Category Archives: We Are Quoted

First, Their Breast Implants Made Them Sick. Then They Were Hit with the Bill.

Catherine Guthrie, Cosmopolitan: August 18, 2020.


Annie Reynoso wanted a tummy tuck. But her doctor said no. Uterine fibroids meant she wasn’t a good candidate for abdominal surgery. He had an idea though, the doctor. If what Annie was looking for was a physical boost, there were other options out there. Like breast implants.

[…]

Then it was a few years later, and odd things started happening: Her breasts swelled to a G-cup. She had fatigue that would knock her out for days. Sudden dizzy spells made it scary for her to drive. She’d get short of breath after walking just a few steps. She had night sweats that soaked her mattress. And there were even stranger symptoms: nausea if she ate before noon, and pain in her chest, neck, ears, and jaw that felt like the worst sunburn of her life. She kept tubes of Aspercreme in her purse, coat pockets, and desk drawer. At least a dozen times a day, she had to slather herself in ointment.

[…]

That’s when something finally changed: A friend of Annie’s started feeling better after her implants were removed, and a rheumatologist told Annie some of her symptoms aligned with Sjögren’s syndrome, an autoimmune disease potentially triggered by her implants. After that, all she could think about was getting them out.

Once again, she waited in a surgeon’s office. A new one this time. She’d gotten her implants in the Dominican Republic, where her family lives and they could help her through the recovery. Now she sat alone in New Jersey, consulting with a doctor about having her implants removed in a procedure called an explant. She was hopeful. Until she was told it would cost $7,500—and that insurance wasn’t likely to cover a dime.

[…]

And yet, there is evidence to suggest that breast implant illness might actually be an autoimmune disorder caused by implants. In 2018, a study in the International Journal of Epidemiology found that women with silicone breast implants had more than a 20 percent increased risk of being diagnosed with an autoimmune or rheumatic disorder.

There is also overwhelming anecdotal evidence online, in Facebook groups like Breast Implant Illness and Healing by Nicole, where hundreds of thousands of women share their stories. And of course, there are the endless comments on posts like Chrissy Teigen’s recent Instagram update about having her implants removed. Women saying they wish they could too—women saying, “Having them is making me sick.”

[…]

For sick women who are financially able to get explant surgery, it can change everything. In a July 2020 study in Annals of Plastic Surgery, researchers found that those experiencing symptoms of breast implant illness saw an improvement in their health within a month of having their implants removed. Like Lauren Dearman, who had explant surgery last November.

She was just 20 when her parents offered to pay $8,000 for her C-cup breast implants. Six years later, she began to have severe abdominal issues and chest pain, bad enough that she went to the ER. She was tired all the time and had such trouble focusing that she couldn’t even write a to-do list. She couldn’t climb the stairs to her third-floor apartment without gripping the railing. Her boyfriend told her she was out of shape. Her boyfriend, she knew, was wrong.

When she came across a Facebook group where women were talking about breast implant illness, the stories read like her own medical file. Within weeks, she made an appointment with a surgeon in Chicago who agreed that her implants could be at the root of her health issues. Lauren cried when she learned how much the surgery would cost. Her parents couldn’t pitch in financially this time, so Lauren withdrew $2,500 from savings and took out a personal loan for $6,500 so she could have the procedure. At $190 a month, she’ll be paying it off for the next three years. But she feels so much better now.

In a health care system that has no problem paying for Viagra (and Viagra overdoses), the fact that women like Lauren have to finance their medical care is infuriating, says Cari M. Schwartz, a lawyer at the firm Kantor & Kantor in California.

Schwartz is working on bringing a class-action lawsuit against insurance companies that deny explant coverage. She’s interviewed hundreds of women across the country desperate to get their implants out. In every case, insurers denied coverage, even when physicians deemed removals medically necessary. Schwartz has seen women rack up credit-card debt, borrow money, lose relationships and jobs, and go bankrupt in an effort to save their health. “Women are essentially told that their health issues are their fault,” she says, “because they chose to get implants.”

In 2019, the FDA said it was putting more effort into educating doctors and patients on the “systemic symptoms” many women with implants experience. Although they also still say they don’t have “definitive evidence demonstrating breast implants cause these symptoms.”

Doctors, too, remain reluctant to get onboard. “To recognize breast implant illness is to kill the goose that laid the golden egg,” says H. Jae Chun, MD, a Newport Beach, California, surgeon who specializes in explant surgery. “And many doctors just aren’t going to mess with the goose.”

