Introduction

Surgical treatment of obesity is often felt to be controversial by lay people, the media, health politicians, and professionals [1]. The causes of obesity are under considerable investigation by biomedical, behavioral, and social scientists. Obesity (bariatric) surgery is an effective treatment of morbid obesity, but does not remove the social causes of obesity nor solve the “obesity epidemic” on a public health level [2–4]. The number of operations performed has increased dramatically, but the number of obese people potentially benefiting from surgical treatment outnumbers the capacity and currently available resources in many countries [5, 6]. Obesity is socioeconomically unequally divided, and the obese are discriminated against in many ways [7], but it is unclear how increasing bariatric surgery affects this.

Health technology assessment (HTA) is the multidisciplinary study of the implications of the development, diffusion, and use of health technologies. It aims to improve health care decision making by providing a joint knowledge base for all stakeholders. HTA extends beyond effectiveness, costs, and safety to considering the social, organizational, and ethical implications of technologies [8]. Bariatric surgery exemplifies the importance of HTA: The Finnish Office for Health Technology Assessment (FinOHTA) was asked by representatives of Hospital Districts and the Social Insurance Institution of Finland to conduct a full HTA on bariatric surgery in 2008 for decision making on resource allocation, organizational, and reimbursement purposes.

This study presents an ethical analysis of bariatric surgery using the EUnetHTA methodology, conducted as an integrated part of a HTA [9]. The study exemplifies the potential for including ethical analysis into a HTA of surgical interventions.

Methods

Ethics, HTA, and EUnetHTA Core Model

Technologies are always introduced into a society or organization with a set of values that either challenge or support their adoption and use. Implementing a technology can also have moral consequences (e.g., resource shifts). HTA is a value-laden enterprise as it supports a certain type of decision making, and the information delivered by an HTA is formulated after several value decisions. Ethics serves to make these value decisions transparent and justified [10–18].

The EUnetHTA model is a standardized comprehensive method for the HTA of medical or surgical interventions developed together with 25 HTA organizations [19]. The model has nine domains of assessment: health problem and current use of technology, description and technical characteristics of technology, safety, clinical effectiveness, costs and economic evaluation, ethical analysis, organizational, social, and legal aspects. The model [20, 21] is available at www.eunethta.net.

In the EUnetHTA model, ethical reflection and value awareness are integrated into the whole HTA process. Instead of analyzing ethical issues as an add-on study by an ethicist alone, they are analyzed together with content experts responsible for other domains.

Due to challenges in literature searches in ethics of novel technologies, relevant ethical issues may need to be identified before literature searches. Casuistic analysis helps identify other, more studied, technologies that pose similar issues. Ethical issues are often discussed within articles not explicitly focusing on ethics but on other facets of the technology. Thus, the EUnetHTA model recommends a reflective process of literature consultations, until “saturation” is reached when further articles do not produce any new arguments or viewpoints.

Planning the HTA

Discussions about ethical issues in the planning phase influenced the HTA in several ways: A strict patient–intervention–comparator–outcome approach was widened, as ethical and psychosocial issues related to treating obesity in general were anticipated. Internists and general practitioners were added to the expert group of surgeons and HTA experts. The endpoints of analysis were expanded to include as many patient-relevant outcomes as possible. A survey of chief physicians in Finnish hospitals was conducted to study potential resource allocation issues. Still, the most important insight was that a preliminary literature search suggested that (a) bariatric surgery appears uncontroversially effective for morbid obesity and (b) a thorough HTA is needed in order to encourage informed health policy and organizational decisions.

Execution

The ethical analysis was conducted in a group led by a physician ethicist (SIS) and including surgeons (VK, TSI), an internist (PM), an obesity researcher (SES), and HTA experts (HA, AM). The group answered the 16 core questions of ethical analysis included in the EUnetHTA model. This aims to increase standardization and transparency of ethical analyses. Each question was first clarified, and then its relevance considered, information sources identified, and literature searches performed. All other domains were consulted because up-to-date information about the empirical issues of bariatric surgery was essential also for the ethical analysis. Finally, the ethicist drafted the answers, which were discussed until consensus was found.

