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35 Prophylactic Procedures forOrthopedic Pathologies
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ing or sometimes eliminating the disease pro­gression and also becoming popular as a part of the rediscovering the importance of public healthcare in recent years.
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2. Galasko C. The anatomy and pathways of skeletal
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Y. Open-Wedge HTO with Absorbable β-TCP/PLGA Spacer Implantation and Proximal Fibular Osteotomy for Medial Compartmental Knee Osteoarthritis: New Technique Presentation. J Invest Surg. 2019:1–11.
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SJ. Relationships between lower extremity align­ment and the quadriceps angle. Clin J Sport Med. 2009;19(3):201.
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15. Barber FA, McGarry JE. Elmslie–Trillat procedure for the treatment of recurrent patellar instability. Arthroscopy. 2008;24(1):77–81.
16. Mulliez A, Lambrecht D, Verbruggen D, Van Der Straeten C, Verdonk P, Victor J.Clinical outcome in MPFL reconstruction with and without tuberositas transposition. Knee Surg Sports Traumatol Arthrosc. 2017;25(9):2708–14.
17. Rhee S-J, Pavlou G, Oakley J, Barlow D, Haddad F. Modern management of patellar instability. Int Orthop. 2012;36(12):2447–56.
18. Barnes CL, Mesko JW, Teeny SM, York SC.Treatment of medial compartment arthritis of the knee: a sur­vey of the American Association of Hip and Knee Surgeons. J Arthroplasty. 2006;21(7):950–6.
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19. Dabash S, Prabhakar G, Potter E, Thabet AM, Abdelgawad A, Heinrich S.Management of growth arrest: current practice and future directions. J Clin Orthopaed Trauma. 2018;9:S58–66.
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21. Yang ZY, Chen W, Li CX, Wang J, Hou ZY, Gao SJ, et al. Medial compartment decompression by bular osteotomy to treat medial compartment knee osteoarthritis: a pilot study. Orthopedics. 2015;38(12):e1110–e4.
22. Ganey T, Ogden J. Pre-and post-natal development of the hip. In: The adult hip, vol. 1. Philadelphia: Lippincott Williams & Wilkins; 1998. p.39–55.
23. Harris NH. Acetabular growth potential in con­genital dislocation of the hip and some factors upon which it may depend. Clin Orthop Relat Res. 1976;(119):99–106.
24. Lokietek W, Legaye J.Le cartilage en Y dans la crois­sance du bassin normal et dans la luxation congénitale de la hanche. Acta Orthop Belg. 1990;56(1):23.
25. Wedge JH, Wasylenko M.The natural history of con­genital dislocation of the hip: a critical review. Clin Orthop Relat Res. 1978;137:154–62.
26. Herring JA. Tachdjian’s pediatric orthopaedics e-book: from the Texas Scottish Rite Hospital for Children. Amsterdam: Elsevier Health Sciences;
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27. Ömeroğlu H, Köse N, Akceylan A.Success of Pavlik harness treatment decreases in patients 4 months and in ultrasonographically dislocated hips in developmental dysplasia of the hip. Clin Orthop Relat Res. 2016;474(5):1146–52.
28. Rosenfeld S, Weinstein S, Schoenecker J, Matheney T.Developmental dysplasia of the hip from birth to arthroplasty: clear indications and new controversies. Instr Course Lect. 2019;68:319–36.
29. Ozkut AT, Iyetin Y, Unal OK, Soylemez MS, Uygur E, Esenkaya I. Radiological and clinical outcomes of medial approach open reduction by using two
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intervals in developmental dysplasia of the hip. Acta Orthop Traumatol Turc. 2018;52(2):81–6.
30. Akman B, Ozkan K, Cift H, Akan K, Eceviz E, Eren A. Treatment of Tönnis type II hip dysplasia with or without open reduction in children older than 18 months: a preliminary report. J Child Orthop. 2009;3(4):307–11.
31. Flecher X, Casiraghi A, Aubaniac J-M, Argenson J-N.Survie de l’ostéotomie périacétabulaire à moyen
terme dans le traitement de la dysplasie acétabulaire de l’adulte. Rev Chir Orthop Reparatrice Appar Mot. 2008;94(4):336–45.
