False, Deceptive, and Misleading Marketing of Nonsurgical Medical Aesthetic Devices: A Nursing Informed Policy Brief

False, deceptive, and misleading marketing of nonsurgical medical aesthetic devices is a policy issue relevant to patient safety...False, deceptive, and misleading marketing of nonsurgical medical aesthetic devices is a policy issue relevant to patient safety and informed consent. These medical devices are being used at increasing rates (American Society for Aesthetic Plastic Surgery [ASAPS], 2018; CoolSculpting, 2020; The Aesthetic Society, 2022) for a variety of aesthetic concerns, by a variety of practitioners (Camp et al., 2010)— with and without formal training in a health care discipline (e.g., nursing, medicine), and in a variety of settings. These devices are not without risk of physical, psychological, and financial harm. While arguments around medical marketing practices have been well and increasingly described in the scientific literature and regulatory space, most have focused on the pharmaceutical and tobacco industries (Conko, 2011; Park et al., 2021; Schwartz & Woloshin, 2019). What is missing is an explicit consideration of medical device marketing. The dearth of literature and lack of attention in policy decision-making to medical device marketing limits available data for robust evaluation of its true impact. The purpose of this nursing-informed policy brief is to (1) provide an overview of the policy issue and context of false, deceptive, and misleading marketing of nonsurgical medical aesthetic devices, (2) present a balanced critique of viable policy alternatives, and (3) advance a recommended policy solution. The nursing lens is applied to assist in framing the issue and the desired outcome from a policy solution. Implications for nursing education, practice, and research are considered.

Policy Issue Identification

The policy issue of focus in this brief is false, deceptive, and misleading marketing practices and media of nonsurgical medical aesthetic devices classified and defined by the FDA as restrictedClass II (moderate risk) medical devices.

History and Relevant Background

Relevant background includes a focused review of informed consent in the context of industry-prepared materials (labeling), medical device regulation, and medical device marketing in the United States (U.S.). The focus is on medical devices so pharmaceutical and tobacco regulatory activities are excluded from this discussion.

Informed Consent

Consent to medical treatment or procedure is a legal requirement defined by the state and implemented in practice according to organizational policy. Healthcare professionals generally have an affirmative duty of disclosure, including the nature, purpose, risks, and benefits of, and alternatives to the proposed intervention. The exact scope and extent of this disclosure varies across jurisdictions. States are almost evenly split between two disclosure standards: malpractice and material risk (Pope, 2017), except Washington state, which updated its state informed consent law in 2016 to reflect a shared decision-making standard following a successful demonstration project.

From a clinical practice perspective, any practice that has adopted a nonsurgical medical aesthetic device is likely familiar with the typical marketing materials. Such materials include traditional promotional brochures, scripts for staff to discuss the new device with prospective and existing patients, web copy for use on the practice website, consultation guides, and informed consent documents. The critical point here is the device manufacturer writes these materials. This matters because if such industry-prepared materials contain false, deceptive, or misleading information about the nature and use of the medical device—or its safety and effectiveness, and these materials are used in the course of clinical practice, there are potential impacts on decision-making and consent to treatment that is adequately informed against deception and coercion. Nurses, physicians, and other healthcare team members may or may not question these materials before using them in clinical practice (Grundy et al., 2013).

Legal Authority and Purpose for Medical Device Regulation

The FDA is the official policymaking body with jurisdiction over medical device regulation.The FDA is the official policymaking body with jurisdiction over medical device regulation. Legal authority is primarily granted under the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA). The general purpose of the FDA in regulating medical devices is to protect the public by ensuring the safety and effectiveness of medical devices and communicating related activities and findings with the general public, healthcare consumers, and healthcare professionals. This is accomplished through a variety of administrative and regulatory functions.

Structure
The Center for Devices and Radiological Health (CDRH) is the branch of the FDA dealing with medical devices. The Medical Devices Advisory Committee supports medical device regulatory activities by making recommendations relating to device classification, possible health risks associated with device use, subject-specific concerns, device exemptions and bans, and clinical study designs about device safety and effectiveness; the Committee also reviews premarket approval applications, guidelines, and guidance documents (Center for Devices and Radiological Health [CDRH], 2019). The Committee consists of 18 panels; nonsurgical medical aesthetic devices generally fall under the purview of the General and Plastic Surgery Advisory Panel. However, there is no clear guidance or requirements for panel approval or involvement in regulatory decision-making.

Regulatory Requirements for Marketing Medical Devices
The Federal Trade Commission (FTC) and the FDA share regulatory authority for consumer protection to enforce truthful advertising in marketing practices of medical devices and to take action for violations. Legal authority is granted to the FTC through the FTC Act (FTCA) and to the FDA through the FFDCA. Shared activities are described through a memorandum of understanding. To simplify, the general division of oversight activities between the FDA and FTC—specifically for medical device marketing—is such that the FTC is primary over advertising other than labeling, and the FDA is primary over labeling and preventing misbranding of medical devices (Memorandum of Understanding Between the Federal Trade Commission and the Food and Drug Administration, 1971). The challenge presented by this guidance is the lack of clarity regarding what advertising, if any, is not considered device labeling as, “According to an appellate court decision: ‘Most if not all advertising is considered labeling….’” (CDRH, 2020, Advertising section). Whether a device is restricted or not appears to also guide whether the FDA (restricted devices) or FTC (nonrestricted devices) is primary.

