Health

FDA Approved Artificial Blood Vessel Despite Warnings

Published

12 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.

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Health

Top 5 states with the highest number of safe hospitals, according to new report

Published

12 hours ago

March 22, 2026

Press Room

Top 5 states with the highest number of safe hospitals, according to new report

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Hundreds of hospitals across the country are being recognized for keeping patients safe, and a handful of states stand out for having the highest number of top performers.

Healthgrades, a platform for finding doctors, health care providers and hospitals, released its 2026 Patient Safety Excellence Awards this month, naming 438 hospitals in 40 states that rank among the top 10% nationwide for patient safety.

The analysis highlights centers that excel at preventing serious, avoidable complications during hospital stays based on 13 patient safety indicators.

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Among all states, five had the highest number of hospitals earning the distinction: Texas, Florida, California, Ohio and Pennsylvania.

Hundreds of hospitals across the U.S. were recognized for top patient safety performance in a new report. (iStock)

These states led the nation in total award recipients, with counts ranging from 21 to as many as 62 hospitals, according to Healthgrades data cited by MedPage Today. The concentration of high-performing hospitals in these states may be partly driven by size, the outlet noted.

“The prevalence of recipients in a particular state could be related to something as simple as that state having a large number of hospitals,” a Healthgrades spokesperson told MedPage Today.

Nonetheless, the findings point to strong safety performance across several of the nation’s most populated regions, particularly major metro areas such as Los Angeles, Dallas-Fort Worth and New York City.

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Patients treated at these hospitals saw significantly lower risks for some of the most common and serious safety events that account for the majority of in-hospital complications, according to a news release.

The rankings are based on data measuring 13 patient safety indicators, including infections and complications. (iStock)

Compared to other hospitals, patients at award-winning facilities were 52.4% less likely to experience an in-hospital fall resulting in fracture; 57.5% less likely to suffer a collapsed lung related to procedures; 67.8% less likely to develop catheter-related bloodstream infections; and 71.9% less likely to develop pressure sores.

Those four indicators alone make up about 78% of all patient safety events, according to Healthgrades, and if all hospitals performed at the same level as this year’s recipients, more than 100,000 patient safety events could have been avoided between 2022 and 2024.

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“The data behind this year’s Patient Safety Excellence Award highlights how measurable improvements in safety can prevent thousands of complications,” Dr. Alana Biggers, a medical advisor at Healthgrades, said in a statement.

Hospitals were required to report zero cases of serious errors, such as leaving a foreign object behind during a procedure. (iStock)

“Hospitals that prioritize evidence-based safety practices not only achieve better clinical outcomes but also cultivate a culture where patients come first,” Biggers added. “These insights give individuals and families the information they need to make confident and better informed healthcare decisions.”

The award is based on an analysis of Medicare inpatient data, evaluating outcomes such as complications, mortality and preventable safety events. To qualify, hospitals must meet strict clinical thresholds and report zero cases of certain serious errors, such as leaving a foreign object behind during a procedure.

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Overall, 250 hospitals ranked in the top 5% nationwide for safety, including facilities affiliated with major systems such as Mayo Clinic, Cleveland Clinic and HCA Healthcare.

Ten states had no hospitals on the list: Alabama, Alaska, Delaware, Iowa, Maine, North Dakota, Vermont, Washington, West Virginia, Wyoming and the District of Columbia.

Some states had no hospitals on the list, highlighting gaps in access to high-quality care. (iStock)

Experts say factors including rural hospital shortages and “care deserts” may contribute to those gaps because patients in underserved areas often face longer travel times and arrive with more advanced conditions.

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Nearly one-third of this year’s recognized hospitals were new to the list, according to Healthgrades, reflecting continued shifts in hospital performance and safety practices across the country.

The full list of hospitals that received the Patient Safety Excellence Award can be found here.

Fox News Digital has reached out to Healthgrades for additional comment.

Deirdre Bardolf is a lifestyle writer with Fox News Digital.

Health

Widespread habit may raise colorectal cancer risk more than you think

Published

24 hours ago

March 21, 2026

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Widespread habit may raise colorectal cancer risk more than you think

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Colorectal cancer is now officially the leading cause of cancer-related death among men and women 50 and younger, according to research from the American Cancer Society.

While some risk factors — like age, family history and genetics — can’t be controlled, there are some lifestyle behaviors that can increase the chances of the disease.

One of those is drinking alcohol, which has been linked to an increased risk of at least six different types of cancer.

HIDDEN VIRUS INSIDE GUT BACTERIA LINKED TO DOUBLED COLORECTAL CANCER RISK, STUDY FINDS

The International Agency for Research on Cancer (IARC) classifies alcoholic beverages as a Group 1 carcinogen, which means there is strong, sufficient evidence that it causes cancer in humans.

Dr. Tereza Cristina Sardinha, chief of colon and rectal surgery services at Catholic Health on Long Island, New York, confirmed that alcohol is a well-known risk factor for all cancers, but particularly those of the gastrointestinal tract.

