Category Archives: In the News

FDA calls for new warnings for breast implants

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Laurie McGinley, The Washington Post: October 23, 2019.

The Food and Drug Administration, under fire from women who say they were harmed by breast implants, proposed on Wednesday that manufacturers detail possible complications from the devices, including rare cancers, a range of other symptoms and the need for additional surgeries.

The agency recommended that manufacturers use a boxed warning — the FDA’s strictest caution — to clearly spell out the risks of implants, including that they are not lifetime devices and that the chances of complications increase over time. The warning also would list the devices’ association with a rare form of lymphoma and say some patients have reported fatigue, muscle aches and joint pain.

The agency also proposed that patients be given a checklist to guide conversations with their surgeons about the risks and benefits of implants before women put down deposits for their surgeries. The move is a response to complaints from patients who said they weren’t adequately told about potential problems before surgery.

“We have heard from many women that they are not fully informed of the risks when considering breast implants,” FDA Principal Deputy Commissioner Amy Abernethy and Jeff Shuren, director of the agency’s Center for Devices and Radiological Health, said in a statement. The new recommendations are “designed to help inform conversations between patients and health care professionals when breast implants are being considered,” they added.

The FDA’s steps are the latest effort to deal with reports of complications involving devices that have been at the center of sometimes angry debate and legal actions for decades. The devices are used in about 400,000 surgeries in the United States every year, with 75 percent of the women involved getting implants for cosmetic reasons. Most of the rest get them as part of reconstruction after surgery for breast cancer.

Over the past few years, patients who say they were harmed by the devices have become increasingly active on social media sites that have enabled tens of thousands of patients to exchange information. The emergence of a rare cancer linked to implants in recent years also has drawn more attention to potential health problems associated with implants.

The FDA has said that 573 cases worldwide have linked the implants to a rare cancer since the agency began tracking the issue in 2011. The vast majority of those cases involved Allergan textured implants, which have been recalled. Thirty-three women have died of what’s known as breast implant-associated anaplastic large cell lymphoma, a cancer of the immune system, the agency said. At the same time, thousands of women have complained of fatigue, brain fog and other problems that collectively are called “breast implant illness.”

Nicole Daruda, an activist from Vancouver, Canada, who runs one of the most popular websites for women who have had trouble with implants, welcomed the FDA’s announcement, but said it was long overdue. “This is what needs to happen,” said Daruda, who had her implants removed after experiencing several health problems. “But I don’t think it would have without our putting intense pressure” on the agency.

Diana Zuckerman, president of the nonprofit National Center for Health Research who has been working on implant issues for 30 years, said the FDA’s moves are “very important.” But she expressed concern they might yet be weakened, and are not legally binding because they are in the form of “guidance” to the industry. Whether the implant makers actually follow the recommendations “depends on how much pressure the FDA puts on the manufacturers,” she said.

The FDA’s steps are the latest in the agency’s stepped-up scrutiny of the devices, which included a dramatic two-day hearing in March during which many women demanded the FDA take steps to ensure patients have more information about the devices. About the same time, Zuckerman and Scot Glasberg, a past president of the American Society of Plastic Surgeons, formed a working group that included activists to make recommendations to the FDA, including for a boxed warning and a patient checklist of possible problems.

What the FDA is proposing “is very close to what we gave them,” Glasberg said, adding that other groups also made suggestions to the agency.

More than 70,000 women also signed a petition asking the FDA to require a checklist. The FDA, in issuing its recommendations on Wednesday, asked for public comment for 60 days before finalizing the guidance.

Breast implants became available in the United States in the 1960s. Three decades later, after years of reports about ruptured devices and possible links to autoimmune diseases, the FDA called for a moratorium on their use, saying manufacturers had not proved the devices’ safety and effectiveness. The devices were available only for cancer patients who were undergoing reconstructive procedures, and even then, only as part of a clinical trial. In 2006, the agency lifted the ban, approving two new silicone implants.

