As VCUG survivors, we have no choice but to exist in a world that invalidates the truth of our lived experiences. In many cases, the profound emotional and physical pain we carry is not only dismissed by society, but by our own families and loved ones.
This is largely due to the gaslighting and misinformation peddled by “dominant players” in the growing billion-dollar VCUG market—specifically, healthcare companies who market the VCUG test as “painless” and “minimally invasive” with a low-risk profile.
In this blog, we’ll review the legal elements of the VCUG patient experience in defense of VCUG survivors.
VCUGs: Inflicting Harm on Generations of Patients Since the 1960s
The voiding cystourethrogram (VCUG) test is the “gold standard” for diagnosing vesicoureteral reflux (VUR) in pediatric urology. Since its initiation in the 1960s, the test has persisted unchanged. More notably, this test 1.) is being performed without the enforcement of a standardized protocol and 2.) in violation of the informed consent doctrine.
VCUG Misinformation & Over-Performance
The American Academy of Pediatrics (AAP) and the American Urological Association (AUA) have failed to implement a standardized protocol for VCUG for several decades. This is alarming given that research shows “VCUG protocols vary substantially” among medical institutions:
“Recent guidelines from the American Academy of Pediatrics (AAP) recommend a VCUG for children between 2 and 24 months of age with urinary tract infections but did not specify how this test should be performed” (November 2016).
Research also shows that VCUGs are over-performed, forcing many children to undergo them without medical necessity. Additionally, these organizations have failed to uphold their legal and ethical obligations under the informed consent doctrine by withholding reasonable information from parents and guardians (Canterbury v. Spence, D.C. Cir. 1972).
VCUGs & Child Sexual Abuse (CSA)
VCUG patients were repeatedly used as proxies for child sexual abuse victims in critically appraised research as early as 1990. The VCUG test has been repeatedly proven to result in comparable trauma to child sexual abuse (CSA) in 1990, 1994, and 2004:
“The study which has come closest to identifying the factors likely to be involved in children’s recall of child sexual abuse is a study by Goodman et al. (1990) involving children who experienced a Voiding Cystourethrogram (VCUG) test to identify bladder dysfunction...” (1997)
“Children’s memory for features of a VCUG experience were examined because this invasive procedure is similar in many respects to incidents of sexual abuse…” (1994)
“The VCUG procedure was used as the target event in this study because it is similar in many ways to child sexual abuse, the real-world behavior that we hope to generalize these results to…” (2004)
Providers have consistently failed to disclose all foreseeable risks of this procedure, which includes psychological trauma “equivalent” to that “of a violent rape, especially in little girls” (May 2014). In the majority of cases, ionizing radiation is the only risk disclosed to parents prior to the procedure, with no mention of any long-term effects. Even then, radiation is depicted as a “negligible” risk, which is clearly contradicted in the literature (2009; 2019).
Disclosing the Long-Term Effects of VCUGs
The AAP and AUA, whose industry relations influence medical institutions all over the world, have a moral and ethical responsibility to disclose all foreseeable risks of this pediatric procedure—a test that requires the child to be fully conscious while separated from their parents, forcibly immobilized using physical restraints or physical force by multiple adults, and involuntarily catheterized while persistent complaints of pain and requests to stop the procedure are ignored. These undisclosed risks include prevalent sexual and medical trauma observed in generations of former patients, including chronic avoidance of medical care and an inability to seek treatment for cancer screenings and reproductive care.
In light of new research, including the first-ever study establishing the long-term effects of VCUG in adulthood, the Unsilenced Movement is dedicated to exploring legal avenues for justice. Andrea McDonald recently published a brief 10-minute presentation at the University of Pennsylvania Perelman School of Medicine on the long-term impacts of VCUG, which you can read or watch below.
ACLU Files Lawsuits After Forced Catheterization: “Cruel & Barbaric”
In the adult medical setting, the performance of VCUG—a common pediatric procedure that routinely involves (1) physical restraint and involuntary catheterization of a naked child without topical agents, pain relief, or sedation (2) who is separated from their guardians (3) while disregarding persistent complaints of pain and requests to pause or halt the procedure—would be criminally prosecutable.
