All posts by BIeditor

Breast Implants will now come with Black Box Warnings, List Risks

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Sara E. Teller, Legal Reader: November 9, 2021

In 2019, a Food and Drug Administration (FDA) panel heard from dozens of women asking the government agency to inform the public in a direct way about the debilitating and potentially life-threatening symptoms commonly referred to as “breast implant illness.”  Now, ten years after discovering a link between some implants and cancer, the FDA has ordered “black box” warnings be put on all boxes and a new checklist of risks to be provided to patients.

The warnings and checklist advise patients of the serious side effects, including the link to cancer of the immune system (anaplastic large cell lymphoma), as well as chronic medical conditions, including autoimmune diseases, joint pain, mental confusion, muscle aches and chronic fatigue.  The checklist even identifies which types of patients could be at higher risk for illness after breast implant surgery.  And this includes breast cancer patients who have had, or plan to have, chemotherapy or radiation treatments – the very same population of women who are commonly encouraged to seek implants for breast reconstruction.

The FDA is also requiring manufacturers to disclose the ingredients used to make implants, and these must be made public within thirty days.  However, one complication is that patients are unlikely to see a warning label on sterile medical device only a surgeon would have access to.  It’s also not clear how the new mechanisms will be reinforced, even though the FDA said all patients “must be given the opportunity to sign the checklist.”

Critics of the checklist have said that the language used is hard to understand and that patients may sign off without fully understanding what they’re signing. “It’s better than nothing, but it’s not as good as it could be,” said Diana Zuckerman, a scientist at the National Center for Health Research and member of the working group that advised the FDA on implant safety. “They say things like, ‘Breast implants are associated with lymphoma,’ but lymphoma is actually caused by the implants.  People understand it if you say, ‘Breast implants can cause lymphoma.’”

She also believes not every surgeon will take the time necessary to allow patients to digest the black box warning information and ask any questions. “What if a surgeon says, ‘Here’s a checklist.  I know it’s long, so it’s up to you if you want to read it or not’?” Dr. Zuckerman said. “Patient groups are very concerned that will happen.”

Dr. Mark Clemens, a professor at M.D. Anderson Cancer Center in Houston and a liaison to the FDA for the American Society of Plastic Surgeons Society, argued, “The black box warning and checklist represent a huge step forward for patient safety and implants.  But more high-quality data about long-term outcomes for women with implants is needed.”

[….]

To read entire article, click here.

When it comes to clinical trials, healthcare’s diversity problem is standing in the way of medical advancement

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Ellen McGirt and Jonathan Vanian, Fortune: November 5, 2021

The healthcare industry has long faced a major diversity problem affecting the clinical trials that pave the way for blockbuster medical treatments.

Historically, the type of candidates who have participated in clinical trials tended to be relatively white and homogenous, not truly representative of everyone who needs access to potentially life-saving treatments.

As Diana Zuckerman, the president of the National Center for Health Research, once told Fortune, the lack of Black female participants in original cancer studies unfortunately resulted in fewer research into triple-negative breast cancer, which affects Black women more than white women. As a result, the researchers developing cancer treatments at that time, “didn’t realize that the treatments that they were studying would not work on those types of cancer,” she said.

Increasingly, however, the healthcare industry is trying to enlist more people of color who come from underrepresented communities into clinical trials, with the hope of improving the quality of future medical treatments that can aid everyone. Pharmaceutical giants Bristol Myers Squibb and Pfizer were two healthcare firms, for example, that have recently made public their efforts to improve the diversity of their clinical trials.

[….]

One way Abbott is attempting to enlist more diverse clinical trial participants is by “purposely going into communities” that lacked access to clinical trials, Earnhardt says. This means opening up clinical trial sites outside of major metropolitan areas like New York City or San Francisco, which typically contain top-tier universities and healthcare centers. People of color who live outside of these urban centers face a number of hurdles trying to enlist in clinical studies conducted hundreds or even thousands of miles away from where they live.

Some of the new clinical testing sites Abbott has established are in places like Gilbert, Ariz., Jackson, Miss., Tallahassee, FL, and San Antonio, TX.

[….]

Read the full article here.