In the meantime, one of the only options for desperate patients is the National Center for Health Research’s program to help women navigate the path to explant. They don’t give out money, but if a woman has health insurance, they’ll do what they can to coach her and her plastic surgeon through the insurance maze. Often, that means helping fill out paperwork explaining why the procedure is medically necessary. It’s a process that can take months and still results in a denial the majority of the time, says Diana Zuckerman, PhD, the group’s president. But so far, they’ve helped more than 1,500 women get the explants they need.

[…]

Read the full article here

The Number Of Women Having Their Breast Implants Removed Is on the Rise

Kristin Canning, Women’s Health: August 8, 2020


Something weird was going on with Laura Miranda’s left breast; the shape was changing. Two days prior to her noticing that something looked off, she’d had her first mammogram (breast cancer runs in her family, so she’s vigilant about getting the necessary tests). Now, her left breast seemed to be “deflated,” as she describes. It was June of 2016.

She’d gotten implants on a whim at 22 to fulfill the big-busted aesthetic ideal at the time. They were offered to her as a gift by the gym she worked for early in her career as a trainer—the athletic club had a partnership with a plastic surgery group, and she was meant to be a sort of walking advertisement for them.

She suspected the pressure from the x-ray machine had caused a leak in one of the implants since she’d previously read that mammogram techs have to use less force when implants are involved. “I thought, ‘that sucks,’ but figured they were 16 years old, and that’s just part of the game,” says Miranda, who is also now a doctor of physical therapy in New York City.

She could deal with a little asymmetry on her chest. What was unbearable were the symptoms to come.

Miranda started experiencing days-long bouts of fatigue and body aches a few weeks later. “I was launching a business and working crazy hours, so I attributed my symptoms to that,” she says. “I didn’t think to see a doctor.”

But she kept feeling worse. Eventually, she was bedridden every few days. “In 2017, I was dealing with intense brain fog and cognitive decline, writing and concentrating for my work was nearly impossible, I had to nap between every client I trained, and my vision was shaky,” says Miranda. “I was so tired that I couldn’t work out, so I gained weight and my mental health was in a really bad place.”

She visited her GP, then a cardiologist, endocrinologist, and holistic health practitioner. She had high blood pressure, but other than that, all her tests came back normal. Around the same time, her sister sent her a social media post from a model who talked about how her implants had made her sick. “I knew deep down that this was probably what was going on with me,” Miranda says.

Googling led her to a Facebook group called Breast Implant Illness and Healing by Nicole, a page started in 2016 by Nicole Daruda, who had her implants surgically removed in 2013 after suffering for years from symptoms much like Miranda’s, which she believed were linked to the devices in her chest. The procedure is known as explantation, or explant surgery, and involves the removal of both the implants as well as the scar tissue capsules surrounding them.

“I had never heard of breast implant illness, and no doctor ever mentioned it to me,” Miranda says. “But seeing all these women with such similar symptoms, who also had implants, made me realize something was going on here.”

She immediately wanted to get hers removed. “It just made sense.”

[…]

The thing is, BII isn’t really new—it’s just finally getting public attention. “Women have been complaining of issues with their implants since the 90s—but social media has allowed them to connect to amplify their voices and concerns,” says Diana Zuckerman, PhD, president of the National Center for Health Research, and its Cancer Prevention and Treatment Fund.

Jade Root, a U.S. Army major and fitness competitor, also found out she was suffering with BII thanks to the BII social media community. She’d gotten implants on the recommendation of her fitness coach seven years ago to make her body appear more proportional and up her chances of success on the stage. She slowly started to develop the classic symptoms often attributed to BII. “I chalked it up to motherhood and my deployment. I was managing a lot,” Root says.

But during a break from bikini competitions, her symptoms became crippling. “I couldn’t recall basic terms I needed to use at work every day, I couldn’t complete the drive to the office without nearly falling asleep, even after getting seven hours of sleep the night before.” Doctors prescribed her two meds for joint pain and numbness and one for sleep, and they attributed her memory loss to anxiety, for which she was prescribed Xanax. “It felt like I was forcing myself to get through every day. I couldn’t live like that.”

[…]

Unfortunately, BII “isn’t a disease we can test for,” says Dr. Alan Matarasso. Determining whether someone is dealing with BII is more a process of elimination of other possible causes. “It’s a constellation of symptoms that can potentially be linked to many conditions,” he explains. “And we know that breast implants are one of the most common and thoroughly studied medical devices on the market, and again, the mass majority of people who have them are happy with them and don’t develop any health problems.”

[….]