State consumer protection acts offer some additional oversight and method for persons seeking legal redress for alleged harms by device manufacturers but are limited by federal preemption clauses in the FFDCA (Byrd, 2019; Congressional Research Service, 2013). Also relevant are nongovernmental—organizational or practice-specific policies for using and reviewing materials and marketing activities by medical device manufacturers, health care professional codes of ethics (professional self-regulation), and industry self-regulation with oversight activities by the National Advertising Division (NAD).

Key Definitions
See Table 1 for key terms defined for the purpose of this paper.

Table 1. Key definitions

Term	Definition
Medical device	“means a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, that is intended for use in humans” (21 CFR 1.71 “Medical device”). See Supplement 1 for the statutory definition of a “medical device” per section 201(h) of the FFDCA. Medical devices are classified according to risk, which informs the relevant regulatory requirements for the device (CDRH, 2022, Step 1 section).
Nonsurgical medical aesthetic devices	are “noninvasive or minimally invasive medical devices that intend to enhance or improve upon aesthetic concerns and include body contouring, skin tightening, and laser technologies” (Hagopian, 2019, p. 5). The focus of this brief is on nonsurgical medical aesthetic devices classified and defined by the FDA as restricted Class II (moderate risk) medical devices, subject to general and special controls. Note “[a] restricted device can only be sold on oral or written authorization by a licensed practitioner or under conditions specified by regulation” (CDRH, 2023b, Restricted devices section).
Labeling	of a medical device is defined by 21 CFR Part 801 and “includes labels on the device as well as descriptive and informational literature that accompanies the device” (Center for Devices and Radiological Health, 2023a, Labeling requirements section). Labeling requirements of medical devices marketed in the U.S. fall under the regulatory scheme of the FDA, and FDA action around labeling of medical devices is directed by Section 201 of the FFDCA (CDRH, 2020). Labeling is commonly thought of as the actual physical label that is affixed to the drug or device container or device itself along with its instructions for use; however, advertising material also falls under the umbrella term “labeling” and subject to FDA oversight.
Direct-to-consumer advertising (DTCA)	refers to industry prepared general public and health care consumer (patient)1-facing materials and marketing activities.
Health care professional (HCP) directed marketing	includes all health care professional-facing marketing materials and activities, such as scripted messaging of advertising, promotional, and patient education and consultation materials, directions or instructions for use of the device as defined above and “detailing visits” and similar activities, including promotional or sponsored meals and office visits by industry representatives (“device reps”).
Media	broadly defined as inclusive of any and all the “leave-behind” or products of communication. All other activities related to marketing other than media are described in this paper as “practices,” which includes, for example, detailing visits by industry representatives, speaker presentations delivered during industry sponsored meals or professional conferences.
Misbranding	“[a] device is misbranded when all or part of the labeling (i.e., the FDA-approved printed material providing information about the device) is false, misleading, or missing” (Johnson, 2016, p. 8). “A restricted device offered for sale in any State uses false or misleading advertising, or is sold, distributed, or used in violation of restricted device regulations under Section 820(e) of the FD&C Act” (CDRH, 2023c, Misbranding section).
Paradoxical adipose hyperplasia (PAH)	a reported complication of cryolipolysis with an estimated incidence “between 0.05% and 0.39%” (Cox et al., 2022, para. 2); and, is “a condition characterized by gradual, paradoxical adipose tissue enlargement in the treated area months after the procedure” (Cox et al., 2022, para. 2) which requires2 surgical intervention with liposuction or direct excision to treat (Nikolis & Enright, 2021).

Note¹ The terms “patient” and “health care consumer” are used interchangeably in this paper for describing all persons considering, seeking, and receiving care and counseling by a health care professional on the use of a nonsurgical medical aesthetic device 2No reports of spontaneous resolution or effective nonsurgical treatment were identified in preparing this paper.

Context

Political and Legal Factors
The political context to consider is the powerful lobbying presence of the medical device industry (Lenzer, 2012). Medical device manufacturers have faced much litigation related to marketing activities regarding direct-to-consumer advertising (DTCA) and healthcare professional-directed marketing and promotion (Marks, 2022). For example, Thompson (2017) reports on a False Advertisement Class Action Lawsuit,

In its motion, Zeltiq argues that “Zeltiq had no duty to educate consumers on parameters of the 510(k) process or clarify that FDA Cleared is not the same as FDA Approved.” Zeltiq also notes that “...their attempt to impose an additional, novel duty of disclosure on Zeltiq is contrary to California law, which rejects a broad obligation to disclose. Instead, the law imposes liability on manufacturers for omissions only where the undisclosed information relates to a known defect in a product that creates an unreasonable safety hazard,” the motion states. (para. 6-7)

The substantive difference in regulatory oversight regarding the safety and effectiveness of medical devices between the premarket notification [510(k)] and premarket approval (PMA) pathways and in the context of limited, if any, formal education on medical device regulation for health care professionals, prompts considering if the nondisclosure described in the above case does present an unreasonable safety hazard in misleading health care professionals. Examples abound of prudent healthcare professionals mistaking the terms as interchangeable.