Patients Must Be Warned of Breast Implant Risks, F.D.A. Says

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Roni Caryn Rabin, The New York Times: October 27, 2021

Federal regulators on Wednesday placed so-called black box warnings on breast implant packaging and told manufacturers to sell the devices only to health providers who review the potential risks with patients before surgery.

Both the warnings and a new checklist that advises patients of the risks and side effects state that breast implants have been linked to a cancer of the immune system and to a host of other chronic medical conditions, including autoimmune diseases, joint pain, mental confusion, muscle aches and chronic fatigue.

Startlingly, the checklist identifies particular types of patients who are at higher risk for illness after breast implant surgery. The group includes breast cancer patients who have had, or plan to have, chemotherapy or radiation treatments.

That represents a large percentage of women who until now were encouraged to have breast reconstruction with implants following their treatment.

The Food and Drug Administration is also requiring manufacturers for the first time to disclose the ingredients used to make breast implants, information that patient advocates have long sought. The information must be made public in 30 days.

It is not clear how the new requirements will be enforced, and patients are highly unlikely to ever see a warning label on a packaged sterile medical device that is usually handled only by a surgeon. F.D.A. officials said in a statement that the patients “must be given the opportunity” to sign the checklist.

[….]

Reactions to the new requirements were mixed. While some doctors welcomed the new warning system, others worried that the potential risks and side effects would not be conveyed adequately by plastic surgeons who were eager to reassure patients the procedure is safe and that the new checklist would be handled in a dismissive manner.

Critics also said the checklist was overly long and written in obtuse language. “It’s better than nothing, but it’s not as good as it could be,” said Diana Zuckerman, a scientist who heads the National Center for Health Research and was a member of the working group that advised the F.D.A. on implant safety.

“They say things like, ‘Breast implants are associated with lymphoma,’ but lymphoma is actually caused by the implants,” Dr. Zuckerman said. “People understand it if you say, ‘Breast implants can cause lymphoma.’”

She worried that surgeons would not take the time to adequately review the information with patients.

“What if a surgeon says, ‘Here’s a checklist — I know it’s long, so it’s up to you if you want to read it or not’?” Dr. Zuckerman said. “Patient groups are very concerned that will happen.”

[….]

To read the entire article, click here.

FDA continues operating without a Senate-confirmed, permanent leader

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Kim Riley, Homeland Preparedness News: September 28, 2021

The U.S. Food and Drug Administration (FDA) remains without permanent leadership during the nation’s ongoing battle against the COVID-19 pandemic.

“It’s of top concern that President Biden still has not nominated someone to serve as permanent FDA commissioner,” a House Energy and Commerce Republican aide told Homeland Preparedness News. “Why hasn’t this been a priority after more than eight months into his presidency, especially to ensure public confidence in vaccine approvals?”

Pressure on the president to make an FDA nomination is mounting as the current Acting FDA Commissioner Janet Woodcock’s term ends on Nov. 15. People want to know: What’s the plan?

[….]

The FDA plays a major role in the federal government’s preparedness and response to the pandemic, such as by expediting access to COVID-19 medical countermeasures for the detection, protection against, and treatment of COVID-19, according to agency staff.

The FDA also is supporting the stability and quality of medical product and food supply chains, and ensuring that its decisions are guided by science using an open and transparent process, agency staff say.

Acting FDA Commissioner Woodcock, who has served in the position since Biden took office in January, began her career with the agency in 1986. This year she has faced opposition from lawmakers on Capitol Hill who oppose her taking over as the permanent FDA chief.

U.S. Sen. Joe Manchin (D-WV), for instance — who holds a key swing vote in the evenly divided chamber — this summer voiced concerns to Biden about “the continued tenure of Dr. Janet Woodcock as interim commissioner.”

In a June 17 letter Manchin sent to the president, the lawmaker specifically took issue with the FDA’s approval for Aduhelm, a treatment for Alzheimer’s disease, despite its advisory panel voting nearly unanimously against its approval, with no panel member voting in favor of approval.

“The FDA’s, and in particular Dr. Woodcock’s decision to go against its advisory committee’s decision, yet again has resulted in at least three scientists resigning from the committee,” Manchin wrote. “This brings into question the current interim leadership of Dr. Woodcock, at a time when strong, trusted leadership at our health agencies is most important.”

