Category Archives: We Are Quoted

A Special Report: Can Breast Implants Cause Chronic Disease?

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by Julie Halpert , October 25, 2022

With new FDA warnings, troubling research, and a growing online population sharing stories and symptoms, experts and women with implants weigh in.

JENNIFER JOHNSON, 43, of Wilcox, NE, underwent a preventative double-mastectomy—a surgical procedure that removes all tissue from both breasts—in July 2008 at age 29 after learning she carried the BRCA2 genetic mutation.

Research shows that having BRCA2 increases risk of developing breast cancer (BC) by 45%. Johnson’s family history didn’t make her keen to play the odds: Her mother died from the disease at 34, as did her sister Debbie at 39, while another sister, Valerie, was diagnosed with BC in her 40s and, thankfully, is still here. After Johnson’s doctor told her that her own chances of facing a similar fate were exceedingly high, she chose the double-mastectomy as the safer bet.

The surgery didn’t spare her, however. A post-op pathology report found that Johnson already had an aggressive type of breast cancer (“stage 1, triple-negative, grade 3”) in her right breast that required immediate treatment.

Her plastic surgeon was “adamant,” she says, that she get breast implants to return her body to normal, since she was so young. She got silicone implants on her 30th birthday. Within several months, she began experiencing intermittent, aching pain in her muscles and joints, as well as “shooting, stabbing pains” in her chest, she reports. She also battled rashes and severe fatigue. “I basically felt like I was dying a slow death, like my body was just giving out slowly over time,” she recalls.

A team of specialists told her nothing was wrong. But her symptoms continued—leaving her distraught. After four years of this, she had her implants removed (known as explant surgery). To her great relief, “I started feeling better right away,” she says. “Every single symptom disappeared within a year.”

Johnson is among those who have experienced what’s colloquially known as breast implant illness (BII), when significant health issues—fatigue, chest pain, hair loss, headaches, chills, photosensitivity, rash, chronic joint pain, among other symptoms—arise after getting implants.

[….]

We asked women who’ve undergone reconstruction or done elective breast implant surgery to share their experiences. We also polled breast health experts on their thoughts about this popular cosmetic surgery being done in the U.S. and around the world—and its potential implications for the chronic community.

SAFETY CONCERNS

Are Breast Implants Safe? Or Not?

In October 2021, the FDA issued new restrictions for breast implants, including a mandated box warning on the product label to inform patients of significant health risks, such as an increased cancer risk; a checklist of items that health care providers should discuss with patients as they consider implants; updated silicone gel-filled breast implant rupture screening recommendations; and a list of specific materials used to create the implant.

Then, this past September, the FDA issued a safety communication following reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas in the scar tissue that had formed around breast implants, noting that “currently, the incidence rate and risk factors for SCC and various lymphomas in the capsule around the breast implants are unknown.” A spokesperson for the agency added, “The FDA recognizes that many patients’ symptoms may take years to develop, and patients may not be aware of the risk of SCC … We will keep the public informed as significant new information becomes available about SCC and lymphoma variants in the breast implant capsule.”

[….]

PATIENT REPORTS

Implants Remain Popular, Yet Some Patients Suffer

Safety issues haven’t dimmed enthusiasm for breast implants. According to a 2020 report by the American Society of Plastic Surgeons (ASPS), there were 137,808 implants provided for breast reconstruction and 193,073 for cosmetic surgery in this country alone. Silicone implants were used in 84% of breast augmentations, while saline implants were used in 16% of such procedures in 2020.

Mark Clemens, M.D., a professor of plastic surgery at MD Anderson in Houston, TX, who has led several MD Anderson-based safety studies on breast implants, says the recent FDA communication shouldn’t alter the perception of breast implant safety. He believes that it was done out of abundance of caution to inform, not frighten, women. When it comes to breast implants, “the vast majority of women will be completely healthy [after getting them] and won’t have any issues,” he says. However, he urges women who notice any signs of abnormality—asymmetry between breasts, the firming of a breast, or a palpable mass or a fluid collection—to consult a physician to ensure there’s nothing wrong.

Diana Zuckerman, Ph.D., president of the National Center for Health Research, a Washington, D.C.-based nonprofit organization that draws from scientific studies to improve public policy and medical oversight in the U.S., believes more independent research is required before an accurate safety assessment can be made. She says that nearly all the research being done on breast implant safety has been conducted by the very hospitals and plastic surgery organizations that either offer reconstruction and elective implant procedures as a service, or represent the surgeons who are paid to perform them—a big source of revenue and conflict of interest, leaving troubling questions of inherent bias being baked into the results.

“I can’t emphasize enough how much resistance there has been from the plastic surgeons’ medical societies and the implant manufacturers” to doing more and better research on implants, Zuckerman says. While some plastic surgeons have vocalized their concerns over the need for better information for their patients, “the medical societies—the major sources of information that FDA officials rely on—have been vehemently opposed,” she reports. “Their usual mantras are some variation of ‘breast implants are the most studied medical device in history’; hundreds of studies prove they are very safe’; and ‘so-called breast implant illness symptoms are common symptoms caused by aging and other factors, not by the implants.’” Implant manufacturers say the same thing—not coincidentally, Zuckerman adds.

Nicole Daruda, age 58 and living in Vancouver Island in Canada, openly doubts the industry’s safety claims. “Breast implants are linked to autoimmune symptoms and diseases and many other health problems,” she maintains. Daruda got cohesive gel implants in 2005 and saw her once excellent health “decimated by breast implants.” Within the first few years of having them she says she experienced fatigue, brain fog, various infections, food allergies, and hypothyroidism, with more symptoms appearing each year.