A second example is a personal injury-product liability action filed by Evangelista, a professional model, against a nonsurgical medical aesthetic device manufacturer, which has prompted increased attention in the news and pop-culture media of nonsurgical medical aesthetic devices. In 2015, her dermatologist treated her with nonsurgical body contouring with CoolSculpting (Evangelista v. Zeltiq Aesthetics, Inc., 2022) , a nonsurgical medical aesthetic device that applies targeted cooling “intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas” through a process termed cryolipolysis (U.S. Food and Drug Administration [FDA], 2022, Definition section). Following treatment, Evangelista experienced a rare but known complication of CoolSculpting – paradoxical adipose hyperplasia (PAH) (Evangelista v. Zeltiq Aesthetics, Inc., 2022). The risk of PAH is an undesirable clinical outcome, but cues to possible policy failure are revealed in subsequent legal action: On September 21, 2021, Evangelista filed a personal injury – product liability lawsuit against Zeltiq Aesthetics, Inc., citing, “unlawful, false, misleading, and deceptive marketing practices and with a willful, wanton, and reckless disregard for her safety” resulting in physical, psychological, and financial harm (Evangelista v. Zeltiq Aesthetics, Inc., 2022, Document 1, p. 2). Media buzz has focused on the clinical issue of PAH—what it is and how it happens. Largely overlooked in the conversation is the policy issue around medical device marketing, highlighted by this legal action as, “The fight isn’t over what happened to the supermodel’s body, but whether or not the company gave her—and others—sufficient warning about the risk of adverse effects” (Marks, 2022, Drop Head Section).

Economic Factors
Healthcare consumer spending on nonsurgical aesthetic procedures is increasing (The Aesthetic Society, 2022). Practitioners--healthcare professionals and otherwise, counseling and performing procedures with nonsurgical medical aesthetic devices have an inherent financial conflict of interest to increase the volume of these procedures, often compounded by employment compensation structures and industry-prepared marketing materials designed to “upsell” nonsurgical procedures. Further, there is concern among healthcare professionals about the commercialization of plastic surgery (Nahai, 2013; Swanson, 2013). The cost of regulatory oversight in reviewing and responding to advertising and promotion of medical devices, including fieldwork, e.g., sponsored dinners, detailing visits, and conferences, is also necessary to consider.

Social Factors
A large body of evidence in the decision science and behavioral economics literature demonstrates the important role of cognitive biases in decision-making. There is explicit relevance to informed consent in that, “[d]efining risk is…an exercise in power” (Slovic, 1999, p. 699). When thinking about decision-making and consent processes for whether or not to proceed with a cosmetic procedure involving a nonsurgical medical aesthetic device, it is important to consider the consequences of four cognitive biases—availability, authority, confirmation, and framing biases. Marketing tactics often employ such biases in practice, for example, with a celebrity or “influencer” campaign or endorsement by a healthcare professional (Hagopian, 2019; Smith & George, 2018).

Technological Factors
Socioeconomic and environmental factors comprise the largest percentage of the determinants of population health (Catlin et al., 2010). Collectively referred to as the social determinants of health, these factors are upstream to clinical encounters, including the media and information environment (Stiefel & Nolan, 2012). Technological advancements and the availability of nonsurgical medical aesthetic devices are notable here. DTCA has evolved with social media marketing, which plays a substantive role in setting the social acceptability of cosmetic procedures and the presence of “influencers” (Hagopian, 2019; Smith & George, 2018). Healthcare consumers often present to clinicians asking for treatment with specific devices. Adopting new technologies in practice is primarily driven by consumer demand rather than evidence (Nahai, 2013; Swanson, 2013).

Interested and Concerned Parties

Interested and concerned parties include persons considering, seeking, and receiving treatment with a nonsurgical medical aesthetic device, health care professionals counseling and treating persons with a nonsurgical medical aesthetic device, the federal government (FDA, FTC), state attorneys general, the medical device industry, industry self-regulatory bodies (e.g., NAD), and health care professional associations, such as, the International Society of Plastic and Aesthetic Nurses (ISPAN), the American Society for Aesthetic Plastic Surgery (The Aesthetic Society), American Society of Plastic Surgeons (ASPS), the American Nurses Association (ANA), and the American Medical Association (AMA).