In 2017 and 2018, the ACLU filed two lawsuits following the forced catheterization of a three-year-old boy and adult plaintiffs (Hunter v. Avera St. Mary’s Hospital and Riis v. Pierre Police Department). “Imagine the Department of Social Services has just threatened to remove your child unless you agree to have their urine collected,” the ACLU states. “Under duress, you consent – only to watch the hospital staff hold your three-year-old son down and forcibly catheterize him while he screamed in pain.”
This is the damning reality for an overwhelming number of families whose children have VUR. Many guardians report feeling powerless and manipulated by medical personnel, including threats to contact CPS if the parent refused to consent to additional VCUG procedures for their child. Others report gaslighting by providers, such as informing parents that their child will likely die without undergoing another VCUG. Moreover, many providers promote the VCUG test—the alleged “gold standard” for diagnosing VUR in children since the 1960s—as the sole option for VUR diagnosis and management and treatment, rather than being informed and educated about the availability of various treatments and diagnostic approaches to VUR management and resolution.
In the 2017 lawsuit against the South Dakota Department of Social Services and, by extension, Avera St. Mary’s hospital, a statement by the ACLU reads:
“In order to gather information to charge his parents, the DSS subjected a vulnerable child to trauma and injury by forcible catheterization. Quite frankly, it’s cruel and barbaric to forcibly catheterize anyone, let alone a three-year-old child, and this process raises serious constitutional concerns…Any child, let alone those suspected of being victims of abuse or neglect should not be subjected to the additional trauma, indignity, and abuse of catheterization.”
Despite differences in legal framework, these facts are precisely what former VCUG patients and their loved ones are forced to reckon with in childhood and well into adulthood. Many former patients identify VCUGs as “medically sanctioned rape” due to prevalent effects of child sexual abuse (CSA) referenced throughout the literature. Regardless of VCUG patients consistently experiencing this procedure as “barbaric” and involuntary, former patients are consistently belittled and dismissed by medical professionals who argue the test was “in their best interests” or, worse, “saved their lives.” In many cases, this invalidation stems from the patient’s own parents and family members, who may never uncover the reality of the misinformation presented to them.
"Quite frankly, it’s cruel and barbaric to forcibly catheterize anyone, let alone a three-year-old child…[No] child should not be subjected to the additional trauma, indignity, and abuse of catheterization."
The concept of VCUGs as “life-saving” rings untrue given that (1) the VCUG is purely a diagnostic tool for the diagnosis of vesicoureteral reflux (VUR) and does not “treat” or improve VUR; and (2) there are alternative measures of care available that would be medically appropriate in many cases, and preferred by parents in the majority of cases due to safety and diagnostic accuracy (February 2022).
According to a 2022 study, parents “would agree with the use of both ceVUS and CEUS as a diagnostic tool again in 96% or 100% of the cases,” and “92.9% would prefer ceVUS to voiding cystourethrography (VCUG).” A more recent study in 2023 also confirmed that “the majority of parents preferred ceVUS…ceVUS was perceived to be more comfortable and provide better results. Many parents highlighted no radiation and no fluoroscopic machinery as factors in preference of ceVUS over fluoroscopy [VCUG].”
These numbers are staggering given that most hospitals do not promote or even offer safer alternatives like ceVUS, including the largest children’s hospital in the United States. Moreover, the vast majority of official medical websites promote the VCUG procedure as a routine outpatient procedure with a low-risk profile. Some of the most high-profile hospitals in the country continue to market the VCUG test as painless and minimally invasive; on the contrary, the literature describes voiding cystourethrograms as extremely invasive, painful, and stressful for children and parents alike.
These numbers are staggering given that most hospitals do not offer safer alternatives like ceVUS, including the largest children’s hospital in the United States.
In Hunter v. DSS, the ACLU states:
“Forcibly catheterizing anyone—let alone a three-year-old child—is barbaric at worst, and an unconstitutional practice at best. We wrote to DSS to demand that they stop catheterizing children and provide an explanation as to why this search was conducted, why the catheterization was permitted, and who made the decision to have this child tested. Further, we have asked the DSS to release their written policies regarding searches of children and catheterization.”