Daruda had her implants removed in 2013, and within four years she says all of her symptoms resolved. She started the Facebook group, Breast Implant Illness and Healing by Nicole, in April 2015 to provide a forum for women experiencing health issues after having implants to support and talk to each other. The group now has more than 170,000 members. Daruda says that she’s heard from thousands of women on her social media platform who report their health has improved after getting their implants removed.

[….]

IMPLANTS AND LYMPHOMA

What You Need to Know About Lymphoma

According to the FDA, as of September 2020, more than 700 people worldwide have been diagnosed with breast implant-associated anaplastic large cell lymphoma, an uncommon cancer. The agency found that the women with textured breast implants have a small but increased risk of developing this disease. The working theory, Dr. Glasberg explains, is that the texturing on the implant drives inflammation, which causes a change in the capsule around the implant that then develops into lymphoma.

Despite his belief that breast implants are safe for the vast majority of women, Dr. Clemens authored a 2021 study that examined eight cases of Epstein–Barr virus-positive large B-cell lymphoma associated with breast implants “and we’ve been trying to understand these better,” he says. (The eight women in the study were all patients at MD Anderson, a medical center that offers breast reconstruction and elective breast implant surgery, who were among the 30 known cases in the world of this type of lymphoma, per the FDA tally.) Increased awareness, combined with more pathology testing of scar tissue, plus physicians and patients being aware of breast implant-associated issues has “drawn our attention to looking for these other diseases,” he says.

IMPLANTS AND AUTOIMMUNE DISEASE

Breast Implants and Autoimmune Disease

Autoimmune issues arise when the body mistakenly attacks its own healthy tissue, causing damaging inflammation and often chronic pain and fatigue, among other symptoms, some of them disabling and/or permanent.

In 2018, MD Anderson conducted the largest study to date to explore long-term safety outcomes of breast implants, finding an association, though not a causation, with some rare diseases, including the autoimmune disorders Sjögren’s syndrome, rheumatoid arthritis (RA), and scleroderma. What’s more, researchers in the Netherlands found that more than two-thirds of women with autoimmune symptoms who had their breast implants removed experienced a reduction in symptoms.

That same year an Israeli study—research that Zuckerman says is both independent and well-designed—compared more than 24,000 breast implant patients to more than 98,000 women without breast implants but who shared similar demographic traits and reported a 22% increase in several autoimmune and rheumatic disorders, as diagnosed by their physicians and reported in their medical records. In addition, the same study reported a 60% increased risk of Sjögren’s syndrome, multiple sclerosis (MS), and sarcoidosis among those with implants, as well.

Dr. Clemens, the principal investigator of the large MD Anderson study, points out that some of those diseases in his study were self-reported by study participants, and not necessarily diagnosed by a physician—a limitation of the research. He doesn’t believe the findings are cause for concern. “The vast majority of patients with implants do not experience these symptoms or diseases,” he says. “However, it is important that they are aware of these conditions so that if they note any changes or have concerns, they can discuss with their treating physician.”

Then again, a 2021 study on breast implants and respiratory health found that 74% of participants who had their breast implants removed showed significant improvements on at least three of the six pulmonary function tests performed—an objective, not self-reported, medical tool.

For her part, Zuckerman notes that research is often funded by implant manufacturers and used to argue that breast implant illness is not real. A major weakness of most BII studies, a report by her organization found, is that they evaluate only diagnosed diseases. The reason why women decide to have their implants surgically removed and not replaced, she explains, is often due to symptoms of autoimmune and connective tissue diseases, rather than official diagnoses.

“The women and their doctors often report a constellation of symptoms that do not fit the exact criteria of known diseases,” she explains, adding that most people aren’t hospitalized for the autoimmune issues most associated with BII. Without symptoms that perfectly fit a specific diagnosis, many women will not have a diagnosis logged into medical records.

[….]

REMOVING YOUR IMPLANTS

Can Implant Removal Mean a Return to Health?

Some women, who can find no other explanation for their symptoms, like Johnson, are having their implants removed. In 2020, 22,676 explants were performed on reconstruction patients in the U.S., per the ASPS. Johnson says she was forced to find a different plastic surgeon to perform the procedure, since the one who put them in didn’t believe they caused health issues.

“He stood back looking at my chest and said, ‘I did an amazing job on those and really don’t want to take them out,’” she recalls.

[….]

Zuckerman believes the health rebound after explant surgery may be higher than the plastic surgery industry acknowledges. Since 2015, her organization has been contacted by more than 4,500 women who had breast implants they wanted removed due to rupture, breast pain, or medical symptoms caused, they believed, by their implants. NCHR was asked to advocate with health insurance companies, Medicare, and Medicaid to cover the costs of implant removal, she adds, since many of the women could not afford explant surgery.

[….]

To read the entire article, click here.

Silicone Breast Implants Were Banned in the ’90s for Making Women Sick. How Did They Make a Comeback?

Uncategorized, We Are Quoted

Eleanor Cummins, Slate, June 9th, 2022

Robyn Towt didn’t want new boobs. But when she was diagnosed with breast cancer and underwent a double mastectomy at 44, friends and doctors told her she needed to “look like a woman” and feel “whole” again. Implants would help put her “back together.”

“I was talked into it,” Towt recently told me over a poolside phone call from her home in Arizona.

She quickly regretted the decision. But it wasn’t the look or feel of her new cleavage that was the problem. Rather, within days of her 2017 implant surgery, she developed strange symptoms, including severe insomnia and crippling fatigue. Nothing her doctor prescribed seemed to help. “She didn’t have any answers for me,” Towt said, adding that the doctor didn’t see a connection to the implants. Prior to the chest enhancement, Towt had walked five or more miles a day and regularly swam, golfed, and wakeboarded. Now, she couldn’t make it to the mailbox.

Robyn Towt didn’t want new boobs. But when she was diagnosed with breast cancer and underwent a double mastectomy at 44, friends and doctors told her she needed to “look like a woman” and feel “whole” again. Implants would help put her “back together.”