In 2011, the FDA issued a safety communication saying that women with breast implants might have a small increased risk of developing the rare lymphoma. In July, the implant maker Allergan announced a worldwide recall of its Biocell textured breast implants after the FDA found a sharp increase in a rare cancer and deaths linked to the products and asked the company to withdraw them from the U.S. market.

The FDA, in its proposed guidance Wednesday, also called for new screening guidelines for possible ruptures, as well as a recommendation that manufacturers include product ingredient information in the devices’ labeling that is easy for patients to understand.

Read the original article here.

Women Should Be Warned of Breast Implant Hazards, F.D.A. Says

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Roni Caryn Rabin, NY Times: October 23, 2019

Women considering surgery to receive breast implants should be warned of the risk of serious complications, including fatigue, joint pain and the possibility of a rare type of cancer, the Food and Drug Administration said on Wednesday.

Agency officials are urging manufacturers to print a boxed warning on the packaging of the implants, and to provide a checklist spelling out the risks for patients considering surgery. It will be left to doctors to review those risks with women seeking breast implants.

The measures are not mandatory and are now open to public comment and industry input. But the recommendations reflect a growing acknowledgment at the agency that implants may cause more harm in women than previously known.

Several years ago, the agency linked implants to a rare form of immune system cancer called anaplastic large cell lymphoma. In July, at the request of the F.D.A., one manufacturer, Allergan, recalled textured breast implants linked to the cancer.

More recent studies have reported higher rates of autoimmune disease among women with breast implants. Advocates for women with these complications called the F.D.A.’s proposals on Monday “an important step,” but noted that the action is only a recommendation.

“What matters most is what happens next,” said Diana Zuckerman, president of the National Center for Health Research in Washington, who has analyzed breast implant studies and has been advising patients.

She said surgeons should be required to go over the checklist with prospective patients before they put down a deposit.

“If breast implants can cause cancer of the immune system, doesn’t it make sense they can cause other systemic problems of the immune system?” Dr. Zuckerman asked.

Millions of women have implants, silicone sacks filled with saltwater or silicone gel that are used to enlarge the breasts for cosmetic reasons or to rebuild them after a mastectomy for breast cancer.

Breast augmentation with implants is the most popular cosmetic surgical procedure. Some 313,000 augmentations were performed in 2018, a 4 percent increase over the number in 2017. Breast reconstruction after cancer surgery accounts for another 100,000 procedures.

But thousands of women with implants have reported developing debilitating illnesses, such as severe muscle and joint pain, weakness, cognitive difficulties and fatigue — a constellation of symptoms some experts call “breast implant illness.”

Some of the ailments are forms of connective tissue disease, which includes lupus, rheumatoid arthritis and other serious autoimmune conditions.

Dr. Zuckerman has found that most breast implant studies were carried out by manufacturers or plastic surgery associations and did not track long-term outcomes, or lost so many participants to follow-up that results were not meaningful.

The studies focused on well-defined illnesses, she said, ignoring debilitating symptoms that lacked specific diagnoses, and most were too small to detect rare diseases.

Earlier this year, the agency warned two implant manufacturers that they had failed to carry out adequate long-term safety studies of implants, which had been mandated as a condition of their approval.

The proposed checklist and boxed warning were developed in response to demands by patients who testified last March at an advisory panel meeting about illnesses they blamed on their implants.

Dr. Diana Zuckerman’s Statement on FDA’s Draft Guidance on Labeling for Breast Implants

Breast Cancer, Breast Cancer, Policy, Press Releases, Testimony & Briefings

Statement of Dr. Diana Zuckerman, President, National Center for Health Research on October 23 Regarding FDA Labeling Recommendations to Improve Patient Communication Draft Guidance

We thank the FDA for proposing a black box warning and a patient Informed Consent check list that provides specific, understandable information about the risks of breast implants.  The FDA’s draft includes the types of information that we have proposed to the FDA in recent months in our work with patient advocates and plastic surgeons.  The devil is in the details, so we look forward to working with the FDA to finalize these materials so that patients can make better informed decisions in the future than most women considering breast implants have been able to make. We will  keep working closely with the FDA, patients, and plastic surgeons to make that goal a reality.

