Health

FDA Approved Artificial Blood Vessel Despite Warnings

Published

10 months ago

March 24, 2025

FDA Approved Artificial Blood Vessel Despite Warnings

When the biotech company Humacyte designed a study to see if its lab-grown blood vessel worked, it decided to measure whether blood was flowing freely through the high-tech tube 30 days after it was implanted in a person.

As those days passed, some of the 54 patients in the study ran into trouble. Doctors lost track of one. Four died. Four more had a limb amputated, including one who developed a clot and infection in the artificial vessel, Food and Drug Administration records show.

Humacyte, which is traded on the Nasdaq, counted all those patients as proof of success in talks with investors and in an article in JAMA Surgery.

At the F.D.A., though, scientists counted the deaths, amputations and the lost case as failures, records show, noting a lack of information to determine if the vessels were clear.

Still, the agency approved the vessels in December without a public review of the study. Top officials authorized it over the concerns of staff members who said in F.D.A. records that they found the study severely lacking or were alarmed by the dire consequences for patients when the vessels fell apart.

Now the company is ramping up its marketing efforts to hospitals and for use on the battlefield.

When a patient’s blood vessel is damaged, doctors typically find a blood vessel from another part of the body and graft it to repair blood flow. They turn to artificial vessels when patients are too badly injured to harvest a vein.

The Humacyte vessel is made from a mesh tube seeded with cells from the human heart. The cells grow over two months in a bioreactor, and at the end of the process, the human cells and genetic material are removed. A lab-grown tube, mostly made of collagen developed from the aortic cells, remains.

Before the vessel was approved, one F.D.A. medical reviewer pointed out that 37 of the 54 patients were not assessed in a safety check four months after getting the implant, with many dead or lost to follow-up. “There is significant uncertainty regarding the safety and effectiveness of this product beyond 30 days,” the F.D.A. report says.

Dr. Robert E. Lee, a vascular surgeon who cared for gunshot-wounded patients in Detroit for 30 years, retired in the fall from the F.D.A. in protest over the matter. In a review of more than 2,000 pages of company records conducted when he was an F.D.A. medical officer, Dr. Lee found that the vessel could rupture with no warning. Those events were “unpredictable, catastrophic and life-threatening,” he wrote in his F.D.A. review, parts of which were made public weeks ago.

“That’s an unacceptable risk for whatever slim benefit, if any, this product provides above the current standard treatments,” Dr. Lee, who had been a reviewer at the agency since 2015, said in an interview. He noted that doctors currently use the patients’ own vessels, if available, or tubes made of Gore-Tex.

An F.D.A. spokeswoman said the approval “was based on a careful evaluation of data from clinical trials that demonstrated a clinically meaningful benefit in restoring blood flow in the affected limb and ultimately limb salvage.”

Humacyte is also developing a graft for patients with dialysis, for those undergoing cardiac bypass surgery and for infants with a heart-related birth defect.

Dr. Laura Niklason, one of the company’s founders, said approval of the vessel, called Symvess, was a “milestone for regenerative medicine overall.”

She had begun work to create the lab-grown vessels decades earlier. In its 20 years, the company had logged no sales and accrued more than $660 million in debt, financial reports show.

In an interview, Dr. Niklason said the disagreement over how to label the patient deaths and amputations as successes or failures arose after the company decided to count cases as failures only when it was certain that blood flow was cut off. The F.D.A. took a more conservative approach to calculating the success rate for the product, she said. “Rational people can disagree,” she added.

The F.D.A. records do not indicate whether the problems with the vessels directly caused the deaths or amputations.

Dr. Niklason said that the company must use the agency numbers in marketing the product to clients but that it could present its more favorable figure to investment analysts. She also said the study was published before the F.D.A. reached its decision.

B.J. Scheessele, the company’s chief commercial officer, told investors this month that Humacyte was in talks with 26 hospitals to begin distribution. Mr. Scheessele also said the company was hoping to sell the vessels to the Defense Department for battlefield injuries. The U.S. Army gave Humacyte $6.8 million in 2017, embracing the product as an option for wounded soldiers.

Each artificial vessel costs $29,500, and Mr. Scheessele said the company hoped to market several thousand each year in the United States.