Literature searches started with asking all participants to notify the ethics team if they found articles discussing ethics (6 of 20 suggestions were considered relevant). Next, a literature search on the ethical aspects of bariatric surgery and obesity was conducted, following guidelines [22]. Keywords used were ethics, moral, social justice, beneficence, freedom, autonomy, altruism, counseling, and informed consent. This yielded 143 hits, of which 32 were considered relevant. Databases (hits/read) included Medline (112/20), Web of Knowledge (9/6), Sociological abstracts (5/5), Euroethics (5/1), Cinahl (2/1), Applied Social Sciences Index and Abstracts, and SocIndex. While writing the report, new questions emerged which required further literature searches (e.g., the discrimination of obese and attitudes of health professionals).

The ethical issues identified were grouped under two main themes: (a) value-related issues of bariatric surgery and obesity and (b) ethically relevant consequences of implementing bariatric surgery. Ethical considerations were also included in the introduction, conclusions, and a summary table of the report, which was finally peer-reviewed by several experts including bariatric surgeons and ethicists.

Results

Value-Related Issues of Bariatric Surgery and Obesity

Bariatric surgery is not a novel technology. Similar operations have long been performed for other indications, such as cancer, and even for obesity in the 1950s [23]. Operations have been improved and their side effects decreased, but much of the novelty lies in performing these in exponentially increasing numbers. This suggests that many of the ethical issues are not related to the surgical operation as such but to treatment of obesity more generally. The ethical issues relating to surgical operations in general are also relevant, but this analysis concentrates on issues specific for surgical treatment of obesity.

Controversies about bariatric surgery reflect two conflicting discourses about obesity, which in their extremes can be described as follows:

  1. (a)

    Obesity is not a disease but an individual characteristic that is the consequence of choices for which the individual bears full responsibility.

  2. (b)

    Obesity is an illness, or at least a risk factor for illnesses, and should be treated as such.

This suggests that attitudes toward obesity are important determinants of attitudes toward bariatric surgery. It also suggests that decision makers may need to consider more than just the clinical effectiveness aspects of bariatric surgery.

Obesity and Individual Responsibility

The question of responsibility reflects a concept of justice, in which health inequality that follows from free individual choices is less problematic than inequality that follows from social or random causes [24]. Should a problem that could be solved by the individual deciding to eat less and exercise more be solved by a publicly funded surgical operation? This breaks down to two questions:

  1. (a)

    Is obesity such a self-inflicted condition that the individual is responsible for it?

  2. (b)

    If so, should this influence treatment or financing decisions regarding bariatric surgery?

Is Obesity an Individual’s Responsibility?

One way of approaching the topic is to ask whether obesity is a “disease” [25]. We decided not to pursue this linguistic approach, however, because (a) even if obesity is not a “disease,” it is a risk factor for diseases and (b) the question about the “labeling” of obesity as a disease is ethically important mainly as an indirect way of approaching the question of responsibility, and the duties of health care.

Obesity is bound to the habits and choices of the individual, but one can ask how freely people can choose their habits and what the living conditions that frame these choices are. The obesity “epidemic” is clearly linked to changes in society [26, 27]. People with higher socioeconomic status have better possibilities for healthy choices. Also genetic factors play a role [28]. Further, even if getting obese were socially determined or under individuals’ control, it does not follow that losing weight is; loosing serious overweight very rarely succeeds with dieting (VIITE). One way of seeing this is to see the loss of control of weight as part of the “disease” of obesity [29]. In conclusion, all these arguments speak against ascribing full individual responsibility for obesity.

Should Conditions on Individuals’ Responsibility Be Treated Differently?

An important principle in health care ethics is to try to benefit the patients [30]. Another is to treat health as a basic need or right, for which unequal distribution is problematic [31]. Both principles make the reason behind health problems less significant. Further, there are many conditions where the individual has some responsibility, but which we routinely treat without questioning the merits of the individual (e.g., cholesterol, lung cancer, sports injuries). So there should be some specific and important reason for treating obesity differently.