Still, new research is pointing to the fact that hundreds of thousands of women aren’t exactly making this up. A study published just last month in The Annals Of Plastic Surgery followed 750 women who had explant surgery in 2017 and 2018, tracking the most commonly reported symptoms of BII (the 11 listed above) before explantation, then from 1 to 1,000 days post-op. The study showed significant improvement in all 11 symptoms immediately following explant surgery, and the improvements were maintained long term. Those results echo the findings of several smaller studies that showed patients who suffered from this type of sickness got better after having their implants taken out.

[….]

Chelsea Harrison, a yoga instructor and former bikini competitor, had to do the same. She got breast augmentation when she was 23. “In one of my first bikini competitions I placed third, and the women in first and second both had implants. I was super self-conscious about it,” she says. A few years later, she started to notice rashes, fatigue, and anxiety, but didn’t link the issues to her implants.

Eventually, she had problems with what’s called capsular contracture, where the scar tissue around the implant hardens and can cause pain. “The first surgeon I visited told me I ‘didn’t want to take my implants out from an aesthetic standpoint,’” Harrison remembers. (It can be surprisingly difficult to find a surgeon willing to do explantation, says Zuckerman, because docs are afraid patients will be displeased with the results. And of course, there are risks with any surgery.)

[….]

In the summer of 2019, the Breast Implant Working Group (which includes Dr. Matarasso and Zuckerman) submitted a proposed black box warning for implant manufacturer websites (like what you might find on a box of cigarettes) and a patient checklist to the FDA for consideration. The checklist is meant to be given to patients who are considering implants for their sign-off, and includes detailed information on the potential health risks associated with them.

“We hear that patients just aren’t getting this information from their doctors, or if they do, it’s a huge 40-to-100-page booklet that’s difficult to read and understand,” says Zuckerman. The FDA then released their own proposed warning and checklist in October 2019 (You can find it starting on page 12 of this document.)

But Zuckerman says that the FDA versions of these warnings use “much weaker” language. “The [Breast Implant Working Group] doesn’t feel like it’s enough, so we sent our criticism along with a petition with over 80,000 signatures to support our black box warning and checklist language.” [….]

The hesitation to adopt strong language around BII may be because several studies have not confirmed the link between breast implants and BII. But, Zuckerman argues, “A lot of these studies that were done in response to early claims from women that their implants were making them sick were funded by manufacturing companies or plastic surgeons, and most did not include enough women who had implants for many years,” she says. “Plastic surgery is big bucks, and it could be less profitable if women are concerned they’ll be harmed; that’s why even doctors who believe in BII have been afraid to speak up about it because they could be ostracized by their colleagues.”

But the tides are changing…somewhat. The ASPS, which is the largest plastic surgeon society in the world, has endorsed the Breast Implant Working Group’s patient checklist and likely will endorse the black box warning with a few proposed tweaks, says Zuckerman. She hopes the FDA will adopt the warning and checklist soon.

[….]

Read the full article here

New Study Backs Breast Implant Illness Claims by Patients

Sasha Chavkin, International Consortium of Investigative Journalists: July 2, 2020


A new study in a leading plastic surgery journal offers more evidence to support the existence of breast implant illness, a malady reported by thousands of women but dismissed as scientifically unproven by many plastic surgeons and some health authorities.

The study focused on 750 women who complained of fatigue, memory loss, joint and muscle pain and other symptoms after having received breast implants. It found that as a group, the women experienced significant relief from their symptoms within 30 days of having their implants removed.

“The data speaks for itself,” said Dr. Lu-Jean Feng, a plastic surgeon and an author of the study. “It’s much more likely that the illness is due to breast implants if the improvements are within 30 days.”

The study adds to growing evidence that some women suffer systemic health problems after getting breast implants. It is well known that breast implants can lead to physical injuries such as rupture, leaking and painful tightening of scar tissue around the implant, known as capsular contracture. But many plastic surgeons have long contended that there is not enough scientific evidence to conclude that breast implants can cause health issues that affect the whole body, such as autoimmune disease and cognitive decline.

In 2018, the International Consortium of Investigative Journalists revealed that thousands of women around the world were suffering from serious illnesses after receiving breast implants as part of its Implant Files investigation.

Among the investigation’s findings were that an increasing number of studies indicated that breast implants were associated with systemic health effects such as autoimmune and connective tissue disease. These illnesses took a devastating toll on patients’ lives, often leaving them unable to work, struggling to maintain relationships and suffering severe pain.