32. Leunig M, Ganz R.The Bernese periacetabular oste­otomy. Der Orthopade. 1998;27(11):743–50.
33. Eceviz E, Soylemez M, Uygur M, Özkan K, Ozkut A, Eren A.Mid-term radiological and clinical results of incomplete triple pelvic osteotomy. Acta Orthop Traumatol Turc. 2016;50(6):660–6.
Ethical andLegal Dimensions
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ofProphylactic Surgery
ZeynepEsraTarakçıoğlu andİlhanÜzülmez
36
36.1 Introduction
Cancer is responsible for the death of one in every six people worldwide [1]. In the distribu­tion of cancer within itself, it is estimated that 3–20% of the cases are assumed to be linked to some genetically inherited genes [2]. These genes not only increase the risk of cancer, but also have severe and fatal consequences. While breast or ovarian cancer incidence in normal individuals, one of the most well-known types of genetic can­cer, varies between 1 and 12%, this probability can reach up to 85–86% in people carrying BRCA1 and BRCA2 genes. Therefore, identifying the genes that inherently carry a potential cancer risk can allow new opportunities to detect, pre­vent, and treat many diseases. Thanks to the rap­idly emerging developments in biology and medicine and the Human Genome Project, genetic tests have started to be used as a novel means of preventing diseases with their ability to early diagnose a potential disease. Genetic test-
Z. E. Tarakçıoğlu Division of Legal Studies, Department of Political Science and Public Administration, Faculty of Economics and Administrative Sciences, Hacettepe University, Ankara, Turkey e-mail: zeynepdilek@hacettepe.edu.tr
İ. Üzülmez (*) Division of Criminal Law and Criminal Procedure, Department of Public Law, Faculty of Law, Ankara Hacı Bayram Veli University, Ankara, Turkey e-mail: ilhan.uzulmez@hbv.edu.tr
ing refers to the medical examinations that aim to reveal or detect the presence of a person’s heredi­tary diseases or predisposition to these diseases either directly or indirectly by examining genetic inheritance conditions [3, 4]. According to the result of the test, an individual with a genetic pre­disposition to a given disease is provided with the opportunity to plan for the future and with the chance to prevent the adverse effects of the disease.
Until recently, patients with a genetic predis­position to cancer were recommended follow up for early clinical diagnosis and treatment, and in some cases, the case ended up with chemother­apy. However, these approaches being inapplica­ble or ineffective in some types of cancer have paved the road for the prophylactic surgical method, one of the most important risk reduction initiatives. In fact, prophylactic surgery is not a recent one. However, it has been one of the fre­quently debated and implemented methods in treating certain diseases [5]. The main factor that leads this method to be frequently debated today is that it poses some legal and ethical problems despite its great success in reducing risk. Before addressing these problems, it is necessary to con­sider what this method is briey. Prophylactic surgery, also known as preventive surgery, is a method that enables the risk to be signicantly reduced or eliminated as a result of completely or partially removing the organ on which cancer may develop. After applying this method, mortal­ity rates can be decreased by 89.5–100% [68].
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2021 O. N. Dilek et al. (eds.), Prophylactic Surgery, https://doi.org/10.1007/978-3-030-66853-2_36
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With this method, it is aimed to prolong the mean-life expectancy. However, the efciency of this method on the quality of life varies from individual to individual, which may be caused by due to the genetic inheritance pattern problem of the disease, in which the problem cannot be sorted out by just removing organs. Some con­comitant conditions may continue to be observed in different ways in other organs and also due to the psychological reasons and physical changes observed post-surgery [6]. In this context, such examples from a wide variety of spectrum as the emergence of drug addictions, restrictions on social and working life, the emergence of per­sonal disabilities or deciencies, early meno­pause, depression, decreased sexual desire, change of body perception, inability to have child, and changes in family dynamics can also be observed [6]. Especially concerning BRCA genes, breast removal (mastectomy) causes a serious change in body perception, and breast implant surgery is frequently resorted to follow­ing prophylactic surgery [9]. The most important setback of the intervention is that it is irrevers­ible. Therefore, it is thought that the operation should only be applied when the benets out­weigh the risks [9]. However, the benets and risks that can arise from this intervention are par­tially unknown. Even if the risk of mortality and recurrence of cancer decrease following the sur­gical intervention in question, there are serious social and psychological effects of such a large surgical intervention. Such a difcult decision that needs to be made considering the social and psychological effects requires an ethical approach, thus requiring a review from a legal aspect. During this investigation, it is necessary to look at the issue from the perspective of human rights. Surgical intervention with a biomedical origin is directly related to such fundamental rights, as the right to life and condentiality raises the legal obligation to protect human rights and human dignity. In this context, we will rst underscore the timeline, starting from the detec­tion of genetic risk to the operation and the accompanying problems that may arise at this stage. Later, the application of the prophylactic
method and the post-intervention phase will be examined legally. The reason why we examine making such staging is that the ethical and legal problems in question are mostly concentrated in these two stages.
