For the purposes of this paper, I will only address one potential regulatory scheme, and only in conjunction with prosthetic enhancement available in the near future ( less than 10 years) that augments slightly, but not significantly, human biological capabilities. I will not address the convergence of technology and the regulatory scheme needed to address that.
Part IV: Regulatory Schemes
Shelves of books could be written on just such a thing. This regulatory scheme most closely conforms with McKibben's idea of market-driven technology because only those augmentations that people choose to adopt will be accepted. Section A introduces the regulatory scheme currently used by the cosmetic surgery industry, while section B illustrates how this regulatory scheme might apply to prosthetic devices.
IV.A: Cosmetic Surgery Regulations:
Cosmetic surgery is largely governed at the state level, though there are some intervening federal laws. For instance, in 1992 the U.S. Food and Drug Administration banned the use of silicon breast implants except in a narrow range of procedures – a decision later reversed by that same agency in 2005.1 Some of the states with the toughest laws on cosmetic surgery include Florida, California, and New York.2 Even then, the laws regulate only office space, anesthesia, and other technical details but often do not address who may get cosmetic surgery. In most states, anyone with a medical degree may perform any surgery the patient requests, even if those people do not have a specialty in that type of surgery.3 In Nevada, for instance, cosmetic surgery is identified as regular medical practice and is governed by the medical malpractice laws of Nevada.4 The American Board of Cosmetic Surgery does certify doctors as Board Certified Cosmetic Surgeons, but a doctor need not be so certified to practice cosmetic surgery.5
This sort of regulatory scheme is quite lax. Indeed, one of the benefits cosmetic surgery confers to patients is that it is essentially a free-market affair. While some regulations governing general patient safety might exist in a given state, and general malpractice law applies, a competent surgeon can perform most any procedure on most any patient. Likewise, insurance often does not cover cosmetic surgery (excepting breast reconstruction after a mastectomy6) so patients who can afford the procedures are able to get the procedures and patients that cannot afford the procedure (or who do not have insurance) are unable to obtain the procedure.
For doctors, this is a benefit because they do not have to worry about insurance companies denying payment for a procedure and can offer their services to credit-checked individuals and demand payment up front. Additionally, so long as doctors perform the procedure with the routine standard of care required for all procedures, there is potentially no limit to the number of patients that they can see and the amount that they can charge for those procedures. Cosmetic surgery “became a highly competitive area of medicine when its potential financial rewards and lack of third-party oversight attracted physicians from other areas of medicine where corporatization and privatization threaten their economic well being and sense of personal autonomy” writes author Deborah Sullivan.7 Unlike traditional surgeries used to treat diseases, cosmetic surgeons often advertise the benefits of the procedures they perform.
Cosmetic surgery is also gaining broad acceptance. Nearly 8.3 million cosmetic surgeries were performed in 2003.8 This is despite the fact that one regulatory requirement, informed consent, is more stringent for elective procedures like cosmetic surgery than for routine medical procedures.9 Yet, in at least one case a patient with Body Dysmorphic Disorder (a preoccupation with physical imperfections that causes significant distress or physical impairment) who won at the district court level had her case overturned at the state supreme court level.10 The plaintiff argued that her Body Dysmorphic Disorder (BDD) rendered her incapable of consenting to cosmetic surgery.11 The plaintiff argued that her string of cosmetic surgeries over a six year period were a result of this BDD.12 The Court of Appeals of New York held for the defendant, finding that the defendant had proven that the plaintiff did not suffer from BDD or any other disease that would render her incapable of consenting.13
Yet, even if this particular plaintiff did not win her informed consent claim, there is at least the danger that a cosmetic surgeon could perform cosmetic surgery on a patient with BDD and later be subject to malpractice claims. Because many people who get cosmetic surgery undergo multiple procedures, differentiating between patients with BDD and patients that wish to improve multiple aspects of their appearance may be difficult. Ultimately, excepting those requirements dictated by statute, how “informed” consent must be remains a judgment call made by the doctor, and medical malpractice claims are likely only to punish those doctors who are extremely negligent or who exercise extremely poor judgment.14
Already the transition from cosmetic surgery to technological enhancement is underway. One author notes that standard cosmetic procedures like Botox might cause women who choose not to undergo a procedure that makes beauty “technologically achievable” to be cast as “technologically primitive.”15 With the advances in prosthetic technology and the potential for cosmetic amputations, this concern is even more important.
