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Biocell textured breast implants under scrutiny as women complain of pain

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For Katherine Smylie, it was a five-year journey to figure out the hair loss, memory fog, irritable bowel syndrome and constant pain — especially the migraines.

“I had migraines every day for over two-and-half years,” the Edmonton woman said.

Her doctors told Smylie she was crazy, she said, and there was nothing she could do. There were days when she wanted to give up, until she met a rheumatologist who put all the symptoms together and told her one thing: Get her breast implants removed.

“I felt like I was validated for once: Finally somebody was listening to me and was caring about my best interests,” Smylie said.

The 47-year-old believes the cause of her health problems was the Biocell textured implants she received in 2012, two years after undergoing a double mastectomy, which was followed by chemotherapy and radiation treatments.

Those same silicone implants, made by Allergan, have come under growing scrutiny from some doctors who say they are seeing many of their patients return with debilitating side effects.

While all textured implants form fluid around them in the body, none are to the extent of the Biocell implant, say doctors, who believe it’s because of the aggressive texturing that promotes adherence and keeps the implant more firmly in position.

Katherine Smylie, who had her Biocell textured breast implants removed after experiencing pain, is shown in her home in Edmonton. (Rod Maldaner/CBC)

Breast implants, particularly textured implants, have been associated with a rare form of cancer known as BIA-ALCL, though a very low number of cases have reported in both Canada and the U.S. (Health Canada reports that the occurrence rate of BIA-ALCL per textured implant sold in Canada is one in 24,177, or 0.0041 per cent.)

And while some women believe breast implants cause other illnesses, such as fatigue, muscle weakness, aches and pains, and brain fog, Health Canada has said there’s no scientific evidence that they are associated with such conditions.

The federal agency did issue a moratorium on the use of silicone breast implants in 1992 over concerns that ruptured implants could cause autoimmune and connective tissue diseases, but subsequent research found no evidence of that.

A new generation of silicone implants were allowed back on the market in 2006, and medical experts have continued to study the devices, included Biocell textured implants.

Recent studies examine textured implants

The most recent study, written by Vancouver-based plastic surgeon Dr. Nicholas Carr, analyzed 539 implants he had removed from patients.

His findings, published last September in the journal Plastic and Reconstructive Surgery, said that of all the different types he explanted, the Biocell textured implants had the shortest shelf life.

“The Biocell implants came out sooner than other types of implants we looked at,” he said. “So sooner than saline implants, sooner than smooth gel implants.”

In a study published last September, Vancouver-based plastic surgeon Dr. Nicholas Carr analyzed 539 implants he had removed from patients, in order to track the lifespan of the devices. (Nicolas Amaya/CBC)

The textured implants came out after an average of four years of being implanted, Carr found, while the saline implants lasted the longest, at seven years.

According to Carr, 25 per cent of his patients had the same reason for wanting the implants removed: They were painful.

“I had a hockey player who found she simply couldn’t play hockey anymore because it was too uncomfortable,” he said.

Textured implants were a popular choice for doctors between 2005 and 2012, when Carr says as many as 3,000 procedures were done annually in Canada — both for cosmetic reasons, as well as post-mastectomy reconstruction.

They were seen as a way of reducing capsular contracture, a tightening of the scar tissue that forms around the incision after the implant is placed. The texturing also acts as a kind of Velcro, preventing the implant from sliding on the chest wall.

The Biocell implants became available in Canada in 2006. It wasn’t long before some doctors say they began noticing inflammatory problems around the implants, including pain and swelling.

Dr. Elizabeth Hall-Findlay was among the first doctors to sound the alarm about Biocell implants, publishing a study in 2011 looking at the number of patients who had formed double capsules after surgery. (Justin Pennell/CBC)

Dr. Elizabeth Hall-Findlay was one of the first doctors to sound the alarm, publishing a study in 2011 looking at the number of patients who had formed “double capsules,” or two distinct layers of scar tissue around the implant.

Up until then, the Banff-based plastic surgeon had performed surgery using the Biocell implants on as many as 100 of her patients. Soon after she started to track their results, she stopped using them.

“I started seeing some of my own patients and patients from other plastic surgeons that had the swelling, had the fluid buildup and had what looks like double capsule formation. Instead of a single capsule, there was one around the implant and one attached to the patient,” she said.

Hall-Findlay said her findings were supported by other plastic surgeons who were seeing the same problems. But she also received criticism from five colleagues, three of whom were Allergan consultants and two of whom were company employees.

“In our journal, there was a letter to the editor by three plastic surgeons, all of whom were on the payroll of Allergan, who implied that I wasn’t doing the surgery properly.”

Lack of adverse event reporting makes tracking difficult

This kind of blowback is one thing. But doctors like Hall-Findlay and Carr also say it’s hard to keep track of the problem because there’s a lack of transparency between Health Canada and the companies that make implants and medical devices.