The senator noted that having a permanent agency head in charge to answer questions from patients and doctors on this approval, and to assure the general public of the FDA’s commitment to public health, “is imperative, and Dr. Woodcock is not the right person to lead the FDA.”

Other experts pointed out similar issues under Woodcock’s leadership.

Diana Zuckerman, president of the National Center for Health Research, told Homeland Preparedness News in an email that a negotiation the FDA recently completed with industry regarding drug user fees “is entirely focused on pleasing industry with quicker approvals, and all but ignores whether the new drugs being approved are proven safe or effective.”

“What is critical is to have a permanent, Senate-confirmed FDA commissioner who understands that the American taxpayer is their customer, not the companies that make the products that the FDA regulates,” Zuckerman wrote. “Unfortunately, recent commissioners, including the current acting commissioner, have repeatedly referred to their goal of providing good customer service to industry.”

Zuckerman also said that while the FDA doesn’t have the authority to make decisions about vaccine or mask mandates, the agency does, for example, have the authority to ensure that the masks being sold to prevent COVID transmission are as effective as possible.  

“The FDA has failed to do that under the acting commissioner, and there really is no excuse for that,” said Zuckerman. 

And “while it has been obvious that the White House has made decisions that were supposed to be made by the FDA,” according to Zuckerman, she doesn’t think having a confirmed FDA commissioner will necessarily improve that situation.   

“It would be improved, however, by a commissioner who is dedicated to public health, knows FDA and the federal government well, and is not afraid to stand up for FDA’s public health mission,” she said.

Steven Grossman, executive director of the Alliance for a Stronger FDA, took a similar stance.

“As is the case now, FDA has been blessed with very strong interim leadership that has served the agency well,” Grossman wrote in an email to Homeland Preparedness News. “However, only a Senate-confirmed commissioner can make — and stand behind — long-term commitments on behalf of the agency.”

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To read the entire article, click here.

Covid-19: FDA set to grant full approval to Pfizer vaccine without public discussion of data

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Gareth Iacobucci, BMJ: August 20, 2021

Transparency advocates have criticised the US Food and Drug Administration’s (FDA) decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine.

Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”1 But in a statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval.

“The FDA has held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to covid-19 vaccines, including a 22 October 20202 meeting to discuss, in general, the development, authorisation, and licensure of covid-19 vaccines,” an FDA spokesperson said.

“The FDA also has held meetings of the VRBPAC on all three covid-19 vaccines authorised for emergency use and does not believe a meeting is needed related to this biologics license application.”

The spokesperson added, “The Pfizer BioNTech covid-19 vaccine was discussed at the VRBPAC meeting on 10 December 2020.3 If the agency had any questions or concerns that required input from the advisory committee members we would have scheduled a meeting to discuss.”

The vaccine has already been rolled out to millions of Americans through an emergency use authorisation. Companies typically apply for full approval after a longer period has elapsed so that more data are available for review.

But with the US government indicating this week that it plans to start making booster shots widely available next month, experts said the decision not to meet to discuss the data was politically driven.

Data scrutiny

 Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee,4 said the decision removed an important mechanism for scrutinising the data.

“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorisation,” she said. “The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval.”

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Public discussion

Diana Zuckerman, president of the National Center for Health Research, who has also spoken at recent VRBPAC meetings, told The BMJ, “It’s obvious that the FDA has no intention of hearing anyone else’s opinion. But if you make decisions behind closed doors it can feed into hesitancy. It’s important to have a public discussion about what kind of data are there and what the limitations are. As we think about risk versus benefit, we need to know.”

Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health and former FDA deputy commissioner during the Obama administration, said that advisory committee meetings were more than just a way of receiving scientific input from outside experts. “It’s also an opportunity to educate the public about the important work that the FDA has done reviewing an enormous amount of data about a product,” he told The BMJ. “It’s a chance for questions to be asked and answered, building public confidence. If there are no advisory committee meetings prior to licensure, the FDA should consider taking extra steps to explain the basis of its decisions to the public.”