The new study by Dr. Feng is not the first to show improvements in women’s health after they had their breast implants removed. But it has several notable elements: it has a relatively large sample size and it shows that major improvements occurred within 30 days of removal. In addition, all the patients were operated on by the same surgeon, Dr. Feng, using the same technique, eliminating the possibility that differences between doctors or methods influenced its results.

The women were surveyed before and after their breast implants were removed, and asked whether they suffered from 11 symptoms commonly associated with breast implant illness, including hair loss, joint pain, chronic fatigue and hives. Patients were asked to rate symptoms on a scale of zero to five. The mean preoperative score was 26.19; it dropped by nearly two thirds to 9.49, after removal.

The study was published in the Annals of Plastic Surgery, a peer-reviewed journal for plastic surgeons.

Diana Zuckerman, president of the health care policy think tank National Center for Health Research, said the publication was significant because it was a sign that the plastic surgery profession was beginning to accept the existence of breast implant illness.

“The plastic surgery journals have not been open to this kind of information,” Zuckerman said.

Breast implants are a crucial and lucrative product for plastic surgeons, and the breast implant business accounts for more than $1 billion in revenues each year.

The U.S. Food and Drug Administration has also shifted its stance on breast implant illness.

After long maintaining that there was insufficient evidence to connect breast implants and many symptoms reported by patients, the FDA now lists “Systemic symptoms Breast Implant Illness (BII)” among the risks and complications associated with breast implants, although it notes continuing scientific uncertainties.

“Symptoms such as fatigue, memory loss, rash, ‘brain fog,’ and joint pain may be associated with breast implants,” states the agency’s website.

Read the full article here

Women with Breast Implants Should Not Need to Wait for Safety Information They Urgently Need

Rose Weitz and Diana Zuckerman, Our Bodies Ourselves: July 1, 2020


Although breast implants have been sold since the 1960s, the U.S. Food and Drug Administration (FDA) first approved the use of silicone gel breast implants in 2006. By then, many women with implants had already reported a range of problems, which result in many women seeking additional surgery within just a few years of implantation.

And the problems have become more serious. Last year, for example, Allergan did a worldwide recall of their textured Biocell breast implants and expanders because of evidence that these implants caused an increased risk of a type of lymphoma called ALCL.

The FDA has the authority both to require solid evidence of safety before putting any implant on the market and to require companies to collect health data from implant patients for years afterward. Without these data, it is impossible for women or their doctors to know what are the possible consequences of different implants, what symptoms to look for, and which implants should be surgically removed – assuming an individual knows the make and model of their implant and can afford up to several thousand dollars to remove it.

Collecting data is a small thing to ask of manufacturers who have been profiting from breast implants for many years. Yet even this has proven too much for these companies, or for the FDA to enforce. For example, in May 2019 the FDA sent letters to two manufacturers, Mentor Worldwide and Sientra, warning that the manufacturers had failed to collect the required data for implants that were already on the market and would need to improve their data gathering or face potential criminal or civil penalties. The FDA also sent warning letters in May 2020 to Allergan and Ideal. The FDA criticized Allergan for their failure to recruit and follow-up with as many patients as had been promised. The agency warned Ideal that the companies’ efforts to rectify previous problems were inadequate, including failing to accurately report consumer complaints, failing to keep adulterants out of its silicone, and failing to notify the FDA about malfunctions of its implants that could result in death or serious injury. Meanwhile, all these implants are still on the market.

Last October, in response to the pleas and demands of thousands of breast implant patients, the FDA proposed that a black box warning be affixed to all implant packages to inform women and their doctors about the most serious risks of breast implants. In addition, the FDA proposed that all patients be required to sign an easy-to-understand checklist of possible risks before implant surgery is scheduled.

These proposals were much weaker than what patients and their advocates had demanded. In response to the FDA’s request for public comments, a Working Group of patients, public health advocates, and plastic surgeons submitted a critique — along with a petition signed by over 70,000 people – urging the FDA to be more explicit about the proposed warnings. Public comments were due in December 2019, but as of June 2020 the agency has still not revised its proposal.

Buyer beware, indeed.

Read the full article here

“We Can’t Ever Go to the Doctor with Our Guard Down”: Why Black Women Are 40% More Likely to Die of Breast Cancer

Maria Aspan: Fortune Magazine June 30, 2020


Racism kills Black Americans, and has long before COVID-19. But its toxic combination with sexism has particularly vast and disastrous consequences for the health of Black women.

While Black people in the U.S. are dying from the COVID-19 pandemic at a disproportionately high rate, this national health crisis underlines an even grimmer status quo: Black Americans are also much more likely to die from far more common and longstanding health problems every day. Black women are at particularly high risk of heart disease and strokes, and are at least three times as likely to die as a result of childbirth as white women, contributing to the overall alarmingly high maternal mortality rate in the United States.