Today, we ask the same of same of the AUA, AAP, and affiliated institutions operating under their influence: (1) To cease the forcible catheterization of children without medical necessity and, notably, without first obtaining legally effective informed consent from the child’s guardian, including the disclosure of all foreseeable risks and alternative treatment options; (2) to provide an explanation as to why a VCUG may be medically necessary in favor of safer, less invasive, radiation-free alternatives, especially given the high rate of spontaneous VUR resolution in the majority of children with low-grade VUR and the high potential for severe psychological harm; and (3) to update and correct current clinical recommendations, standards, and policies governing the referral, performance, and follow-up protocols for voiding cystourethrograms (VCUGs).
Holding Professional Organizations Ethically Accountable for VCUG
The AAP and AUA have rejected persuasive evidence and unreasonably prolonged the performance of VCUGs for decades, robbing countless patients of the ability to recognize the harm they sustained and thus depriving them of the right to live happy, healthy lives by withholding crucial information that would surely impact the decision-making of VCUG patients and their guardians in many cases.
Both the AAP and AUA maintain key relationships with various stakeholders in the healthcare industry, including pharmaceutical companies, medical device manufacturers, and providers. In addition to influencing research, education initiatives, and the development of clinical guidelines in pediatric urology, these professional organizations also exercise a political influence in lobbying activities, influencing healthcare policies at the local, state, and federal levels.
The American Urological Association is especially active in influencing reimbursement policies and regulatory frameworks related to urological practice and standards. In 2023, the organization invested nearly a half-million dollars in lobbying expenditures. The AUA operates under a robust governance structure and has a significant responsibility to patients globally, including setting clinical standards that promote patient safety and high standards of care.
The American Academy of Pediatrics is the largest professional association of pediatricians in the United States. The organization has published hundreds of policy statements and practice recommendations that influence medical institutions within and beyond U.S. borders. In addition to its key role in disseminating best practices in pediatric care, the AAP also has the largest pediatric publishing program in the world, ranging from medical textbooks to practice management. The organization also engages in lobbying activities, including $980,000 in lobbying expenditures in 2023 alone.
Additionally, there are several major companies in the billion-dollar VCUG market, in which “unprecedented growth” is predicted between 2024 and 2031:
“The Global Voiding Cystourethrogram VCUG Market, characterized by a rapid and substantial growth in recent years, is anticipated to experience continued significant expansion from 2023 to 2031. The prevailing upward trend in market dynamics and anticipated expansion signal robust growth rates throughout the forecasted period. In essence, the market is poised for remarkable development.”
In 2024, the AUA and AAP have disclosed financial relationships with “dominant players” in the VCUG market, including Merck, Medtronic, and Pfizer.
Empowering Former VCUG Patients to Recover Their Voices
The vast majority of former VCUG patients are forced to exist in a world that not only constantly invalidates their traumatic experience, but also ignores the far-reaching impacts of VCUG that permeate every aspect of their lives. Many survivors are left to blame themselves for the life-altering effects of VCUG for years or decades, unaware that they are not alone in their unique hardships. Our grassroots organization has generated tremendous traffic and reached millions of people in the span of a few months.
With hundreds of survivors connected on various social media platforms in just one year, we anticipate many more coming forward to seek justice. At Unsilenced, we’ve met survivors as young as 10 and as old as 60. Our allies in the medical community, including pediatric providers, psychiatrists, mental health experts, physical therapists, and other specialists, have joined us in speaking out against the life-altering harm of this procedure.
At this time, I will focus on the legal framework in hopes of enlightening others to the urgency and validity of our cause.
Liability Under the Informed Consent Doctrine
While many former patients are restricted from taking legal action due to state-specific statutes of limitations, this test is still performed on up to 1 million children every year, including approximately 400,000 in the U.S. alone. The Unsilenced Movement has connected with many parents who were not informed of the psychological risks, and whose children are currently undergoing therapy or treatment for VCUG trauma.
For these reasons, we believe current performance of the voiding cystourethrogram (VCUG) procedure constitutes a violation under the informed consent doctrine: (1) the risks and benefits of the proposed treatment and of alternative treatments are not being disclosed; (2) with full information, guardians are likely to decline the proposed treatment for their child, specifically in favor of safer alternatives, and (3) the treatment, even when appropriate and carried out skillfully, is a substantial factor causing the patient’s injuries.