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To read the entire article, click here https://www.bmj.com/content/374/bmj.n2086

Beleaguered FDA in talks for drug-company funding

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Eleanor Laise, Marketplace: July 13, 2021

Fees paid by drug and device makers influence agency operations at the expense of patient safety, critics say.

Amid a firestorm over its approval of a new Alzheimer’s treatment, the Food and Drug Administration is holding closed-door meetings with companies it regulates — talks that critics say allow drug and device makers to exert outsize influence over the agency’s operations, threatening to erode public trust in the agency at a critical moment.

The talks focus on “user fees” that pharmaceutical and medical-device companies pay to the FDA annually and when applying for approval of new products. The FDA in recent years has become increasingly reliant on such payments, which funded nearly half of the agency’s total spending in fiscal year 2020. In exchange for the fees, the FDA agrees to certain deadlines for reviewing new-product applications, the type and frequency of meetings with companies submitting applications, and other commitments. The medical-product user-fee agreements are generally renegotiated every five years — a process that’s happening now, in advance of the current agreements’ expiration next year — and submitted to Congress for authorization.

Although the FDA is required by law to consult with patient and consumer advocacy groups on the discussions and make minutes of its industry meetings public, the meat of the talks often remains hidden, observers say. Since September of last year, the FDA has held more than 150 meetings with industry to discuss fee agreements for brand-name prescription drugs, generics, medical devices and biosimilars (products similar to branded biologic drugs), which together are expected to generate nearly $2 billion for the agency this fiscal year. Yet consumer advocates and other outside groups attempting to track the discussions say they remain in the dark about most of the details. FDA summaries of some recent meetings have been posted months after the fact or sum up a discussion in a single sentence. Medical-product safety experts say they’ve repeatedly asked for more access and details on the negotiations, to no avail.

“We simply can’t get a view into this process, and the lack of transparency is deliberate,” says Madris Kinard, a former public health analyst at the FDA and CEO of Device Events, which tracks medical-device adverse-event reports.

Details about the negotiations that have trickled out raise alarms among some medical-product safety experts, academic researchers and consumer advocates that the industry’s leverage in these talks ultimately puts patients at risk. User fees are speeding more products to market without a corresponding increase in resources to track the safety of those products, critics say. Yet in the current round of negotiations, FDA efforts to allocate more user fees toward monitoring the safety of medical products already on the market have met industry resistance.

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The main idea behind the user-fee programs was to speed up FDA review of medical-product marketing applications — and they’ve delivered on that front. The median time to approval for standard new-drug applications was 10 months in fiscal 2018. In the years before user fees were first enacted, the median FDA application review time was nearly three years, according to a study by Kesselheim and colleagues at Harvard and Brigham and Women’s Hospital.

[….]

But user-fee deadlines can have serious side effects, some experts say. As the opioid crisis was exploding, “there was a question of ‘Why does the FDA keep approving the opioids?’ ” says a former FDA official. “One reason was that they had applications and had user-fee obligations to review the applications.” So long as an application met the standard requirements, “it would be approved,” he says. “That’s an example of the mindset” created by the deadlines.

Several studies have linked faster drug-approval timelines to safety issues. A 2014 study in Health Affairs found that drugs approved after user fees were enacted were more likely to get new black-box warnings or be withdrawn from the market than drugs approved in the pre-user-fee era. Other studies have found that, compared with drugs approved at other times, drugs given the green light shortly before their user-fee deadlines were more likely to have subsequent safety issues.

[….]

In the current round of medical-device user-fee negotiations, one of the FDA’s goals is to improve device safety, including through increased funding for surveillance of devices already on the market, the agency says. That proposal met stiff resistance from the industry, according to outside groups that have received FDA briefings on the talks. At an April 7 negotiation meeting, the industry expressed the view that fees “should be solely for the premarket review process,” according to a summary posted by FDA. Medical-device trade group AdvaMed didn’t respond to requests for comment.

At the start of the prescription-drug user-fee negotiations, the FDA also emphasized its hope of improving the Sentinel Initiative, a system for assessing the safety of approved medical products. But a related proposal advanced by the FDA during the negotiations was shot down by the industry, a December meeting summary notes.  

