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Neuroethics ISSN 1874-5490 NeuroethicsDOI 10.1007/s12152-014-9224-1

Self-Estrangement & Deep BrainStimulation: Ethical Issues Related toForced Explantation

Frederic Gilbert

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ORIGINAL PAPER

Self-Estrangement & Deep Brain Stimulation: Ethical IssuesRelated to Forced Explantation

Frederic Gilbert

Received: 5 May 2014 /Accepted: 14 October 2014# Springer Science+Business Media Dordrecht 2014

Abstract Although being generally safe, the use ofDeep Brain Stimulation (DBS) has been associatedwith a significant number of patients experiencingpostoperative psychological and neurological harmwithin experimental trials (i.e. self-estrangement,hypersexuality, hypomania, suicidality, impulsecontrol disorders, etc.). A proportion of these post-operative severe adverse effects have lead to thedecision to medically prescribe device deactivationor removal. However, there is little debate in theliterature as to what is in the patient’s best interestwhen device removal has been prescribed; in par-ticular, what should be the conceptual approach toethically guide the decision to remove or maintainimplants. The purpose of this article is to examinethe ethical issues raised when patients refuse braindevice explantation despite medical prescription. Inorder to illustrate these issues, we report and dis-cuss a clinical case involving a patient sufferingfrom treatment resistant depression who experi-enced forms of postoperative self-estrangement, aswell as suicidal attempts, but who resists givingconsent to device explantation.

Keywords Consent . Deep brain stimulation .

Depression . Forced explantation . Forced removal .

Harms . Self-estrangement

Introduction

When to Medically Prescribe DBS Device Removal?

Every time a medical device is implanted or inserted in ahuman brain, such as Deep Brain Stimulation (DBS),there are probabilities that it may need to be removed orexpelled at some points in time due to medical reasons.Statistically, DBS is generally safe, and most DBS de-vices will not have to be expelled. However, a signifi-cant proportion of devices are medically required to beexplanted from patients’ brains. DBS removal involvessubstantial risk of reversible and irreversible harms,such as requiring additional brain interventions, furtherhospitalizations, long-term use of antibiotics or othermedications, possible loss of the benefits of future stim-ulation and psychological distress. Due to these poten-tial risks of harms, obtaining patient consent is a sinequa non condition to remove DBS devices.

The current uses of DBS for neurological conditions,such as Parkinson’s, teach us that there are standardpostoperative physical adverse events that can lead tothe medical decision to prescribe removal of DBS de-vices. These events include (but are not limited to) non-response, infection, lead migration and/or dislodgment,lead fracture, erosion, electrical short circuit or opencircuit, asymptomatic intracranial haemorrhage, foreignbody reactions, cerebrospinal fluid leak, subcutaneousbleeding along the extension wire and component mal-function [1–3]. In parallel to these physical incidents,there have been reports of DBS devices causing theworsening of some symptoms [3], and involving tran-sient or permanent neurological deficits [4]. Beyondthese common DBS instances of physical adverseevents, there have been occurrences of postoperative

NeuroethicsDOI 10.1007/s12152-014-9224-1

F. Gilbert (*)Ethics, Policy & Public Engagement, ARC Centre ofExcellence for Electromaterials Science (ACES), Universityof Tasmania, Hobart, TAS, Australiae-mail: fredericgilbertt@gmail.com

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disruptions of patients’ mood or personality that haveled to prescribed removal and turned off stimulation [5,6]. The later ethical issues associated with a patientexperiencing problems with their postoperative senseof the self that have been described in terms of identity,agency, authenticity, autonomy and self-estrangement[7, 25, 8–10]. However, little is known about whatshould be prescribed and indicated to patients whenfacing these later issues, especially psychiatric patients.