36.2 Detection ofGenetic Risk
Various legal and ethical problems may arise in the stages, starting from genetic risk detection to resort to the risk-reducing intervention. Since the prophylactic intervention is a treatment applied with the aim of providing medical relief, it gives rise to a special relationship between the patient and the doctor, together with some responsibili­ties specic to the nature of this emerging rela­tionship. Respecting condentiality and the obligation of illumination is of particular impor­tance for these issues. Attributing a special mean­ing to these obligations results mainly from the nature of the genetic information on which the intervention is based, not from the intervention procedures. Namely, the information obtained from gene analysis belongs to the person’s iden­tity and, therefore, must be protected [10]. However, using such information in an unfair and harmful manner may give rise to more compre­hensive consequences than the ordinary health data itself. The European Court of Human Rights concluded that DNA proles contain a large amount of personal data [11]. Therefore, it is pos­sible to use genetic information, which includes comprehensive information about a person’s belonging to a certain group and his/her health status in parallel with discriminative purposes. Indeed, the Nazis can be given as a historical and real example of the abuse of genetic information for the purpose of racism and genocide. Therefore, the concept of “genetic exceptionalism” is used by some authors to express that genetic informa­tion is different from other data related to health [12, 13]. According to those who advocate this view, genetic information is unique since it pro­vides information about the person’s current and prospective health status and the health status of the family members, and even about the next gen-
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erations [1319]. An opposing view of which approaches with suspicion toward this view states that it is not possible theoretically and practically to separate genetic information and health infor­mation from each other [20].
Such an assessment related to genetic infor­mation also bears noteworthy legal consequences. If we accept that there is no difference between genetic information and data related to health in terms of qualication, international regulations regarding the protection of health information and data such as the European Charter of Patients’ Rights, the Amsterdam and Lisbon Declaration, may be considered sufcient for the protection of genetic information. However, in the event that a possible difference is considered, genetic infor­mation will need to be specially protected. Although there is no consensus on this matter, some international conventions dwell on this sub­ject. The rst of these is the Convention for the Protection of Human Rights and Human Dignity concerning Biology and Medicine, and the rst binding international contract in its eld adopted in 1997: Convention on Human Rights and Biomedicine Agreement. It is clearly stated in Article 11 of the related convention that no dis­crimination can be applied to anyone due to their genetic inheritance. Another legal text that directly prohibits genetic discrimination is the Universal Declaration on the Human Genome and Human Rights, released by UNESCO. In Article 6 of this declaration, nobody can be dis­criminated against due to their genetic structure; otherwise, in this case, some consequences that may harm human rights, fundamental freedoms, and human dignity can occur.
Nevertheless, the reection of discrimination due to individuals’ hereditary characteristics on existing human rights texts came to the agenda later concerning the developments in genetics [17]. For this reason, genetics is not explicitly included as a reason for discrimination in such essential human rights texts as the Universal Declaration of Human Rights and the European Convention on Human Rights (ECHR). However, since the causes of discrimination are not conclu­sive in international conventions, they also cover
genetic discrimination. As can be seen, genetic discrimination has been considered as an issue that needs to be regulated in documents dealing with human rights. In this regard, this issue is regarded as a human rights issue in the interna­tional arena.