[….]

Revolving doors

“There’s not a lot of friction between the industry and the agency” in prescription-drug user-fee negotiations, says a former FDA official. “The industry knows it’s getting good value.”

A sign of the amicable relations: One FDA official leading the current round of prescription-drug user-fee negotiations left the agency in April of this year, according to her LinkedIn profile, to become vice president of science and regulatory affairs at BIO — one of the industry groups she’d just been negotiating with. The former FDA official, Khushboo Sharma, participated in a user-fee negotiation meeting with BIO and other industry representatives as recently as Feb. 12, according to meeting summaries posted by the agency. “That is obviously an outrageous situation and clearly undermines the integrity” of the process, says Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank.

Asked for comment, the FDA sent a link to its post-employment restrictions, which say in part that current employees who have begun seeking employment outside the federal government must immediately recuse from certain matters that affect “the discrete industry, economic sector, or other defined class of organizations in which the prospective employer operates.” BIO didn’t respond to a request for comment. Sharma says that she worked with FDA ethics officials “to ensure I was recusing myself from all appropriate activities. I started seeking post-employment opportunities after negotiations had concluded.”

When the agency’s position does conflict with an industry’s, the FDA “is not going to come out on top,” says Lisa McGiffert, a patient-safety advocate at the nonprofit Patient Safety Action Network. Given the industry’s track record of snagging many items on its wish list, some observers are concerned that the current round of negotiations could chip away at FDA standards for approving new drugs. One issue: the use of “real-world data,” which can come from insurance claims, medical records, disease registries and other sources beyond the bounds of clinical trials. In an August 2020 letter to the FDA about user-fee reauthorization, PhRMA said that real-world data and evidence “may, in some circumstances, be adequate on their own to satisfy the substantial evidence criteria for demonstrating effectiveness” of drugs.

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To read the entire article, click here.

Former ‘Bachelorette’ Clare Crawley Is Removing Her Breast Implants Over Health Concerns—Here’s What to Know

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Korin Miller, Health: July 06, 2021

Clare Crawley is opening up about her decision to have her breast implants removed over concerns they’re impacting her health.

The Bachelorette star shared the news in a video posted to Instagram that she titled, “Coming to Terms.”

“I’m sharing this in hopes that it might help others going through something similar feel not so alone,” Crawley, 40, wrote in the caption. “I feel that this was important to share so I can be a resource for anyone going through this as well. I know how being your own health advocate is hard sometimes, and can feel like an uphill battle. This is the reality of life for so many people though! I’m just so incredibly thankful to all the people who are in my life that support me not only in my peaks but in the valleys as well.”

In the video, Crawley revealed that she’s been struggling with persistent medical issues over several years. “I’ve been going through things medically with my body that I have not had answers to, to be honest,” she said. “My skin has been having really bad hives and rash. My whole body is just inflamed and itchy.”

Crawley said that she’s also had “blood test after blood test” and seen several doctors. But test results didn’t give her answers about what is going on in her body.

After having two mammograms and an ultrasound—which revealed what she said were sacs of fluid behind her implants—she consulted with her doctor and decided to have her implants removed. “As much as I love my implants, my body is fighting them and recognizes it as something obviously foreign in my body,” she said, adding that blood tests showed an elevated white blood cell count over the past few years. “My body can’t heal. My body is in fight mode, constantly. It’s exhausting, it’s frustrating. It’s all making sense.”

While Crawley said that her decision isn’t the right one for everyone, it’s what’s best for her. “My health is the most important thing. They are coming out,” she said.

Crawley received messages of support in the comments, including from Kayla Lochte, wife of Olympic swimmer Ryan Lochte, who shared in March that she had her implants removed over health concerns—specifically she specifically cited as breast implant illness (BII). “Best of luck Clare! Get those toxic bags out,” she said.

While Crawley herself didn’t specifically say that she has BII, she implies it. Here’s what you need to know about the condition—and what to do if you think your breast implants may be impacting your health.

What is breast implant illness, exactly?

It’s important to get this out of the way upfront: Breast implant illness (again, BII) isn’t a medical diagnosis, and there are no hard numbers on how often BII happens.