Any reporting of an adverse event is primarily made by industry to Health Canada, but the responses go directly back to the company. Surgeons and hospitals aren’t legally required to flag any complications or injuries, though they may decide to do so for ethical reasons.

“We don’t get reports from Health Canada, we don’t get reports from industry as to what our colleagues are finding. The only way we find that out is by communicating directly with our colleagues,” Carr said.

Both Allergan and Health Canada provided written responses to CBC about the safety of Biocell textured implants.

Allergan said that “the safety profile of Allergan’s breast implants is supported by extensive pre-clinical device testing, more than a decade of worldwide clinical use, as well as a large number of peer-reviewed and published studies.” The company also said it provides patient information leaflets and fully supports informed consent.

Breast implants have either a smooth or textured surface. For the textured implants, two of which are shown here at right, the pebbling acts as a kind of Velcro, preventing the implant from sliding on the chest wall. (Nicolas Amaya/CBC)

Health Canada said it “considers reporting of medical device incidents, including those for breast implants, to be an important part of our post-market surveillance activities.”

But the federal agency has resisted calls for a central registry, saying registries “do not necessarily provide useful safety and effectiveness information … due in part to bias in the pool of patients who are generally willing to participate.”

Biocell textured implants have fallen off in popularity among many plastic surgeons. While there are no firm numbers available, based on his research, Carr estimates about 20 per cent of patients have had their implants removed.

Because of the lack of data available, the experiences of the other 80 per cent remains a big question mark. But both Carr and Hall-Findlay caution that removing the implant isn’t always necessary.

“I don’t think that [women] actually have to have them removed if everything is going fine. They just need to know that if they get swelling, or they get a problem with their breast implants, to go see a plastic surgeon and get them checked out,” said Hall-Findlay.

As for Smylie, she says getting her implants removed was just as difficult as getting the diagnosis; her doctors were reluctant and only offered a partial procedure that she worried would leave remnants of the implants in her body.

She eventually found a specialist in Florida who agreed to remove them completely last month. The relief was almost immediate, Smylie said.

“It was such a sigh of relief to wake up and not have a migraine for the first time in two-and-a-half years. It was amazing.”

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Post-vaccine surge? Michigan’s spring coronavirus case spike close to previous year’s autumn high

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(Natural News) The spike in new Wuhan coronavirus infections recorded in Michigan over the spring is similar to a spike seen during the 2020 fall season. According to a Wall Street Journal analysis, the state’s daily coronavirus case count averaged more than 7,000 for almost two weeks – before taking a slight dip to 6,891 on April 20. This echoed similar figures back in November and December 2020, which saw sharp rises in infections for those two months before plunging.

Back in autumn of last year, Michigan averaged more than 7,000 cases per day for a span of 10 days. New infections dropped slightly, then briefly spiked as the December holidays approached. It then fell to the low 1,000s for the succeeding two months – until ascending again in March.

According to University of Michigan internal medicine professor Dr. Vikas Parekh, the sudden increase in new infections could be attributed to several factors. Among the factors he cited was re-openings, which increased people’s interactions and mobility. Parekh said the loosened restrictions contributed to the spread of the highly contagious U.K. B117 variant.

“As the B117 variant spreads nationally, we will likely see other stats [with] their own surges – although I hope none are as bad as Michigan,” the professor remarked. He continued: “The milestone just tells us we are not yet in the clear, especially as we still have large portions of our population who are not vaccinated yet.”

Parekh also expressed optimism over the lower daily caseloads the Great Lakes State reported. He said he believes both cases and hospitalizations have plateaued and will likely decline soon. The professor commented: “[COVID-19] positivity has been declining now for one week, which is usually a leading indicator of case decline.”

Meanwhile, the state cited younger populations and youth sports, such as basketball, wrestling and hockey, to increase new COVID-19 infections. Because of this, Gov. Gretchen Whitmer called to suspend youth sports and indoor dining in the state. She also exhorted high schools to conduct remote class sessions for two weeks to curb the spread of the pathogen.

Michigan still experienced the spike in cases despite having one of the highest vaccination rates in the country

During the opening stages of the U.S.’s immunization drive against COVID-19, Michigan boasted of having one of the highest vaccination rates nationwide. A report by Bridge Michigan even noted the initial “frenzy for vaccines” that “far exceeded the state’s limited supply.” But things have appeared to turn around for Michigan, as it now struggles to reach the 70 percent vaccination rate needed for herd immunity.

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Scottish mom’s legs turn into a pair of “giant blisters” after first dose of AstraZeneca’s coronavirus vaccine

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(Natural News) Sarah Beuckmann of Glasgow, Scotland, felt a tingling sensation in her legs and noticed a rash flaring up around her ankles a week after getting her first dose of AstraZeneca’s coronavirus (COVID-19) vaccine on March 18.