Treatment Resistant Depression and Explantation

Understanding how Treatment Resistant Depression(TRD) patients view and perceive themselves after im-plantation of DBS devices is essential for rehabilitationpractice and for obtaining successful remission. Thesubjective experiences that implanted TRD patientshave about their postoperative sense of self is critical;in a limited, but significant number of cases, it may beassociated with risk of harms, such as suicidality [7, 11,12]. Consequently, it is an important task to examineunder which circumstances removal (deactivation-activation) should be ethically prescribed, particularlywhen a TRD patient may be opposed to removal. TheDBSmedical team has an obligation to promote medicalbenefits and avoid specific harms to patients, as well asrespect a patient’s right to decisional sovereignty.

Little has been discussed about the ethical issues re-lated to implantable brain device removal, in particular inpatients who categorically refuse the explantation. Insuch circumstances, there is a need to debate what shouldbe the ethical rights and obligations of the patient andinvestigators. Which ethical or legal principles may jus-tify a removal decision? Can a device be removed with-out patient consent? What is entailed in the notion ofprescribed removal; can it imply a form of forced explan-tation? Some have asked whether therapeutic privilegecould be invoked for explantation to be performed with-out informed consent [13].May appealing to the principleof non-maleficence be ethically enough to justify pre-scribed explantation, especially when potential long-termbenefits may possibly outweigh current adverse effects?

This manuscript has four sections. The first sectionreports a clinical case, which illustrates the difficulties inimposing device removal even when a patient sufferingfrom TRD experiences feelings of self-estrangementand engages in postoperative suicide attempts. The sec-ond section sheds light on whether DBS adverse effects,such as postoperative feelings of self-estrangement, may

justify explantation of devices. The third section ex-plores the ethical issues associated with the notion ofprescribed explantation, especially when it involves cer-tain degrees of coercion. The last section addresses thequestion of why removing devices is not ethicallyenough.

Clinical Case

A 32-year-old patient with a decades-long history ofdepression agreed to participate in a randomizeddouble-blind Deep Brain Stimulation trial study forTreatment Resistant Depression. Prior to the interven-tion, the patient self-reported more than 30 ineffectiveand/or poorly tolerated medication trials and an ineffec-tive course of electroconvulsive therapy. The patient hadinserted bilateral stimulators within the subcallosal cin-gulate cortex. The consent form indicated that at the endof the second phase of the study (6 months after thebeginning of the first phase), all patients would beoffered active DBS and the opportunity to participatein a long-term extension of the study and/or to receiveongoing clinical follow-up outside the study.

A few weeks into the trial, the patient subjectivelyfelt worst. The patient reported feeling more depressedsince the surgery, had difficulties concentrating, hadincreased frequency of suicidal ideation (passive notactive). The trial psychiatrist reported the patient de-scribing for the first time a postoperative sense of de-personalization. The patient reported feeling devoid ofany real thoughts or emotions and described a sense ofdisconnection or detachment: “It felt as if I was living on‘auto-pilot’, simply going through the necessary mo-tions of living, while lacking any genuine emotionalreaction or connection to what I was doing or the peoplewith whom I interacted. […] I was merely “existing” inthis life instead of actually living or experiencing it”.

Less than 3 months into the trial, the patient wasadmitted to hospital due to an increasingly depressedmood with specific lethal suicide plans. The patient wassent to Psychiatric Emergency Services Unit. Despitedescribing suicidal ideation of increasing intensity, thepatient could not identify a specific stress factor that ledto this increase. The patient was aware of feeling frus-trated that the DBS trial had not led to clear improve-ment over the past 2–3 months. The patient describedfeeling increasingly unable to deal with being chroni-cally depressed.

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Ten months into the trial, police had to physicallypull the patient off the roof ledge of a parking garage(police were alerted by someone from an adjacent officebuilding who saw the patient on the ledge). The patientwas forcibly taken to the emergency department whereshe was assessed, held overnight, and released the fol-lowing morning.