DUTY OF CARE
Providers and the affiliated professional organizations under which they operate owe pediatric patients and their guardians a standard of care that honors their Hippocratic Oath and the informed consent doctrine, including obtaining legally effective informed consent to ensure parents are equipped to make fully informed decisions for their child’s care. These obligations include:
Informing parents of all foreseeable information regarding a proposed treatment in a way that is easy to understand and includes both the parent and the patient in the decision-making process whenever possible, including the disclosure of all risks (including psychological harm) and disclosing safe, available alternatives (of which there are several, including a radiation-free test with a greater diagnostic value), including the option of no treatment; and
Establishing and enforcing a uniform standardized protocol for VCUG performance, referrals, medical necessity, sedation, and follow-up, especially given that children’s bodily tissues are tenfold as sensitive to ionizing radiation and research shows that “the range of [radiation] doses is extremely wide.”
BREACH OF DUTY
Courts have consistently upheld that informed consent is “predicated on the duty of a physician to disclose to a patient information that will enable him to evaluate knowledgeably the options available and the risks attendant upon each before subjecting that patient to a course of treatment” (Howard v. University of Medical & Dentistry of New Jersey, 2002). Similarly, in Matthies v. Mastromonaco (1999), the court upheld that “a physician has a duty to disclose information that will enable a patient ‘to consider and weigh knowledgeably the options available and the risk attendant to each.’” In Canesi v. Wilson (1999), the court ruled that an informed-consent plaintiff “must prove that a reasonably prudent patient in the plaintiff’s position would have declined to undergo the treatment if informed of the risks that the defendant failed to disclose.”
In other words, the plaintiff has legal standing to recover damages in an informed consent violation lawsuit if they can establish that, had they been fully informed about the nature and risks of the proposed treatment, they would have opted for an alternative measure of care or opted not to undergo the procedure at all.
In Canterbury v. Spence (1972), the court ruled that “true consent to what happens to one’s self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each…[It] is the prerogative of the patient, not the physician, to determine for himself the direction in which his interests seem to lie.”
For former VCUG patients who live with untreated PTSD for years or decades while wrestling with the inability to seek medical care, the right of their guardians to give informed consent to this over-performed procedure—often without medical necessity—is of the utmost importance. That decision rests solely in the hands of the patient and, by extension, their legal guardians who must consent on their behalf.
“True consent to what happens to one’s self is the informed exercise of a choice...It is the prerogative of the patient, not the physician, to determine for himself the direction in which his interests seem to lie.”
It is not up to any provider to dictate whether any foreseeable risk of VCUG, including post-traumatic stress disorder and a myriad of other mental and physical health conditions, is in the best interests of the patient’s holistic well-being. There are alternative measures available that do not carry the equivalent risks of lifelong trauma; however, patients and parents are still not afforded the right to bodily autonomy.
Put simply, even pediatric patients are deserving of the same dignity, respect, bodily autonomy, and legal protections that adult patients are afforded under the law.
A Call to Action for Pediatric Providers
This is not the first time the American Academy of Pediatrics has sought to evade the legal consequences of unethical priorities. Recent lawsuits testify to the far-reaching impacts of the AAP’s insistence on prioritizing profit over the safety of patients—even in a patient cohort as young and vulnerable as infants, toddlers, and children, who are particularly susceptible to these abusive practices due to their inability to legally consent to medical care.
Put simply, even pediatric patients are deserving of the same dignity, respect, bodily autonomy, and legal protections that adult patients are afforded under the law.
In State of Rhode Island v. Isabelle Ayala (2023), we again bear witness to the AAP’s efforts to discredit the patient experience while suppressing the value of critically appraised research as legitimate evidence of harm:
“Despite immediate and sustained criticism pointing out the misrepresentations and apparent lack of evidentiary backing in this policy statement, as well as a continually growing body of international research undercutting the policy statement’s conclusions and recommendations, Defendants have doubled- and tripled-down on their commitment to the policy statement and its ‘affirmative model’ of treatment, while continuing to promote and profit off it” (emphasis added).
Moreover, the AAP authored a new policy statement which “not only misrepresented or misleadingly presented its purported evidentiary support but was also rife with outright fraudulent representations.”
In the case of voiding cystourethrograms (VCUGs), the AAP has failed overwhelmingly in their response to decades-old evidentiary support that the VCUG test is over-performed and inflicts true and lasting harm on individuals well into late adulthood. The profound harm of child sexual abuse and sexual trauma on young developing brains and bodies is extensive and well-documented. Rather than enforcing a standardized protocol and taking the appropriate steps to fully inform parents and guardians of such risks, the AAP opted to publish “guidelines” in 2011, in which they acknowledge the potential for VCUG trauma but decline to take any concrete measures to improve testing performance and protocols.