She also had flu-like symptoms right after the vaccination.

Beuckmann called her doctor to arrange an appointment the morning she noticed the rash, but by the afternoon her skin was already breaking out into blood-filled blisters. Blisters also appeared on her legs, hands, face, arms and bottom.

“I ended up asking my husband to take me to A&E,” said Beuckmann, referring to “accident and emergency,” the equivalent of an emergency room (ER). “When I got there, my heart rate was sitting at 160bpm, which they were very concerned about. I got put on an ECG machine.”

Doctors determine AstraZeneca’s COVID-19 vaccine triggers the rash

Medics carried out tests for HIV, herpes and other skin conditions to work out what triggered the rash, but all results came back negative. Doctors finally determined that the vaccine caused her rare reaction after carrying out two biopsies.

“Once they found that it was a reaction to the vaccine, they put me on steroids and that really seems to be helping my progress,” said Beuckmann. She had been advised by her doctor not to get the second dose of AstraZeneca’s COVID-19 vaccine because of her reaction.

Beuckmann spent 16 days at Queen Elizabeth University Hospital. She was discharged to recover at home. The 34-year-old mother of one is currently wheelchair-bound due to the bandages on her legs and blisters on the soles of her feet. She may need physiotherapy to help strengthen her leg muscles.

“They are starting to heal and they’re looking a lot better than they were but as the blisters started to get worse, they all sort of merged together,” she said. “I didn’t know what was going on.”

With the blisters merging, her legs have looked like a pair of “giant blisters.” Beuckmann admitted that at one point she feared her legs might have to be amputated.

Dermatologist agrees COVID-19 vaccine causes the blisters

Dr. Emma Wedgeworth, a consultant dermatologist and spokeswoman at the British Skin Foundation, agreed that Beuckmann had likely suffered a reaction to the vaccine.

“Vaccines are designed to activate the immune system. Occasionally people will have quite dramatic activation of their immune systems which, as happened in this case, can manifest in their skin” Wedgeworth told MailOnline. “This poor lady had a very severe reaction, which thankfully is extremely rare.”

It is not clear why Beuckmann, who works in retail, was invited for a vaccine. Scotland’s vaccine rollout was focused on people over the age of 50 when she got vaccinated, although vaccines are available to those who are considered at risk from the virus, or live with someone considered vulnerable.

At least 20 million Briton have had AstraZeneca’s COVID-19 vaccine, which drug regulators say causes a rash in one percent of cases. They say rashes caused by the jab tend to go away within a week.

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Trojan labs? Chinese biotech company offers to build COVID testing labs in six states

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In 2012, BGI acquired Complete Genomics, a DNA sequencing company and equipment maker. The funds for the $117.6 million purchase were raised from Chinese venture capitals. The company has expanded its footprint globally. According to its website, BGI conducts business in more than 100 countries and areas and has 11 offices and labs in the U.S.

People are concerned about China’s access to American DNA data

Some said that with Complete Genomics providing an American base, BGI would have access to more DNA samples from Americans, helping it compile a huge database of genetic information. Some also worried about the protection of the genetic information’s privacy.

According to a 2019 report from the U.S.–China Economic and Security Review Commission (USCC), BGI “has formed numerous partnerships with U.S. healthcare providers and research organizations to provide large-scale genetic sequencing to support medical research efforts,”

There are three main reasons why many people in the biotech community and government have expressed concerns about China’s access to American DNA data.

In the “60 Minutes” interview, Evanina discussed the very likely scenario in which Chinese companies would be able to micro-target American individuals and offer customized preventative solutions based on their DNA.

Evanina asked: “Do we want to have another nation systematically eliminate our healthcare services? Are we okay with that as a nation?”

The second concern is that China may use DNA to track and attack American individuals. As the USCC report states: “China could target vulnerabilities in specific individuals brought to light by genomic data or health records. Individuals targeted in such attacks would likely be strategically identified persons, such as diplomats, politicians, high-ranking federal officials or military leadership.”

The third concern is that China may devise bioweapons to target non-Asians. Steven Mosher, president of the Population Research Institute, discussed it in his article “What Will China Do With Your DNA?” published by The Epoch Times in March 2019.

He wrote: “We know that the Asian genome is genetically distinct from the Caucasian and African in many ways. … Would it be possible to bioengineer a very virulent version of, say, smallpox, that was easily transmitted, fatal to other races, but to which the Chinese enjoyed a natural immunity? … Given our present ability to manipulate genomes, if such a bio-weapon can be imagined, it can probably – given enough time and resources – be realized.”

An article from Technocracy said: “China’s aggressive collection of American DNA should be doubly alarming because it can only spell one ultimate outcome: biowarfare. That is, genetically engineering viruses or other diseases that will be selectively harmful to U.S. populations.”

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