Health
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.
A look back at the medical miracles of 2025
Fox News senior medical analyst Dr. Marc Siegel joins ‘Fox & Friends’ to highlight 2025 breakthroughs, from a pineapple-derived burn cream to a newly approved heart procedure.
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America has been at the forefront of medical innovation since the nation’s founding in 1776.
From groundbreaking surgeries to cancer breakthroughs, U.S. physicians have helped transform nearly every field of medicine.
As America marks its 250th anniversary, experts are highlighting some of the most influential medical innovations in the nation’s history.
No. 1: Orthopedic care
John Uribe, MD, orthopedic surgeon and system chief executive at Baptist Health Orthopedic Care in Florida, said he believes the greatest breakthrough in orthopedics is the evolution of joint replacement surgery, particularly of the hip and knee.
AMERICA’S LIFESPAN HAS DOUBLED SINCE 1776 — EXPERTS REVEAL WHAT CHANGED
“A generation ago, severe arthritis or joint damage often meant a lifetime of pain, limited mobility and loss of independence,” he told Fox News Digital.
“Today, orthopedic surgeons can replace a damaged joint with highly durable implants, use advanced imaging and navigation, and increasingly rely on robotic-assisted technology to personalize implant positioning and improve precision.”
“The future of orthopedics will be less one-size-fits-all and more focused on matching the right procedure, implant, recovery plan and technology to the individual patient,” a doctor said. (iStock)
Today, patients can walk the same day after joint replacement, return home sooner and recover with less disruption than in the past, according to Uribe.
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“Hip and knee replacements, arthroscopic procedures, advanced fracture care and spine treatments have allowed patients to stay active longer and maintain independence as they age,” the doctor said. “The biggest impact is that orthopedic care can give people back parts of their lives they thought they had lost.”
“For many patients, the goal is no longer just to relieve pain; it is to restore movement, independence and quality of life.”
No. 2: Mental health treatment
For most of America’s 250 years, mental illness was largely treated indirectly with medication, or not at all when medication was ineffective, according to Dr. Russ Voltin, a West Virginia-based practicing psychiatrist and medical consultant at BrainsWay.
The biggest breakthrough, Voltin told Fox News Digital, has been neuromodulation therapies like deep transcranial magnetic stimulation (TMS), which are “clinically proven to non-invasively target the brain circuits involved in conditions such as depression and OCD, helping rebalance neural activity at its source.”
“Mental health is brain health, and for the first time, we have treatments designed to address it that way.”
For most of America’s 250 years, mental illness was largely treated indirectly with medication, or not at all when medication was ineffective. (iStock)
A generation ago, a patient who didn’t respond to medication had very limited options, he said.
“Today, a clinician can offer noninvasive brain stimulation in an outpatient chair – no anesthesia, no sedation, none of the prominent side effects of medication, and all with limited lifestyle interruption.”
The FDA recently expanded clearance for an accelerated Deep TMS protocol that shortens the initial phase of depression treatment from about four weeks of daily visits to just six treatment days.
“Mental health is brain health, and for the first time, we have treatments designed to address it that way.”
“For someone in a depressive crisis, this is the difference between waiting and getting better,” the expert said.
In clinical trials, roughly 78% of patients reached remission and more than 80% were still in remission a full year later.
“The biggest shift is that for people who once cycled through medication after medication with no relief, durable recovery is now a realistic goal rather than a hope.” (iStock)
“As a clinician, that last figure is the one that matters most: People going back to work, repairing relationships and re-entering their own lives, not just scoring better on a questionnaire,” Voltin said.
“The biggest shift is that for people who once cycled through medication after medication with no relief, durable recovery is now a realistic goal rather than a hope.”
No. 3: Cancer care
Cancer care has advanced dramatically over the past 250 years, with breakthroughs in prevention, screening, diagnosis and treatment transforming patient outcomes.
Leonard Kalman, MD, acting system chief executive at Baptist Health Cancer Care and acting executive medical director at Baptist Health Herbert Wertheim Cancer Institute in South Florida, said one of the most important breakthroughs in oncology is the understanding that “at its core,” cancer is a genetic disease.