For more information see FDA’s Draft Guidance here.

Hospitals Push Women to get 3D Mammograms, Despite No Evidence they Save More Lives

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Megan Henney, Fox Business, also posted in Yahoo Finance: October 20, 2019

Hospitals and doctors are aggressively promoting high-tech breast cancer screenings, spending millions of dollars to market 3D mammograms to patients — despite no evidence that they save more lives than traditional mammograms.

According to a Kaiser Health News investigation, over the past six years manufacturers of 3D equipment have paid doctors and teaching hospitals more than $240 million, including $9.2 million related to 3D mammograms. Almost half of that money went to related research, while some paid for speaking fees, consulting, travel meals or drinks.

The report found that influential journal articles, some cited hundreds of times by other researchers, were written by doctors with financial ties to the 3D industry.

Currently, Medicare and most insurance companies cover the cost of an annual screening mammogram for women over the age of 40. But 3D screenings add about $50 to the cost of a typical mammogram. Kaiser reported that Medicare, which began paying for 3D exams in 2015, spent an additional $230 million on breast cancer screenings within the first three years of coverage. By 2017, nearly half the mammograms paid for by the federal program were 3D.

Overall, 3D screenings may slightly increase the cancer-detection rate, finding about one extra breast tumor for every 1,000 women screened in the U.S., according to a 2018 analysis in the Journal of the National Cancer Institute. It can also prove more effective for women with dense breast tissue.

But new technology isn’t always better, said Diana Zuckerman, president of the Cancer Prevention and Treatment Fund at the National Center for Health Research.

“Hospitals love new gadgets, and 3D mammography has been promoted as the latest, greatest best thing,” Zuckerman told FOX Business. “It’s expensive, and then they’re going to pass those prices onto patients.”

When the Food and Drug Administration approves new technology, the agency is not required to prove that it’s better — only that it’s as good as what already exists, she said. Despite that, the new equipment is generally more expensive, sometimes ten times as much; in order to pay for it, hospitals tend to charge “quite a lot of money” to the patient, Zuckerman said, as well as use them on patients who don’t necessarily need to be tested.

“I personally find it problematic, and I can only say that if I have trouble sometimes determining how much is hype and how much is fact, I can only imagine people who don’t do this for a living have trouble figuring it out,” she said.

Read the original story here or here.

Breast implants, heavy metals & autoimmune disorders: What should be in FDA warnings?

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Kris Pickel, AZ Family: October 18, 2019

As the Food and Drug Administration considers issuing stronger warnings for breast implants, there is a debate brewing over the content of those warnings.

The FDA is looking at several options.

• A checklist of possible risks. Doctors would be required to go over the checklist with patients who are considering breast implants.

• Listing the ingredients in breast implants.

• A box warning, also known as a black box warning. It’s the strongest warning the FDA issues signifying there is a risk of serious or even life-threatening adverse effects.

The FDA recently updated its website, acknowledging what has become known as breast implant illness.

“Some breast implant patients report a variety of systemic symptoms, such as chronic fatigue, brain fog, joint and muscle pain, which may not meet the diagnostic criteria to be categorized as a disease. Patients refer to these symptoms collectively as ‘breast implant illness (BII).’ In some cases, patients report that removal of their breast implants without replacement appears to reverse their symptoms.”

The regulatory agency is reacting to pressure from a growing movement by tens of thousands of women who believe breast implants made them sick. They describe many more symptoms than what the FDA recognized.

BII is not a new problem

Women have expressed concerns about breast implants for decades. Many women say doctors discount any connection the implants and the issues they experience, often making them feel their illness and symptoms are psychosomatic.