“I was talked into it,” Towt recently told me over a poolside phone call from her home in Arizona.

She quickly regretted the decision. But it wasn’t the look or feel of her new cleavage that was the problem. Rather, within days of her 2017 implant surgery, she developed strange symptoms, including severe insomnia and crippling fatigue. Nothing her doctor prescribed seemed to help. “She didn’t have any answers for me,” Towt said, adding that the doctor didn’t see a connection to the implants. Prior to the chest enhancement, Towt had walked five or more miles a day and regularly swam, golfed, and wakeboarded. Now, she couldn’t make it to the mailbox.

Like many desperate patients, Towt turned to the internet, where she trawled cancer recovery forums for insight. Towt found that many women experienced symptoms similar to hers, but most wrote it off as side effects from chemotherapy or radiation—two treatments Towt hadn’t undergone for breast cancer. She tried their recommendations, too, for essential oils and nighttime baths, but they didn’t work, either. Then a woman messaged Towt privately and pointed her in a new direction: “Look into your breast implants,” she said. What Towt found surprised her.

Over the past decade or so, more than 350,000 people in the U.S. have reported adverse events related to silicone gel breast implants to the FDA. Their complaints range from autoimmune symptoms to a rare cancer called breast implant–associated anaplastic large cell lymphoma. Despite the number and severity of the issues described, the experiences of such patients have long been ignored by physicians, manufacturers, and regulators. The famous among them land in the pages of Page Six and People. Bachelorette star Clare Crawley saysher implants caused “crazy health problems,” while Danica Patrick reported hair breakage and heavy metal toxicity; both documented their removal surgeries on Instagram. But for many, the confusion around what’s now called “breast implant illness,” or BII, has left them to suffer alone.

[…]

But the problems with silicone implants have been apparent to some for decades. Since 1982, patients had been suing implant manufacturers in court, with millions of dollars awarded in damages. In June 1988, cancer patient–turned–consumer advocate Sybil Goldrich wrote about her “Restoration Drama” in an essay for Ms. magazine, helping to bring what would eventually be called BII to national attention. Following two mastectomies, Goodrich’s body rejected multiple implants in increasingly painful ways. “I was no closer to restoration than when I had started,” she wrote. “I simply had several more glaring scars on my disfigured torso.”

Goldrich’s case piqued the interest of Diana Zuckerman, currently president of the nonprofit National Center for Health Research, and at the time, an investigator of federal health programs and policies for the U.S. Congress. Zuckerman asked the FDA to turn over all of its safety and effectiveness data on breast implants. She was shocked by how little there was. “They had a few studies that had been submitted to them with rabbits or dogs or rats,” she told me. The animals had been injected with silicone directly. Not one study involved actual implants in actual human beings.

A congressional hearing ensued in December 1990—and the whole world was watching, as evidenced by extensive coverage on TV news and newspaper write-ups over the course of the decade. “The manufacturers are sweating bullets right now,” one anonymous congressional aide told the New York Times in 1992. That year, the FDA instituted what would become a 14-year moratorium on silicone breast implants, during which time they planned to collect and review the evidence. One major manufacturer, Dow Corning, eventually stopped making implants for good after a $3.2 billion product liability settlement (though it continues to produce the silicone used in other companies’ implants). But the industry ultimately came out on top.

To read the entire article, click here.

Trump Covid Report Stirs Calls for FDA to Rebuild Public Trust

We Are Quoted

Celine Castronuovo and Jeannie Baumann, Bloomberg Law, August, 26, 2022

A House report detailing coordinated attempts by Trump White House officials to influence the FDA’s pandemic response underscores the need for more transparency at an agency that’s facing historically low public trust, health policy analysts say.

The House Select Subcommittee on the Coronavirus Crisis said this week that advisers to former President Donald Trump sought to build support for hydroxychloroquine as a Covid-19 treatment, despite limited evidence on its efficacy. The report serves as a reminder of how allegations of behind-the-scenes political pressure can influence the public’s perception of federal health agencies’ independence.

“When things are happening behind closed doors, it’s easier for people to try to mess with the FDA,” said Joshua M. Sharfstein, who served as the FDA’s second-in-command during the first two years of the Obama administration.

“The more transparent FDA is, the harder it is for someone to come in and try to interfere with decisions,” he added.

The report comes as positive ratings of the US public health system dropped by nearly 10 percentage points over the past decade, according to a May 2021 joint study by the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health.

Former federal officials and policy watchers say the FDA must maintain transparency in decision making to prevent external influence, especially as the agency oversees several ongoing health priorities—including authorization requests for omicron-specific Covid-19 vaccines and responses to the growing monkeypox outbreak.

The latest findings have garnered mixed reactions, with some policy watchers saying it shows the FDA defended scientific evidence in the face of efforts to politicize health policy. Others say any reports of attempted political interference is damaging to public trust in the FDA and other agencies.

FDA Commissioner Robert M. Califf has said he will make combating health misinformation a priority of his tenure. And “throughout the pandemic, the FDA career staff has worked around-the-clock to make the best, science-based decisions on behalf of the American people in a rapidly evolving and unprecedented public health emergency,” agency spokesman Michael Felberbaum said in an emailed statement.

Building Resiliency

The subcommittee’s document, which also alleges efforts to promote convalescent plasma as a Covid-19 treatment ahead of the 2020 Republican National Convention, marks the second in a series unveiling findings from an investigation into Trump administration interference with federal health agency pandemic responses.

Many of the Trump administration’s alleged attempts to interfere happened behind closed doors, though the report found the FDA stood up to pressure to keep hydroxychloriquine around after data showed it lacked efficacy as a Covid-19 treatment. The FDA authorized the drug in March 2020 as a treatment for certain hospitalized Covid-19 patients. It revoked the emergency use authorization in June 2020.