Today, physicians can cure certain leukemias and lymphomas that were “once far more difficult to treat,” an expert noted. (iStock)
“Cancer can be driven by inherited germline mutations or by somatic mutations that occur in normal tissue and lead cells to become malignant,” he told Fox News Digital. “That discovery has transformed how we understand, diagnose and treat cancer.”
Today, physicians can cure certain leukemias and lymphomas that were “once far more difficult to treat,” the doctor noted.
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“We can also extend life while preserving quality of life for many patients with metastatic cancers — including diseases such as lung cancer, melanoma and prostate cancer, where treatment options were much more limited a generation ago,” Kalman said.
Many of those advances have shifted cancer care toward more individualized treatment, allowing physicians to tailor therapies based on a patient’s specific disease.
“For many patients, the goal is no longer just to relieve pain; it is to restore movement, independence and quality of life.”
“Advances in targeted therapies, immunotherapy, molecular testing and supportive care allow physicians to better personalize treatment, manage side effects and help patients live longer with a better quality of life, even when cancer has spread beyond the primary tumor,” the doctor said.
No. 4: Cardiovascular care
Tom Nguyen, MD, system chief executive at Baptist Health Heart & Vascular Care and chief medical executive at Baptist Health Miami Cardiac & Vascular Institute in South Florida, highlighted the ability to diagnose heart disease earlier and treat “even the most complex conditions” with safer, more precise and less invasive therapies.
“Cardiovascular disease remains the leading cause of death worldwide, but patients who once might have died in their 40s or 50s are now routinely living into their 80s and 90s with an excellent quality of life,” he told Fox News Digital.
Although cardiovascular disease is the leading cause of death worldwide, patients who once might have died in their 40s or 50s are now “routinely living into their 80s and 90s with an excellent quality of life,” the doctor said. (iStock)
Procedures like open-heart surgery, coronary artery bypass surgery, coronary stents, catheter-based valve replacement, advanced imaging and robotic heart surgery have “completely transformed what is possible,” according to Nguyen.
“Robotic heart surgery is a powerful example of how far the field has come,” he said. “For appropriately selected patients, surgeons can now perform highly complex heart procedures through much smaller incisions using robotic technology that provides exceptional visualization, precision and control.”
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The biggest achievement, Nguyen said, is not only helping people live longer, but also helping them “live better.”
“Today, heart and vascular specialists can perform procedures that would have seemed almost unimaginable just one generation ago,” he said. “Patients are surviving heart attacks, valve disease, rhythm disorders and complex vascular conditions at rates that would have been difficult to imagine decades ago.”
“Many complex cardiac operations that once required opening the chest can now be performed through small incisions, or robotically – allowing patients to recover much faster with less pain and disruption to their lives,” a doctor said. (iStock)
Success isn’t measured only by survival, Nguyen added. “Our ultimate goal is to help patients feel better and return to the lives they enjoy.”
No. 5: Neurology
Michael McDermott, MD, system chief executive of Baptist Health Brain & Spine Care and chief medical executive at Baptist Health Miami Neuroscience Institute, said the ability to safely operate on the brain is the greatest advancement in American neuroscience.
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“Less than a century ago, a craniotomy was an extraordinarily risky operation, and survival itself was far from guaranteed,” he told Fox News Digital. “Today, advances in anesthesia, electrocautery, imaging, surgical navigation, brain mapping and intraoperative neurophysiologic monitoring have transformed brain surgery into a highly precise and much safer procedure.”
The ability to treat acute stroke in real time has been “equally transformative,” McDermott noted.
The growth of artificial intelligence is “beginning to transform spine surgery,” a neurologist said, by helping physicians identify which patients are “most likely to benefit from complex corrective procedures and by allowing implants to be precisely modeled before surgery.” (iStock)
“Using advanced imaging and mechanical thrombectomy, physicians can now remove a clot from the brain and restore blood flow before permanent damage occurs in many eligible patients,” he said. “At the same time, innovations such as high-intensity focused ultrasound for essential tremor demonstrate how neuroscience has become increasingly precise and less invasive.”
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Today, neuro experts can accomplish tasks that “would have been difficult to imagine just one generation ago,” McDermott noted.
“We can remove blood clots from the brain during an active stroke, implant deep brain stimulation devices for Parkinson’s disease, and perform highly sophisticated brain and spine surgery using advanced imaging, navigation and artificial intelligence,” he said.
