A Texas man’s mother has filed a lawsuit after he died following a penis enlargement treatment he received at the AdvancedYOU wellness center, seen here along East Mockingbird Lane in North Dallas. The lawsuit alleges the man underwent the treatment without adequate warnings, medical evaluation or physician oversight.
Chris Swann/The Dallas Morning News
Oren Varkony went to a Dallas wellness center last fall for a fourth round of injections meant to enlarge his penis.
That morning, court records show, he was injected with 10 syringes of hyaluronic acid filler, a gel-like substance commonly used in the face to smooth wrinkles and add volume. By that afternoon, back home in Round Rock, the 36-year-old was struggling to breathe. By that evening, he was dead.
An autopsy report provided to The Dallas Morning News by the family’s attorney determined Varkony died from a hyaluronic acid pulmonary embolism. That means filler had entered his bloodstream, traveled to his lungs and blocked small blood vessels there. The pathologist classified his death as an accident.
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Varkony’s mother is now suing William Moore, who performed the injections; AdvancedYOU, the Dallas wellness center founded by Moore where Varkony was treated; The PhalloFILL Clinics, a company started by Moore that marketed the procedure; and others involved in his care. She alleges in the lawsuit filed in late September in Dallas County District Court that her son underwent the treatment without adequate warnings, medical evaluation or physician oversight.
“The death of [Oren Varkony] was preventable,” the lawsuit says, alleging the treatment was sold under a system “engineered to minimize the involvement of any physician who might have said no.”
Moore, who is not licensed to practice medicine in Texas, declined to answer questions about Varkony’s case beyond a statement to The News, citing the pending litigation. He also declined to say whether other PhalloFILL patients have suffered serious complications.
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“We categorically deny these allegations and are confident the complete evidence will demonstrate that we acted appropriately and responsibly,” Moore wrote. “Because these matters remain pending, we will address the facts in the appropriate legal and regulatory forums, not through the media.”
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PhalloFILL lists providers of the procedure in 21 states, Puerto Rico, Canada and Mexico. The company says its network has performed thousands of treatments.
PhalloFILL’s website calls hyaluronic acid penis fillers “safe and effective,” says the treatment is non-surgical and reversible, and lists temporary swelling, tenderness and bruising as possible side effects. The company says its providers are trained in a protocol designed “to guide the injection process safely and consistently.”
Varkony’s attorney disagrees.
“It’s snake oil,” said Michael Sawicki, an attorney representing Varkony’s family. Sawicki said Varkony’s mother and sister declined to comment.
Two expert reports filed in the case by doctors hired by Varkony’s family, Beaumont anesthesiologist G. Ray Callas and Frisco plastic surgeon Nicholas Walker, concluded Varkony’s evaluation, injections, warnings and physician supervision fell below accepted standards and contributed to his death.
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The filler used on Varkony was Revanesse Versa+, according to the experts’ reports. The U.S. Food and Drug Administration has approved it for certain facial wrinkles and folds, not penis enlargement. Using an approved product for another purpose is called off-label use and is not, by itself, illegal.
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Texas considers penis filler injections the practice of medicine. A physician can perform them or authorize a properly trained person, the Texas Medical Board told The News.
“Texas law grants considerable latitude to the delegating physician,” board spokesman Spencer Miller-Payne said. “However, the supervising physician is responsible for the delegate’s treatment.”
The board has no rules specific to penis filler. Miller-Payne said officials know of “a few complaints about this topic, but the number remains low.”
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“Unfortunately, we cannot comment on any potential or pending investigations,” he said when asked whether the board was investigating anything related to Varkony’s death.
“We can’t really hurt someone with this”
Research on penis augmentation is limited.
A 2026 review listed on PubMed found 23 studies involving 2,620 patients in eight countries and concluded hyaluronic acid injections may have fewer complications than permanent fillers, but more research is needed.
In March, British-Nigerian influencer Igho “Tiny” Ubiribo, 43, died after receiving hyaluronic acid penis filler in Thailand. A London coroner ruled the injections caused a pulmonary embolism, the same cause of death listed for Varkony.
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Moore told MedEsthetics Magazine in 2023 that he began developing PhalloFILL in 2020 and initially tested the procedure on friends. At the time, he said a reassuring part about the procedure was “we can’t really hurt someone with this.”
“There’s nothing that we can hit that would shut off blood flow, so there’s nothing that we could hit that could cause a problem,” Moore told MedEsthetics.
On PhalloFILL’s webpage listing its Texas locations, the Dallas wellness center appears under “Doctor Name: William A. Moore.”
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His biography on AdvancedYOU’s website says he holds a master’s degree in health and human performance with a concentration in clinical exercise physiology and a bachelor’s degree in health and kinesiology.
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AdvancedYOU and the lawsuit identify Holly Barko, a board-certified anesthesiologist, as its medical director. Her Texas license is active, and her public state Medical Board profile shows no disciplinary history. Barko, who is also being sued by Varkony’s mother, hasn’t responded to phone and text requests from The News for comment.
The lawsuit alleges Barko was responsible for the protocols, delegation and supervision of PhalloFILL procedures at AdvancedYOU. But Varkony’s treatment notes don’t identify the physician who authorized Moore to perform the injections, court records show.
Four sessions
Before his first procedure, Varkony received a remote medical evaluation from an advanced practice registered nurse, according to the expert reports. The evaluation approved Revanesse but described only its approved facial uses and didn’t mention penis injections.
Varkony also signed a consent form acknowledging the injections were not FDA-approved for penis enlargement. It warned of infection, allergic reaction and tissue damage if a blood vessel became blocked and listed death among the general risks of invasive procedures.
Lawsuit records show Varkony prepaid $8,700 for 20 syringes of filler and underwent four sessions between June 25 and Sept. 3, 2025. Six syringes of filler were billed for each of the first three. He received 10 syringes in the final session, the most during any of his visits. Moore was the injector.
After Varkony’s first treatment in June, he texted that the head of his penis was “still swollen and numb” and felt “a lump on the left side near the tip,” according to the expert reports.
A person identified as “Bill,” whom the experts identified as Moore, replied: “I am 100% certain it’s not filler. It’s soft tissue injury from the needles and erection combined.”
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Varkony later texted “Bill” that he thought he might have caused “some kind of delayed onset reaction.” The lawsuit records don’t show that Varkony was examined in person or referred to a physician afterward.
Varkony’s final treatment in Dallas began around 11:30 a.m. Sept. 3. Hours later, he developed shortness of breath and called 911 from his Round Rock home, nearly 200 miles south of Dallas.
The autopsy says paramedics found him with dangerously low blood pressure and oxygen levels. Doctors initially treated him for a possible severe allergic reaction, but his condition worsened. He was pronounced dead at 7:28 p.m.
The autopsy found no evidence of an allergic reaction. Instead, the pathologist found material consistent with hyaluronic acid near where Varkony was injected and in small blood vessels in his lungs. The family’s experts suggest some filler may have entered his bloodstream during earlier treatments.
The lawsuit alleges he was not specifically warned that filler could enter his bloodstream, reach his lungs and kill him.
“To me, the real focus is what the defendants did in this case. That’s the real story,” Sawicki said. “And the fact that they’re promoting this to just about anybody and everybody.”