Meanwhile, the FDA muscled guidance past the White House that made clear the agency wouldn’t let politics tamper with its decisions, all while facing pressure to authorize vaccines before the 2020 election.

Former FDA Commissioner Stephen Hahn said in an interview with the subcommittee that chief of staff Mark Meadows and other White House officials had “objections” to vaccine guidance language requiring that manufacturers submit at least two months of follow-up safety data for late-stage clinical trials. Hahn said he resisted attempts to change the guidance because “any changes would be obviously reported and would further reduce vaccine confidence.”

[….]

Fighting Misinformation

Califf’s efforts to highlight the dangers of the pandemic’s rise in health misinformation is one way to rebuild public trust in the FDA, although the overall effort will be a challenge, policy analysts say.

“There are some people for whom I think it will be difficult, if not impossible, to regain their trust,” Diana Zuckerman, president of the National Center for Health Research and a former senior policy adviser to the Clinton White House, said. “It’s not really that much the fault of anything that the FDA did; it’s the fault of the misinformation they’re getting from news sources or social media.”

Califf wrote in an Aug. 22 article in the Journal of the American Medical Association that “the global information environment has been contaminated by misinformation and disinformation.”

“The FDA must be more proactive in preempting and countering misinformation,” he said, adding that there’s also a need for “collaboration across sectors to create an information environment in which decisions” by “consumers, patients, and clinicians are more likely to be informed by reliable information based on high-quality evidence from trustworthy sources.”

Zuckerman argued that “Commissioner Califf has made it clear that he will not let the FDA’s reputation be undermined by misinformation.”

“He’s not going to have a political hack telling him what to do or say, and he’s shown a commitment to focusing on the science and protecting the reputation of the FDA,” she said.

To read the entire article, click here.

Danica Patrick reveals she had breast implants removed after suffering complications

We Are Quoted,

Katie Kindelan, Good Morning America, May 2, 2022

Former NASCAR driver Danica Patrick revealed she had her breast implants removed after suffering medical complications she believes were caused by the implants.

Patrick, who turned 40 in March, shared in an Instagram post that she had her implants removed this month, nearly eight years after undergoing breast augmentation surgery.

“I wasn’t sure I was ready to share this…. but then I remembered that true vulnerability is sharing something you’re not really ready to. So here it is,” Patrick wrote on Instagram, before going on to describe the complications she said she faced.

Patrick said she first noticed complications about three years after getting breast implants, including weight gain and hair breakage.

Nearly two years ago, at the end of 2020, Patrick said the “wheels came off” with her health.

“I had cycle irregularity, gained more weight, my hair wasn’t looking healthy at all and my face was a different shape (weird I know),” she wrote, adding that she also faced dizziness, adrenal fatigue, hypoglycemia, leaky gut and more. “So I went down the rabbit hole to figure it out. I did every test that could be done.”

Patrick wrote that she went to multiple doctors, took thyroid medications, tried a 90-day protocol to heal her gut and at one point was taking “up to 30 pills a day” to improve her health, all to no avail.

Ultimately, Patrick said she came to the conclusion that she had breast implant illness, a term coined by clinicians and patients to describe symptoms reported by women after breast reconstruction or augmentation using implants, according to the Food and Drug Administration.
After undergoing surgery to remove the implants, Patrick said she quickly noticed improvements to her health.

“Within hours after surgery this is what I noticed – my face had more color and less dark circles … my face started producing oil again,” she wrote. “I could take a 30% deeper breath into my chest already, and I had so much energy when I woke up.”

[….]

What to know about breast implant illness

Breast implant illness is not yet a recognized medical term but is described by experts as a “diagnosis by exclusion,” according to Diana Zuckerman, Ph.D., president of the National Center for Health Research, who has studied the health impact of breast implants for over 30 years.
“Diagnosis by exclusion means that there is no test for it, but there are tests for other things that have the same symptoms or similar symptoms,” Zuckerman said. “And if there is no other reason for this array of symptoms, then there are doctors who will call it breast implant illness.”

There are as many as 40 symptoms of breast implant illness, but the most common symptoms include joint and muscle pain, fatigue, memory problems or brain fog, hair loss and difficulty breathing, according to Zuckerman.

She said Patrick’s story of taking years to get to a diagnosis is not uncommon for women who suffer health complications due to breast implants.

It can take years for breast implants to start causing complications, which makes it more difficult to link complications back to breast implants, according to Zuckerman, who was not involved in Patrick’s care. She also noted that many of the symptoms of breast implant illness can, and are, attributed to other things.

“When [women] go to the doctor and say, ‘I have joint pain. I’m really tired,’ the doctor will say things like, ‘No wonder you’re tired, you have a young child,’ or, ‘No wonder you’re tired, you’re 45 years old. You’re not 25 years old anymore,” said Zuckerman.

“So there’s been this, some might call it gaslighting, but this sense that these are common symptoms and they could be anything,” she said. “But, what is distinct about them is there are so many women who are experiencing them, and there are very good studies showing when women have these symptoms and they have their breast implants taken out, almost all of them get better.”

Breast implant surgery is considered an elective procedure that is done not only for cosmetic reasons but also for women undergoing breast reconstruction after a medical procedure such as a mastectomy.

Saline-filled and silicone gel-filled are the two types of breast implants approved for use in the United States, according to the FDA.

Breast implants may cause damage if they leak in the body, or because they can cause scar tissue to build in the body, according to Zuckerman.

“When women have a breast implant, their body almost always forms a scar tissue capsule around the implant,” she said. “The body is basically protecting itself by surrounding this foreign body, this breast implant, with scar tissue, and that scar tissue can get very thick and can get very hard and be a bad symptom in that it can be painful.”

Zuckerman said that the popularization of social media has helped women with similar symptoms connect and share their experiences, leading to greater awareness and more diagnoses of breast implant illness.