Nicole Daruda is one of the key figures behind the growing number of women demanding stronger warnings.

With recent attention on symptoms and illnesses potentially caused by breast implants, hundreds of women are requesting to join her Facebook group, Breast Implant Illness and Healing by Nicole, every day.

Five years after getting implants, Daruda was too sick to work.

She says at that time, there was almost no information available on a possible link between breast implants and the often-debilitating symptoms that plague some women.

“I put the words together, ‘breast implant illness,’ because I didn’t know what else to call it,” Daruda said.

n March, the FDA held public meetings on the safety of breast implants.

Women showed up from across the country, demanding stronger warnings that list the chemicals and heavy metals contained in breast implants. And they don’t just want the cautions to come from the FDA. They believe the caveats should come from breast implant manufacturers, too.

When Daruda had her implants removed, she described them as “sticky,” with silicone coming through the shell. It’s a condition known as “gel bleed.”

While the FDA acknowledges that gel bleed happens, it does not list it as a known risk or complication of breast implants.

“I lost over a decade of my life and health to breast implants,” Daruda said. “After my explant, it took me four years to recover the better part of my health. I still have permanent damage to my kidney from heavy metal.”

[…]

An estimated 35 million women have breast implants. Many of them never reported negative health effects.

Cohen Tervaert says certain factors can increase a woman’s risk of having an adverse reaction to implants. Those factors include allergies (any type from hay fever to metal allergies), an autoimmune disease, and a family history of autoimmune diseases.

Large-scale studies need to be done, according to Cohen Tervaert, but how they are done needs to change.

After his presentation to the FDA, the agency asked registries that collect data on patients and the safety and performance of breast implants to start tracking information on autoimmune diseases.

While many health professionals and implant manufacturers are quick to note that the safety of breast implants has been studied extensively, Dr. Diana Zuckerman, president of the nonprofit National Center for Health Research and an expert on national health policy, says women cannot make informed decisions based on those studies.

The former senior policy advisor to the White House was vital in helping women with breast implant illness to organize and work with the FDA to secure the public meetings on breast implant safety.

“There are hundreds of studies of breast implants published in the last few decades, but almost all are so biased that they are fatally flawed,” she explained. “Almost all were paid for by the companies that make breast implants or the doctors whose salaries depend on those surgeries. The researchers asked the wrong questions and studied implants in ways that didn’t make sense. For example, they studied too few women, studied women with implants for a short period of time, and didn’t study the debilitating symptoms that women said they were experiencing. They also tended to study women with any kind of breast implants, instead of studying whether some breast implants were safer than others. And because of who was paying for the studies, even when the researchers found that implants caused medical problems, those findings were often misrepresented or completely covered up.”

When it comes to proving cause and effect between breast implants and illnesses, Cohen Tervaert believes the evidence is there.

Citing laboratory studies, he says mice prone to autoimmune diseases like lupus or arthritis developed the conditions after the implants were introduced. At the same time, mice that showed no prior sensitivity to autoimmune diseases did not develop health problems with the implants.

Another finding is that more protracted illness appears to result in more difficult recoveries.

“Proof that we have is, that if you remove the breast implant, breast implant illness can be reversible, especially if the period between implementation and explantation is very short,” Cohen Tervaert said. “You see, quite often, complete recovery of the symptoms.”

“If it’s, however, longer, than there is only partial recovery,” he continued. “And if you have developed an autoimmune disease, those autoimmune diseases can be difficult to treat until you remove the breast implants.”

A 2017 study found silicone from breast implants can migrate throughout a woman’s body — even if the implant was not ruptured — because silicone can “bleed” through the shell.

Silicone has been found not just in the tissue around the implants, but also in various organs throughout the body, including the central nervous system and brain.

Women studied had symptoms ranging from fatigue and cognitive impairment to headaches and body pain. The study found 60% to 80% of patients showed health improvements after their implants were removed.

