Category Archives: We Are Quoted

Trump’s pick for FDA to test ‘due diligence’ of Agency’s science

We Are Quoted

Nyah Phengsitthy, Bloomberg Law, November 25, 2024

Marty Makary, an outspoken critic of the nation’s food and drug regulator, stands to shake up the FDA’s standards in science and decision-making under President-elect Donald Trump.

The Johns Hopkins surgeon selected Nov. 22 by Trump to lead the US Food and Drug Administration may have laid out his blueprint for a potential agency overhaul if confirmed as commissioner—and it starts with his criticisms over vaccine policy, food safety, and the pharmaceutical industry.

Makary has taken numerous shots at FDA decisions, including the agency’s approval of Covid-19 vaccines by Moderna Inc. and Pfizer Inc., its “cozy relationship” with drug manufacturers, and the approval of a drug to treat Alzheimer’s. He’s also offered judgment on the nation’s food supply, questioning the various chemicals in foods and infant formula.

While some of his opinions have drawn opposition, his critiques put to practice could reshape areas of the agency that have come under scrutiny, health policy experts say. His challenge on vaccine approvals, food safety, and the status quo ideas in the medical establishment signal a commissioner who won’t allow the agency to lower its standards and will tap more into science and decision-making.

“A lot of what he’s been talking about are things we need to be thinking about,” said Diana Zuckerman, president of the National Center for Health Research. “When you have somebody who’s outspoken on the side of public health, I think that’s something we should hear.”

[….]

“Dr. Makary seems like a person who could be persuadable by an evidence-based argument,” said Peter Lurie, president of the Center for Science in the Public Interest and former associate commissioner for public health strategy and analysis at the FDA.

“But the most consistent through-line between the HHS, CDC, and FDA nominees seems to be being vaccine-skeptical or worse.”

‘Sticking to the Science’

Though it’s unclear how Makary’s concerns will play out as chief, he could demand the agency carry out deeper examinations and assessments in its everyday decisions.

The FDA in recent years has come under fire for some scientific conclusions and the information used to back its regulatory decisions. This includes its authority over e-cigarettes, the abortion pill mifepristone, laboratory-developed tests, and major drug approvals.

“You want to have that person very much sticking to the science, so that we know that these new medicines, medical devices, whatever comes to the market, is truly safe and effective,” said Reshma Ramachandran, an assistant professor at Yale School of Medicine.

“He has a pretty profound background in research, so that gives me some comfort knowing he will hopefully continue to follow the science in making decisions.”

Makary also “recognizes the value of not letting approval standards dip dangerously low,” said Holly Fernandez Lynch, a professor of medical ethics at the University of Pennsylvania. She pointed to when he criticized the FDA for approving Alzheimer’s drug aducanumab despite safety concerns.

The author and professor has taken issue with the lack of transparency between the agency and pharmaceutical industry. He’s also a critic of the Orphan Drug Act, which allows manufactures to secure protections for rare disease drugs when they hit the market.

“He wants to make sure that the agency’s decisions are being made from a scientific perspective, and not being unduly influenced by the sponsors who are bringing forward the products,” Ramachandran said. “I’m hoping he’ll maintain that thinking to make sure the agency is doing its due diligence in its work.”

[….]

Food Safety

Makary’s agenda may test the FDA’s oversight on food safety—another area that has been scrutinized in recent years.

He has called the food supply “poisoned” with “highly addictive chemicals.” He’s also scrutinized the amount of seed oils in infant formula, and questioned why Froot Loops are sold with different food dyes in the US than in Canada.

His appointment would come as the FDA rolls out its Human Foods Program, which was created under the agency’s largest reorganization.

Notably, the program is in the midst of establishing a framework to assess chemicals in food already on the market—a move that was criticized for being conducted through an ad hoc basis and largely behind closed doors.

Makary could take “positive steps” in regulating and eliminating “harmful components that are still allowed in food, supplements, food containers and packaging,” according to Ana Santos Rutschman, professor at the Charles Widger School of Law at Villanova University.

“Among all the nominations so far in the public health space, this is the candidate with the strongest credentials,” Rutschman said. “And I think that there is, at least for now and in theory, room for some positive developments at the FDA.”

To read the entire article in Bloomberg Law, click here.