Patrick wrote on Instagram that she watched “over 100 stories on YouTube” of women with breast implant complications.

“Social media has really made the big difference here,” Zuckerman said. “It wasn’t until Facebook and other social media options became available that women could really share their stories.”

“We’ve certainly known women who’ve spent tens of thousands of dollars on tests and specialists, and nothing helped and then they went online and found a Facebook page or some other social media, and they started reading these stories of other women that sounded just like them,” she said.

[….]

Zuckerman, a member of the working group that advised the FDA on implant safety, said she advises women who are thinking of getting implants to make sure they also have the resources to get them removed later on if needed.

“Don’t get them unless you can afford to have them taken out,” she said. “A lot of women spend all this money getting them put in, and then when they get sick, they don’t have the money to get them taken out. It costs just as much, sometimes more, to have them taken out.”

To read the entire story, click here.

Bella Hadid regrets getting a nose job at 14. How young is too young for plastic surgery?

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Jenna Ryu, USA TODAY: March 21, 2022

For years, Bella Hadid denied she’d had plastic surgery. But now, she’s changing her tune and speaking about a cosmetic procedure she regrets: the nose job she got when she was 14. 

“I wish I had kept the nose of my ancestors,” Hadid told Vogue last week. She’s the daughter of Dutch-born former “Real Housewives of Beverly Hills” star Yolanda Hadid and Palestinian real estate developer Mohamed Hadid. “I think I would have grown into it.”

And it’s not uncommon for teens to get cosmetic procedures. According to the American Society of Plastic and Reconstructive Surgeons, nearly 230,000 cosmetic surgeries were performed on teens ages 13-19 in 2017, and some as young as 15 are even documenting their plastic surgeries on social media. 

According to Dr. Steven Pearlman, a board-certified facial plastic surgeon, it’s legal to perform plastic surgery on anyone under 18 — as long a parent or legal guardian consents. However, some experts caution it can be “damaging” and “concerning” for teens who are under 18 to get cosmetic procedures while their bodies are still developing.

“Girls nowadays live in a culture with so much pressure to change their appearances, whether it’s putting on makeup or something more extreme like cosmetic surgery,” says Leora Tanenbaum, feminist and author of “I Am Not a Slut.”

[….]

Pearlman says that in his experience with young patients, “it’s more often that the psychological impact of a rhinoplasty, (like) improved self-esteem, surpasses the physical changes to their nose.”

However, he says teens need to be emotionally mature enough to understand the complications that come with surgery. Though there’s aren’t additional risks for teens, potential side effects of a nose job, for example, include bleeding, infection, poor wound healing or scarring according to the American Society of Plastic Surgeons.

“Some teens are more psychologically mature than others, but it’s important to note that their brain development is not at a point where they can really think through long term implications and they aren’t able to fully appreciate what the consequences might be,” explains Diana Zuckerman, president of the National Center for Health Research.

In addition, research shows that teens between the ages of 13 and 19 are especially vulnerable to peer pressure and more likely to have an unhealthy fixation on physical beauty, which may drive some to get procedures that they will later regret.

“There’s probably nobody as self-conscious as a 14 year-old girl,” Zuckerman says. “Some people have features that may make them self-conscious and it can be psychologically debilitating, but it’s also true that as people get older, they get less self-conscious and their face comes into their own.”

A ‘no win situation’

Though the decision to get plastic surgery can be empowering, experts say the marketing of these procedures to young girls is not: Rather “it’s almost always damaging” when social media and influencers force an impossible blueprint of beauty onto teens. 

“The current message is, ‘This is what you’re supposed to look like, and if you don’t, it should be fixed,” Zuckerman says. “And often these teens never even considered these features as ‘imperfections’ until they were pointed out to them.”

[….]

“For minors and parents considering having these procedures done, think about the price you will be paying societally by making this decision. Because for every individual, no matter how empowering it is for them personally, that strengthens and reinforces the pressure for everyone else,” Tanenbaum says.

Ultimately, it is up to the teen and their parent to make an informed decision about proceeding with plastic surgery.

But in an ideal world, Zuckerman hopes plastic surgeons and practitioners will use their discretion to hold off on performing cosmetic procedures on teens.

“I think it’s in parents’ and children’s best interests to delay those decisions partly because the standards we have about what is beautiful will likely change… but I know parents can feel pressured by their teenage children, and they just want their kids to be happy,” she says.

“So it would be great if surgeons had some kind of basic ethical decision of denying certain kinds of surgeries until a teenager is of age, like at least 18.”

To read the entire article, click here 

She’s the reason Arizona has a law requiring surgeons to warn patients about the dangers of breast implants

Other Testimonies About Breast Implant Complications, We Are Quoted

Bianca Buono and Katie Wilcox, Arizona News 12 NBC: February 22, 2022

PHOENIX — Migraines. Headaches. Insomnia. Difficulty breathing. Trouble swallowing.

Robyn Towt survived three bouts with cancer. But it was breast implants that made her the sickest.

“I couldn’t figure out what was wrong with me,” Towt said.

At first, it was a mystery. She had recently survived breast cancer then had a double mastectomy with breast reconstruction. The cancer was gone, so why was she feeling so badly?

“My entire team of doctors failed me,” Towt said.

Towt said her team of doctors never mentioned that her breast implants could cause those side effects. She started doing her own research, desperate to figure out why she was feeling this way.

[….]

Undisclosed risks

Diana Zuckerman, president of the National Center for Health Research, has been outspoken about the dangers of implants for years.

“One of the things that’s been so tragic for all these years is how many women got sicker and sicker and sicker, year after year after year, going to doctors saying what’s wrong with me and the doctor saying, you know, I don’t know, do these tests and try to figure it out,” Zuckerman said.