Then there are the shocking statistics around breast cancer, which affects one in every eight women and is the most common non-skin cancer affecting women. Black women are less likely to develop it—but 40% more likely to die from it than white women, according to the U.S. Centers for Disease Control and Prevention.

The reasons behind this awful disparity are wide-ranging, and include systemic problems both within healthcare and far beyond it. Now the disproportionately high toll of COVID-19 on the Black population in the U.S. and the simultaneous national reckoning over racism are drawing new attention to the racial inequities hurting Black women—and amplifying the voices of doctors, scientists, and public health experts who have long sounded the alarm.

[…]

Women of all races could be legally omitted from government-funded clinical trials before 1993, and are still often under-represented in most research studies of conditions that affect them. Pregnancy and menstrual cycles are thought to “complicate” the results of trials that are mostly conducted on white men, who are seen as the “norm.”

This can obviously backfire. In 2013, the U.S. Food and Drug Administration sharply cut its recommended dosages of Ambien for women, after years of complaints about grogginess and falling asleep while driving, when followup tests showed that women metabolized the active ingredient in sleeping aids much more slowly than men.

When it comes to clinical trials funded by pharmaceutical companies, “the FDA encourages but does not require diversity in clinical trials,” says Diana Zuckerman, a scientist and president of the National Center for Health Research. “Worse, the agency frequently approves drugs and devices for all adults, even if they were primarily studied on white adults.”

One treatment that the FDA approved in April, for the “triple-negative” type of breast cancer that disproportionately affects Black women, was approved after being tested on 108 patients. Eight of them, or 7%, were Black. Another breast-cancer treatment was approved last year after being tested on 234 patients; seven of them, or 3%, were Black.

[…]

Read the full article here

CRS: Congress Can Rein in FDA’s Flexible Covid-19 Vaccine Trial Policies

Beth Wang, Inside Health Policy: June 03, 2020


The Congressional Research Service says Congress could rein in FDA’s broad discretionary authority over vaccine clinical trial policies by legislating how the agency and Institutional Review Boards approach clinical trial designs and reviews for the current COVID-19 pandemic, as well as for future emergencies. In a Tuesday (June 2) report, CRS suggests Congress could provide more specific direction to FDA and IRBs on how to approach clinical trials in emergency situations, and also could appoint a neutral scientific body to consider ethical and scientific issues as well as general guidelines for trials. Congress also could fund global collaboration among regulators, and provide additional funding and resources to facilitate clinical trials, the report suggests, echoing recent calls from lawmakers who have said the United States should get involved with global efforts to fund and develop COVID-19 vaccines and treatments.

Diana Zuckerman, president of the National Center for Health Research, applauded CRS for explaining the vaccine approval process to Congress and for telling lawmakers what their options are so Congress can, in Zuckerman’s words, “ensure a better outcome than we’ve seen with the disastrous coronavirus testing situation (in terms of accuracy, transparency, and availability).” The document, she told Inside Health Policy, does a good job of explaining that FDA has authority to lower approval standards for any drug or vaccine unless Congress steps in. “[B]ased on FDA’s actions of the last 3 months, it seems likely that they will do so in ways that could create the free-for-all that currently exists for coronavirus testing,” Zuckerman wrote in an email. “So the CRS is telling Congress that legislation is the option they have if they want to ensure a better outcome.”

Existing law, CRS says, requires FDA and IRBs to weigh considerations about safety and effectiveness against the desire to bring products to market quickly when evaluating proposed clinical trial designs for vaccines.

[…]

Congress previously told FDA what to do in the drug trial and approval space through passage of the 21st Century Cures Act, but FDA was given leeway in how to interpret the law, Zuckerman explained. “It pushed FDA in a particular direction but still gave the FDA the authority to rely on the agency’s subjective judgment,” she said. If Congress were to step in and tell FDA what it should do, it would be a radical departure, Zuckerman added. “[But it’s] probably necessary given FDA’s response to the pandemic so far, and the Administration’s track record of ignoring Congress when it suits them,” she said.

Read the entire article here.

Allergan is trying to track down women with breast implants it recalled nearly a year ago

Maria Aspan, Fortune: June 03, 2020


More than 10 months after recalling some of its breast implants, Allergan is making a new effort to find tens of thousands of women who still have the dangerous devices.