Medical advancements have improved quality of life in patients with brain tumors and spinal complications. (iStock)
Advances like image-guided surgery, intra-operative brain mapping, neurophysiologic monitoring and radio-surgery allow surgeons to remove tumors more safely while protecting areas of the brain responsible for movement, speech and other critical functions, he said.
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Beyond brain tumors, other advances across neuroscience, like corrective spine surgery, have allowed doctors to restore posture and mobility in patients with severe spinal deformities. Meanwhile, focused ultrasound can “significantly reduce tremors that interfere with everyday activities such as writing, eating or drinking,” McDermott noted.
“Increasingly, our goal isn’t simply to help patients survive – we’re helping them maintain their independence, preserve function and return to the lives they want to live.”
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Health
West Nile virus detected in southern state as health officials warn residents about mosquitoes
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Health officials in Nashville are urging residents to protect themselves from mosquito bites after West Nile virus was detected in mosquitoes for the first time this year.
The Metro Public Health Department (MPHD) announced the virus was found in a mosquito pool collected near Cass Street in North Nashville, marking the city’s first detection of West Nile virus in 2026 and the earliest positive mosquito sample of the season.
The detection comes after health officials reported elevated West Nile virus activity in mosquito pools during 2025, when one human case of the virus was confirmed.
“We can all play a role in reducing the presence of mosquitoes in our community, making our outdoor areas both more pleasant and safer from mosquito-borne diseases like West Nile virus,” Dr. Sanmi Areola, director of health at the Metro Public Health Department, said in a statement to Fox 17.
MEASLES-INFECTED TRAVELER MAY HAVE EXPOSED PASSENGERS AT LAX AND NEARBY HOTEL, HEALTH OFFICIALS WARN
A close-up shows mosquitoes feeding in Tehatta, India, on May 1, 2026. Health officials in Nashville recently detected West Nile virus in a mosquito pool, prompting residents to take precautions against mosquito bites. (Soumyabrata Roy/NurPhoto via Getty Images)
“As our team educates those in the area where West Nile virus was found, we hope the rest of our community does what they can to protect themselves and their families from mosquitoes this summer.”
According to the Centers for Disease Control and Prevention, West Nile virus is the leading mosquito-borne disease in the United States. Most people infected with the virus do not develop symptoms, but about one in five experience fever, headaches, body aches, vomiting, diarrhea or a rash. Fewer than 1% develop a serious neurological illness that can affect the brain or spinal cord, with older adults and people with weakened immune systems facing the greatest risk.
Public health officials routinely trap and test mosquitoes throughout the summer to monitor for West Nile virus activity. A positive mosquito sample does not necessarily mean people in the area will become infected, but it serves as an early warning that the virus is circulating locally.
In response to the positive test, MPHD said crews are distributing educational flyers in the affected neighborhood, increasing mosquito trapping, monitoring standing water and applying larvicide where needed to help reduce mosquito populations. The department said it does not spray insecticide to kill adult mosquitoes.
POTENTIALLY SEVERE MOSQUITO-BORNE VIRUS SURGES IN US ABOVE NORMAL LEVELS
The Aedes mosquito is a known vector for several viruses, including West Nile virus, yellow fever virus, dengue virus, chikungunya virus, and Zika virus. (Soumyabrata Roy/NurPhoto via Getty Images)
Residents can also request a free backyard inspection from the department’s Pest Management team to identify areas where mosquitoes may be breeding.
Health officials recommend eliminating standing water from bird baths, flowerpots, buckets, old tires, children’s toys and other outdoor containers where mosquitoes lay eggs. Trimming overgrown vegetation around homes can also help reduce mosquito activity.
A field sample of mosquitoes that could carry West Nile Virus is seen at offices of the Riverside County Department of Environmental Health on April 26, 2007, in Hemet, California. (David McNew/Getty Images)
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To help prevent mosquito bites, the health department recommends using EPA-approved insect repellents containing DEET, picaridin or oil of lemon eucalyptus, wearing long sleeves and pants outdoors during peak mosquito hours around dusk and dawn, and making sure window and door screens are in good repair.
Officials said reducing mosquito breeding around homes can help lower the risk of West Nile virus and other mosquito-borne illnesses throughout the community.
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