In the followingmonths, the treating team recognizedfurther deterioration in the patient’s behavior. The pa-tient reported that the feeling of detachment had inten-sified markedly, becoming much more pronounced andclearly defined. The patient reported strongly believingthat “the sudden and unexpected worsening of thesefeelings played a very significant role” in the increasein suicidality that followed shortly after reporting thesefeelings to the trial’s psychiatrist. On month 14, thepatient attempted suicide by overdose. The DBS-related device was immediately turned off. Prior todeactivation, three setting of device stimulation adjust-ments were tested through the lifetime of the trial.

The informed consent form stipulated: “The doctormay […] withdraw you at any time if he/she considersthis to be in your best interest. You may also be with-drawn if you are not able to follow the study proce-dures.” Given the severe adverse affects, removal of thedevice was prescribed by the treating team based on thebelief that no therapeutic benefit would accrue fromfurther treatment. The team argued that the DBS trialwas an experimental treatment and not a therapeuticintervention within a consented study protocol, as aresult the team argued the study was completed andwithout benefit to the patient.

Despite absence of any benefit from the trial and theseverity of suicidality, the patient formally resists thedevice removal, unto this day.

Postoperative Feelings of Self-Estrangement:When is There Sufficient Harm to PrescribeExplantation?

How implanted patients experience and interpret them-selves from their unique perspective is central to under-standing the DBS postoperative impact on a patient’sself, and consequently understanding how it can trans-late into harm. Empirical research has not yet fullyexamined the subjective experiences that implantedTRD patients have about their postoperative sense ofthe self. Should disruptive and radical alteration of a

patient’s postoperative sense of self be a justification toprescribe explantation?

In the above case, the treating psychiatrist reportedthe patient describing an early postoperative sense ofdepersonalization. Neurobiological studies into the phe-nomenology of depersonalization have revealed patientsfeeling estranged from their affective response, anddetached from the normal feeling of self [14, 15]. Inthe above case, the patient described feeling devoid ofany real thoughts or emotions and experiencing a senseof detachment: “It felt as I was living on ‘auto-pilot’”.Postoperative feelings described by the above patientare not rare. A significant number of patients havereported experiencing a postoperative sense of self-estrangement [7, 16, 17, 24]. Postoperative self-estrangement does not necessarily constitute harm.DBS postoperative self-changes are expected; essential-ly, it is the sole purpose of invasive brain intervention.TRD patients consent to DBS intervention mostly for anopportunity to alter their TRD states; consequently,patient’s strongly expect changes in their self. In thatrespect, postoperative self-estrangement may enhanceor restore one’s control over one’s life or illness. How-ever, in some cases, DBS radical modifications of theself may lead to a loss of control or experiencing feel-ings of powerlessness [7].

The above patient reported that her feelings of de-tachment intensified markedly after the DBS study be-gan; consequently, the patient believed the “unexpectedworsening of these feelings played a very significantrole” in the increase in suicidality. Noteworthy, thesepostoperative feelings of estrangement represent a po-tential form of harm to the patient, but would not sys-tematically lead to suicidality. Although suicidabilitycannot be reduced to these postoperative feelings ofestrangement, their combination with other factorsmay exacerbate the risk of harm and experiencing pow-erlessness. For instance, the above patient describedfeeling frustrated that the DBS trial had not led to clearimprovement. The patient reported feeling increasinglyunable to deal with being chronically depressed. Theseobservations seem to refer to a sense of estrangementinvolving feelings of powerlessness. The patient appearsnot to be able to regain control of her depressive feel-ings. From this perspective, the continuous absence ofthe capacity to regain control of her feelings may havecontributed to turning the estrangement into harm, es-pecially suicidality. A fundamental question that needsto be answered in neuroethics is: Should TRD patients

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who experience postoperative self-estrangement, (asso-ciated with powerlessness, which might trigger postop-erative psychological and physical harm) have theirdevice removed? Should explantation be an appropriateprescription in such circumstances, and what conceptualapproach could ethically guide the decision to remove?