Drinking alcohol has been linked to an increased risk of at least six different types of cancer. (iStock)

“The alcohol, or ethanol, will metabolize and break down into acetaldehyde,” she shared with Fox News Digital. “This metabolism of alcohol is very toxic to the DNA of the cell, which over time can lead to the development of cancer.”

Alcohol also changes the microbiome of the gut, which is another strong factor in cancer risk, according to Sardinha.

Colorectal cancer is now officially the leading cause of cancer-related death among men and women 50 and younger. (iStock)

“The microbiome has a significant effect on many pathogens in the colon and rectum, and diet and alcohol definitely affect the types of bacteria in your gut.”

When the gut’s “first line of defense” is disrupted, it can trigger a series of changes, particularly DNA damage, inflammation and oxidative stress within cells, the doctor said.

“These processes are closely linked to cancer development, which is why alcohol is considered a carcinogen.”

NEARLY 40% OF CANCERS CAN BE PREVENTED WITH 3 LIFESTYLE CHANGES, STUDY FINDS

The relationship between alcohol and colorectal cancer risk is “dose-dependent,” she said.

“Patients who drink regularly for a long period of time, meaning at least 10 years, will have a lifetime increase in the development of colorectal cancer.”

“The negative impact of spirits (hard liquor) is greater than beer, which is more than wine,” a doctor told Fox News Digital. (iStock)

Research shows that for those who drink at least two drinks per day — which is considered “moderate consumption,” the doctor said — the lifetime risk of colorectal cancer will increase by at least 25%.

A heavier drinker, consuming more than two drinks a day, will have an exponentially greater risk.

COLORECTAL CANCER NOW DEADLIEST TYPE FOR CERTAIN GROUP OF AMERICANS, STUDY FINDS

“What really makes the difference is not only the volume but the frequency,” Sardinha said. “I just saw one of my patients who I operated on last week, and she drinks six beers a day, and she developed colon cancer. She’s not morbidly obese, she’s not a smoker. The only risk factor she has is alcohol.”

The doctor advises her patients to avoid alcohol “or at least minimize intake.”

“What really makes the difference is not only the volume but the frequency.”

If someone stops drinking, the risk won’t disappear immediately, the doctor noted.

“It takes about an average of 10 years to know if cancer risk decreased or not,” she said. “But we do know that if you continue drinking, your risk will definitely increase.

MOM WITH NO SYMPTOMS HAD STAGE 4 COLORECTAL CANCER — AND A RARE SURGERY SAVED HER LIFE

“That’s why we recommend that patients stop drinking or exponentially decrease their intake in the same way we tell them to exercise and increase fruits and vegetables in their diet.”

Sardinha pointed out that alcohol isn’t the only culprit.

“Not all heavy drinkers develop cancer, so there has to be some other mechanism that plays a role,” she said.

And not all types of alcohol are equal in terms of colorectal cancer risk, according to Dr. Nathan Goodyear, integrative medicine physician at Williams Cancer Institute in California.

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“The negative impact of spirits (hard liquor) is greater than beer, which is more than wine,” he told Fox News Digital.

A Danish study also found that wine consumption was associated with a lower risk of death, while beer and spirits were not, Goodyear pointed out. Spirits had the highest risk, especially at three to five drinks per day.

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“The effects of wine, beer and spirits were independent of each other,” the doctor said.

The context in which alcohol is consumed can also play a role, he noted.

In addition to stopping or limiting alcohol intake, doctors say other healthy lifestyle behaviors, like exercise, have been shown to decrease the chances of colorectal cancer. (iStock)

“In the U.S., alcohol is often used in the context of addiction — another hit to keep the high,” Goodyear said. “But in some communities, such as Sardina, Italy, and Ikaria, Greece, wine is part of the culture, social connections and community.”

“Wine is taken outside the context of addiction and taken within the context of a plant-based diet, social settings, daily movement, faith, community and life.”

Other ways to minimize risk

In addition to stopping or limiting alcohol intake, Sardinha shared other healthy lifestyle behaviors that have been shown to decrease the chances of colorectal cancer.

One “huge and well-established” factor is regular exercise, she said.

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“If you don’t exercise, if you don’t move, you definitely increase your risk of colorectal cancer,” she told Fox News Digital. “Even for patients who have been diagnosed with cancer, once they have surgery and are able to exercise, that will improve their long-term prognosis.”

Smoking is another highly carcinogenic habit, and it’s a common myth that it’s only associated with lung cancer.

“We do know that if you continue drinking, your risk will definitely increase.”

“Smoking is a risk factor for most cancers, and colorectal cancer is one of them,” Sardinha said.

Taking steps to address and prevent obesity is also a well-established way to minimize risk, as is adopting a healthy, high-fiber diet to promote proper bowel function, according to the doctor.

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“Diets that are lower in fiber are often more constipating, and, therefore, if there’s anything in the food that is carcinogenic, that is going to have more direct, prolonged contact with the bowel wall, with the cells, and increases the chances of DNA damage,” she said.

“Obviously, we cannot change our family history, but those good lifestyle habits will make a difference in the risk of colorectal cancer.”

Melissa Rudy is senior health editor and a member of the lifestyle team at Fox News Digital. Story tips can be sent to melissa.rudy@fox.com.