36.2.1 Protection ofGenetic Information: Condentiality
Genetic discrimination is dened as discrimina­tion observed against the individual or the indi­vidual’s family members due to real or perceived differences other than the “normal” genotype [21]. The most frequently expressed fear in indi­viduals with genetic risk is the use of genetic information in a way that may end up with dis­crimination [22]. Indeed, one of the areas where abuse of genetic information has the most com­prehensive consequences is the issue of discrimi­nation. Due to hereditary characteristics, individuals may not benet from equal condi­tions in decision-making processes in different elds, such as health and life insurances, employ­ment, custody, adoption, admission to a school, or loan application [21]. Therefore, failure to pro­tect information related to genetic diseases and violation of condentiality may leave the indi­vidual as a victim in many life areas. The issue of genetic discrimination, which has come to the fore, especially in employment1 and insurance law, has prompted some states to make special arrangements regarding the issue [23]. In the USA, for example, the regulations envisioned by states in the 1970s on a federal basis were fol­lowed by such regulations as the Americans’ Disabled Americans Act (ADA) and American Health Insurance and Portability and Responsibility Act (HIPAA) [24, 25]. However,
1
The main reason for discrimination in the employment eld is that employers want to work with healthy people, believing that productivity will decrease and increase costs. On the other hand, insurance companies use infor­mation about the health status of the insurant or the person who wishes to be insured to protect and increase their protability.
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the Genetic Information Nondiscrimination Act was adopted in 2008 since these regulations were far from providing sufcient assurance.2 With this law, discrimination based on genetic infor­mation was prohibited in health insurance and working areas. It is possible to see similar regula­tions in some countries, such as Canada, England, Austria, Germany, and Switzerland. For instance, with the Genetic Diagnostics Act of 2009 in Germany, the subject was specially regulated. It was legally set forth that insurers shall not demand genetic testing and also no information about previous genetic tests
3
of the individuals [26]. In Switzerland, The Bill regarding Genetic İnvestigations in Humans, rules that insurance companies shall not request genetic reviews or use previous test results. However, it remains doubtful how successful these regulations are in protecting people’s condentiality with genetic risk and preventing discrimination because genetic tests are not the only source of informa­tion about individuals’ susceptibility to a certain disease or risk. Indeed, some of the rst docu­mented cases of genetic discrimination in America include implications from the individu­als’ particular family history [27]. However, we previously stated that genetic testing includes information about individuals and family mem­bers of the individuals as well. Some of the arrangements mentioned above provide only pro­tection for the insurant and remain silent about using the insurant’s test result arrangements. Even if employers and insurance companies are prohibited from accessing genetic test results, they may have some justied interests in access­ing individuals’ health data. In this case, how
2
The use of genetic information is not clearly regulated in the law in question. However, to investigate in terms of discrimination, those who have genetic risk should be evaluated as “disabled” under the law. Although the Equal Employment Opportunity Commission (EEOC), which determines the principles of implementation of the con­tract, was included under the title of disability, the subject gave rise to various American doctrine debates.
3
In Article 18 of the mentioned law, an exception is stipu­lated for this rule regarding the high amount of insurance contracts. Accordingly, test results can be taken into account for life insurances exceeding 300,000 euros.
health data and genetic information can be sepa­rated is another problem that needs to be resolved. Therefore, it seems possible for employers and insurance companies to learn and use various information sources about genetic risk despite these regulations. For this reason, such various segments as physicians and genetic counselors with direct access to genetic information should act more carefully than other health data of the individuals in terms of keeping this information condential. Otherwise, possible criminal and legal consequences may arise since the patient’s condentiality is severely breached.
Another issue that needs to be discussed in terms of condentiality concerns the sharing of genetic information with family members. Undoubtedly, family members are most likely to be affected by the individual’s test results at risk. For this reason, it is thought that information about the test results should be shared with fam­ily members. If the patient shares this informa­tion with his/her family or consents it to be shared, no legal problem can be mentioned. However, some patients may not consent to share their information with various concerns like fam­ily dynamics, geographical and social distance, and the test results being not related to family members [28]. In this case, such things as how to act and how to solve the legal and ethical prob­lems may remain controversial. The focus of this discourse is how to balance the patient’s con­dentiality with the overall interest of family members. As is known, due to the trust relation­ship established between the patient and the doc­tor, the condentiality of the patient should be respected. In this context, the medical evalua­tions about the patient should be condentially conducted, and unless the nature of the disease requires, the personal and family life of the patient should not be interfered with [29].