“And then they finally discover on social media, that there are tens of thousands of women with exactly the same health problems they have, who also happen to have breast implants, and then they get their implants out, and they get better.”

Zuckerman has been pushing for acknowledgment from the FDA that breast implant illness exists, advocating for more research around what exactly causes it and pushing for transparency when it comes to the risks.

She says the FDA took a step in the right direction last year when the agency announced breast implants would be equipped with a black box warning.

The FDA boxed warning informs patients of the following:

  • Breast implants are not considered lifetime devices
  • The chance of developing complications increases over time
  • Some complications will require more surgery
  • Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
  •  BIA-ALCL occurs more commonly in patients with textured breast implants than smooth implants, and deaths have occurred from BIA-ALCL
  • Breast implants have been associated with systemic symptoms

“They’re going to have what’s called a black box warning, that’s like the kind of warning you see on cigarette packages that tell you cigarettes can kill you,” Zuckerman said.

Arizona’s first-of-its-kind bill

Even still, that warning wasn’t always relayed by plastic surgeons to patients. That’s why lawmakers in Arizona decided to take matters into their own hands.

“We have to do something,” said state Sen. Michelle Ugenti-Rita.

Consultations for breast augmentations look different now in Arizona than they did a year ago.

That’s because a first-of-its-kind bill has passed in Arizona created to protect women against a badly kept secret involving breast augmentation surgery: breast implant illness.

“I was shocked to learn that there were so many women with very very similar stories and experiences. And yet there was nothing being done from the medical community’s perspective and point of view,” Ugenti-Rita said.

[….]

To read the entire article click here.

FDA’s agenda in limbo as Biden’s nominee stalls in Senate

Published Newspaper or Magazine Articles, Uncategorized, We Are Quoted,

Matthew Perrone, Fox13: February 08, 2022

WASHINGTON — (AP) — President Joe Biden’s pick to lead the Food and Drug Administration has stalled in the narrowly divided Senate, an unexpected setback that could delay decisions on electronic cigarettes and a raft of other high-profile health issues pending at the agency.

Biden nominated Dr. Robert Califf for the job in November after a 10-month search that critics complained left a leadership vacuum at the powerful regulatory agency, which has played a central role in the COVID-19 response effort.

Califf, a cardiologist who was an FDA commissioner under President Barack Obama, was viewed as a safe choice who could easily clear the Senate, given his 2016 confirmation by an overwhelming vote, 89-4.

But his latest Senate bid has been snared by political controversies on both the left and right that threaten to sink his nomination and leave the FDA in limbo for months — possibly even until a new Congress convenes next year.

No vote has been set on Califf’s nomination as Senate Democrats, the White House and other administration officials make a full-court press to lock up the votes needed to pass the 50-50 chamber. Former FDA officials warn that failure to move on Califf’s nomination will make it even harder to find and confirm future nominees.

“If he can’t get confirmed it bodes poorly for almost anyone else who could be nominated,” said Dr. Stephen Ostroff, who twice served as acting FDA commissioner. “What you’re seeing here is a lot of extraneous issues inserting themselves into the confirmation process and the same thing would happen to virtually anyone else nominated.”

Five Senate Democrats are opposing Califf due to his consulting work for drugmakers and the FDA’s track record of overseeing addictive painkillers that contributed to the U.S. opioid epidemic. That group includes Sens. Joe Manchin of West Virginia and Maggie Hassan of New Hampshire, both from Republican-controlled states ravaged by the epidemic.

With Sen. Ben Ray Luján of New Mexico absent and recovering from a stroke, Democrats need the support of six Republicans to confirm Califf.

[….]

The White House long assumed enough Republicans would support Califf to easily overcome any Democratic defections, given his strong support from the pharmaceutical lobby. Indeed, Califf seemed to be cruising toward confirmation after a cordial hearing before the Senate’s health committee in December, which included friendly exchanges with most of its Republican members.

But two days after his appearance the FDA eased longstanding restrictions on abortion pills that allowed women to order them through the mail. Although Califf had no role in that decision, dozens of anti-abortion groups lobbied Republicans to vote against him based on earlier changes impacting the medications while he was at the FDA.

[….]

“It is troubling to see Dr. Califf judged on issues that are a very small part of the FDA’s responsibilities,” said Steven Grossman of the Alliance for a Stronger FDA, which represents industry, patient and consumer groups that interact with the agency. “This narrow focus increases the likelihood there will be more and longer periods when FDA is without permanent leadership.”

The White House is unlikely to send another FDA nominee to Capitol Hill if Califf can’t clinch 50 votes, noted Grossman, a former HHS and Senate staffer.

In that scenario, the current acting FDA chief, Dr. Janet Woodcock, could continue leading the agency for months to come — potentially into next year. She can serve as acting commissioner as long as Califf’s nomination is pending, followed by another 210 days after it is withdrawn or expires, under federal law.

[….]

Last week Sen. Elizabeth Warren, D-Mass., announced her support for Califf after he agreed to not work for any pharmaceutical company for at least four years after leaving the FDA. Califf has recently served as a board director or adviser to more than a half-dozen drug and biotech companies, according to his ethics disclosure form.

“I think all this publicity that ‘maybe Califf isn’t going to make it’ is going to get people more focused on why they want Califf there,” said Diana Zuckerman, of the nonprofit National Center for Health Research. “I think he still has a very good chance.”

To read the entire article, click here.

What’s Wrong with the FDA?

We Are Quoted

Shannon Brownlee and Jeanne Lenzer, Washington Monthly: January 20, 2022

If Robert Califf, the White House nominee for commissioner of the U.S. Food and Drug Administration, is confirmed by the Senate, he’ll take the reins of an agency with its reputation in tatters. Once revered as the global leader in drug regulation, the FDA has approved one bad drug and medical device after another over the past 30 years, leaving staff demoralized and overseas regulators scratching their heads. Meanwhile, about a third of Americans refuse to get vaccinated for COVID-19, in part because they distrust government and scientific institutions.