Nursing Perspective

Professional nursing values and obligations provide frameworks to consider the policy issue and the nursing response. The ANA Code of Ethics for Nurses with Interpretive Statements (2015) (the Code) guides the nursing profession in describing the nonnegotiable obligations of all nurses across all roles and settings practicing in the U.S. (ANA, 2015, Preface) and is explicitly noted as “both normative and aspirational” (p. viii). With nursing ethics fundamentally grounded as a social ethic, the Code helps nurses see the world as it is and as it could be in our (nursing) serving humanity. The Code informs the actions and behavior of nurses during informed consent, for example, in discussing the duty of nurses to minimize unwanted medical treatment related to a failure of informed consent (ANA, 2015, Provision 1, Interpretive Statement 1.3 The Nature of Health) and in describing a person’s right to necessary support in decision making for medical treatments. These attend to the context, or manner, of disclosure in addition to the content, or material, of disclosure in informed consent (ANA, 2015, Provision 1, Interpretive Statement 1.4 The Right to Self-Determination). The core nursing value of human dignity is relevant here. Nursing’s whole person view situates autonomy and self-determination in the context of respect for human dignity and informs a nurse’s role, professional scope of responsibility, and approach to supporting a person's decision-making and their consent or refusal to a treatment or procedure. “[N]ursing bases its commitment to respect for autonomy in human dignity. Nurses offer information and advice to patients in ways that exercise compassion, affirm patient dignity, and recognize the patient's uniqueness as a person” (Fowler, 2015, p. 18). In doing so, nurses consider actual and potential external and internal factors influencing decision-making. For example, the nurse critically appraises oneself for any biases or conflicts of interest at the intrapersonal level, and, at the interpersonal level, the nurse acknowledges the power differential inherent in the nurse-healthcare consumer relationship and authentically engages with healthcare consumers in decision-making (Crigger, 2009). Further considerations at the meso and macrosystem levels include the social and structural determinants of health, such as access to care, access to the internet, financial constraints, and power differentials beyond the nurse-patient dyad—to include information asymmetry among, for example, health care consumers, clinicians, and the medical device industry. Rather than a misplaced emphasis on the theoretical, detached, or acontextual individual choice, respect for human dignity appreciates the complexity of reality in that care, decision-making about care, and a person's health and wellness do not exist in a vacuum.

Explicit phenomena of concern to nursing as described in Nursing’s Social Policy Statement (2010) include “health literacy [and] decision making and the ability to make choices” (p. 14). Clarifying the role of the nurse and the context of care delivery related to advertising and promotion of medical devices lends further consideration of nursing expertise in the environment of care and nursing’s primary focus on human responses to actual or potential changing states of health and wellbeing. Here, the meaning of human responses concentrates on the human response to false, deceptive, or misleading advertising; collective human response can be drawn from decision science (The Decision Lab, n.d.) and behavioral economics literature. Relevant nursing diagnoses prompting a nursing response are associated with information behavior challenges, including decisional conflict, readiness for enhanced emancipated decision-making, and readiness for enhanced health literacy (Herdman et al., 2021). Decision quality is the desired outcome of consent and occurs when a person seeking and receiving care is informed, meaningfully involved, and the resulting decision is concordant with their values and preferences (Sepucha et al., 2013, 2016).

Issue Statement

The policy analysis...applied three criteria for evaluation: (1) Impact on the Decision Quality of Persons Considering, Seeking, and Receiving Treatment with a Nonsurgical Medical Aesthetic Device, (2) Feasibility, and (3) Cost...Labeling of medical devices should be monitored to ensure DTCA and healthcare professional-directed marketing and promotion is truthful, balanced, and not misleading.

Policy Goals and Objectives

The goal of federal regulation of medical device labeling is to ensure the safe and effective use of medical devices to protect and promote public health. Policy objectives include the following:

1. Support healthcare consumers and professionals in their ability to make informed decisions about the adoption and use of medical devices;
2. Ensure public-facing and professional-facing information about the safety and effectiveness of medical devices is truthful, balanced, and not misleading;
3. Educate the general public, healthcare consumers, and healthcare professionals on how to recognize and appropriately respond to medical device labeling that is false, deceptive, or misleading (or otherwise considered “misbranded”);
4. Facilitate engagement and vigilance of interested and concerned parties with reviewing industry-prepared materials and activities; and,
5. Take action against adulterated or misbranded medical devices (including labeling that is false, deceptive, or misleading).

Policy Options

Policy options to address false, deceptive, and misleading marketing practices and media of nonsurgical medical aesthetic devices classified and defined by the FDA as restricted Class II (moderate risk) medical devices include:

