vitamin D deficient, for instance.23,24

In my view, optimizing your vitamin D levels is one of the absolute best respiratory illness prevention and optimal health strategies available. Influenza has also been treated with high-dose vitamin C,25 and taking zinc lozenges at the first sign of respiratory illness can also be helpful.

Following other basic tenets of health, like eating right, getting sound sleep, exercising and addressing stress are also important, as is regularly washing your hands.

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