The FDA has not decided if it will impose stricter guidelines on breast implant studies.

The agency issued warning letters to implant makers Mentor and Sientra in March, citing “low recruitment, poor data, and low follow-up rates in their required post-approval studies.”

The FDA gave the manufacturers a two-week deadline to fix the issues. Seven months later, no action has been taken against the manufacturers.

An FDA spokesperson tells CBS 5 Investigates they will not speculate on possible punitive actions.

Also in March, the FDA announced that it would hold future meetings to discusses material used in medical devices, including breast implants. They say they will focus on why some people have adverse reactions while others do not.

“The vast majority of patients implanted with medical devices have no adverse reactions,” the FDA said. “The device works and performs as expected to treat medical conditions or help patients better manage their health. However, a growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices. For example, they develop inflammatory reactions and tissue changes, causing pain and other symptoms that may interfere with their quality of life.”

A date for the meeting has not been set.

Read the original story here.

Massive Marketing Muscle Pushes 3D Mammograms, Despite No Evidence They Save More Lives, Investigation Shows

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Liz Szabo, USA Today: October 18th, 2019.

When Dr. Worta McCaskill-Stevens made an appointment for a mammogram last year, she expected a simple breast cancer screening – not a heavy-handed sales pitch.

A receptionist asked if she wanted a free upgrade to a “3D mammogram,” or tomosynthesis.

“She said there’s a new approach and it’s much better, and it finds all cancer,” said McCaskill-Stevens, who declined the offer.

A short time later, a technician asked again: Was the patient sure she didn’t want 3D?

Upselling customers on high-tech breast cancer screenings is just one way the 3D mammography industry aggressively promotes its product.

A KHN investigation found that manufacturers, hospitals, doctors and some patient advocates have put their marketing muscle – and millions of dollars – behind 3D mammograms. The juggernaut has left many women feeling pressured to undergo screenings, which, according to the U.S. Preventive Services Task Force, haven’t been shown to be more effective than traditional mammograms.

[…]

The American Cancer Society, Susan G. Komen and the U.S. Preventive Services Task Force also say there isn’t yet enough evidence to advise women on 3D mammograms.

When the Food and Drug Administration approved the first 3D mammography system, made by Hologic, the agency required the technology to be safe and effective at finding breast cancer – not at improving survival.

“The companies do the minimal research needed to get FDA approval, and that usually means no meaningful evidence of how it helps patients,” said Diana Zuckerman, president of the National Center for Health Research.

Valenti said Hologic presented strong evidence to the FDA. “The data was overwhelming that 3D was a superior mammogram,” Valenti said.

Describing a breast exam as 3D may conjure up images of holograms or virtual reality. In fact, tomosynthesis is closer to a mini-CT scan.

Although all mammograms use X-rays, conventional 2D screenings provide two views of each breast, one from top to bottom and one from the side. 3D screenings take pictures from multiple angles, producing dozens or hundreds of images, and take only a few seconds longer.

Yet some studies suggest that 3D mammograms are less accurate than 2D.

A 2016 study in The Lancet Oncology found that women screened with 3D mammograms had more false alarms. A randomized trial of 29,000 women published in The Lancet in June showed that 3D detected no more breast tumors than 2D mammograms did.

And, like all mammograms, the 3D version carries risks. Older 3D systems expose women to twice as much radiation as a 2D mammogram, although those levels are still considered safe, said Diana Miglioretti, a biostatistics professor at the University of California-Davis School of Medicine.

Valenti said the newest 3D systems provide about the same radiation dose as 2D.

Diagnosing more cancers doesn’t necessarily help women, Brawley said. That’s because not all breast tumors are life-threatening; some grow so slowly that women would live just as long if they ignored them – or never even knew they were there. Finding these tumors often leads women to undergo treatments they don’t need.