The pharmaceutical company, now owned by AbbViesaid this week that it will launch a digital and social media ad campaign to alert patients about the July 2019 recall of its textured Biocell implants. Those implants have been linked in academic studies to a sometimes-fatal cancer known as BIA-ALCL, for “breast implant–associated anaplastic large cell lymphoma.” More than 33 women have now died from BIA-ALCL.

Allergan’s announcement comes two weeks after Fortune published an investigation into the persistent problems with breast implants and the health risks, including BIA-ALCL, they have created for millions of women worldwide. These risks have been amplified by decades of inadequate study and problems that were hidden by breast implant manufacturers, as well as the generally poor tracking of medical devices, our investigation found.

Many women affected by Allergan’s Biocell recall told Fortune that they found out about it through social media or news reports, rather than directly from the company or the U.S. Food and Drug Administration, which requested the recall.

On Monday, Allergan acknowledged that it does not have device-tracking information for some 52,000 Biocell breast implants. Despite “robust efforts” to reach patients since last July, “the company is still seeking to directly contact all U.S. Biocell patients that have not yet been notified,” Allergan said in a press release.

“We are continuing to make every effort to make sure that each and every patient is made aware of the Biocell recall, and knows their implant type and implant history,” John Maltman, Allergan’s vice president of medical affairs, said in the release.

A company spokesperson did not respond to a request for more specifics about when the ad campaign would launch, or what exactly it would entail. And longtime critics of breast implant safety greeted Allergan’s announced plans with skepticism.

“I don’t know how visible it’s going to be,” says Diana Zuckerman, president of the National Center for Health Research. “Will the kind of money and effort be put into this in a way that’s comparable to ad campaigns when they’re selling something?

The new ad campaign appears to be at the behest of the FDA, which “asked Allergan to develop a strategy to contact patients who may not have heard about the recall,” an agency spokesperson told Fortune by email on Tuesday, adding that the FDA “is working with Allergan to amplify the message and outreach related to its July 2019 voluntary recall of certain breast implants.”

This is the latest of several actions the FDA has taken on breast implant safety in the wake of Fortune’s investigation. Last month, after speaking with Fortune, the FDA sent a warning letter to Allergan over its longtime failure to comply with regulatory requirements for selling its implants. At the same time, the agency also sent a letter to a smaller manufacturer warning about manufacturing and quality-control issues.

[…]

Read the full article here.

A Patient’s Guide to Telemedicine

Michelle Llamas, Drugwatch: May 20, 2020


Telemedicine allows patients to have a remote, non-emergency office visit with their health care provider by using a smartphone, computer or tablet. Research shows most patients are highly satisfied with telemedicine visits, and in most instances these visits are as good as in-person visits.

Telemedicine has been growing in popularity in recent years. As more states are implementing laws to facilitate telemedicine, more Americans are embracing remote visits with their health care providers.

From 2016 to 2017, health insurance claims for telemedicine grew by 53 percent, according to FAIR Health’s FH Healthcare Indicators and FH Medical Price Index 2019. It grew more than claims for urgent care centers, retail clinics and emergency departments.

By 2017, about 76 percent of hospitals in the United States connected with patients and other practitioners virtually through video or other technology, according to the American Hospital Association.

Because of the COVID-19 pandemic, analysts for Forrester Research predicted virtual health care interactions could top one billion by the end of 2020, CNBC reported.

Telemedicine vs. Telehealth

Telemedicine is a component of a larger group of remote health care services called telehealth, though sometimes people use the terms interchangeably.

The main difference between the two is that telemedicine specifically refers to medical information exchanged remotely to improve a patient’s health. Information can be exchanged through email, two-way video, smartphones and other wireless tools.

Telehealth encompasses telemedicine and other types of remote health care information exchanges, such as health education, medical provider training, administrative meetings and more.

[…]

Is Telemedicine as Good as an In-Person Visit?

The majority of telemedicine uses are just as good as in-person visits, according to research by the American Telemedicine Association (ATA). They may also be less expensive than in-person visits.

There has been over 40 years of research and thousands of studies related to telemedicine, and ATA reviewed these for cost effectiveness and quality of care in its 2013 report, Telemedicine’s Impact on Healthcare Quality and Cost.

“For most telemedicine applications, studies have shown that there is no difference in the ability of the provider to obtain clinical information, make an accurate diagnosis, and develop a treatment plan that produces the same desired clinical outcomes as compared to in-person care when used appropriately,” the ATA said.

Eighty-three percent of the time, patients can resolve their health issues during the first telemedicine visit, according to Red Quill Consulting.

One key thing to consider is preparing ahead of time, according to Diana Zuckerman, president of the National Center for Health Research.