1. Do nothing option: Continue current methods of regulatory oversight and public and health care professional education. This includes (1) Passive oversight with no requirement for approval of final labeling by the FDA for medical device manufacturers applying for the 510(k) pathway; (2) A reactive approach to compliance and enforcement through (a) direct regulation at the federal level with shared authority between the FDA (per labeling requirements as prescribed by the FFDCA) and the FTC (truthful advertising as prescribed by the FTCA); (b) tort liability at the state level (State consumer protection acts); (c) industry and health care professional self-regulation (NAD; health care professional associations); and, (3) No formal outreach and awareness program to educate the general public, health care consumers, or health care professionals on how to recognize and respond to false, deceptive, and misleading advertising and promotion of restricted medical devices, and absent or variable organizational or practice-specific policies for use and review of industry-prepared materials.
2. Incremental change option: Increase formal awareness and outreach programs to health care professionals. This includes adapting the Office of Prescription Drug Promotion (OPDP), FDA, and FTC BadAd Program (focused on prescription drug promotion) (Abrams, 2020) for restricted medical devices to educate healthcare professionals on device labeling—including both direct-to-consumer and healthcare professional directed marketing that present a regulatory concern, and how to recognize and report false, deceptive, and misleading advertising and promotion of restricted medical devices. The BadAd program helps healthcare professionals learn to recognize and respond to common regulatory issues in prescription drug promotion, including minimization of risk, exaggeration of effectiveness, and unsubstantiated claims (Abrams, 2020). Potential policy levers include indirect regulation at the federal level through funding (e.g., if led by the FDA CDRH), direct regulation at the state level through professional licensing boards, or self-regulation through developing professional education standards on medical device regulation.
3. Major change option: Active oversight of health care professional-directed marketing. This would require manufacturers of all restricted (FDA Class II-III) medical devices to submit all healthcare professional-directed marketing and promotional materials for final approval by the FDA before use. Potential policy levers include direct regulation at the federal level through strengthening and expanding the regulatory authority of the FDA over healthcare professional-directed marketing and indirect regulation at the federal level through funding necessary to accomplish active oversight as described.
4. Major change option: Ban DTCA of restricted (FDA Class II-III) medical devices. This alternative was discarded and not included in the critique, with the rationale of it not being a viable policy solution in the U.S., given the constitutional arguments related to protected commercial speech. It is listed here, however, because a review of recent history reveals strong, but unsuccessful, attempts to advance this alternative. Leading proponents calling for a ban of DTCA for prescription drugs and medical devices include the American Medical Association (2015). 

Policy Analysis

Criteria for Evaluation
The policy analysis presented below applied three criteria for evaluation: (1) Impact on the Decision Quality of Persons Considering, Seeking, and Receiving Treatment with a Nonsurgical Medical Aesthetic Device, (2) Feasibility, and (3) Cost, in critiquing each policy alternative. See Table 2 for the full description of each criterion used for this analysis.

Table 2. Criteria for evaluation

Criterion	Description
Impact on the decision quality of persons considering, seeking, and receiving treatment with a nonsurgical medical aesthetic device	This criterion focuses on the potential of the policy option to meaningfully impact decision quality, examining informedness, meaningful engagement in decision-making (shared decision-making), and decision concordance with informed preferences and values (Sepucha et al., 2013, 2016), reflective of best available evidence and persons unique circumstances.
Feasibility	This criterion identifies the realistic potential of the option to succeed with consideration of political will, engagement of interested and concerned parties, and operational considerations—including around implementation, fitness with local context, and potential for unintended consequences. This criterion also assesses the reasonable likelihood of improving the recognition of and appropriate response to medical device labeling (and other medical device advertising and promotional material and activities) that is false, deceptive, or misleading.
Cost	This criterion evaluates cost, including sustainability considerations, around potential sources and size of available funding.

Critique of Policy Options

Critique of Option 1
Do nothing option.

Criterion 1: Impact on the Decision Quality of Persons Considering, Seeking, and Receiving Treatment with a Nonsurgical Medical Aesthetic Device
Pro. The current marketing methods promote awareness of the availability of nonsurgical options and access to clinicians—which could support an argument of decision quality related to informedness, as persons may not otherwise know about such devices and clinicians sans marketing activities.

Con. The fundamental purpose of marketing is to increase the use of advertised medical devices toward increased profit. Reasonable concern exists about consumers learning of nonsurgical medical aesthetic devices outside of counseling with a qualified healthcare professional, given the potential for anchoring bias, inherent financial conflict of interests, and the market presence of actors performing aesthetic procedures—the presence of all of which may contribute to misleading health care consumers (Smith & George, 2018). Subjective arguments for and against DTCA and other forms of marketing and promotion by the medical device industry are notably limited by the paucity of research on the subject matter.

Criterion 2: Feasibility
Pro. Continuing current oversight methods requires no change, so is assumed to be feasible.

Con. Current methods of oversight are vague. The usability and usefulness of current methods for reporting false, deceptive, and misleading advertising are limited by unclear and inconsistent communication to interested and concerned parties—namely healthcare consumers and professionals. Burdensome voluntary reporting with vague guidance for healthcare consumers and professionals presents a concern for meaningful participation in reporting activities.

Criterion 3: Cost
Pro. Continuing current practice requires no additional cost.

Con. There is concern for potential financial harm to persons receivingunwanted or unwarranted treatments with a nonsurgical medical aesthetic device as a consequence of being misled by marketing media and practices. The potential loss of trust in the healthcare consumer-professional relationship related to marketing activities is of further concern. A call for further research on “[e]xamining the effect of advertising and the level of patient wariness of physicians who accept industry-based payments, for example, could prove useful” (Ortiz & Rosenthal, 2019, p. 41).

Critique of Option 2
Incremental change option.

Criterion 1: Impact on the Decision Quality of Persons Considering, Seeking, and Receiving Treatment with a Nonsurgical Medical Aesthetic Device
Pro. Awareness and outreach efforts support ongoing initiatives at the FDA OPDP related to increasing healthcare professionals' ability to recognize and respond to common tactics used in pharmaceutical marketing (Abrams, 2020) and to increase awareness of goals from Healthy People 2030 related to health literacy (Healthy People 2030, n.d.).