A 2017 study estimated 1 in 3 women with breast cancer detected by a mammogram are treated unnecessarily. It’s possible 3D mammograms make that problem worse, by finding even more small, slow-growing breast tumors than 2D, said Dr. Alex Krist, vice chairman of the U.S. Preventive Services Task Force, an expert panel that issues health advice. By steering women toward 3D mammograms before all the evidence is in, “we could potentially hurt women,” Krist said.

Some experts worry that patients, who tend to overestimate their risk of dying from breast cancer, are acting out of fear when they choose treatment.

“If there was ever an audience susceptible to direct-to-consumer advertising, it’s women afraid of breast cancer,” Zuckerman said.

Some proponents of 3D mammograms imply that women who opt for 2D are taking a risk.

The first question many women have about 3D mammograms is: Are they less painful?

In ads, Hologic claims its 3D device was less painful for 93% of women. But that claim comes from a company-funded study that hasn’t been formally reviewed by outside experts, Zuckerman noted. Given the limited data provided in the study, it’s possible the findings were the result of chance, said Zuckerman, who called the ads “very misleading.”

Valenti said peer review is important in studies about cancer detection or false alarms. But when it relates to “general patient satisfaction or patient preference, those are data that we get in other ways,” he said. “Plenty of [doctors] have the [3D] system now and you can get feedback from them. “

While screenings may not generate a lot of income, they can attract patients who need other, more profitable hospital procedures.

“Anytime you diagnose more tumors, you can treat more tumors,” said Amitabh Chandra, director of health policy research at Harvard University’s John F. Kennedy School of Government.

Click here to read the full article.

Some textured implants have a cancer risk. Here’s why women are told not to remove them

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Joce Sterman and Alex Brauer, WJLA: September 16, 2019.

WASHINGTON (SBG) – We’ve all heard of recalls on cars and dangerous toys, but a global recall of a device that’s surgically implanted inside your body has thousands of women on alert. The recall of Allergan’s textured BIOCELL breast implants was prompted by a government analysis that showed an increased risk of cancer. Still, women who have them are generally being told not to have them removed from their chests.

For the last two months, Raylene Hollrah’s email and phone have been blowing up, with hundreds of women contacting her non-profit, dedicated to raising awareness about the emerging cancer. It’s called Breast implant-associated anaplastic large cell lymphoma, also known as BIA-ALCL.

The fear women are dealing with comes following the August global recall of Allergan’s BIOCELL textured implants due to the increased the risk of lymphoma, a cancer of the immune system that Raylene now knows all too well.

When she was diagnosed with BIA-ALCL in 2013, it was a brutal double whammy. Hollrah had survived breast cancer and a mastectomy. During reconstructive surgery in 2008, she got the textured implants that eventually gave her cancer a second time, making her just the 25th documented case of BIA-ALCL in the United States at that time. Her treatment and the research that preceded it came courtesy of Dr. Mark Clemens, who is a pioneer when it comes to researching the disease at MD Anderson Cancer Center in Texas.

In 2017, our Sinclair station in Washington, WJLA/ABC7 was one of the first in the country to tell Raylene’s story and highlight the link between textured breast implants and lymphoma. In that report, reporter Kimberly Suiters pointed out the Food and Drug Administration was aware of 258 confirmed cases of BIA-ALCL. But she said the warnings were not making it to women who might be at risk.

When she was diagnosed with BIA-ALCL in 2013, it was a brutal double whammy. Hollrah had survived breast cancer and a mastectomy. During reconstructive surgery in 2008, she got the textured implants that eventually gave her cancer a second time, making her just the 25th documented case of BIA-ALCL in the United States at that time. Her treatment and the research that preceded it came courtesy of Dr. Mark Clemens, who is a pioneer when it comes to researching the disease at MD Anderson Cancer Center in Texas.

In 2017, our Sinclair station in Washington, WJLA/ABC7 was one of the first in the country to tell Raylene’s story and highlight the link between textured breast implants and lymphoma. In that report, reporter Kimberly Suiters pointed out the Food and Drug Administration was aware of 258 confirmed cases of BIA-ALCL. But she said the warnings were not making it to women who might be at risk.