Should Devices be Removed? Exploring the Notionof Forced Explantation

Although it has been argued that DBS “consent docu-ments should explicitly describe the conditions underwhich investigators would recommend discontinuationof stimulation and even removal of the device”, deviceimplantation and explantation are not necessarily con-joined concepts in terms of consent [18]. A patient whoconsents to implantation may object to consent to pre-scribed explantation. Medically prescribed decisions toremove DBS devices may come in degrees ofcoercion for patients resisting removal. A certain degreeof coerciveness may conceptually be understood as thenotion of forced explantation. To our knowledge, theconcept of forced explantation of brain devices hasnever been discussed per se in the literature. The conceptof forced intervention conveys strong meanings andacceptions, especially in a context of psychiatric sur-gery. Thus, we shall define forced explantation as acertain physical or psychological degree of coercivemeasures to remove brain devices in the absence ofconsent; including indirectly and psychologically forc-ing a patient into a decision s/he strongly resists andfights. The concept of forced explantation raises impor-tant ethical problems because it constitutes a directthreat to the fundamental moral principle of patientautonomy; while indicating presence of medical pater-nalism. Such paternalism would involve the absence ofpatient sovereignty to appreciate what is in her/his bestinterests and decide accordingly. Prescribed explanta-tion does not necessarily involve the patient’s best in-terest. Performing explantation resulting from some de-grees of coerciveness may place patients at greater riskof harms, and often for no apparent benefit other thanremoving the device. Forced removal entails askingwhat may ethically justify explantation when a patientobjects. What are the ethical approaches that can guidethese justifications? May a traditional harm-benefit ratiobe ethically sufficient? The above case will be used toshed light on these concerns.

Refusing Removal

While the patient was still hospitalised following a newattempted suicide by overdose on month 14, DBS de-vices were deactivated. During the same period ofhospitalisation, the medical team articulated their inten-tion to see the patient undergo removal of the DBSimplants. From a medical point of view, the clinicalteam had an obligation to advocate for the patient’s bestmedical interest, especially when the patient sufferedfrom increased suicidality. Nevertheless, the patienthad decisional capacity to refuse the prescribed explan-tation; especially because she believed many potentialtherapeutic outcomes could benefit her in the long term -should the device be reactivated. On a first approxima-tion, the obligation to protect patient vulnerability tosuicidality may seem to supersede the patient’s capacityto refuse consent to brain device removal. Tojustify this position, as seen above, the DBS med-ical team concluded that no therapeutic benefitwould accrue from further treatment. This particu-lar DBS trial was an experimental treatment andnot a therapeutic intervention within a consentedstudy protocol; as a result the team argued thestudy was completed and without benefit to thepatient. Within these circumstances, given the ab-sence of immediate medical benefit, to what extentshould patient decisional sovereignty prevail?

First, the patient challenged the argumentclaimed by the team according to which “the studywas completed and without benefit to the patient”.Indeed, with the randomised double-blind designof the study (50 % of participants having theirdevices “on”), the patient’s devices could verywell have been “off” for the entire study period.Only a few clinicians within the DBS team knewwhich group the patient belonged to. In order tomaintain the study’s integrity, that informationcould not be revealed. Plus, the patient disputedthe argument that “no therapeutic benefit wouldaccrue from further treatment”. In many cases, itcan take upwards of 1 year or more (even up to2 years) of continuous active stimulation before apatient may start to notice any benefit [19, 20]. Inthat respect, explantation may limit the patient’saccess to potential therapeutic benefit. Should theethical guidance to prescribe explantation be bal-anced between existing adverse effects and poten-tial benefits?