Con. Increased formal awareness and outreach efforts may not produce the desired result—careful attention to planning, methods, and evaluation measures to accurately assess impact is critical. Another relevant factor to consider is whether participation and completion of any educational program is made voluntary or mandatory for health care professionals, such as for continuing education credit submitted with licensing or certification renewal.

Criterion 2: Feasibility
Pro. The BadAd program for prescription drug promotion offers an existing model for educational programming with demonstrated effectiveness (Abrams, 2020).

Con. Efforts to promote engagement by interested and concerned parties may require resources that are currently unavailable. Further, the action of reporting (i.e., where and to whom) and the need for the reporting system to respond may not be feasible in the current regulatory structure as there is not an “Office of Medical Device Promotion” equivalent to the OPDP at the FDA. An increase in device reports by healthcare professionals without the infrastructure to support the review and response to them may negatively impact the program's effectiveness.

Criterion 3: Cost
Pro. Adopting the BadAd program design of an online, self-directed tutorial reduces the cost and need for in-person instructors. The program is likely sustainable through several potential funding streams. For example, if led by the FDA CDRH, one option is to use the fees from manufacturers applying to market their devices in the U.S. per the Medical Device User Fee Act (MDUFA) to support the program. Relevant healthcare professional associations could lead the development, implementation, and maintenance of the educational program as another option.

Con. There is an upfront cost to adapt the BadAd program for medical devices and ongoing costs associated with maintaining a website to house the program, its usability, and updating the learning content as appropriate.

Critique of Option 3
Major change option.

Criterion 1: Impact on the Decision Quality of Persons Considering, Seeking, and Receiving Treatment with a Nonsurgical Medical Aesthetic Device
Pro. The substantial role of healthcare professional-directed marketing is pivotal to this issue. Most promotional spending by the pharmaceutical industry is on marketing to healthcare professionals. Marketing to healthcare professionals outspent DTCA by 3:1 in 2017, with more than $18.5 billion out of a $24 billion budget spent on direct marketing to healthcare professionals (Abrams, 2020). A 2021 study exploring Open Payments data found that “relative to drug firm payments, device firm payments [to physicians] as a percentage of industry revenue were seven times as large” (Bergman et al., 2021, Abstract). News reports echo concerns relevant to the medical device industry (Schulte & Lucas, 2021).

Con. The limited evidence around the impact of industry payments to healthcare professionals on this issue lessens support for this action. Furthermore, more data on industry payments to healthcare professionals related explicitly to nonsurgical medical aesthetic devices is needed. These payments are not subject to the exact reporting requirements as manufacturers of devices eligible for payment under Medicare or Medicaid (U.S. Centers for Medicare & Medicaid Services, n.d.), so it may be challenging to capture.

Criterion 2: Feasibility
Pro. Focusing on healthcare professional-directed marketing (labeling) for active regulatory oversight, as opposed to more broadly on all industry-prepared marketing, may be met with less opposition by the device industry. Given the potential under this regulatory scheme for rejection of a device application based on reasons related to marketing, this option may also prompt improved industry self-regulation to avoid time delay in moving the device to market.

Con. Collaboration between interested and concerned parties is necessary because the issue extends beyond the scope of healthcare professionals (Dyer, 2001). Concerns exist regarding the limitations of current regulatory structures to support an increase in review and response to reports on marketing practices. A potential unintended consequence is that this option may only give the illusion of active oversight if the structure and support are insufficient, which may undermine or decrease vigilance in reviewing industry-prepared materials by end-users (i.e., healthcare consumers and healthcare professionals).

Criterion 3: Cost
Pro. One potential funding source is increased fees required of device manufacturers submitting a device application (PMA or 510(k) pathway) to market a device in the U.S.

Con. If the aforementioned funding stream is adopted, anticipating pushback from the industry is prudent. The possibility of decreasing the number of devices brought to market with the potential to advance the health and wellness of people in the U.S. is a possible unintended consequence.

Comparison of Policy Options
Analyzing proposed policy alternatives using a scorecard (Table 3) shows option 2, incremental change by increasing formal awareness and outreach programs to health care professionals on recognizing and responding to false, deceptive, and misleading advertising and promotion of restricted medical devices, as the clear lead for recommendation. Reasons for the failure of option 1 (do nothing) center on the fundamental lack of regulatory attention to marketing practices of the device industry as being no longer acceptable. The current political and social climate is also favorable for a policy response, mainly concentrating on education. Reasons for the failure of option 3 (major change) primarily focus on the limitations of the current structure and resources of the FDA CDRH to realistically accommodate the active reviewof all health care professional-directed marketing.

Table 3. Scorecard comparison of policy alternatives

	Alternatives
Criteria	Continue current oversight	HCP education and outreach programs	Active regulatory oversight of HCP-directed marketing
Impact on decision quality	-	+	+
Feasibility	+	+	+/-
Cost	+	+	-
	2+/1-	3+	2+/2-
Score for each alternative	1	3	0

Note: HCP, health care professional.