Vivek Ramaswamy’s crusade to change FDA could boost biotech, and himself

We Are Quoted

Daniel Gilbert, The Washington Post, November 25, 2024

Vivek Ramaswamy, an outspoken ex-biotech executive turned fierce critic of the industry’s main regulator, is now in a position to reshape the agency he derides as the “Failed Drug Administration” in ways that could benefit him personally.

Newly tapped by President-elect Donald Trump to co-lead an initiative to slash the federal bureaucracy, Ramaswamy has heaped criticism on the Food and Drug Administration for “unnecessary barriers to innovation.” At the same time, the company he founded, Roivant Sciences, is pursuing studies for three drugs that, if positive, could land before the FDA during Trump’s second term. His stock in Roivant is worth about $670 million.

Ramaswamy argues that the FDA should err on the side of approving promising therapies faster and then monitoring their effects after doctors start prescribing them. The agency should place “greater emphasis on post-approval surveillance for safety issues to protect patients, rather than adding time and cost to innovative development,” he said in a statement. He highlighted the FDA’s standard requirement of two trials for approval and suggested a single trial — which would generally save biotech firms time and money — would be adequate.

Ramaswamy, with billionaire Trump adviser Elon Musk, is spearheading the “Department of Government Efficiency,” an outside-government project to streamline bureaucracy and carry out “mass head-count reductions,” the two wrote in a Wednesday op-ed. Ramaswamy left Roivant’s board in February 2023 when he launched his presidential campaign but is still one of its largest shareholders.

“It’s an obvious conflict of interest,” said Diana Zuckerman, president of the nonpartisan think tank National Center for Health Research, who points out that the FDA has already lowered its standards considerably to speed novel drugs to market. “Some people might think, ‘He’s a knowledgeable person.’ He’s a knowledgeable person with a vested financial interest in what he’s saying.”

In an interview, FDA Commissioner Robert Califf said he knows and respects Ramaswamy but pushed back on some of the entrepreneur’s harshest criticisms, such as once questioning the need for the agency. “We tried that,” he said, pointing as an example to the drug thalidomide that caused birth defects in babies in the 1960s, “which is why the FDA exists in its current form.”

“Almost every additional authority at FDA has been because of a catastrophic public health event that harms people,” he said.

Califf defended the two-trial standard, particularly for new drugs when there are already effective therapies available, while emphasizing that the FDA frequently accepts less evidence for potentially life-changing therapies. As for Ramaswamy’s financial stake in biotech, Califf said, “at FDA, you’re not allowed to make decisions about industries in which you have a vested interest.” He added, “I would just say, the amount of money he has invested and what’s at stake speaks for itself.”

[….]

Of all novel drugs approved in 2020, more than half relied on a single such trial, one study found.

On Saturday, Ramaswamy praised Trump’s choices to lead the FDA and other health agencies, saying he had met with them and “it’s clear they’re serious about reducing cost & they understand innovation is a key part of the solution.” Marty Makary, whom Trump tapped to lead the FDA late Friday, has emerged as a forceful critic of the agency’s culture, faulting it in a 2021 op-ed for a “counterproductive rigidity and a refusal to adapt.”

Ramaswamy made his name as a wunderkind biotech analyst on Wall Street while earning a law degree at Yale, before striking out on his own as an entrepreneur. He told Forbes for a 2015 cover story that Roivant would be the “Berkshire Hathaway of drug development.”

[….]

Ramaswamy pulled off what was at the time, in 2015, the largest public offering in biotech, raising $360 million with the listing of Axovant, a Roivant subsidiary developing an Alzheimer’s drug. Controversy followed as a clinical trial failed to show a benefit and the stock value collapsed.

Roivant has gone on to develop several drugs that won FDA approval, but it has made a bigger splash for its savvy dealmaking.

[….]

Roivant executives have told investors its pipeline of experimental drugs could someday be worth $10 billion a year in sales. Ramaswamy holds a roughly 7 percent stake in the company, in addition to stock options to purchase millions more shares.

Trial results for two drug candidates — one to treat an autoimmune condition that causes a skin rash and muscle weakness, another for an eye inflammation disease — are expected in the second half of 2025, executives have said. The trial for the autoimmune condition is designed to support FDA approval without a second one, the company has said.

Roivant declined to comment.