Despite the person’s given consent, sharing the genetic information with the family may lead to violations of condentiality and, together with some consequences, within an unknown scope. It is also possible to inform the other family members about the genetic risk to let them take precautions against the possible disease, which
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may require disclosure of special information [16]. For this reason, many scholars believe that the moral obligation to inform family members about genetic risks lies upon the doctor’s side [4]. However, it is not clear how to balance the condentiality of the individual at risk and the sharing of any information related to the indi­vidual. We believe that the balance that needs to be established between the condentiality of the individual at risk and the sharing of information should be established following the conditions of the concrete events, especially considering the person’s family dynamics. For this reason, it does not seem possible to give a precise answer to this question covering all instances. Failure to give an exact answer to this question gives rise to an uncertain situation for physicians. It paves the way for legal and ethical problems. Therefore, it is imperative to regulate this issue with legal regulations. Regarding the issue, if various states’ legislation is examined, the general trend is to protect condentiality [30]. The main dif­ference among countries is observed in terms of the scope of this protection. For example, France and Sweden seek absolute consent and authority for family members’ access to genetic informa­tion [31]. On the other hand, in countries such as America, Austria, Japan, Singapore, Israel, England, Canada, sharing genetic information under certain conditions is deemed possible, even if there is no individual consent. We see that the difference lies in these exceptional cases. Generally, the case of preventing death, illness, or severe injury of family members has been regulated as an exception. It is stated in Singapore that the physician may have a legal responsibil­ity to warn family members in the event of a seri­ous genetic risk [32]. While Austria seeks “serious” conditions, the USA and Canada refer to “exceptional and compelling” conditions, and Israel refers to “severe” conditions in such cases [33]. Unlike other regulations, it is considered sufcient to share New Zealand information when it is relevant to family members [34]. It should be noted that the regulations made in the international arenas on the subject are in the same direction. The Committee of the Council of
Europe adopted the principle of not disclosing personal information in principle 9 of recom­mendation numbered R (92) 3 on 10.02.1992. However, it was stated that this rule could be exempted if there are severe genetic risks for other family members. As can be seen, while many legal regulations have adopted condenti­ality as an important rule, they brought an excep­tion to this rule in cases where serious and severe consequences could occur for family members’ interest. Therefore, the general tendency is to protect neither absolute condentiality nor third parties. In terms of the concrete event, the indi­vidual or the committee (which may be a physi­cian or ethics committee) will try to set between these two values. In our opinion, conducting such an investigation based on a concrete event will ensure that the conditions in which the indi­vidual undergoing genetic testing will also be taken into account [35].
36.2.2 Illumination andConsent
After determining the genetic risk, another issue that may raise legal and ethical problems is the obligation of illumination. The patient’s rights over his/her body require that the person should be the determining party during a medical inter­vention. Therefore, consent is sought as a prereq­uisite to say that medical interventions are lawful. In such interventions, the necessity of seeking consent as a source of lawfulness is considered necessary not only in terms of law, but also in the ethical evaluation of the issue. However, for the consent given for the intervention to be valid, the patient must be thoroughly and detailedly illumi­nated. The obligation of illumination can be briey dened as a necessity to provide the required information to the individual who will undergo the physician’s procedure before any medical intervention is planned. In this context, if the patient does not accept the recommendation, the physician must convey the consequences of various treatment modalities and their benets as well as the risks and possible complications. It should also be mentioned that the test result
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indicates an existing risk rather than an existing disease, especially in cases of genetic diagnosis because some patients may tend to consider the results of genetic testing as an irreversible indica­tion, which may affect the decision-making phase. Therefore, in interventions based on genetic testing, physicians should be more sensitive about the patient’s illumination and should obtain the patient’s consent within this framework. However, prophylactic surgery is a frequently used method, especially for geneti­cally transmitted diseases, but it is also a method that can be brought to the agenda with the increas­ing risk in many diseases that do not exhibit hereditary transition cause cancer. For example, the gallstones of a patient who has no complaint related to gallbladder can be removed from gall­stones during surgery. However, in order for this intervention to be accepted as lawful, physicians must obtain the patient’s consent by illuminating the patient before the intervention from a per­spective that there are stones in the gall and that this may cause serious problems in the future. Otherwise, the prevention and elimination of a risk detected during the operation without the patient’s consent may end with some outcomes for the physician’s side.