Medicalization of Obesity

Previous argumentation suggests that individual responsibility for obesity is not very important from the point of view of medical ethics. However, the question can also be posed from society’s point of view. Does it matter whether society sees obesity as being under the individuals’ responsibility or not? What are the consequences of medicalizing obesity [25]? We took a pragmatic view on medicalization and did not assume it to be morally good or bad as such but assumed that the value of medicalization depends on its consequences and thus varies by technology. Medicalization of a problem (like obesity) can become ethically acceptable if a new medical technology is devised that solves the problem.

First, it was noted that the very highest end of obesity is already quite medicalized, i.e., commonly seen as a disease. Thus, medicalizing obesity may lower the threshold between what is held as “common” overweight and “morbid” obesity. This would increase the number of people considered sick. Considering obesity a disease may have consequences for, among others, health care, the individual, or society.

In health care, in general, the more disease-like a condition is considered, the stronger duty there is to provide treatments for it. Discrimination based on disease or disabilities is usually not accepted, so medicalization may advance the rights of the obese. In theory, medicalization also relates to the question whether health care aims to reduce obesity, or to reduce the negative health consequences of obesity. In practice, however, bariatric surgery is usually only performed on patients with a major risk of co-morbidities, so this question does not appear important. Another way medicalization may influence health care is via views about etiology. Even health professionals often take removing causes of illness as an ideal of treatment [32]; seeing obesity as a psychological problem implies psychological treatments, hormonal causes imply medical treatments, and social causes imply social interventions. This way of thinking is problematic for bariatric surgery, as obesity is not commonly considered a malfunction of the gastrointestinal tract. But the logic does not hold: Intervening with the causes is not necessary for treatment, as effective treatments might work via totally different pathways. However, for prevention, the intervention must influence the causal chain. Thus, preventing and treating obesity can be seen as separate enterprises. Prevention will not help those already obese. So, in conclusion, medicalization of obesity might have organizational consequences in health care, but it was not considered ethically problematic from clinicians’ point of view.

For patients, in theory, medicalization makes also all obese people sick, irrespective of the rest of their health status. This “sick role” can have societal consequences: On the one hand, it reduces the responsibility for getting well (i.e., losing weight without the help of health care), but on the other hand, it implies an expectation that the individual wants and tries to get cured from the disease [33]. Ascribing less individual responsibility might reduce the social stigma and discrimination associated with obesity [34], thus benefiting the obese who want to lose weight [25]. Empirical studies show that obesity is not only a problem of physical health but causes psychological and social problems, loss of quality of life, dignity, and integrity of the obese [35, 36]. Of particular importance are negative stigmatization, prejudices, and discrimination [7, 37]. Stigmatization is related to ideas about etiology and responsibility, and it has been suggested:

  1. (a)

    Weight control is assumed to be under individual control and responsibility.

  2. (b)

    Obesity is a negative phenomenon, so there is something lacking in self-control or the character of an obese person.

  3. (c)

    The lack of control correlates with other negative properties that characterize the whole person, such as laziness, inefficiency, weak character, and poor treatment adherence [34].

Discrimination of the obese has been documented in many countries in, for example, work life [38], relationships, health care, education, and the media [7, 37]. It is possible that discriminative attitudes can be decreased by emphasizing that the causes of obesity are outside individual’s control [7], i.e., medicalization.

On the other hand, medicalization might be harmful for those obese who do not want to be sick, or who do not try to lose weight. It might increase the pressure to undergo bariatric surgery [39]. Still, in conclusion, our assessment was that because discrimination against the obese is so widespread and well-documented, the benefits of medicalizing obesity might outweigh the potential harms, on the patient level at least. This agrees with the view of a previous panel of obesity experts who concluded that “considering obesity [to be] a disease is likely to have far more positive than negative consequences and to benefit the greater good” [25].

For society, the consequences of medicalization were most difficult to estimate. Medicalization of obesity is related to the social norms of health and beauty. As obesity correlates negatively with socioeconomic class, the medicalization of obesity will affect the lowest socioeconomic groups most [39]. On the other hand, the benefits of treating obesity will fall on these groups, although only if treatments for obesity are distributed according to need. This might not happen in many places without active support [40]. Finally, the consequences of medicalization on preventing obesity and promoting weight control were considered important but difficult to estimate. Still, the assessment was that the issue of individual responsibility is more pertinent to prevention and promotion than for situations where bariatric surgery is already indicated.