Many families have suffered as a direct result of the AAP’s unwillingness to uphold their responsibilities under their Hippocratic Oath, including their obligation to respect the dignity and autonomy of patients regardless of age and other qualifying characteristics. Rather than establishing standardized protocols and taking the simple step to inform parents and patients alike of the psychological risks, which carry real and lasting harm, the AAP made no improvements or changes to the VCUG procedure.
In a 2017 study, the authors issued this conclusion after analyzing the guidelines issued by the American Academy of Pediatrics (AAP), National Institute for Health and Care Excellence (NICE), Italian Society of Pediatric Nephrology, Canadian Paediatric Society (CPS), Polish Society of Pediatric Nephrology, and European Association of Urology (EAU)/European Society for Pediatric Urology (ESPU):
“The analyzed guidelines tried to reconcile recent reports about diagnosis, treatment, and further diagnostics in pediatric UTI with prior practices and opinions, and economic capabilities. There was still a lack of sufficient data to formulate coherent, unequivocal guidelines on UTI management in children, with imaging tests remaining the main area of controversy. As a result, the authors formulated their own proposal for UTI management in children.”
A more recent 2023 study highlights the lack of efficacy of the 2011 guidelines in their survey of a large multisite pediatric care center:
“Despite established guidelines, practice patterns varied among pediatricians. Pediatricians typically followed the AAP's guidelines regarding VCUGs (62%), with only a few adhering to urologic recommendations (9%). Despite the consistency between AAP and AUA guidelines regarding the age at which to refer a patient for cryptorchidism, about 70% of practitioners referred patients too early or too late. Harmonized, consolidated guidelines between pediatricians and pediatric urologists would improve patient care and efficiency of the healthcare system.”
Conclusion
For decades, the AAP and AUA have failed to respond to concerns and evidentiary harm inflicted by their inability to establish a standardized protocol or VCUG performance, referrals, sedation methods, and follow-up; to enforce legally effective informed consent standards that respect the autonomy of parents and patients; to disclose the several safe and available alternatives that include a radiation-free procedure with an equal or greater diagnostic value; and to correct the widespread misinformation online and promoted in healthcare clinics regarding the risks that VCUGs pose to infants and adolescents.
Put simply, the availability of a radiation-free procedure with a comparable or greater diagnostic value that is also more affordable to families should, in theory, render the VCUG unnecessary, regardless of profitability for dominant players in the VCUG market. At the very least, longstanding research establishes the necessity of making two methods available to every child undergoing VCUG: (1) the standardized practice of topical agents or numbing gels for pain relief, and (2) safe sedation methods.
The decades-long failure of medical personnel and affiliated professional organizations in positions of authority and governance to take accountability for improving and standardizing quality care for pediatric patients has resulted in direct harm to patients and their loved ones. The AAP and the AUA exercise tremendous influence in the U.S. and beyond, and has had nearly 40 years to address prevalent concerns regarding the similarity of VCUGs to child sexual abuse (CSA) since 1990.
Join the Unsilenced Movement
Our organization is dedicated to restoring the agency of parents and children by ensuring families are fully informed of the risks of VCUG. While we are dedicated to empowering patients and their guardians to make fully informed decisions for their health, our top priority is respecting each individual’s right to bodily autonomy; thus, our organization does not seek to “ban” or terminate the availability of any medical care or procedure.
We fully support the VCUG test being available to those who choose it; however, it is an ethical and moral violation to offer and even push this treatment on families without disclosing all pertinent information under the informed consent doctrine.
For this, we hold providers and relevant medical institutions directly accountable for failing to equip individuals with the resources and information they need and deserve to make decisions in the best interests of their health.
Children deserve better than repeated exposure to the equivalent experience of “a violent rape.” We call on medical authorities in pediatric urology to take concrete steps to acknowledge this decades-long harm, improve the standard of care by establishing safer alternatives and standardized protocols, and properly educate families regarding their options for VUR diagnosis and management under the informed consent doctrine.
Only then can we hope to restore agency to the young and vulnerable patient cohort entrusted to their care, all of whom are equal human beings entitled to dignity and autonomy under the law.
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