Dr. Niklason said in an interview that her interest in engineering a blood vessel was twofold. As a young doctor, she had observed that arterial disease was devastating.

She described an experience as a medical resident in the late 1990s watching a senior doctor make incision after incision in a patient’s legs and arm, seeking a healthy vessel to use in a heart bypass surgery. She called the procedure “barbaric.”

“To provide a new blood vessel for a patient who needs one, we usually have to rob Peter to pay Paul,” she said.

Since Dr. Niklason first began meeting with the F.D.A. in 2015 about starting a trial in humans, the agency repeatedly found fault with the company’s efforts to study the vessel’s use. Its trial involved people suffering major trauma, such as gunshot or car crash injuries, took place in U.S. hospitals and in Israel. The participants had an average age of 30, and half were Black patients.

Humacyte also provided the vessels to doctors treating injured soldiers in Ukraine.

By Nov. 9, 2023, Dr. Niklason described results of the studies to investors on an earnings call in glowing terms. Initially, she said the rate of blood flow through the vessels at 30 days was 90 percent — beating existing products on the market.

And the results in Ukraine were “remarkable,” she said. “We’re proud to be able to help our Ukrainian surgeon colleagues save life and limb in this wartime setting.”

Over the ensuing months, though, reviewers at the F.D.A., including Dr. Lee, would examine the same studies and conclude that they did not look nearly as good.

As a vascular and general surgeon in Detroit, Dr. Lee had decades of experience with victims of gunshots, stabbings, car crashes and other accident victims who might receive such vessels.

He said he was alarmed by the account of a man in Ukraine who began bleeding at the site of his surgical wound eight days after the vessel was implanted. Doctors discovered a two-millimeter hole in the Humacyte vessel and repaired it with sutures, according to F.D.A. records. Four days later, the patient was bleeding again, requiring removal of the graft the next day. The review suggested that an infection could have played a role.

Of 71 cases that Dr. Lee examined for a safety review, seven people, or about 10 percent, experienced vessel failures that resulted in major bleeding, according to the F.D.A. review. Dr. Lee said that was unheard-of in his experience with Gore-Tex grafts.

“Plastic arteries, they don’t usually present with catastrophic hemorrhage, unexpected like this,” Dr. Lee said. “You know the patients are sick,” with a fever or other signs of an infection, he continued. “You know something’s brewing, and you usually have time to take care of it.”

Hoping to glean more information about the root cause of the mid-vessel blowouts — and to be sure doctors were aware of the possibility — Dr. Lee began seeking a public advisory hearing on the device.

Thomas Zhou, a biostatistician in the biologics division of the F.D.A., also flagged concerns from the U.S. arm of the study and the data from Ukraine.

“Neither study met the usual criteria for an adequate and well-controlled trial,” he wrote.

The study of 16 patients treated in Ukraine was retrospective and observational, meaning researchers could look back at a larger pool of data and select the best cases. It showed “limited support of efficacy,” partly because the injuries were “skewed to shrapnel injuries” and not the devastating wounds typically seen on the battlefield, he said.

The U.S. study was “poorly conducted” and underwent “multiple major changes” during the trial, the statistical review said.

The records also show that F.D.A. scientists dismissed as successful the patient deaths and amputations, citing a lack of information or imaging studies.

As a result, the F.D.A. concluded that the vessel’s success rate for that key study was 67 percent, rather than the company’s 84 percent, F.D.A. records show. In comparison, artificial grafts already had blood flow rates of 82 percent, the review said.

The company also reported an 84 percent success rate at 30 days in an article published in November in JAMA Surgery, which is widely read by surgeons. The article stated that the Humacyte vessel “demonstrates improved outcomes” over other artificial vessels.

It also said the Symvess “provides benefits” in “infection resistance.” The F.D.A. review said there was no clinical evidence demonstrating that extra effect.

Dr. Lee failed to persuade top F.D.A. officials to hold a public advisory committee meeting where the study results could be discussed and reviewed by independent experts. The agency decided instead to send records to three external reviewers, who in turn identified failure of the Humacyte vessels “as a serious risk,” but added that “the appropriate patient population” would benefit, according to documents.