Ramaswamy criticized the FDA during his failed bid for the GOP presidential nomination, a campaign where he sought to distinguish himself with a provocative style on an array of subjects. He called the agency “corrupt” and its actions “hypocritical, harmful & unconstitutional” in July 2023.

After he endorsed Trump, he continued to slam the agency. “It’s not at all obvious that we’re better off for having an FDA at all,” he said in May, dedicating an episode of his podcast to the issue. He suggested that the private market could be a better judge of what patients should trust, similar to how customers rely on J.D. Power ratings to buy cars. “The FDA has actually crowded out the rise of those alternative intermediary institutions,” he said.

[….]

Several academic scholars interviewed for this story said they disagree with Ramaswamy’s contention that conducting two major clinical trials to replicate results is unnecessary.

Sanket Dhruva, a professor at the University of California at San Francisco School of Medicine, acknowledged that clinical trials are expensive and add to the cost of developing new medicines. Still, he said, “What about costs that are passed on to the health-care system using tests and treatments that are relatively unproven?” He argued that approving less-studied drugs can give patients false hope or cause them harm and add to higher insurance premiums.

[….]

Read the full article in The Washington Post here.

F.D.A. names a new chief of medical devices

We Are Quoted

Christina Jewett, The New York Times, Oct. 22, 2024

The Food and Drug Administration on Tuesday announced that Dr. Michelle Tarver, an agency veteran, will be the new director of the medical device division.

Dr. Tarver will face a slate of pressing tasks, that include addressing calls to strengthen standards to protect the public from issues like racial bias in artificial intelligence software and hastily authorized and faulty cardiac devices, like external defibrillators.

She will also confront the challenge of restoring credibility to a division clouded by ethical lapses of Dr. Jeffrey Shuren, her predecessor, and of navigating her way in an agency with close ties to the industry.

In addition, Dr. Tarver is assuming the position at a time of stunning technological advancement, overseeing research and potential approvals of devices meant to tap into brain signals to restore speech and movement.

The division reviews thousands of medical products that are central to medical diagnosis and surgery, like DNA tests and surgical staplers. Other devices are implanted in the body for decades, including pacemakers and hip prostheses. The division has a budget of about $790 million and a staff of about 2,500.

A 15-year veteran of the agency, Dr. Tarver is viewed by those inside the F.D.A. as a candidate who would sharpen the division’s focus on safety and quality. She is an ophthalmologist who continues to treat patients on the weekends, and she is also trained as an epidemiologist and has developed ways to measure patient preference in medical care.

“Dr. Tarver demonstrates a true passion about data, science, medicine and the evidence, all of which are critical to supporting and driving the F.D.A.’s decisions,” Dr. Robert Califf said in an announcement to agency staff Tuesday. “She works to build collaboration and transparency in achieving the strategic priorities for the center and the agency.”

Dr. Tarver said in a statement that she was honored to lead the division and planned to “remain committed in our service to public health and ensuring all patients in the U.S. have access to high-quality, safe and effective medical devices.”

Dr. Shuren headed the division for 15 years and has been credited with speeding the pace of approvals and solidifying the United States as a destination for medical device study and innovation. He has also been divisive, facing pressure from the start of his tenure to strengthen lax device-approval standards. Those calls have continued unabated over the years. The American Medical Association, a major doctors group, voted in 2023 on a resolution urging the agency to raise the bar on product authorizations and to more carefully monitor the safety of approved products.

Dr. Shuren announced his retirement in July, and the agency has said he will leave by the end of the year.

An investigation by The New York Times found that his official work had overlapped for years with that of his wife, Allison Shuren, a lawyer for major medical device companies. The F.D.A. acknowledged ethics violations, saying that Dr. Shuren should have sought authorization or stepped aside in some matters, but asserted that the lapses had not affected regulatory decisions.

In recent weeks, two lawmakers called on the inspector general of the Health and Human Services Department to investigate whether those matters were “simply an appearance of impropriety or actual inappropriate and unethical conduct.”

Before joining the agency in 2009, Dr. Tarver had been an assistant professor at the Johns Hopkins School of Medicine.

At the F.D.A., she became a medical officer in the ophthalmology unit, and then took on other roles, including working with the division’s patient engagement advisory committee.