IV.B: Prosthetic Augmentation As Cosmetic Surgery
However elective amputation and augmentation is regulated, it seems likely that amputations that occur for the usual reasons now (disease or traumatic injury) will still be performed in hospitals, and may very well be covered under insurance plans. The danger in not opening up prosthetic technology as an elective procedure lies in the potential for only those sorts of patients to receive those procedures. In a fictional book, Machine Man, author Max Barry confronts this very issue.16 When a scientist suffers a horrible accident in a lab that severs his leg, he is taken to a hospital, treated, and fitted with a prosthetic leg. As an engineer, he devises ways to make his leg increasingly more efficient and functional until he realizes that his biological leg is holding him back. It is then that he decides to have another “accident” to sever his biological leg.
If elective amputation is banned, we will likely see one of two things happen (or perhaps both things.) First, people who want prosthetic limbs might travel to other countries that permit voluntary amputation to have the procedure performed. We see this now with patients who are unable to get other types of procedures in the States. Second, we might see an increase in traumatic “accidents” since only those sorts of people will be able to receive prosthetic limbs. If prosthetic limbs are vastly more efficient than biological limbs and provide superior functionality, as I have argued that they will, then those who have traumatic injuries might be seen as fortunate or lucky.
If, instead, elective amputation and replacement is embraced we might sidestep both issues. Under the current cosmetic surgery regulatory scheme having a limb amputated and replaced ought to be akin to getting a facelift or liposuction. A team of doctors no larger than that needed for other major cosmetic surgeries could likely perform the procedure in a clinic not unlike current cosmetic surgery clinics.
One downside to this sort of procedure is that it is likely to be very expensive. With prosthetic limbs costing up to $35,000 now, and the medical team and surgery needed to amputate a limb and fit the prosthetic likely costing ten times that amount, a new arm could be a half-million dollar affair.
Yet, within an open regulatory system we might yet see business solutions that drive the cost down considerably. Another fictional work, Deus Ex: Human Revolution, confronts this question.17 In that game a prosthetic company, Sarif Industries, creates and sells limbs for human augmentation. Sarif sells those limbs to another company called Liberty In Mind and Body (LIMB), which in turn creates clinics throughout major cities that offer what amount to installation services for their prosthetic technology. Additionally, these LIMB clinics offer repair and upgrade services, anti-rejection medication, and other services for Sarif patients.18 By bundling the sale of the limb with installation, and by having staff doctors performing the procedures, Sarif and LIMB are able to offer prosthetic limbs at much lower prices that we might expect today.
Yet, even this sort of arrangement requires careful regulation. For instance, if prosthetic technology is available only to those who can pay in full up front, the technology might well be available only to the rich. This could very well lead to the sort of class division that critics fear. If, on the other hand, financing is available for prosthetic technology and other market actors likewise help to drive the price down, the technology might be embraced by a larger portion of society. Yet, these sort of financing plans come with their own sets of concerns. For instance, if one finances a car now and falls behind on payments, the car company can come and repossess your car. The vehicle itself is the collateral. Yet it is nearly inconceivable that a company could come and repossess people's arms, much less their hearts or their lungs.19
Even if voluntary augmentation is handled in a cosmetic surgery context, informed consent will remain an issue. Because of how invasive the surgery is, many more things can go wrong with limb replacement and amputation than with, say, a Botox injection. While we know the sorts of things that can go wrong reasonably well now, based on the number of amputations and prosthetic limbs currently performed and fitted, as technology continues to change we will have much less knowledge about possible side effects with with to adequately inform patients. For instance, nearly all amputees suffer from phantom limb pains now.20 Infection and a failure in healing is also relatively common.21 Yet, it is unknown whether the newest prosthetic devices can help with either of these side effects that persist after modern-day amputations and replacements. Further, because lung replacements and other advanced devices to not yet exist, the potential side effects from those prostheses are completely unknown.
Yet, we have methods for introducing new medical devices and procedures now, and it is likely that the same sorts of testing that we currently use would suffice to meet the burden of proving a new device or procedure safe. With this sort of testing comes the sort of knowledge necessary to offer patients true informed consent. One difficulty with this sort of testing regimen is that drugs and procedures are currently tested only on the sick and injured. Yet, if amputation and replacement becomes a voluntary procedure, it may make more sense to test this procedure out on willing volunteers (who, perhaps, cannot give true informed consent because the risks are, by definition, unknown) who only know what the limb ought to do.