“It’s important to make a list in advance of every question and comment before the [telemedicine] doctor’s visit,” Zuckerman told Drugwatch. “Being organized with anything that concerns you is even more important when the doctor doesn’t see you in person and can’t notice health issues that might be more obvious in person.”

Zuckerman advises consumers to write down and keep track of their medical provider’s answers during a telemedicine visit.

Getting Started

Patients who want to conduct a telemedicine visit with a provider will first need to confirm that the provider offers this option. Second, they will need a reliable internet connection and a smartphone, computer, laptop or tablet.

If you don’t have a preferred medical provider, you can check with your insurance company for providers that participate in their telemedicine program. You’ll also want to check with your insurance company’s policies on paying for these visits.

Ask your HR department if your employer has a preferred telemedicine provider.

[…]

Read the full article here

FDA Warns Allergan Over Breast Implant Studies

Sasha Chavkin, International Consortium of Investigative Journalists: May 19, 2020


United States health authorities issued a warning letter to leading global breast implant manufacturer Allergan for failing to properly carry out post-market safety studies.

The U.S. Food and Drug Administration found that Allergan did not meet its standards for recruiting and following up with participants in studies that included several styles of implants withdrawn from sale worldwide last year due to cancer risks.

Another company, Ideal Implant Incorporated, was rebuked for failing to properly track complaints by customers or take adequate corrective actions for problems identified during a site inspection.

“The FDA will continue to hold manufacturers accountable if they fail to fulfill their obligations,” Dr. Binita Ashar of the FDA’s Center for Devices and Radiological Health said in an agency statement announcing the warning letters.

In November 2018, the International Consortium of Investigative Journalists revealed that thousands of women around the world were suffering from serious illnesses after receiving breast implants, a finding that was part of its global Implant Files investigation.

In the months after the Implant Files’ publication, regulators around the world took action to better protect patients. Authorities in France, Canada, and the United States announced bans on Allergan Biocell implants, which were associated with increased risk of a rare form of cancer.

The moves prompted Allergan to announce a global recall of Biocell products last July. (Earlier this month, Allergan was acquired by global pharmaceutical giant AbbVie.)

The recalled implants are among the ones that Allergan was failing to properly study, the FDA found. The agency noted that the studies were crucial to identifying the risks for patients already implanted with Biocells.

“Post-approval studies are especially important to inform our understanding of the long-term potential risks associated with Allergan’s implants, including the models that have since been recalled from the market,” Ashar said in the FDA’s statement.

The agency touted the warning letters as a part of its “ongoing efforts” to better protect breast implant patients, also citing its Medical Device Safety Action Plan and the development of a National Breast Implant Registry to collect data on breast implant safety.

But Dr. Diana Zuckerman, the director of the National Center for Health Research, a health policy think tank, said the agency must also be willing to take tough measures against companies that fail to follow its rules.

Zuckerman noted that breast implant makers have a history of poor compliance with safety studies mandated by the FDA, which approved silicone breast implants for the U.S. market in 2006 despite scant data on their long-term safety.

Instead, the agency allowed manufacturers Allergan and Mentor to conduct long-term safety studies after their products were already on the market. Within three years, Allergan and Mentor lost touch with 40% and 80% of the patients, respectively, in key sections of these post-approval studies, torpedoing the FDA’s demand that they collect reliable long-term data.

Nonetheless, the agency permitted the implants to remain on the market.

Zuckerman was skeptical that the warning letters would have much effect unless the FDA showed it was willing to take products that violated its rules for safety studies off the market.

“It absolutely should be possible to take off the ones that aren’t studied properly,” Zuckerman said. “I guarantee if they did that the ones that are still on the market would finish their studies.”

Read the full article here

‘They killed her’: Why are breast implants still putting millions of women at risk?

Maria Aspan, Fortune: May 18, 2020


Thirty-three years before her death, Paulette Parr visited her doctor for a popular and relatively routine procedure. It was 1986, and Parr was 35, working in human resources at the local hospital in Sikeston, a 16,000-person Missouri enclave midway between St. Louis and Memphis. A married mother of two young boys, she was interested in what plastic surgeons still call a “mommy makeover,” a catchall for the various procedures that nip, tuck, and lift women back to a pre-childbirth shape. For Parr, that meant getting her first set of breast implants.