Dr. Tarver later moved on to an F.D.A. office focused on emergency preparedness and response as well as digital health.

Maria Gmitro, president of the Breast Implant Safety Alliance, said she had been impressed with Dr. Tarver’s warmth and willingness to listen. Ms. Gmitro said she had raised concerns about whether women were aware that they received recalled breast implants that were associated with rare cases of blood cancer.

Ms. Gmitro said Dr. Tarver helped her group in a practical manner, working to open access to data on age and gender for an analyst examining reports of harm related to breast implants.

“So we are very optimistic with Dr. Tarver being in this position,” Ms. Gmitro said. “I’m hopeful about the progress that can happen.”

Diana Zuckerman, president of the National Center for Health Research, a nonprofit that tracks F.D.A. device policy, said she had found Dr. Tarver to be concerned about patient safety and “in making sure that patients understand the risks and benefits” of devices.

Scott Whitaker, president of AdvaMed, the largest device industry trade association, said the group was pleased with Dr. Tarver’s appointment.

[….]

Dr. Tarver will face skepticism from advocates for people who have had unwanted symptoms after LASIK surgery, such as distorted vision and eye pain.

Dr. Tarver was a leader in the agency’s ophthalmology division for years and played a role in F.D.A.-backed research on the procedure. Yet after more than 15 years of advocacy and an agency proposal in 2022 to strengthen warnings to prospective patients, no change has come about, said Paula Cofer, who suffered harm from LASIK and served as a patient representative on a 2008 panel on the matter.

The F.D.A. has said it is still reviewing comments submitted on the 2022 proposal. Among its opponents are clients of Dr. Shuren’s wife, which include a group of prolific laser surgeons and a company that makes LASIK lasers.

“She’s been involved in LASIK device policy at the agency for what, 15 years, and during this time, the agency has failed to act on evidence of high rates of harm to the public due to LASIK devices,” Ms. Cofer said. “This is just not passing the smell test.”

To read the entire New York Times article, click here.

He Regulated Medical Devices. His Wife Represented Their Makers.

Uncategorized, We Are Quoted

Christina Jewett, The New York Times, August 20, 2024

When he announced in July that he would be retiring from the Food and Drug Administration later this year, Dr. Robert Califf, the agency’s commissioner, praised him for overseeing the approval of more novel devices last year than ever before in the nearly half-century history of the device division.

But the admiration for Dr. Shuren is far from universal. Consumer advocates see his tenure as marred by the approval of too many devices that harmed patients and by his own close ties to the $500 billion global device industry.

One connection stood out: While Dr. Shuren regulated the booming medical device industry, his wife, Allison W. Shuren, represented the interests of device makers as the co-leader of a team of lawyers at Arnold & Porter, one of Washington’s most powerful law firms.

Dr. Shuren signed ethics agreements obtained by The Times that were meant to wall him off from matters involving Arnold & Porter’s business. But it’s not clear how rigorously the ethics agreements were actually enforced. His wife’s law firm refused to provide a list of clients — and the agency had no legal authority to require it, said Michael Felberbaum, a spokesman for the F.D.A.

In a review of thousands of pages of court documents and F.D.A. records and dozens of interviews with current and former agency staff members and advocates, The Times identified some clients and several instances in which the Shurens’ roles intersected.

Her partner at the helm of the firm’s life sciences team began representing Theranos, the discredited blood testing company, in 2015, demanding that the F.D.A. halt an inspection at its sites in California. While Dr. Shuren said he was recused from the matter, court records suggested he remained involved.

In another case, Ms. Shuren’s firm was working on a $63 billion acquisition of the company Allergan in 2019 when Dr. Shuren initially declined to urge a recall of the company’s breast implants tied to a rare cancer.

The couple’s work overlapped again in 2022 when Dr. Shuren announced a proposal to strengthen warnings given to patients preparing for LASIK vision correction surgery. Two of Ms. Shuren’s clients opposed the plan; the recommendations have yet to be put in place.

In response to inquiries over several weeks about these cases, the F.D.A. initially said it had no indication that Dr. Shuren had violated ethics rules and needed time to “substantively evaluate” follow-up questions from The Times. In a statement Friday, Shannon P. Hatch, an F.D.A. spokeswoman, said the agency had found that “it appears there were certain instances from about 10 years ago for which Dr. Shuren should have either recused himself or sought ethics authorization to participate to avoid any potential appearance of bias.”