Noted Limitations of Data Quality and Availability
There is limited data in the literature on the marketing of medical devices. The context for the discussion is focused on nonsurgical medical aesthetic devices, but when this data is unavailable, it includes the pharmaceutical and tobacco industries, as these labeling regulatory requirements also fall under FDA purview.

Summary and Recommended Policy Solution
Labeling (including DTCA and professional-directed marketing and promotion) of restricted medical devices should be monitored to ensure industry-prepared materials and communications are truthful, balanced, and not misleading. Increasing formal awareness and outreach programs to healthcare professionals by adapting the FDA OPDP BadAd Program for restricted medical devices to educate healthcare professionals is recommended for policy action. Educational programming should include medical device regulation, device labeling, and how to recognize and appropriately respond to false, deceptive, and misleading advertising and promotion of restricted medical devices. Case studies could highlight issues presented in this brief with nonsurgical medical aesthetic devices classified and defined by the FDA as restricted Class II (moderate risk).

The reality of the FDA or other healthcare professional associations developing, adapting, and implementing medical device-specific programming may prove challenging and take considerable time to implement—at least in the short term. Regardless, some lessons and recommendations can be readily implemented in nursing education, practice, and research. A call to action to educate healthcare professionals on recognizing and appropriately responding to false, deceptive, and misleading advertising is vital.

Implications for Nursing Education

Implications for nursing education include preparing nurses to recognize and respond to false, deceptive, and misleading claims in industry-prepared patient education and informed consent materials. Educators could include content about media and marketing when discussing the social determinants of health, including the safe use of social media, and the importance of qualified healthcare professional presence in this informational space.

Medical Device Regulation
Content on medical devices in core nursing curricula is limited and variable across programs. Instead, learning about medical devices is variably placed in professional development courses such as quality and safety, informatics, and, perhaps, policy and professional leadership. The point is not to argue that a device-specific course is necessary, but rather to call attention to an essential gap in learning that may be present. Medical devices range from everyday exam gloves and other personal protective equipment to implanted devices such as artificial hips, breast implants, mechanical heart valves—and everything in between. Without education on how medical devices are regulated, nurses may likely make false assumptions or be otherwise misled about medical device safety, effectiveness, and appropriate use (including scope of practice considerations and professional liability coverage around off-label use of devices). As such, medical device regulation education should include an overview of device classification, the most common premarket regulatory pathways for legally marketing a device in the U.S., and how to report adverse events involving a medical device (Swayze & Rich, 2011).

Supplement 1

Medical device “means a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, that is intended for use in humans” (21 CFR 1.71 “Medical device”).

Per Section 201(h) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• (A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o)

(CDRH, 2022, Step 1 section).

Information and Media Literacy
Information literacy is threaded throughout nursing education and heavily concentrated in research and evidence-based practice courses. A key consideration is to include all types of media used and encountered during everyday nursing practice. Media literacy should be focused on recognizing common regulatory concerns with promotional and other healthcare consumer and healthcare professional-directed media and practices. For example, evaluation of industry-prepared materials (e.g., brochures) used to support patient education, and appraising research articles on the topic to inform decision making. Healthcare professionals must evaluate effectiveness studies to readily identify false and misleading claims, such as overstating effectiveness. Curricular content preparing nurses to perform patient education should include assessing for information challenges (e.g., uninformed, mis- or disinformed, information overload) and how to appropriately respond (e.g., educational response, fact-fallacy-fact messaging, evidence-based shared decision-making).

Table 4. Additional resources to support education and practice

Topic	Resources
Medical device regulation	Center for Devices and Radiological Health. (2023b). Overview of device regulation. U.S. Department of Health and Human Services, U.S. Food and Drug Administration. Retrieved October 09, 2022, from https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation Johnson, J. A. (2016). FDA regulation of medical devices (No. R42130). Congressional Research Service, 53, https://sgp.fas.org/crs/misc/R42130.pdf
Medical marketing	The FDA Bad Ad Program and Prescription Drug Promotion: https://www.fda.gov/drugs/office-prescription-drug-promotion/bad-ad-program Schwartz, L.M., & Woloshin, S. (2019). Medical marketing in the United States, 1997-2016. JAMA, 321(1), 80-96. https://doi.org/10.1001/jama.2018.19320 Hagopian, C. O. (2019). Ethical challenges with nonsurgical medical aesthetic devices. Plastic Surgical Nursing, 39(1), 5. https://doi.org/10.1097/PSN.0000000000000253 Smith, C. P., & George, D. (2018). When is advertising a plastic surgeon’s individual “brand” unethical? AMA Journal of Ethics, 20(4), 372–378. https://doi.org/10.1001/journalofethics.2018.20.4.msoc2-1804
Reporting adverse events	Swayze, S. C., & Rich, S. E. (2011). Promoting safe use of medical devices. Online Journal of Issues in Nursing, 17(1), 9. U.S. Food and Drug Administration. (n.d.). MAUDE—Manufacturer and User Facility Device Experience [Database record]. U.S. Department of Health and Human Services. Retrieved October 09, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

Supplement 2
Action-oriented Appraisal for Media Use in Clinical Practice

Consider applying an action-oriented appraisal by asking three practical questions:

1. What is the purpose?
   • Promoting, such as, we have [x] service, price, provider, or similar type language?
   • Informing, educating, or deciding about a condition, diagnosis, medication, medical device, or otherwise?
   • Entertaining?