Allergan voluntarily pulled the implants as well as its related tissue expanders from the market, but they remain in thousands of women, many of them breast cancer survivors. And while a letter obtained by Spotlight on America shows the company is offering free replacement implants, it won’t pay for revision surgery.

The letter explains the decision not to cover surgical fees is in line with an FDA recommendation that textured implants not be removed in patients who have shown no symptoms of BIA-ALCL. The FDA is telling doctors to stop using the implants but has told women they can keep the implants if they’re not symptomatic.

Diana Zuckerman with the National Center for Health Research says, “Some of the women are going to say I don’t care what the FDA says, I’m getting them out.”

Zuckerman explained the FDA’s advice to keep the implants balances the risks of surgery with the chances of getting this type of lymphoma, which is rare. BIA-ALCL is also highly treatable and Zuckerman says removing the implants before a woman is diagnosed with BIA-ALCL is not a 100% guarantee that she won’t develop the disease.

And there’s another big question following the recall: exactly who has these implants? Zuckerman says many women don’t know and may struggle to find out as doctors don’t have to keep these records permanently.

That’s a big deal considering it could take years for this kind of cancer to develop. For Raylene Hollrah, her BIA-ALCL diagnosis came five years after she had her implants placed. After cancer a second time, she had them removed permanently. Now Hollrah has become an advocate for women in this same situation, making sure they know about BIA-ALCL.

So far no one has firmly pinpointed why these implants are a cancer risk, although many theories exist. And while the recall right now is only for Allergan’s BIOCELL textured implants, the FDA said it, “will continue to evaluate any new information and may, as a result, take action regarding other breast implants, if warranted.”

[…]

Read the full article here.

What Does Vaping Do To Your Lungs? Here’s What We Know

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Yvonne Kim, Elite Daily: September 11, 2019.

In recent months, the national uptick in teen vaping has become less of a viral trend and more of a burgeoning public health emergency. Although e-cigarettes are nothing new, they are coming under increased scrutiny as otherwise healthy, young smokers experience a sudden rise in lung problems — and, now, even deaths. With investigations ongoing, it remains unclear exactly what vaping does to your lungs, but here’s what we know so far.

[…]

As of Sept. 6, the CDC has cited about 450 cases across 33 states of common symptoms — including chest pain, shortness of breath, and vomiting — among people with histories of vaping. While lung scan results appear similar to pneumonia, tests show there are no infections, according to The New York Times. There is yet no specific substance or product that links all the cases, but the CDC plans to continue identifying a cause through interviews and investigation. It launched an official investigation on Aug. 1, 2019, according to the press release.

“We are committed to finding out what is making people sick,” CDC Director Robert Redfield said in another press release. “All available information is being carefully analyzed, and these initial findings are helping us narrow the focus of our investigation and get us closer to the answers needed to save lives.”

How Safe Are Breast Implants, Really?

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Rebecca Nelson, Elemental by Medium: September 3, 2019.

When Jamee Cook got breast implants at 21, she hoped to feel more confident about her body. Instead, the implants nearly ruined her life.

Just three years after her surgery, Cook, who is now 42, started having a slew of medical problems: fatigue, fevers, sinus infections, memory problems, and trouble concentrating. She felt like she constantly had the flu and could barely muster the energy to take care of her three kids. Because of her health problems, she had to quit her job as a paramedic. Four years ago, she finally saved up enough money to get her implants removed due to the complications and discovered her symptoms subsided. “I felt like I did a turnaround,” she says. She had finally gotten her life back.