In announcing approval of the graft on Dec. 20, Dr. Peter Marks, head of the biologics division, called the vessels “innovative products that offer potentially lifesaving benefits for patients with severe injuries.”

But the product is accompanied by a black box warning — the agency’s most serious — for failures that “can result in life-threatening hemorrhage.” The F.D.A. also is requiring the company to continue reporting safety data.

Dr. Hooman Noorchashm, co-director of the Amy J. Reed Medical Device Safety Collaborative at Northeastern School of Law, said the F.D.A. should not have approved a product that its scientists deemed inferior to existing options.

“If the graft falls apart,” he said, or if it disconnects to where it is attached to the vessel, “it is basically akin to the patient getting shot.”

Dr. Lee said he hoped the F.D.A., with new leadership under the Trump administration, would still hold a public meeting.

“Every surgeon who uses it needs to see the things that I did,” he said.

Click to comment

Health

Brain Health Challenge: Test Your Knowledge of Healthy Habits

Published

2 hours ago

January 5, 2026

Press Room

Brain Health Challenge: Test Your Knowledge of Healthy Habits

Welcome to the Brain Health Challenge! I’m Dana Smith, a reporter at The New York Times, and I’ll be your guide.

To live a healthy life, it’s crucial to have a healthy brain. In the short term, it keeps you sharp and firing on all cylinders. In the long term, it can reduce your risk of cognitive decline, dementia and stroke.

Practicing basic healthy behaviors, like eating nutritious food and getting regular exercise, is the best way to enhance your brain power and protect the longevity of your neurons. These types of lifestyle habits can benefit the brain at any age. And while they won’t guarantee that you’ll never develop dementia or another brain disease, several clinical trials have shown that they can improve cognition or slow decline.

Every day this week, you’ll do an activity that’s good for your brain, and we’ll dig into the science behind why it works. Some of these activities can provide a small immediate cognitive benefit, but the bigger reward comes from engaging in them consistently over time. So along with the neuroscience lessons, we’ll include a few tips to help you turn these actions into lasting habits.

To keep you accountable, we’re encouraging you to complete this challenge with a friend. If you don’t have a challenge buddy, no problem: We’re also turning the comments section into one big support group.

There are so many fascinating ways your daily behaviors affect your brain. Take sleep, for example.

Lots of studies have shown that getting a good night’s rest (seven to eight hours) is associated with better memory and other cognitive abilities. That’s because sleep, especially REM sleep, is when your brain transfers short-term memories — things you learned or experienced during the day — into long-term storage.

Sleep is also when your brain does its daily housekeeping. While you rest, the brain’s glymphatic system kicks into high gear, clearing out abnormal proteins and other molecular garbage, including the protein amyloid, which is a major contributor to Alzheimer’s disease. A buildup of amyloid is one reason experts think that people who routinely get less sleep have a higher risk of dementia.

What other behaviors play a big role in brain health? For today’s activity, we’re going to test your knowledge with a quiz. Share your score with your accountability partner and in the comments below — I’ll be in there too, cheering you on.

Health

What your butt shape could reveal about your health, according to scientists

Published

2 hours ago

January 5, 2026

Press Room

What your butt shape could reveal about your health, according to scientists

NEWYou can now listen to Fox News articles!

An often-overlooked part of the body may reveal important clues about overall health.

Researchers from the University of Westminster in the U.K. discovered that the shape of the gluteus maximus muscle in the buttocks changes with age, gender, lifestyle and frailty, as well as certain conditions like osteoporosis and type 2 diabetes.

Using advanced MRI scans that create 3D images, researchers revealed “distinct” patterns in the gluteus maximus associated with type 2 diabetes.

HOW TO AVOID GETTING ‘OFFICE CHAIR BUTT’ FROM PROLONGED SITTING AT WORK

This suggested that the shape of the muscle, rather than the size, may “reflect underlying metabolic differences,” a press release stated.

The findings were presented in December at the annual meeting of the Radiological Society of North America (RSNA) in Chicago.

Butt shape may indicate underlying health conditions, according to new research. (iStock)

Unlike previous studies looking at muscle size or fat, the 3D imaging identified exactly where the muscle changes occur, according to the researchers.