   To determine the purpose, consider the author, including their actual or appearance of conflict of interest. In reviewing, consider the validity (trustworthiness, the credibility of the author and source), applicability or relevance, and importance. Ensure that materials do not contain common regulatory concerns such as exaggerated claims, for example, in overstating effectiveness; omitted or minimized risks; or include misleading comparisons, for example, with differing clinical study designs, methods, and patient populations in whatever is being presented. Information should be truthful, balanced, and not misleading.

2. What prompts review?
   • New materials or changes in guidelines, evidence, personnel, or resources.
3. Who is the person or people-in-context?
   • Who is using the media, when are they using it, and why (for what purpose)? What are their unique circumstances, internal factors (e.g., personal health literacy, attention, and information processing capacity), external factors such as time, context (e.g., illness, grave diagnosis, stress), and are the materials readily available when needed?

Implications for Nursing Practice
Recommendations for nursing practice include intrapersonal factors, interpersonal factors, and environment of care considerations. At the intrapersonal level, nurses must understand the mechanism of action of the medical device or devices they are using, preparing, or promoting. Just as there is an expectation to understand the mechanism of action of drugs when passing or prescribing medications, there is an expectation that nurses understand the medical devices they are using.

Inventorying all media used by the practice in the care environment is essential to identify marketing gaps. This includes all “leave-behind” or communication products, web copy, educational or promotional brochures and handouts, phone scripts, informed consent documents, and other industry-prepared materials healthcare providers and consumers use. Reviewing and critically appraising all media used in practice is essential, as is developing a policy and procedure for using and reviewing industry-prepared materials. Healthy People 2030 offers updated policy guidance for organizational health literacy in recognizing the responsibility of producers and disseminators of health information (Healthy People 2030, n.d.).

The medical device industry and its representatives hold differing values and priorities than health care professionals—the former is generally understood as considering values of safety and quality care—including education and consent, as a means to an end of profit, and the latter considering such values as ends in themselves. There is a responsibility to continue a dialogue with patients and the public to question false and misleading claims and to push back against deceptive tactics (Nahai, 2013; Solomon et al., 2016). If healthcare professionals refused to use deceptive marketing materials (Nahai, 2013), would the device companies not have to change to improve their education and promotional activities? This question is based on the assumption that in the context of restricted devices, the medical device industry—despite its considerable market power—is to some degree ultimately bound by the need of a qualified health care professional to prescribe and administer their manufactured device.

There is a parallel here to the role of physician-directed marking efforts by the pharmaceutical industry in contributing to the harm of the opioid epidemic (Keefe, 2021). Healthcare professionals ought to learn from the danger of medical marketing tactics employed, for example, around detailing visits by pharmaceutical sales representatives (“drug reps”) (Keefe, 2021), and must be vigilant in recognizing the same patterns with the medical device industry. Specifically, it is prudent to review any industry-prepared materials before use in clinical practice. Healthcare professionals are responsible for recognizing, removing, revising, and reporting false, deceptive, and misleading advertising. Similar work by other health care professionals offers guidance for teaching and learning about acceptable DTCA (American Medical Association, 2022).

Implications for Research

Implications for research include expanding current research methods to consider evolving designs such as digital ethnography developed by those studying media manipulation and other critical internet studies (Media Manipulation Casebook, 2020). For example, applied to the Evangelista v. Zeltiq Aesthetics, Inc. (2022) lawsuit, the internet is a valuable archive that allowed retrieval of the device manufacturer's language related to the safety and effectiveness of the device, including information specifically about PAH, at the time Evangelista was making decisions about and receiving CoolSculpting procedures. Further implications for research include identifying gaps in evidence regarding improving practice and understanding the impact of marketing practices and media on health outcomes.

Conclusion

This nursing-informed policy brief describes the policy issue of false, deceptive, and misleading marketing of nonsurgical medical aesthetic devices. Education about medical device regulation and common regulatory concerns with marketing practices and media encountered and used in everyday clinical practice and beyond is lacking for nurses and other healthcare professionals. Viable policy alternatives for addressing the issue are critiqued, and a policy solution of increased formal education for healthcare professionals on recognizing and responding to false, deceptive, and misleading marketing of medical devices through adaptation of an existing awareness and outreach program is presented. Implications for nursing education, practice, and research are discussed.

Author

Chelsea O. P. Hagopian, DNP, APRN, AGACNP-BC
Email: cpharr@emory.edu
ORCID ID: 0000-0001-7267-0095

Chelsea O. P. Hagopian is an Assistant Clinical Professor at the Emory University Nell Hodgson Woodruff School of Nursing and serves as Executive Director for the Georgia Nursing Workforce Center. She holds a Doctor of Nursing Practice in Health Systems Leadership. Her scholarship focuses on informed consent and ethical challenges with nonsurgical medical aesthetic devices. She has practiced clinically in plastic and reconstructive surgery as a registered nurse and an ANCC board-certified adult-gerontology acute care nurse practitioner.

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