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Existing Adverse Effects vs Potential Benefits

From the DBS medical team’s perspective, even if therewere probabilities of a long term potential benefit,preventing existing and further harm may be more im-portant than probabilities. In other words, the prescribedexplantation was not a withdrawal of access to approvedtreatment, but rather was an action to prevent furtherharm within an experimental regimen. However theargument made by the team leader according to which“the prescribed explantation was not a withdrawal ofaccess to treatment, but rather was an action to preventfurther harm within an experimental regimen” may bedisputed by the patient as conflicting with informationprovided by the informed consent forms. Indeed, in thisparticular trial, as seen above, the informed consentstates “at the end of the second phase of the study(6 months after the beginning of the first phase), allpatients would be offered active DBS and the opportu-nity to participate in a long-term extension of the studyand/or to receive ongoing clinical follow-up outside thestudy”. The patient agreed to participate in the follow-upstudy; the DBS was activated at the end of the studyperiod (6 months). Accordingly, the patient’s withdraw-al from the extension study following a suicide attemptmay be interpreted as a way of denying access to activeDBS long-term extension of the study and to receiveongoing clinical follow-up. In that matter, the patientstill hoped that potential benefits may take place furtherin time.

The DBS medical team preferred focusing on benef-icence, to the extent they argued to prioritise the impor-tance of existing DBS adverse effects over potentialDBS beneficial effects on the patient’s illness. The no-tion of potential DBS beneficial effects leaves room fora high risk of harm in the follow-up study, as well asuncertainty in relation to future clinical responses. Interms of potential DBS beneficial effects, the team ar-gued there was no clear long-term data on the safety ofcontinuing to have the device implanted, in particular,on how it may impact on future treatments needed bythe patient. One could argue that maintaining the deviceincreases a risk of loss of future treatment opportunity.Therefore, from the DBS medical team’s point of view,the harm-benefit ratio was not favourable in terms ofpotential treatment; the only existing benefits were thoserelated to device removal.

However, in favour of the patient position, we canargue that prioritising existing DBS severe adverse

effects over the potential DBS beneficial effects mayneglect the fact that not all therapeutic stimulation ad-justments were tried up until the point of deactivation. Inher case, only three settings of device stimulation ad-justment were tested through the lifetime of the trial.Device stimulation involves multiple setting adjust-ments, entailing various combinations of stimulationpower levels and active/inactive contacts that can bemade throughout the process. The different combina-tions not tested may possibly lead to direct or long termbenefits to patients. One must not forget that thesestimulation tests may appear of little harm to patientsgiven they already had undergone the surgical risk as-sociated with being surgically implanted and experi-enced the burden of the implantation. In that respect,one can debate what should ethically qualify as themedical obligations of the DBS team, as well as whatthe patient’s duty should be when facing these removalchallenges. Defining explantation in terms of a patient’sbest interest is not a straightforward task (not exclusive-ly in terms of medical interest). Justifying explantationonly with respect to a ‘life threatening’ issue, such assuicidality, may neglect other important factors. It en-tails that any medical decision leading to prescription ofDBS explantation can hardly be justified in terms of thepatient’s best interest if it does not threaten the patient’slife. The way we understand the patient best interestsshould take into account patient capacities to knowwhatis better for herself. Ethically speaking, the underlyingquestion is: in what respect should patient self-governance prevail over the medical obligation to pro-tect patients from existing DBS severe adverse effects?

Even if vulnerability to suicidality is a critical compo-nent which should justify protection of patients, this doesnot make it the only aspect the medical team shouldconsider to protect patients during experimental trials;protecting patient decisional sovereignty may play out tobe equally important in some cases. However, it does notmean that DBS teams have a duty to protect patientautonomy above all other considerations nor imposingpaternalistic conclusions. Protecting patients is not neces-sarily a matter of keeping them away from immediateharm; it may be a matter of treating them in the way thatrespects their postoperative self. As explored in our sec-tion entitled “Postoperative feelings of self-estrangement:When is there sufficient harm to prescribe explantation”,understanding postoperative feelings of self-estrangementis fundamental to comprehend what constitutes a patient’sbest interest, especially when facing explantation.

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Why Removing the Devices is not Ethically Enough?