In conclusion, although potentially important, appraising the pros and cons of medicalization of obesity was considered difficult. The risks of medicalization might fall on those obese who do not want treatment and onto society at large, whereas the benefits probably fall on those obese who are discriminated and stigmatized, or want treatment.

The Ethically Relevant Consequences of Performing Bariatric Surgery

The HTA concluded that bariatric surgery is effective, cost-effective, and probably cost-saving. The analysis so far did not identify compelling ethical arguments against performing bariatric operations in general. Thus, the question turns to the ethical issues that should be taken into account when performing and organizing obesity surgery.

Respecting Patient Autonomy

Respecting autonomy is important in current medical ethics and law [30]. The final arbiter of benefits and harms of a treatment should be the patient him/herself. Patient autonomy was considered exceptionally important in obesity surgery: Given that the harms of obesity—and the benefits and harms of obesity surgery—are so multi-faceted and can influence people’s lives deeply, the patient must be the one to autonomously choose the treatment.

Autonomy requires competence and adequate information. Surgical operations always require great trust between the patient and the surgeon, as the patient must give up his autonomy for the period of the operation [41]. Informing patients about the perioperative risks was not assumed to differ from other comparable surgical procedures. Informing patients about the long-term consequences of bariatric surgery, however, was assumed to be challenging but exceptionally important for several reasons: The operation is not immediately lifesaving, it is irreversible (except gastric banding), and the treatment requires (and its success hinges on) the patient permanently and significantly changing his/her eating habits [42]. The importance of ascertaining that the patient has understood the implications of the operation supports a thorough assessment process before the decision to operate. In many countries, patients also undergo a psychological or psychiatric examination. However, as the evidence on which psychiatric disorders or symptoms are contraindications of bariatric surgery appears inconclusive [43, 44], care is needed not to unjustly discriminate against psychiatric patients.

Patient autonomy may be influenced by the marketing and attitudes of health professionals. Marketing may be widespread and does not necessarily give a balanced view of the pros and cons of operations [45]. Also the negative attitudes of health care personnel toward obesity might jeopardize access to treatments, or make access unequal [32, 46].

Patients can only autonomously choose surgery if alternative non-surgical treatments are also available. It would enhance autonomy further if several types of operations were available. Gastric banding is different from other operations in being, for the most part, reversible, in cases where the patient feels the harms have outweighed the benefits. Gastric banding is also the most straightforward and quickest operation type. However, gastric banding is not as effective as some other operations in the long term and requires more medical interventions in the form of adjustments [2, 47, 48]. The most popular operation types vary by country; gastric banding is popular in Australia, increasing in the USA, and decreasing in Europe [49]. This is not explained by the evidence base but is more likely explained by treatment systems and financial incentives.

Justice and Equality

Justice and equality are important principles of health care ethics. New technologies may influence the justness of the health care system, or require special considerations in order to secure justice is not compromised.

Obesity is socioeconomically segmented and socioeconomic differences in health and health care are often considered unjust [50]. Our previous discussion about the role of individual responsibility suggests that this holds also for obesity, so unequal access to treatment of obesity is a problem of justice and health inequality. Factors determining just access to health care vary between countries, but special emphasis may be warranted to secure access to bariatric treatment of obesity according to needs.

Justice also requires coherence of the health care system so that obesity and bariatric surgery are treated similarly to other relevantly similar conditions and treatments. These may vary between countries, but in the Finnish context, the following aspects were analyzed:

  • Access to and funding of other treatments of obesity than bariatric surgery (psychosocial treatments, medicines, liposuction)

  • Treatments of other conditions often considered self-inflicted (high cholesterol, blood pressure, smoking, injuries) or their consequences

  • Treatments of other negatively stigmatized and psychosocially disruptive conditions (e.g. psychiatric disorders, sexually transmitted diseases)

  • Treatment of other equally serious health problems

  • Other treatments which are equally cost-effective

In Finland, medical treatments of obesity are funded like other medications, but treatments considered esthetic (like liposuction) are not funded. The self-inflicted nature of conditions is not taken into consideration, even in more clear-cut cases like lung cancer of heavy smokers or sports injuries. There are problems of access in psychiatry, but these are not deliberate. Rationing based on cost-effectiveness is not officially done, but bariatric surgery would pass all cost-effectiveness criteria (if bariatric surgery is actually cost-saving, as suggested, resources could be allocated to other health care needs). In conclusion, in the Finnish health care system, bariatric surgery should be publicly funded, as it should be seen as an effective treatment (or prevention) of significant and disabling disease. If it were seen primarily as a treatment of psychosocial problems, the status would be more unclear, and as esthetic surgery it would not be publicly funded.