Ms. Hatch confirmed that the lapses occurred in the Theranos case as well as another one identified by The Times involving Alcon, an eye care drug and device company that was a client of Ms. Shuren’s.

In 2014, Alcon went before an agency committee convened to advise on whether to approve a lens implanted in the eye. According to a meeting transcript, Dr. Shuren signed off on the appointment of eight new voting members and a new chairman for the hearing, which recommended approval.

Ms. Hatch said the agency “has no indication that any F.D.A. regulatory decisions were impacted by Dr. Shuren’s wife’s employment nor that Dr. Shuren made any decisions in the interest of parties other than the public served by the F.D.A.”

While the agency conducts a nationwide search for Dr. Shuren’s replacement, he will work in the commissioner’s office to help ensure a smooth transition, according to the July statement by Dr. Califf announcing his retirement.

The F.D.A. said Friday, “Dr. Shuren has been advised of the need to exercise greater caution in matters concerning his recusal obligations and will be provided additional administrative support to better ensure future compliance.”

Neither Dr. Shuren nor Ms. Shuren responded to requests for interviews.

When The Times initially requested Dr. Shuren’s ethics records from the division he led, an official in the information disclosure unit wrote that the request was “complex” and would take up to two years to fill. Four months later, the F.D.A. provided an agreement that turned out to be two pages long after a lawyer for The Times had requested that a branch of the F.D.A. other than Dr. Shuren’s address the matter.

During the decade and a half of overlapping career trajectories, “Dr. Shuren has not requested, nor has he received any waiver or agency authorization to participate in any particular matter relating to his wife’s employment or any of her clients,” Mr. Felberbaum said.

[….]

Ms. Shuren earned from $1 million to $5 million, according to her husband’s financial disclosure form in 2018, the only one that estimated her income. Dr. Shuren’s F.D.A. salary is $400,000 a year.

Dr. Shuren led an office with about 2,500 staff members and a budget of about $790 million. He oversaw thousands of devices, ranging from tests to detect blood-lead levels to IV infusion pumps to ventilators.

Dr. Peter Lurie, a former F.D.A. associate commissioner, said he hoped the next division chief would shape a legacy that is more impartial toward device companies.

A surge in injuries

Early in his tenure, Dr. Shuren dismissed criticism from the business community over what it viewed as the slow pace of device approvals compared with Europe. Citing Europe’s lower standards and safety problems, he told The Times in 2011 that the F.D.A. would stand firm.

“We don’t use our people as guinea pigs in the U.S.,” he said at the time.

But congressional leaders on both sides of the aisle pressured the agency for faster medical device approvals. By 2014, Dr. Shuren pledged to make the United States the first place for device makers to sell their products.

[….]

In a recent presentation, he boasted that the number of first-in-the-world approvals had soared to 125 in 2023, from 25 in 2009.

“Do things now come here first?” he asked at a conference in May, referring to the new devices. “The answer is yes.”

Over time, Dr. Shuren drew closer to the medical device industry. In 2012, he co-founded a nonprofit called the Medical Device Innovation Consortium with a former executive from Medtronic, a leading device company.

To do so, Dr. Shuren secured a waiver from agency ethics rules, which prohibit federal officials from serving on boards of nonprofits to avoid divided loyalties or interests.

Most of the consortium’s board members were device industry executives, and many of its staff members had previously worked for the industry’s lobbying organizations.

As a board member, Dr. Shuren expanded the nonprofit while facing disturbing episodes at the agency over harm done by medical devices. Thousands of women reported injuries and side effects from Essure devices — small metal birth-control implants that dislodged from the fallopian tubes, tore delicate anatomy or caused allergic reactions. Other women were outraged to discover that an F.D.A.-cleared device called a power morcellator used to pulverize uterine growths might have actually spread their cancer.

Dr. Shuren promised in 2019 that a consortium project called NEST, or the National Evaluation System for Health Technology, would “empower the F.D.A. to more quickly identify, communicate and act on new or increased medical device safety concerns.”

The group has “obviously failed to do that,” said Diana Zuckerman, the president of the National Center for Health Research, a consumer watchdog group.