In the case of the FDA, at least some of that mistrust is deserved even if the COVID vaccines are generally safe. (We’ve both taken them.) The most recent FDA disaster erupted in June, when officials approved the Alzheimer’s drug Aduhelm over the objections of the agency’s biostatistician and an 11-member committee of expert advisers. The data submitted by Biogen, the drug’s manufacturer, failed to show that Aduhelm is effective. It also poses a significant risk of harm, including brain bleeds and swelling in about a third of test subjects. Agency higher-ups decided to overlook these shortcomings and put the drug on a fast track for approval.

[….]

The Aduhelm debacle and other FDA blunders can be traced to declining scientific standards at the agency and increasingly cozy ties with the companies it regulates.

[….]

All of which suggests there’s not much chance that Califf would be the reformer the FDA needs. With eternal hope that the full Senate will reject him or, if he’s confirmed, he and the White House will pursue a reform agenda, we talked to several experts about their priorities for fixing the agency. In their view and ours, the following represent the top five actions that need to be taken.

1. Enforce commitments made by drugmakers.

The FDA awards expedited or fast-track approvals for drugs with a promise by the manufacturer that it will conduct further, more rigorous studies. However, by 2018, according to a recent review, companies followed through on only 38 percent (166 of 437) of drugs.

[….]

2. Rescind the approval of drugs that cause harm but don’t benefit patients.

When follow-up studies show that drugs are ineffective or dangerous, the FDA needs to pull them. Right now, drugs are still being prescribed to patients even though rigorous clinical trials have shown they don’t work. The agency recently allowed four out of six widely used (and heavily advertised) cancer drugs to stay on the market after their follow-up studies failed to show any benefit. Only five of 54 costly, toxic cancer drugs approved by the agency between 2008 and 2012 improved survival rates.

[….]

3. Restore rigorous scientific standards.

Many experts, including multiple FDA insiders, have complained about the progressive decay of scientific standards at the agency. This has only gotten worse since 2016, with the passage of the 21st Century Cures Act, which gives the FDA enormous leeway in what kinds of studies it demands of companies in order to get their drugs approved. The FDA needs flexibility, says Steven Goodman, associate dean of clinical and translational research at Stanford, “but it has been erring on the side of lowering the scientific bar.”

For most drugs, companies should be required to produce two randomized clinical trials, the gold standard of medical science, showing that the drug provides meaningful benefit. Fewer drugs should be approved based on a “surrogate marker,” often an imaging study or blood test that is affected by a drug but may have little to do with whether or not patients benefit. “Too many FDA decisions have been based on wishful thinking rather than medical evidence,” says Diana Zuckerman, president of the National Center for Health Research, a Washington, D.C.–based public health think tank.

4. Clean house.

Somebody needs to jam the revolving door at the FDA. Physicians, scientists, and administrators come to the agency from industry, push industry-friendly decisions, and then leave government for new, lucrative positions in the private sector.

Take Patrizia Cavazzoni, the head of the FDA Center for Drug Evaluation and Research, who oversaw the approval of Aduhelm. Before joining the agency in 2019, Cavazzoni spent nearly two decades in high-level positions with the pharmaceutical giants Pfizer, Eli Lilly, and Sanofi-Aventis. After overruling the FDA advisory committee’s resounding vote against Aduhelm, she suggested that industry “partner” with the FDA in choosing committee members, an idea that violates the whole point of having outside, independent advisers.

[….]

5. Stop Big Pharma financing.

Finally, President Biden should call on Congress to fully fund the FDA by repealing the legislation mandating that the drug industry pay for its own reviews. “What really needs to happen is to mitigate the power that Pharma already has over the FDA,” says Erick Turner, professor of psychiatry at Oregon Health & Science University and a former member of an FDA advisory committee. That can’t happen as long as the FDA is dependent on industry money.

[….]

To read the entire article, click here.

Breast Augmentation and Plastic Surgery Are on the Rise – What Are the Risks?

How Safe Are They?, We Are Quoted, , , , ,

Juliana Guarracino, Honeysuckle Magazine: December 29, 2021

In the past year, the Brazilian butt lift (BBL) has swarmed many TikTok feeds with women sharing their experiences, both good and bad. From 2017 to 2019, the number of BBL procedures has increased by about 38 percent. This is despite a 1 in 20,117 patient mortality rate when performed by a board-certified plastic surgeon in the United States, which is higher than the death rate of outpatient surgery overall. This has accompanied an overall 33 percent increase in cosmetic surgery for women between 2000 and 2020. Though, with a growing number of patients, the safety measures meant to guarantee their safety are disputed among experts.

[….]

What Are the Risks of Breast Augmentation Surgery?

A lot of information on social media, according to Youn, tends to be advertisements, rather than credible material. There is little regulation, however, on who is able to perform plastic surgery in the United States. As Youn mentioned, not all doctors seem to put patient safety first. By law, any licensed doctor can perform plastic surgery regardless of their field and qualifications. Board certification is also not required for plastic surgeons. With such a lack of legal oversight, the idea behind this checklist is that it can help inch patients and surgeons closer to honest and informative conversations.

“With breast augmentation, it is very appealing that a patient may want it so badly, [overlooking] that there are potential downsides or risks or maintenance,” said Dr. Allison Lied, board-certified plastic surgeon and member of HealthyWomen’s Health Advisory Council. Recent regulations seek to provide patients with the information necessary to make an educated decision. Since cosmetic surgery is elective, it is especially important that there be informed consent as the procedure has the ability to put a healthy individual into a potentially life-threatening condition, according to both Lied and Youn. “I think [checklists are] good because it makes the patient slow down and consider those potentials.”