As one of the largest muscles in the human body, the gluteus maximus “plays a key role” in metabolic health, according to lead study author E. Louise Thomas, Ph.D., professor of metabolic imaging at the University of Westminster’s School of Life Sciences.

OLDER AMERICANS ARE QUITTING GLP-1 WEIGHT LOSS DRUGS FOR 4 KEY REASONS

The researchers analyzed more than 61,000 MRI scans from a large UK health database to better understand the muscle’s structure.

The data also included the participants’ physical measurements, demographics, disease biomarkers, medical history and lifestyle habits. The researchers studied how these variables were linked to muscle shape over time.

An infographic from the Radiological Society of North America presentation displays research findings on the shape of the gluteus maximus. (RSNA)

“People with higher fitness, as measured by vigorous physical activity and hand grip strength, had a greater gluteus maximus shape, while aging, frailty and long sitting times were linked to muscle thinning,” study co-author Marjola Thanaj, Ph.D., a senior research fellow at the University of Westminster’s Research Centre for Optimal Health, said in the release.

5 FITNESS TRENDS THAT WENT VIRAL IN 2025 – EXPERTS WEIGH HYPE VS RESULTS

The researchers concluded that butt shape changes may indicate an “early functional decline” and “metabolic compromise” in type 2 diabetes patients.

CLICK HERE FOR MORE HEALTH STORIES

Men with type 2 diabetes showed muscle shrinkage, while women displayed enlarged muscle, likely due to “infiltration of fat” within it, according to the researchers.

These results suggest that men and women have “very different biological responses to the same disease,” Thanaj suggested.

Butt shape changes may indicate an “early functional decline” and “metabolic compromise” in type 2 diabetes patients. (iStock)

Men who were categorized as “frail” were recognized as having more “general shrinkage” across the gluteus maximus, but women experienced a “limited” frailty effect.

Building strong glutes for better health

Strengthening the glutes is an “investment in long-term health,” according to Tanya Becker, co-founder of Physique 57 in New York City.

“While full-body strength training is essential, focusing on your glutes — the largest muscle group in your body — deserves special attention,” she told Fox News Digital.

“While full-body strength training is essential, focusing on your glutes — the largest muscle group in your body — deserves special attention.” (iStock)

Becker refers to the glutes as the body’s “shock absorbers,” because they protect the lower back, knees and hips from taking on stress they weren’t designed to handle.

Larger muscle groups also burn more calories and help regulate blood sugar, the expert added, noting that muscles are often referred to as the “organ of longevity.”

CLICK HERE TO DOWNLOAD THE FOX NEWS APP

Strengthening the glutes also helps to protect the lower back, hips and knees, and also improves posture and balance, reducing the risk of falls and improving mobility.

“People with higher fitness, as measured by vigorous physical activity and hand grip strength, had a greater gluteus maximus shape.”

Advertisement

Becker recommends traditional weighted exercises like squats, lunges and bridges, although they are not suited for everyone, especially older adults with injuries and joint pain.

“Pilates and barre classes offer bodyweight exercises that are ideal for beginners or individuals with physical limitations,” she suggested. “They can be done anytime, anywhere, making them accessible for beginners before progressing to weighted versions.”

Glute bridges (demonstrated above) are a recommended exercise for strengthening those muscles. (iStock)

Becker shared the following three glute exercises that improve hip mobility, stability and overall strength.

No. 1: Quadruped leg lifts (strengthens entire core and glutes)

Start on the hands and knees, engage your core, and lift one leg off the floor (bent or straight). Pulse up and down a few inches for 30 to 60 seconds, then repeat on the other leg.

CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER

No. 2: Clamshells (strengthens gluteus medius)

Lie on your side with knees bent at 90 degrees in front of you. Lift your top knee away from your bottom knee, then lower slowly.

For an increased challenge, lift both feet off the ground while keeping the heels together. Repeat for 30 to 60 seconds per side.

Strong muscles are responsible for maintaining metabolic health, according to Becker. (iStock)

No. 3: Glute bridges (strengthens lower back and glutes)

Lie on your back with knees bent and feet parallel, a few inches from your hips. Engage your abs, and squeeze your glutes to lift your hips toward knee height, then lower.