In the introduction of this paper, we asked: What ethicalapproaches may guide justifications for prescribing re-moval of DBS devices? The above case appears todemonstrate that a traditional harm-benefit ratio maynot be ethically sufficient. Other aspects, which maybe indirectly interacting with patient’s medical interestsmay be quintessential to justify (or not) devices remov-al. We discuss three of them.

First, in order to respect patients’ decisional sover-eignty and to meet patients’ best interests, the medicalteam should devote the necessary time to clearly answerpatient concerns, particularly with respect to the pointthat medical interest is not the only approach to take intoaccount. Giving a patient a formal opportunity to con-tribute to the process leading to the prescription ofremoving devices, for instance, by allowing her/him toask questions as needed, should be an essential require-ment. Effort devoted to informing and enrolling patientsshould be regarded as an equal model to support, as wellas de-enrolling a patient facing potential prescribedexplantation –when patients are still competent to con-sent. The potential option to remove DBS devicesshould be regarded and treated as an extension of theprocedure to obtain patient consent to participate in thetrial. Notwithstanding a DBS team’s aspiration to pre-scribe DBS devices removal during the trial, and wheth-er or not a patient consents to the decision, helpingpatients to expose their concerns should be an unavoid-able step toward DBS removal. Decision of deviceremoval is not straightforward; rather it involves a com-plex and multifaceted process, very likely resulting inquestions for patients to which the DBS team should beethically and legally obliged to respond. However, theopportunity to discuss explantation should be elaboratedin a way so as to avoid any further disappointmentstemming from some patient’s false hopes. Having nohope for a reversal of an explantation decision can beargued better than any therapeutic false hope. The lackof interaction and communication between a patient anda medical team, especially when a DBS removal hasbeen advised, is likely to increase therapeutic false hopeas well as the degrees of coercion upon which theprescribed explantation will be interpreted by the pa-tient. Without continual dialogue, the medical decisionwill be imposed rather than discussed; increasing apatient’s feelings that s/he is victim of a coercedexplantaiton.

Second, the situation in which device removal isoffered might be ethically debatable, in particular if ittake place or immediately follows a stay in the IntensiveCare Unit (ICU), as we have seen in the above case. Thelegitimacy of informed consent given during, or imme-diately after, ICU has been questioned by some studies[21]. Patients in ICU may lose the ability to makecompetent judgments, as such, they constitute a vulner-able cohort needing exceptional protection. Despite thefact that informed consent is an essential approach torespect a patient’s autonomy, the standard informedconsent procedure may not be sufficient to be ethicallywarrantable in such ICU contexts [21]. Given the ex-ceptional vulnerability of patients in ICU, the assess-ment guiding a decision to consent may bemisleading interms of what is in the patient’s best interests followingdeparture from ICU. Patients experience unusual medi-cal circumstances in ICU, often involving heavy medi-cations and life support technologies, as a result somepatients may suffer from memory loss and impairedcognitive capacities. The ICU is not representative ofthe quality of life a patient will experience post-ICU.The goal of the medical team is to prevent any futurestay in ICU by identifying whether or not DBS devicesmay have contributed to the incident leading to ICU.Regardless of the medical outcomes, understanding therisk of keeping the DBS device is critical for a patient.Understanding the risk is a fundamental step towardconsent or objecting to device removal; however med-ical circumstances into which these critical details areintroduced and explained to patients may be regarded asethically inappropriate, in particular in a context of ICU.Here again, feelings of being forced into an explantationprocedure may be exacerbated by the context of how thepatient was informed.