With these new mandates, surgeons must review the checklist with patients, and to confirm their understanding, patients must initial and sign the document. While this may be satisfactory enough to ensure that patients receive all information needed to guarantee their safety, Dr. Diana Zuckerman, president of the National Center for Health Research, is still concerned about the enforcement of the regulation.

“There is nothing to stop the surgeon… from saying ‘I have to give this [checklist] to you and you have to sign it, but honestly this is the safest procedure possible, and breast implants have been studied and you really don’t have to worry at all,’” Zuckerman said. While she is glad to see further regulation, she questions how the FDA will be able to ensure the thoroughness of the consultation and discussion of the checklist. “Are the women actually reading [the checklist]? Are they understanding it?”

Despite the checklist being comprehensive and informative, the design of the checklist may hinder a patient’s ability to understand the surgery and how a patient’s health may be affected, according to Zuckerman. “It starts with information you’ve already heard about… then, by the time they get to page four or five where the more important information is, are [patients] even going to be paying attention?”

The Best Breast Augmentation Information Versus FDA Hesitation

Before the release of the FDA’s most recent mandate, The Breast Implant Working Group, which includes Zuckerman along with surgeons, health policy experts and patients, spoke with the FDA to request a checklist that is more “user-friendly” than the one that the FDA had planned to release. Suggestions included clarifying potential risks, such as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), a cancer of the immune system, and Breast Implant Illness (BII), which includes symptoms like memory loss, chronic fatigue and a low-grade fever. They also advised implementing a more comprehensive list of possible symptoms with stronger descriptions. The Working Group recommended that the FDA work with manufacturers to create a certification course for surgeons using their implants as well in order to address the issue of enforcement for the checklist. While these experts and advocates believed that these revisions would help to ensure informed consent for patients, the FDA proceeded with their own checklist, largely ignoring the recommendations made by the team.

[….]

While it is understandable that the FDA would be cautious about passing new regulations on something that is perhaps novel and under-researched, this is not the case for breast augmentation. With 193,073 individuals receiving breast augmentation surgery in 2020, the FDA’s hesitancy to recommendations and research may prove more dangerous than beneficial.

“No matter what’s in writing and what’s required, once you are in the doctor’s office and it’s just you and the doctor or you and the nurse, what is there to ensure you are getting accurate information?” said Zuckerman. Patients can do their own research on surgeons and procedures, but experts and policy makers in the field can further support their education and safety. For those women going under the knife and the experts supporting them, being listened to may be what defines the future of women’s health. “It’s one thing to have a good idea, another to implement this idea and another idea to enforce it.”

To read the entire article, click here.

Biden’s Drug Agency Nominee Returns With Deeper Industry Ties

We Are Quoted,

Alex Ruoff, Jeannie Baumann and Celine Castronuovo, Bloomberg Business: November 23, 2021

President Joe Biden’s choice to lead the Food and Drug Administration made millions of dollars from health and drug companies since his last stint in government, raising new questions about his ties to firms the agency oversees.

Robert Califf was paid $2.7 million by Verily Life Sciences, the biomedical research organization operated by Alphabet Inc., and sits on the boards of two pharmaceutical companies, AmyriAD and Centessa Pharmaceuticals PLC. He also reported ties to 16 other research organizations and biotech companies, ethics and financial disclosure documents show.

Califf’s deep industry ties have prompted at least two Democratic senators to oppose his nomination, complicating his path to confirmation and echoing concerns that emerged when he was last nominated. While Califf previously was paid largely as a consultant for drugmakers before, in recent years he’s been hired as a top adviser and board member to major health-care companies creating innovative technologies and medicines.

[….]

Consulting, Stock Options

Califf’s reported income from the health industry skyrocketed between stints at the FDA.

Califf was a paid consultant for Johnson & Johnson, GlaxoSmithKline PLC, AstraZeneca PLC, and Eli Lilly from 2009 to 2016, according to disclosures compiled by ProPublica. During this time he collected fees ranging from $2,160 to $9,000. Califf had also disclosed accepting consulting fees from drugmakers Amgen Inc., Eli Lilly & Co., and Merck & Co.

After his time leading the FDA, Califf earned $56,299 in fees from the biopharmaceutical firm Cytokinestics Inc. and unvested stock options worth as much as $5 million from Centessa Pharmaceuticals.

Califf is an expert in clinical trial research and cardiovascular medicine and founded the Duke Clinical Research Institute, a large academic center that received more than half its funding from the drug industry.

This kind of expertise is almost impossible to acquire without working with or for the pharmaceutical industry, David Magnus, director Stanford Center for Biomedical Ethics, said. Drugmakers have historically provided the funding for most clinical trials, he said.

[….]

During his first tour at the FDA, Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, Howard Sklamberg, who was a deputy commissioner under Califf, said.

“He was very, very, very careful,” Sklamberg, who’s now an attorney at Arnold & Porter LLP, said.

He may have more ties to track this time.

“It seems he would have to recuse himself from a large number of decisions,” Lisa Bero, chief scientist for the University of Colorado Center for Bioethics and Humanities, said.

Califf’s years of ties to the pharmaceutical industry don’t seem to have been “a deciding factor” in the White House’s nomination decision, Diana Zuckerman, president of the National Center for Health Research, said in an interview with Bloomberg Law.

“Dr. Califf has these other very important, positive attributes of having been FDA commissioner, having been a high-level person at FDA even before he was commissioner, and having a track record of showing his commitment to scientific evidence,” Zuckerman said.

The plan offered by Califf to manage his financial interest appears to fairly standard and routine, New York University bioethicist Arthur Caplan said. “I don’t find it disqualifying that he has industry ties,” he said, adding that he’s breaking ties with for-profit, academia, and other think tank types of organizations. Califf “showed himself to be independent and fair” when he was last at the agency, Caplan said.

To read the entire article, click here.