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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.\u00a0<\/p>\n
Chris Swann\/The Dallas Morning News<\/p>\n
Oren\u00a0Varkony went to a Dallas wellness center last fall for a fourth round of injections meant to enlarge his penis.<\/p>\n
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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.<\/p>\n
An\u00a0autopsy report provided to The Dallas Morning News by the family\u2019s 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.\u00a0\u00a0<\/p>\n
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Varkony\u2019s mother is now suing William Moore<\/a>, who performed the injections; AdvancedYOU<\/a>, the Dallas wellness center founded by Moore where Varkony was treated; The PhalloFILL<\/a> 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.\u00a0<\/p>\n \u201cThe death of [Oren Varkony] was preventable,\u201d the lawsuit says, alleging the treatment was sold under a system \u201cengineered to minimize the involvement of any physician who might have said no.\u201d\u00a0\u00a0<\/p>\n Moore, who is not licensed to practice medicine in Texas, declined to answer questions about Varkony\u2019s case beyond a statement to The News, citing the pending litigation. He also declined to say whether other PhalloFILL patients have suffered serious complications.<\/p>\n Related: Texas AG announces second investigation into health insurer over delayed, denied care<\/a><\/p>\n \u201cWe categorically deny these allegations and are confident the complete evidence will demonstrate that we acted appropriately and responsibly,\u201d Moore wrote. \u201cBecause these matters remain pending, we will address the facts in the appropriate legal and regulatory forums, not through the media.\u201d<\/p>\n Article continues below this ad<\/p>\n PhalloFILL lists providers of the procedure in 21 states, Puerto Rico, Canada and Mexico. The company says its network has performed thousands of treatments.<\/p>\n PhalloFILL\u2019s website calls hyaluronic acid penis fillers \u201csafe and effective,\u201d 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 \u201cto guide the injection process safely and consistently.\u201d<\/p>\n Varkony’s attorney disagrees.<\/p>\n \u201cIt\u2019s snake oil,\u201d said Michael Sawicki, an attorney representing Varkony\u2019s family. Sawicki said Varkony’s mother and sister declined to comment.<\/p>\n Two expert reports filed in the case by doctors hired by Varkony\u2019s family, Beaumont anesthesiologist G. Ray Callas and Frisco plastic surgeon Nicholas Walker, concluded Varkony\u2019s evaluation, injections, warnings and physician supervision fell below accepted standards and contributed to his death.\u00a0<\/p>\n Article continues below this ad<\/p>\n The filler used on Varkony was Revanesse Versa+, according to the experts\u2019 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.<\/p>\n Related: Frisco counselor convicted in $26 million health care fraud over depression treatments<\/a><\/p>\n 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\u00a0The News.<\/p>\n \u201cTexas law grants considerable latitude to the delegating physician,\u201d board spokesman Spencer Miller-Payne said. \u201cHowever, the supervising physician is responsible for the delegate\u2019s treatment.\u201d<\/p>\n The board has no rules specific to penis filler. Miller-Payne said officials know of \u201ca few complaints about this topic, but the number remains low.\u201d<\/p>\n Article continues below this ad<\/p>\n \u201cUnfortunately, we cannot comment on any potential or pending investigations,\u201d he said when asked whether the board was investigating anything related to Varkony\u2019s death.<\/p>\n “We can’t really hurt someone with this”<\/p>\n Research on penis augmentation is limited.\u00a0<\/p>\n A 2026 review listed on PubMed<\/a> 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.<\/p>\n In March, British-Nigerian influencer Igho \u201cTiny\u201d Ubiribo, 43, died after receiving hyaluronic acid penis filler in Thailand<\/a>. A London coroner ruled the injections caused a pulmonary embolism, the same cause of death listed for Varkony.\u00a0<\/p>\n Article continues below this ad<\/p>\n Moore told MedEsthetics Magazine in 2023<\/a> 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.”<\/p>\n \u201cThere\u2019s nothing that we can hit that would shut off blood flow, so there\u2019s nothing that we could hit that could cause a problem,\u201d Moore told\u00a0MedEsthetics.<\/p>\n On PhalloFILL’s webpage listing its Texas locations, the Dallas wellness center appears under “Doctor Name: William A. Moore.”<\/p>\n