[….]

That said, the US Food and Drug Administration (FDA) concluded last year that breast implants should have a “black box” warning to help women make “informed decisions” about potential risks associated with breast implants, including BII, which the FDA labels as “systemic symptoms.” It’s also important to note that BII is different from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma that can develop following breast implants, per the FDA.

BII is tricky to diagnose. “The symptoms women report are pretty nonspecific, and could be related to another illness,” Janie Grumley, MD, a breast surgical oncologist and director of the Margie Petersen Breast Center at Providence Saint John’s Center and associate professor of surgery at Saint John’s Cancer Institute in Santa Monica, Calif., tells Health. “It ends up being that, once we’ve worked out everything else and can’t figure out what’s going on, that’s when we think the issue may be breast implants.”

Research has suggested this is a real health concern. One July 2020 retrospective study published in the Annals of Plastic Surgery looked at 750 patients who had their breast implants removed by a surgeon over a two-year period. Researchers found that patients had “significant and sustained improvement” in 11 different symptoms after surgery. Patients found their symptoms improved within 30 days after having their implants removed.

Another study published in the same journal in January 2019, found that people with silicone breast implants had higher rates of the autoimmune conditions Sjogren syndrome, scleroderma, and rheumatoid arthritis than those who don’t have implants. They also had a higher risk of stillbirth and melanoma.

Why might breast implants make some people sick?

“All breast implants have a silicone shell that also contains various chemicals and small amounts of heavy metals,” Constance M. Chen, MD, a board-certified plastic surgeon and breast reconstruction specialist, tells Health. “Some breast implants also have a silicone filling that can leach off an intact implant or spill out of a ruptured implant. The silicone, chemicals, and/or heavy metals in the body can make some women sick.”

[….]

Scar tissue usually develops around the implant inside the body in an attempt to protect it from the “invader,” Diana Zuckerman, PhD, president of the National Center for Health Research who has researched breast implant safety, tells Health. “For some women, the scar tissue provides the protection they need, and they feel fine,” she says. “For other women, their bodies react more strongly, with an autoimmune reaction or other kind of reaction.”

What should you do if you suspect your implants might be causing your health issues?

You should talk to your doctor, Dr. Grumley says. Just know this, per Dr. Zuckerman: There’s no test that can tell if the implants are making you sick while they’re still in your body. But, she says, “if women find that they are developing symptoms that don’t go away, they should consider getting their implants and the scar capsule removed.”

It’s important to see a doctor who has experience in breast implant removal, Dr. Zuckerman says. Not only do they know what they’re doing, they’ll also know to remove the scar tissue that’s formed, which can contain silicone gel. If they don’t, “the chances of your health improving is not as good,” she explains.

[….]

To read the entire article, click here.

My breast implants are making me sick — and I’m not alone

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Pamela Appea, Salon: June 20, 2021

In November 2016, a few weeks after I had breast implant surgery, I came down with an unexpected case of thrush (an unappealing fungal infection characterized by a thick white coating on my tongue). As a Black married mother of two, even though I was still sick, I tried — but failed — to power through and take care of my kids. With intense flu-like aches, pain, and fever, it hurt to eat, drink, swallow, or even open my mouth. I couldn’t properly brush my teeth for several days.

Unfortunately, my primary care physician was on vacation. Panicked, I called the Manhattan oncologist whom I had seen a few weeks earlier. He’d been very kind to me following my DCIS breast cancer diagnosis, unilateral mastectomy and post-surgical treatment. The officer’s medical team could barely understand me when I tried to make the appointment on the phone.

“I don’t think you have thrush — didn’t I just see you a few weeks ago?” he said, trying to put me at ease as I stared at his cheerful neon tie. (I think he prided himself on his fun ties.)

It was torture opening my mouth so the doctor could diagnose me.

“Okay, that’s the worst case of thrush I’ve seen in some time,” the seasoned specialist said. He said he was putting me on antibiotics stat. I asked — or rather, wrote on a notepad, since I couldn’t speak clearly — if there could be any connection between the my immune system and the very new breast implant that was now in my body. The oncologist emphatically dismissed the notion as impossible.