If you feel pressure in your neck, you’ve lifted too high. Perform for 30 to 60 seconds. Complete three sets with 30-second rests between them.

TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ

Those looking to start a new fitness routine should first consult with a doctor.

Fox News Digital reached out to the study authors for comment.

Angelica Stabile is a lifestyle reporter for Fox News Digital.

Health

Viral New Year reset routine is helping people adopt healthier habits

Published

14 hours ago

January 4, 2026

Press Room

Viral New Year reset routine is helping people adopt healthier habits

NEWYou can now listen to Fox News articles!

What if your New Year’s resolution could fit inside a tote bag? Social media users are trying the “analog bag” trend, replacing phones with offline activities.

The trend is widely credited to TikTok creator Sierra Campbell, who posted about her own analog bag — containing a crossword book, portable watercolor set, Polaroid camera, planner and knitting supplies — and encouraged followers to make their own.

Her video prompted many others to share their own versions, with items like magazines, decks of cards, paints, needlepoint and puzzle books.

CREATIVE HOBBIES KEEP THE BRAIN YOUNG, STUDY FINDS — HERE ARE THE BEST ONES TO PURSUE

“I made a bag of non-digital activities to occupy my hands instead of the phone,” said Campbell, adding that the practice has significantly cut her screen time and filled her life with “creative and communal pursuits that don’t include doom-scrolling.”

“I created the analog bag after learning the only way to change a habit is to replace it with another,” she told Fox News Digital.

Social media users are trying the “analog bag” trend, replacing phones with offline activities like cameras, notebooks and magazines. (Fox News Digital)

The science of healthier habits

Research on habit formation supports the idea of the analog bag, according to Dr. Daniel Amen, a California-based psychiatrist and founder of Amen Clinics.

“Your brain is a creature of habit,” Amen said during an interview with Fox News Digital. “Neurons that fire together wire together, meaning that every time you repeat a behavior, whether it’s good or bad, you strengthen the neural pathways that make it easier to do it again.”

CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER

Studies show that habits are automatic responses to specific cues — such as boredom, stress or idle time — that typically deliver some kind of reward, according to the doctor. When no alternative behavior is available, people tend to fall back on the same routine, often without realizing it.

Research suggests that replacing an old habit with a new one tied to the same cue is more effective than trying to suppress the behavior altogether.

CLICK HERE TO DOWNLOAD THE FOX NEWS APP

“[When] cutting out coffee — you need to have another drink to grab for, not just quit cold turkey. It’s how the pathways in our brains work,” Campbell said.

By substituting a different routine that still provides stimulation and engagement, people can gradually weaken the original habit and build a new automatic response.

Substituting another activity instead of scrolling on your phone can help quell the impulse to reach for it. (iStock)

“Simply stopping a behavior is very challenging,” Amen said. “Replacing one habit with something that is better for your brain is much easier. That’s how lasting change happens, one step at a time.”

CLICK HERE FOR MORE HEALTH STORIES

If alternatives are within arm’s reach, people will be more likely to use them, the doctor said. “Your brain does much better with small, simple actions than big, vague intentions.”

Instead of saying, “I’ll stop scrolling today,” the doctor recommends choosing a small habit you can do in a few moments in specific situations, like knitting 10 rows of a scarf on your commute or reading a few pages of a book while waiting at the doctor’s office.

“If alternatives are within arm’s reach, you’re more likely to use them,” a brain doctor said. “Your brain does much better with small, simple actions than big, vague intentions.” (iStock)

Campbell shared her own examples of how to use an analog bag. At a coffee shop with friends, she said, she might pull out a crossword puzzle and ask others to help with answers when the conversation lulls.

Instead of taking dozens of photos on her phone, she uses an instant camera, which limits shots and encourages more intentional moments.

TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ

In casual outdoor settings, such as a park or winery, she brings a small watercolor set for a quick creative outlet.

“It’s brought so much joy,” Campbell said of the analog bag trend, “seeing how it resonates with so many.”

Khloe Quill is a lifestyle production assistant with Fox News Digital. She and the lifestyle team cover a range of story topics including food and drink, travel, and health.