Another point to consider when it comes to risk reduction methods is the probability that this method may not eliminate potential risk and that the presence of risk may prevail, though in a decreasing trend. This is more important in pro­phylactic surgery, which has severe social, psy­chological, and physical results. As mentioned earlier, the method mentioned above requires removing a potential risk but at the same time healthy organ, which can lead to irreversible and irrecoverable consequences. Those with a large intestine may have to wear a lifetime colostomy bag, and patients who receive a pancreas may have to use insulin medicine for a lifetime, women may lose their reproductive ability, and children who have their thyroid removed may be forced to use drugs for life. For this reason, phy­sicians should convey the results of alternative treatments and irrecoverable results to the patients, considering their age and marital status.
However, the physician must express his/her thoughts on the application of the prophylactic method to the patient explicitly because the researches show that the decision-making pro­cess for the prophylactic method is especially difcult for women and open to be affected due to the familial nature of the genetic test [36]. After Angelina Jolie underwent a bilateral pro­phylactic mastectomy, this surgical procedure’s demand has increased signicantly among women [8]. This situation reveals that although a positive development occurs for women with genetic risk, the individual may not always make an objective decision during the decision-mak­ing process. Therefore, physicians should clearly demonstrate the potential risks and the benets to be obtained at the end of the operation. However, it may not always be possible to reveal the benets and risks in the prophylactic method, as it is implemented not to improve the current health condition, but to protect against prospec­tive diseases [37]. Consequently, due to this method’s nature, the scope of the obligation of illumination expands. It leaves the responsibility to the physician’s side in terms of giving detailed information about the purpose and application of the intervention in addition to the risks and ben­ets. However, the patient, who does not want the application of this method for various rea­sons, should also be informed about the disad­vantages and alternative methods that can be followed. Otherwise, it can be speculated that the physician has not fully fullled the obliga­tion of illumination. A doctor who recommended a test that should be performed concerning the diagnosis of cancer in a case in America, who at the same time did not illuminate the patient about the drawbacks of refusing to take the test, was found faulty as the patient died of cancer [38]. The decision in question is the rst deci­sion that imposes responsibility on a physician for an act of neglect without any physical inter­vention [39]. Of course, the physician cannot inform about the intervention process and after­ward, with all of the risks and benets. For this reason, the point that is important in terms of the obligation of illumination should be to bring the
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patient to a position, where he/she gives the deci­sion about his/her future with his/her own will, considering the risks and the benets he/she can get. For this, it should be stated that the physi­cian has the duty of providing consultation about all material risks that a reasonable person would like to be informed about before making a deci­sion [39].
36.3 Implementation
ofProphylactic Method andPost-intervention
The main issue to be considered regarding the prophylactic method, which aims a risk reduc­tion, is in compliance with the subject in question with the concept of lawfulness. As is known, interventions other than medical necessities can damage a person’s body integrity. For this reason, only the medical interventions considered com­pulsory according to medical science, namely those based on indication, are considered lawful. Therefore, there should be a legal or medical ground that justies why the physician initiates the diagnosis and treatment process. However, with its primary aim of preventing disease rather than healing it, the prophylactic method comes to the fore. It gives rise to debates in terms of law­fulness because the application of such an inter­vention with the potential to create serious physical, psychological, and social problems based merely on the patient’s consent with no indication can put the physician under criminal and legal responsibility.
The point that medical science has reached today causes the indication to be discussed and interpreted again. The obligation of indication, which was previously regarded as one of the basic elements of medical intervention, has expanded as a concept with modern medicine development. Therefore, a reconsideration of social and psychological causes within the indi­cation concept has started [40]. It has been even argued that the patient’s consent could replace the indication [29]. According to this view advo­cated in the German doctrine, consent, in the
absence of an indication, allows the intervention to be legitimate, only when it ts within morality and manners, not harming the addressee and complying with the duty of care [41]. According to the opinion mentioned earlier, consent and indication are not cumulative but alternative cri­teria of medical intervention. In our opinion, it does not seem possible to agree with this view. The rule of law has not vested the people with the right to dispose of their lives and bodily integrity as they wish. The law also undertakes the duty to protect people event against their own will. Therefore, the consent of the victim only makes the medical intervention legitimate when the indication is present. For this reason, it is neces­sary to make special legal regulations for such controversial situations as organ and tissue trans­plantation, esthetic operations with no indication in terms of legality, and legitimacy of the inter­vention [
42]. In the study in question, consent
and indication were accepted as cumulative con­ditions that make medical intervention legitimate and evaluated accordingly.