Once he got the results of my lab work back, my physician said there was no evidence of anything wrong; I should bounce back in a few days. “These things sometimes happen,” he told me, smiling as he ushered me out.

While the antibiotics eventually cleared up the thrush, unfortunately I have never fully bounced back. In subsequent years since my breast implants were put in, it became even more clear that something was going on with my immune system. But none of my doctors really listened.

Although it was not formerly recognized by the medical community until recently, Breast Implant Illness (BII) has, in the past few years, finally received attention from both media and researchers. Nicole Daruda founded a Facebook’s support group, called Breast Implant Illness Healing by Nicole, in 2013; now, it boasts over 145,000 members. Daruda tentatively estimates that 50,000 women in the US have BII, although precise research-backed numbers are not readily available

“We are overwhelmed by women trying to join the Facebook group to be educated about Breast Implant Illness,” Daruda said. She estimates that 3,000 to 5,000 women message the group’s moderators every month. To try to meet the demand, Daruda later founded a nonprofit, Healing Breast Implant Illness Society of North America.

Research is just barely starting to emerge on BII. One study, published in Annals of Plastic Surgery in 2020, followed 750 women suffering from Breast Implant Illness over a multi-year time period. Once these women surgically removed their breast implants, the vast majority reported the majority of their symptoms had significantly improved or disappeared entirely.

Awareness appears to be growing, too. A wave of celebrities are talking more openly about breast implants and their health and wellness — including Victoria Beckham, Ayesha Curry, Ashley Tisdale, Chrissy Teigen and others.

A documentary that touches on the subject of BII, “Explant,” is screening right now at the Tribeca Film Festival. The film follows Michelle Visage, one of the celebrity judges on “RuPaul’s Drag Race.” Visage, a media personality, singer, DJ and actor who was well known for her signature Double-D breasts, found that doctors didn’t take her seriously when she told the specialists her immune system was out of whack. Visage experienced chronic health issues, including Hashimoto’s disease, that she now attributes to her breast implants.

Awareness of BII is crucial given the popularity of breast implants. Since 1998, the number of breast augmentation procedures in the US has increased threefold; now, they are one of the most sought-out cosmetic procedures.

“The desire for breast augmentation seems so powerful regardless of what else is going on in the world,” said Dr. Diana Zuckerman, founder of the National Center for Health Research. “What most concerns me is how reluctant most plastic surgeons have been to make sure their patients know the risks before making a decision.”

Because breast implant technology has existed for decades, many women erroneously believe they are safe.

[….]

In the years after my implant, some of my symptoms mirrored women on support groups I found online, which is how I figured out I had Breast Implant Illness. While symptoms sometimes waxed and waned, I got used to experiencing a host of autoimmune and other symptoms like insomnia, brain fog, extreme breathlessness, cuts that took weeks to heal, rashes, frequent colds and much more.

But BII is no longer regarded as a myth. Many or even most doctors, including plastic surgeon Dr. Anthony Youn, believe Breast Implant Illness is real. Dr. Youn acknowledges it is a controversial topic among many of his fellow American plastic surgeons.

“If you’re happy with your breast implants and you don’t believe they are adversely affecting your health, then there is no need for treatment. If you are sick and believe your implants may be the cause, speak with your primary care physician and a board-certified plastic surgeon about whether explantation may be a possible solution for you,” Dr Youn said. “There are many causes of the symptoms of Breast Implant Illness (BII) that don’t involve breast implants, so it’s often best to rule those out first,” he continued.

In his 17 years of practice in the metro Detroit region, Dr. Youn, a member of the American Society of Plastic Surgeons and The Aesthetic Society, has performed surgery on thousands of women who elected to get breast implants. Anecdotally, he estimates the number patients who later returned to his practice stating they had Breast Implant Illness symptoms is an extremely small percentage.

[….]

Though not all women with breast implants go on to develop Breast Implant Illness, all women deserve education, informed consent, insurance coverage and most important information about potential risks. If, in 2015, there had been an FDA Breast Implant Black Box Warning (which was officially unveiled in late 2020), I honestly never would have gotten breast implants in the first place.

To read the entire article, click here.