Predicting Need and Rationing Bariatric Surgery

Bariatric surgery has increased in recent years and is still increasing; the number of operations varies greatly between countries but is still far from the number of obese who might benefit from treatment [5, 6]. It is possible that indications for surgery loosen as the supply of operations increase [51–53]. As weight is fairly normally distributed, lowering the BMI limit for operations (from the recommended BMI 40, or BMI 35 with co-morbidities [54]) will dramatically increase the number of potential patients. Still, it is likely that the benefits of surgical treatment of obesity do not start abruptly to outweigh the harms at some BMI, but more likely increase on a continuum. Thus, predicting the level where the bariatric surgery stabilizes is at present difficult.

Increasing operations will require more resources. These can either be new, or come from other sectors of health care, depending on the system and whether the operations are actually cost-saving. Irrespective of the cost-effectiveness of the operations, however, the resource implications will differ between different sectors of health care; for example, bariatric and plastic surgery, pre-operative counseling, and follow-up will expand and treatment of diabetes and its complications will decrease. Costs will be incurred first and the savings with accrue later. Thus, some health care organizations and groups stand to gain and some to lose [1]. Depending on the structure and incentives of the health system, this may pose a risk of irrational use of resources, from the society’s perspective. If there are not enough resources to meet demand, some rationing will occur. Ideally, this should be done transparently [31]. Some resources, like experienced surgeons, may be difficult to acquire quickly even with money. In conclusion, the number of patients potentially benefiting from the surgical treatment of obesity is in many countries vastly greater than the supply of operations, so some rationing is needed, at least in the short term. The ethical analysis presented so far suggests that rationing bariatric surgery should be done according to the same principles and procedures that are used to ration other cost-effective treatments for serious diseases.

Conclusions

We have presented the results of an ethical analysis of obesity (bariatric) surgery, conducted as an integrated part of a full health technology assessment. We did not fully appraise the importance of the arguments identified, as FinOHTA has no mandate to give recommendations. The aim is to inform and support decision making, not make decisions on behalf of legitimate decision makers. Conducting a value-free ethical inquiry is, however, theoretically impossible, so we have tried to be as explicit and open about the value judgments applied as possible. In addition to the analysis of bariatric surgery, our study also exemplifies the potential contribution of ethical analysis for HTA in advancing the discussion about the value-related issues of health technologies.

The analysis began with the hypothesis that the self-inflicted nature of obesity and individual responsibility for treating it would be the central ethical issues around bariatric surgery. This hypothesis was rejected, as we could not identify sustainable and important arguments supporting either individual responsibility for obesity, or the idea that obesity should not be treated even if it were the individuals’ responsibility. Most ethically controversial issues relating to obesity surgery were found to be related to the treatment of obesity in general, not its surgical treatment. The public provision of obesity surgery should not be rationed differently from other surgical or medical interventions. The many possible effects of medicalizing obesity were considered difficult to balance, but potentially significant; treating obesity as a disease is likely to benefit many of the obese by reducing stigma and increasing access to treatments, but the societal consequences are difficult to predict.

Several ethical issues were considered important when organizing and performing surgical treatments for obesity. Patient autonomy, especially informing the patient, was thought to require special attention for several reasons: The operations are not immediately lifesaving; its success depends greatly on the patient understanding and adhering to life-long changes in eating habits; there may be commercial interests and societal prejudices that influence the autonomy of patients. Finally, given that obesity is more prevalent in socioeconomically disadvantaged populations and the obese are widely discriminated against, as well as the supply of obesity surgery not meeting the need in many places despite being cost-effective, a special emphasis on justice in access to surgical treatments of obesity is probably warranted.