For the next 15 years, through losing her first husband and remarrying and getting promoted to her hospital’s purchasing department, Parr was mostly happy with her implants, and with how they made her look and feel. But they were silicone-based, a type the U.S. Food and Drug Administration banned in 1992 over concerns that they were causing autoimmune and safety problems, and Parr eventually started to worry about them. So by 2002, when she learned that one of her implants had ruptured and was leaking silicone into her body, Parr’s surgeon replaced them with saline-filled versions. Her new Biocell implants were covered in a roughly textured silicone shell, designed to reduce movement of the device.

That’s when Parr’s implant-related health problems really began, according to a lawsuit her husband has filed against pharmaceutical company Allergan, the maker of Biocell products and one of three major manufacturers of American breast implants. In 2010, after one of her saline implants started leaking, her plastic surgeon replaced them with yet another set of Biocell textured implants, this time filled with silicone, which the FDA had allowed back onto the market in 2006.

“They were gorgeous, and they were put in by a reputable doctor,” says Paulette’s widower, Calvin Parr, months after her death. “We never gave it a second thought.”

Breast implants have long been a punch line, mocked as frivolous markers of female vanity. But that dismissive attitude overlooks a business with a serious and sometimes deadly impact on the health of its overwhelmingly female customer base. More than 8 million American women have undergone breast-related plastic surgeries since 2000; in 2018 alone, more than 400,000 women chose one for either cosmetic or reconstructive reasons. Breast augmentation is the most popular cosmetic procedure tracked by the American Society of Plastic Surgeons.

Many women, especially those affected by breast cancer, say they are grateful to have implants as an option. “It’s a decision that’s personal,” says Lynn Jeffers, the society’s current president, a plastic surgeon, and a cancer survivor who’s getting post-mastectomy reconstruction. “With the data that I have now, I’m comfortable having implants.”

And pharmaceutical companies have been very comfortable selling them, despite a long history of government recalls and product-liability lawsuits. Allergan, which was acquired by AbbVie in May, sold $399.5 million worth of implants in 2017, before regulators around the globe started banning some of its products. Its main rival, Johnson & Johnson, doesn’t break out results for its Mentor Worldwide breast implant business. Smaller specialist Sientra reported annual “breast products” revenues of $46.4 million in 2019.

Those numbers pale in comparison to blockbusters like Allergan bestseller Botox, which raked in $3.8 billion last year. But like Botox, breast implants can have attractive recurring revenue built in for manufacturers and the doctors who use their products. Even under ideal circumstances, breast implants “are not lifetime devices,” the FDA warns, and will likely need to be replaced every 10 to 15 years, for a cost of up to $12,000 per cosmetic procedure.

Yet as doctors, patients, lawyers, and public health experts tell Fortune, breast implants have remained on the market despite decades of inadequate testing and study, recurrent safety concerns, and poor regulatory oversight. Those problems plague many medical devices, which range from machines used outside the body to artificial parts implanted within it. But breast implants are unique in their affiliation with female sexuality and physical appearance, their intersecting roles as elective beauty products and clinical tools that can help cancer survivors feel more like themselves—and the degree to which patients’ mounting concerns about them have been dismissed for decades. Now, that accumulated failure of oversight has created sweeping, sometimes tragic crises for potentially millions of women.

“There are a lot of women who are really suffering,” says Diana Zuckerman, president of the National Center for Health Research. “You have these products that are widely, widely sold, and every few years we learn something new about the problems they cause.”

Breast implant makers walk a particularly fine line when it comes to creating a product that is both safe and “realistic.” Today’s implants are either filled with saline (more likely to break) or silicone (more natural looking and feeling but plagued by a history of safety concerns). Their exteriors can be either smooth or made of a “textured” silicone shell. Smooth implants are more popular in the U.S., but surgeons working with mastectomy patients sometimes prefer textured versions, because the products’ rougher surface enables tissue to grow onto the implant more easily.

All of these variations are prone to malfunctions or side effects, which can include ruptured implants; a buildup of scar tissue that can cause pain and tissue hardening; a large collection of symptoms often known as “breast implant illness,” which can include joint pain, migraines, and chronic fatigue; and, increasingly, a sometimes fatal cancer of the immune system known as ­BIA-ALCL, for “breast implant–­associated anaplastic large cell lymphoma.”

“The breast implants that are on the market right now all have issues,” says Madris Tomes, a former FDA manager who tracks reported medical device failures at her Device Events firm. “I wouldn’t recommend them to anyone that I care about.”

The causes of the various problems with breast implants are still poorly understood, which public health experts blame on a lack of testing or objective, long-term studies that do not rely on manufacturer-provided data or funding. Device makers also have yet to fully report the data the FDA required as a condition of allowing silicone implants back on the market in 2006.

[…]

Read the full article here