Can California’s public universities mandate COVID-19 vaccines?

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Robert M. Kaplan and Diana Zuckerman, Ph.D., Monterey Herald: April 26, 2021

Last week, the University of California and the California State University system proposed mandating COVID-19 vaccines for faculty, staff, and students beginning in the fall.  Only those with medical conditions aggravated by vaccination or those with legitimate religious objections would be excused.  The policy is consequential: Public university students, faculty and staff include nearly 1,000,000 Californians. But is the mandate feasible? And, should the California universities dive headfirst into what promises to be a complicated controversy?

With waning competition for shots, public health officials now worry about vaccine hesitancy. Lower vaccination rates give more opportunities for variants to develop and could make the pandemic last longer. We all benefit when more people are vaccinated.  Yet, national polls by Stanford and YouGov show that about 20% of Americans will refuse to be vaccinated, and one in three estimate their likelihood of getting vaccinated is below 50%. Only 20% strongly agree that vaccines should be mandated and 45% report that vaccinations should be strictly voluntary.

Requiring vaccinations may be legal. Since 1905, courts have consistently upheld vaccination mandates, but with some exemptions.  Although 50 states and Washington D.C. can require vaccines for primary schools, all states allow medical exemptions.  Further, 45 states permit religious exemptions and 15 recognize philosophical objections.  Only 16 states allow post-secondary institutions to require vaccinations for influenza or hepatitis B.

Despite these precedents, the UC/CSU proposal could be derailed because current CDC policy only allows mandates for vaccines approved by the Food and Drug Administration. Technically, no COVID vaccine is currently approved. Instead, the three vaccines have been authorized under a different vetting mechanism called Emergency Use Authorization.  Unlike FDA approval, EUA is a temporary agreement that allows medical products to be used in emergency situations based on FDA’s determination that the benefits “may” outweigh the risks.  That requires a less rigorous standard of evidence than FDA approval. Before the pandemic, EUAs were only used to speed emergency treatments to a relatively small number of people threatened by Ebola, Zika, and anthrax.

To be fair, each of the three authorized (but unapproved) COVID vaccines underwent rigorous testing in large studies. However, the FDA had announced that full approval of these vaccines would require following study participants for “at least one to two years.”  For the EUA’s,  FDA permitted just two months of follow-up and stated that while two months was the minimum to determine safety, it wasn’t sufficient to determine how long the vaccines would be effective.

With the EUAs in hand and bolstered by promising early results and extremely high demand for vaccines, companies had no incentive to continue the trials. Despite advice by scientists to continue studies with the inclusion of a control group, all three companies provided the vaccine to participants who had received a placebo. The ethical reasons for this are obvious; however, the consequence is that a rigorous evaluation of the long-term benefits and side effects is no longer possible in the absence of a placebo control group.

What do we know about safety?  137 million Americans have had at least one dose of the vaccine.  Although at least half have experienced bothersome reactions, very few have reported serious side effects that resulted in permanent damage or death. The FDA and CDC have two systems to track real-world reactions. V-SAFE is an app that regularly asks vaccinated individuals to report any health problems. Unfortunately, very few individuals use it.  The other system, the Vaccine Adverse Event Reporting System (VAERS) is designed for health care providers to report bad reactions to vaccines.   As with V-SAFE, reporting is not enforced and therefore reactions are under-reported.  The current systems are limited because they were not designed to accurately determine how many people experience adverse events.

UC/CSU should be commended for proposing a bold strategy to address a serious problem.  A mandate to vaccinate university communities could turn the campuses into COVID safe zones. However, it is likely to encounter serious legal challenges if none of the vaccines are FDA approved before the mandate is implemented. Instead of waiting for the FDA to deny approval for insufficient evidence, the UC and CSU systems could use their exceptional creativity and research capability to produce better evidence that would inform the FDA about the long-term scientific safety and effectiveness of the vaccines.

Robert M. Kaplan is a faculty member at Stanford University’s Clinical Excellence Research Center and a former Associate Director of the National Institutes of Health. Diana M. Zuckerman is the President of the Washington DC-based National Center for Health Research. She is an expert on the safety and effectiveness of medical products. You can view the original article here.