Agency critics have compared the NEST effort to a fox guarding a henhouse, citing the industry’s leadership at the consortium and a lack of specific safety accomplishments.

Last year, the American Medical Association, the nation’s largest physician group, raised “serious safety concerns” about medical devices, highlighting secrecy around reports of device-related injuries and a system that allowed many devices onto the market with little to no testing in humans.

The F.D.A. defended its approval process, saying it had increasingly sought more evidence before clearing products for sale. Regarding NEST, the agency noted a report by the U.S. Government Accountability Office, a watchdog agency, that said the program would begin monitoring the safety of two types of medical devices in December.

Medical specialists have also raised concerns about the safety and effectiveness of some devices approved during Dr. Shuren’s tenure. They include the CoolSculpting device, which was meant to zap fat but disfigured some people, and the Q-Collar sports safety device, which some experts say may offer little protection from injuries to the brain.

[….]
But safety issues multiplied on his watch. The most urgent F.D.A. recalls of devices that can cause serious injury or death have ticked up, to nearly 100 so far this year, from 29 in 2012, the first year such measures were tracked in an agency database. In March, a heart device was recalled after 49 deaths were linked to a specific concern.

Reports of device-related injuries soared to 900,000 in 2023, up from about 190,000 in 2012, according to Device Events, a company that makes F.D.A. data user-friendly for subscribers.

Dr. Hooman Noorchashm, a Harvard-trained cardiothoracic surgeon, said he believes the problems are a result of low standards and deference to industry. He emerged as a critic of Dr. Shuren’s after his wife died of a cancer that he said was spread by a power morcellator.

“Essentially,” he said, “he’s pumping medical products into the U.S. marketplace, outside of an evidence-based paradigm.”

Theranos hires Ms. Shuren’s team

When Dr. Shuren was named acting director of the medical device division in 2009, agency lawyers drafted an ethics agreement to prevent conflicts of interest involving his wife and her law firm. Top officials were to screen potential issues of concern, and other agency officials were to take the lead in such cases, according to the document.

[….]

A major test occurred in 2015. Daniel A. Kracov, Ms. Shuren’s partner in running the firm’s drug and device team, began representing Theranos.

At the time, he was challenging the F.D.A.’s authority to conduct an inspection at two Theranos offices in California. F.D.A. officials were concerned that the company was shipping its “nanotainer” blood-storage device without agency clearance. Theranos records for 2015 and 2016 show a $1.6 million payment to Arnold & Porter for legal services.

Dr. Shuren said around that time that he was recused from dealing with Theranos, recalled Alberto Gutierrez, then the F.D.A.’s senior scientist on diagnostic tests. But Dr. Gutierrez said he had not been informed that the agency expected another official to step in for Dr. Shuren, and Dr. Gutierrez continued to send him periodic emails about Theranos. Walter Brown, a lawyer for Mr. Balwani, gave the judge 91 documents that he said proved Dr. Shuren was dealing with Theranos matters.

Alison Daw, a lawyer representing the F.D.A., argued that Dr. Shuren had not had substantial involvement.

[….]

Breast implants tied to cancer

In the spring of 2019, the drug and device maker Allergan was under scrutiny at the F.D.A.: Women were developing a rare form of lymphoma linked to the company’s textured breast implants, which had been recalled by more than 30 countries.

At the same time, Arnold & Porter was engaged in legal issues involving Allergan. In April, a member of Ms. Shuren’s team began to defend Allergan in a California lawsuit over Botox pricing. The firm was also ushering AbbVie through a $63 billion acquisition of Allergan — a success Ms. Shuren’s team highlights on the firm’s website.

Mr. Felberbaum said Dr. Shuren was not aware of either the Botox case or the acquisition.

[….]

In May, Dr. Shuren and another F.D.A. official announced that the implants would not be recalled. In June, AbbVie announced its decision to purchase Allergan for $63 billion.

In July, Dr. Shuren and the other official reversed course and said that they would urge a recall, citing additional reports of injuries and deaths related to the lymphoma. Ms. Baumann of Arnold & Porter said that the firm represented AbbVie over antitrust questions and that Ms. Shuren had not worked on the matter.

[…]

To read the entire article, click here.

A Special Report: Can Breast Implants Cause Chronic Disease?

We Are Quoted, , , ,

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?

We Are Quoted

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.