Cook is not an outlier among women with breast implants. The safety of breast implants has long been a topic of debate in the medical community. After a safety scare in the 1990s, silicone implants were banned for more than a decade before the U.S. Food and Drug Administration (FDA) allowed them back on the market in 2006. But a growing body of evidence suggests that these newer breast implants aren’t as safe as this generation of women has been led to believe. The FDA requested in July that the implant manufacturer Allergan recall their textured implants, citing a link to a rare cancer called breast implant-associated anaplastic large cell lymphoma. And an online movement of thousands of women who say their implants have made them sick is calling more attention to other long-term complications.

Breast implants first came on the market in the U.S. in the 1960s. They are classified as medical devices by the FDA and an estimated 10 million women around the world have them currently. While the vast majority of those women don’t have issues, there’s increasing evidence that implants are associated with serious risks. But the available data on their safety is of poor quality, and doctors, researchers, and patients disagree about what some of the risks actually are — making it all the more difficult for women to determine them before making a decision.

The medical community has long downplayed the potential complications of implants, says Diana Zuckerman, the president of the National Center for Health Research in Washington, D.C., who has studied implants. “There are many, many plastic surgeons whose entire livelihood depends on doing breast augmentation surgery. If they were to tell every patient what all the risks are, they’d have fewer patients.”

Here’s what’s known for sure: Nearly 600 cases of breast implant-related anaplastic large cell lymphoma, a cancer of the immune system, have been reported to the FDA. As of July, 33 people died from it. Textured implants made by Allergan were linked to the cancer, and recalled globally that month. While the FDA says there’s generally a low risk of people with breast implants developing cancer from them, the agency said in a statement at the time that “we believe all individuals who are considering a breast implant of any type be informed of the risk.”

“Of the millions of women with breast implants, we know that complications occur in at least 1% of patients,” says FDA spokeswoman Stephanie Caccomo. “We believe, though, that all women should be aware of the potential risks and complications of breast implants, which are not lifetime devices.”

People who consider implants may be unaware that they are viewed as temporary devices to be removed or replaced at a later date. According to the FDA, the longer people have the implants, the higher their risk for complications. “The life of breast implants varies by person and can’t be predicted,” reads a FAQ about breast implants on the agency’s website. “That means everyone with breast implants will face additional surgeries — but no one can tell them when. And while a few people may keep their original implants for 20 to 30 years, that is not the common experience.”

[…]

Read the full story here.

E-cigarettes affect a person’s blood vessels after just one use, study finds

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Caitlin O’Kane, CBS News: August 22, 2019.

Vaping, even temporarily, can affect the blood vessels in healthy people — even if the vape pod does not contain nicotine, according to a new study published in the journal Radiology this week.

Researchers from the University of Pennsylvania School of Medicine studied 31 volunteers, all of whom were healthy, non-smoking adults with an average age of about 24 years old.

The participants were monitored as they each took 16 three-second inhalations from a disposable e-cigarette. The researchers used an ePuffer with flavored e-cigarette liquid but no nicotine in it. A research coordinator made sure sure the participants did not cough or swallow the vapor.

The researchers then conducted MRI scans on the participants and found a reduction in blood flow in the femoral artery in their legs. This change occurred after just one vaping experience.The findings suggest vaping impaired function of the endothelium, or inner lining of blood vessels, a press release on the study explained.

“These products are advertised as not harmful, and many e-cigarette users are convinced that they are just inhaling water vapor,” Alessandra Caporale, Ph.D., a post-doctoral researcher and lead author of the study, said in a statement. “But the solvents, flavorings and additives in the liquid base, after vaporization, expose users to multiple insults to the respiratory tract and blood vessels.”

[…]

“Lung damage is what we’re most focused on right now, but there’s so much more going on,” Dr. Diana Zuckerman, president of the National Center for Health Research, recently told CBS News. “There are chemicals in Juul and e-cigs and we’re not exactly sure what the impact is going to be because we haven’t seen it before.”

A study published in the journal Pediatrics last year found a number of different toxic chemicals in e-cigarettes, including one linked to several types of cancer. Some of the chemicals turned up even when teens used non-nicotine products like fruit-flavored vapes.

Read the original story here.