Third, patients face adversities through experimentaltrials, where many interests are shared by different per-sons/organizations/teams, as well as trials being vulner-able to major financial investments. These many inter-ests may generate an imbalance of decisional powerwhich can be painfully felt by a patient; such as beingexperienced as a decision imposed on the patient. Un-fortunately, due to illness, in particular with TRD, apatient may not have the energy or the financial re-sources to explore ways to fight these issues further withlegal counsel. Resisting explantation in an imbalancedcontext may intensify a patient’s frustration, especially ifthey feel there is a complete breakdown of the therapeu-tic relationship. Some patients may experience feelings

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of rejection from their treating team. Being a participantin an experimental trial is never easy; it is even moredifficult when the purpose of the trial does not turn outas it should have. Participants are often the first to sufferfrom these issues. Patients allow the DBS team to put anexperimental device in their brain (whether or not it isactive when removed is considered irrelevant) and, giv-en the nature and complexities of patients’ concernsregarding devices, the DBS team has a strong obligationto address these patients’ issues. Regardless of the DBSteam prescriptions and whether or not the patient agreeswith it, handling explantation as if patients are justrandom numbered test subjects is paternalistic and canbe interpreted as disrespectful and dismissive. Conse-quently, it may increase a sense of being pushed intoDBS removal without consent.

These three points highlight that willingness to dis-cuss removal with a patient should take place as soon asthe medical team has certainty of a patient’s best medicalinterest, especially strong evidence of no potential longterm benefit. However, the authority behind patient’sbest medical interest might not capture faithfully pa-tient’s best interest and long-term benefit (patient’s bestmedical interest is not isomorphic with ptient’s bestinterest). A patient’s best medical interests may beframed on a short-term view in experimental trials. Riskassessment should be based on re-evaluation of any newinput provided by many perspectives (i.e. DBS team,family, outside psychiatrist, etc.).

Conclusion

The primary goal of DBS intervention for TRD is tohelp the implanted person to reacheive a certain sense ofthe self. Aside from potential neurological risks (i.e.infections, bleeding, etc.), as in any other invasive brainintervention, there are serious psychological risks [22].Even positive outcomes may not be experienced aspositively as the patient initially expected whenconsenting to the trial [23–25]. Postoperative personal-ity or identity disruption may illustrate a need for astronger ethical guidance in psychiatric applications ofDBS [26]. It is clear that much additional work will berequired before a complete understanding occurs ofDBS postoperative sense of self-estrangement experi-enced by patients. It is hoped that this paper will en-courage further investigations into the notion of power-lessness and its relation with postoperative harm to TRD

patients. In particular, how it may lead to medical deci-sions to prescribe explantation. Patient best interest isoften weighted in terms of potential benefit and harm.Existing and potential severe risk of harms often guidethe decision to remove. An important ethical question iswhether patient decisional sovereignty should overruleabsence of immediate medical benefit. The therapeuticpurpose of ensuring a patient’s well-being byminimising risk of harm antagonizes the decision torefuse explantation. Invoking the principle of non-maleficence may not ethically be enough to justifyprescribed explantation as in a patient’s best interest;especially if it involves a certain degree of coerciveness.Arguably, although it would be praiseworthy to pre-scribe explantation when the treatment seems to carrya more obvious risk of harm with a less-than-certainchance of benefit, it should not be considered obligatory.Protecting patients is not necessarily a matter of keepingthem away from existing and potential harms; it may bea matter of considering their interest in respect of theirpostoperative decisional sovereignty above medical pa-ternalism (if capacity to consent is preserved).

Although DBS removal may be a necessary proce-dure in most cases, it may induce inadvertently iatro-genic harm, both physical and psychological. Whenexplantation is prescribed, patients may find themselvesleft with many important unanswered questions andconcerns with regard to the DBS device itself, as wellas what medical option is now left to them. The DBSteam’s prescription of explantation could be easier tounderstand and therefore accept if the DBS team couldspend the necessary time to clearly answer patient con-cerns, as well as give the patient the opportunity to askquestions and clarify things as needed. Regardless of theDBS team’s prescription, and whether or not a patientagrees with it, the opportunity to discuss a patient’squestions and concerns about removability should beallowed and interpreted as a formal extension of theprocess of obtaining informed consent.

Acknowledgments Fondation Brocher for its hospitality. Thaksto Eliza Goddard and Susan Dodds. ARCCentre of Excellence forElectromaterials Science (ACES), Project ID: CE140100012.

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