Finally, though the process is unlikely to need to change from the current methods, recognizing those patients with Body Dysmorphic Disorder may become more difficult. It is one thing to recognize patients suffering from BDD when they have dozens or hundreds of cosmetic procedures to fix minor “flaws”, even if that recognition is not always crystal clear. It may be another to distinguish between people who have all their limbs and organs removed because of a disorder, and similar people who undergoes the same procedures because they want to become a more efficient and functional being overall.
Prosthetic technology does not currently offer superior performance to human biological limbs, but there are good reasons to think that in the very near future this will change. When it does, it is likely that people will want to voluntarily replace portions of their biological bodies with mechanical analogues. Proponents of this sort of technology point to benefits like increased functionality and elimination of the stigma of being disabled for individuals, and increases in education, creativity, and resources, and reductions in hunger and disease for society. Critics worry about multiple unsafe procedures, security risks, psychological harm, and the loss of identity for individuals, superhuman villains, stratification, and the loss of some essential human essence plaguing society.
Yet, even those ardently against prosthetic technology seem to agree that the technology is coming, and that people will want it. They are likewise unsure about how to stop people from getting this sort of technology. Because prosthetic technology is coming, and an open regulatory scheme might solve some of the problems critics identify while providing all of the benefits the proponents suggest, it may be the best option for regulating voluntary amputation and bionic augmentation. Such a scheme currently exists for cosmetic surgery, and might provide a blueprint for future procedures as well.
1Martin Donohoe, Women's Health in Context: Cosmetic Surgery Past, Present and Future: Scope, Ethics, and Policy, 11(2) Medscape Ob/Gyn (2006). Available at www.medscape.com/viewarticle/542448_2.
2Jayne O'Donnell, Cosmetic surgery laws often aren't enough, USA TODAY, Dec. 10, 2012, http://www.usatoday.com/story/money/2012/12/10/cosmetic-surgery-laws-effect-debated/1759839/.
4See generally Nev Rev Stat. § 630 (2013). Available at: http://leg.state.nv.us/NRS/NRS-630.html (making no mention of cosmetic, plastic, or elective surgery).
5See Frequently Asked Questions 3, American Board of Cosmetic Surgeons http://www.americanboardcosmeticsurgery.org/images/stories/GeneralFAQs.pdf (last accessed Apr. 25, 2013).
6See United States Department of Labor, Your Rights After A Mastectomy, Nov. 2012, http://www.dol.gov/ebsa/publications/whcra.html.
7See Deborah Sullivan, Cosmetic Surgery: The Cutting Edge Of Commercial Medicine In America 189, (2001).
8See Theresamarie Mantese, et. al., Cosmetic Surgery and Informed Consent, 85(1) Mich. Bar J. 26, 27 (2006).
10Id. at 28.
14Interview with Jenny Hullinger in San Diego, CA (Apr. 14, 2013). (Jenny works in a cosmetic surgery office in San Diego, California and related that doctors have wide ranges of discretion in deciding which patients to see, how informed the consent must be, and whether or not a patient just really likes cosmetic surgery or has a disorder like BDD.)
15See Abigail Brooks, “Under the Knife and Proud of It”: An Analysis of the Normalization of Cosmetic Surgery, 30 CRIT SOCIOL. 207, 225 (2004).
16See generally Max Barry, Machine Man, (2011).
17Eidos Montreal, Deus Ex: Human Revolution, Square Enix, (2011).
18In the game, the anti-rejection medication became a major plot point,as it was very expensive and those that could not continue to take the medication eventually underwent a painful process whereby their bodies rejected the limb. While this need not be the case in reality, it is a concern to watch.
19Inconceivable in reality, that is. For fictional accounts, See Repo Men (Universal Pictures 2010), or Repo: The Genetic Opera (Cinespace Film Studios 2008). Both films deal with companies repossessing prosthetics or organs, respectively. For a view of this sort of repossession in a secured transactions context, see John Niman, Secured Transactions In Bionic Or Genetic Organ Replacement, BOYDFUTURIST Oct. 13, 2011, http://boydfuturist.wordpress.com/2011/10/13/secured-transactions-in-bionic-or-genetic-organ-replacement/.
20Risks, SURGERY, Nov. 24, 2009, http://www.surgery.com/procedure/amputation/risks.