Oren Varkony, a 36‑year‑old resident of Round Rock, Texas, died on September 3, 2025 after receiving a fourth round of hyaluronic acid injections at a Dallas wellness center operated by William Moore. The autopsy determined the cause of death was a pulmonary embolism caused by filler material that entered his bloodstream and blocked vessels in his lungs.

Legal action filed

Varkony’s mother filed a lawsuit in Dallas County District Court in late September, naming Moore, the AdvancedYOU wellness center, the PhalloFILL Clinics network, and several individual providers as defendants. The complaint alleges that her son underwent the procedure without adequate warnings, proper medical evaluation, or appropriate physician supervision. The suit claims the treatment was marketed through a system designed to minimize physician involvement, making the fatal outcome “preventable.”

Defendant response

William Moore, who is not licensed to practice medicine in Texas, declined to comment on the specifics of the case, citing pending litigation. In a written statement he categorically denied the allegations and said the evidence will show the clinic acted responsibly. Moore indicated the matter will be addressed in legal and regulatory forums rather than through the media.

Procedure and regulatory context

PhalloFILL, the company that markets the penis‑filler procedure, lists providers in 21 states, Puerto Rico, Canada, and Mexico, and claims thousands of treatments have been performed. Its website describes hyaluronic acid penis fillers as “safe and effective,” noting that the procedure is non‑surgical and reversible, with temporary swelling, tenderness and bruising listed as possible side effects. The filler used in Varkony’s case was Revanesse Versa+, an FDA‑approved product for certain facial wrinkles but not for penis enlargement. Using an approved product for an off‑label purpose is legal, though it does not guarantee safety for that use.

Texas law treats penis‑filler injections as the practice of medicine. A physician may perform the injections or delegate them to a properly trained individual, provided a supervising physician remains responsible for the delegate’s treatment. The Texas Medical Board has no specific rules for penis fillers but acknowledges a few complaints have been received, though the number remains low. The board declined to comment on any pending investigations related to Varkony’s death.

Expert opinions

Two doctors hired by the Varkony family—an anesthesiologist and a plastic surgeon—concluded that the evaluation, injection process, warnings, and physician supervision fell below accepted standards and contributed to the fatal outcome. The experts noted that Varkony’s initial remote evaluation was performed by an advanced practice registered nurse who approved the filler for its facial uses but did not address its off‑label use for the penis.

Patient experience

Varkony prepaid $8,700 for 20 syringes of filler and underwent four treatment sessions between June 25 and September 3, 2025. After his first session he reported swelling, numbness, and a lump near the tip of his penis. Moore responded that the symptoms were “soft tissue injury from the needles and erection combined.” Varkony later expressed concern about a possible delayed reaction, but records do not show any in‑person examination or referral to a physician after the treatments.

During the final session on September 3, Varkony received ten syringes of filler—the highest dose of any session. Hours later, he experienced shortness of breath, called 911 from his home in Round Rock, and was pronounced dead at 7:28 p.m. The autopsy found no evidence of an allergic reaction; instead, hyaluronic acid material was identified in the lungs, suggesting filler entered the bloodstream during one or more of the treatments.

Broader context

Research on hyaluronic acid penis augmentation remains limited. A 2026 PubMed review identified 23 studies involving 2,620 patients across eight countries, concluding that while hyaluronic acid may have fewer complications than permanent fillers, more research is needed. Earlier this year, a British‑Nigerian influencer died in Thailand after a similar procedure, with a coroner ruling the injection caused a pulmonary embolism.

The case highlights ongoing concerns about the regulation of off‑label cosmetic procedures, the adequacy of medical oversight, and the responsibilities of wellness centers that market such treatments. As the lawsuit proceeds, it may prompt further scrutiny of Texas’s medical‑board policies and the practices of clinics offering penis‑filler injections.

Original reporting: Texarkana Gazette — read the source article.