Since the discussion on the concept of indica­tion exceeds this study’s scope, it should be con­tented with giving brief information on the subject. Although the prophylactic method does not aim to treat an existing disease or to prevent a potential danger to be caused by it, it is intended to eliminate the potential risk that a person may encounter as a result of a genetic anomaly. In this regard, the reason for the application of the said method is the protection of the individual at risk. Therefore, given the meaning of the con­cept of indication today, it should be accepted that the concept covers not only the measures to eliminate the disease, but also diagnostic and preventive interventions along with it. Interventions that are mandatory for diagnosis, treatment, and protection are accepted as indica­tions in the doctrine. In this respect, it should be accepted that the prophylactic method, which serves to reduce the risk and thus protects the patient from the disease which has the potential to develop in the late stages, also provides the indication requirement. Besides, due to the posi­tive effects of the method in question on psy-
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Z. E. Tarakçıoğlu and İ. Üzülmez
chology, it is also possible to evaluate it within a psychological indication.4 However, at this point, it should be stated that the social or psy­chological indication should be based on con­crete data. In a good example of a decision on the related matter, New York Supreme Court ruled that a psychological condition that might give rise to a medical necessity was not enough to justify the procedure of a bilateral mastec­tomy surgery aimed at eliminating gynecomastia symptoms. Although the 17-year-old had experi­enced emotional distress and depression due to symptoms, the court ruled that no psychiatrist, psychologist, or medical specialist, including the pediatrician, had been consulted, thus ruling that the feeling of embarrassment was not sufcient alone for medical necessity [43, 44].
Considering the legal regulations and deci­sions regarding the concept of indication, we can say that the aim of protection and prevention is also included. An exemplary regulation in this regard can be given from Turkish law. The pur­pose of diagnosis, treatment, and protection is considered a medical requirement in the third paragraph of the 13th Article of the Medical Deontology Regulation and the 12th Article of the Patient Rights Regulation. Another example can be given in American law. In the California Welfare and Institutions Code 14059.5, the con­cept of medical necessity is dened as follows: “A service is medically necessary or a medical necessity when it is reasonable and necessary to protect life, to prevent signicant illness or sig­nicant disability, or to alleviate severe pain.” Florida District Court of Appeals dened the concept of medical necessity in Gallagher Bassett Services, Orlando v. Mathis decision as: “Medically necessary” or “medical necessity” means any medical service or medical supply, which is used to identify or treat an illness or injury, is appropriate to the patient’s diagnosis
4
According to Gürelli, it can be accepted legitimate to cor­rect a disorder of the organ from which this disorder origi­nates to correct mental disorders stemming from organic origin. At the same time, surgery and interventions aimed at changing the symptoms with psychiatric indications should be considered unlawful.
and status of recovery and is consistent with the location of service, the level of care provided, and applicable practice parameters. The service should be widely accepted among practicing healthcare providers, based on scientic criteria, and determined to be reasonably safe. The ser­vice must not be of an experimental, investiga­tive, or research nature [45]. Although the aim of protection is not mentioned in the decision in question, it is claimed in the related doctrine that preventive medical interventions have “an indi­rect aim of treatment” [40, 41, 46]. Therefore, the concept of treatment can be dened as the whole of measures taken, medications, or surgical inter­ventions to reduce the risk of a disease, as well as to eliminate and cure a disease [47]. In this respect, discussions on prophylactic interven­tions depend on the meaning to be attributed to the concept of treatment. At this point, it is neces­sary to state that there are court decisions that consider individuals’ carrying genetic risk as a disease [48]. Suppose the approach followed in the court decisions in question is adopted. In that case, the indication will not need to be separately discussed since the prophylactic method can be started to be considered therapeutic because there is an existing disease. However, since there is no consensus neither in America nor internationally, it is necessary to evaluate whether the obligation of indication exists before applying each prophy­lactic method. The physician cannot apply such a surgical method to remove a healthy organ as prophylactic surgery without concrete data revealing the indication. Otherwise, the interven­tion will not be considered lawful, and the physi­cian will be held deliberately responsible for his/ her actions.
In addition to the interventions caused by genetic risk, sailors who are about to sail away or go mountain climbing to a country with poor health services sometimes resort to prophylactic appendectomy as a preventive measure in their expeditions exploring space or the north pole [37]. In this case, since there is no genetic factor that tends to develop into a disease, it is seen that the obligation of indication remains uncertain. For this reason, it is suggested that prophylactic
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