The term “informed consent” was first used in a 1957 case by Paul Gebhard wherein the suing party claimed that their doctor did not fully explain the risks involved with their recommended treatments. Dr. Arthur Caplan, who heads the University of Pennsylvania's Center for Bioethics, argued in an article on Gebhard’s work that the ruling on Gebhard’s case produced “the first articulation of what was meant by the legal phrase 'full disclosure': the idea that you had to disclose all of the relevant risks and benefits to the patient.” Of course the concept dates back centuries before that, yet this is the first moment in which the term was reified into something more meaningful for relations between patients and their doctors. Since the first usage in 1957, informed consent has worked its way slowly into the medical world. While not entirely regulated by the federal government, many state legislatures ensure that patients will informed to some degree by their doctors and nurses before they consent to any procedures.
Chikako Takeshita, author of The Global Biopolitics of the IUD, writes that informed consent has a fraught history with contraceptives in America. First, informed consent laws did not apply to contraceptives at the time of their release in the 1960s. In fact, the only reason informed consent was extended to contraceptives at all was an effort by women’s health activists demanding “full disclosure of known risks associated with pill use” (Takeshita, Page 97). At the time, doctors were split on whether or not to support information pamphlets inserted alongside oral contraceptives. Some objected, fearful that relinquishing their control and authority over patients would cost them business. Others argued that it was good for their businesses, protecting doctors from malpractice suits by placing the burden of knowledge into the hands of patients; as the pamphlets required little more engagement from doctors than their standard practices (Takeshita, Page 97). While informed consent has become more normalized since the 1970s, the latter set of doctors were right about the ways informed consent legalese protects their interests. Takeshita notes that some doctors used the informed consent pamphlets and forms to demonstrate to courts that the problem was not medical malpractice, but instead patient misuse or a biological fault. She writes, “...the informed consent practice does not necessarily protect the woman from health risks; instead it makes her conform to the norms of the capital market, requiring her to be the willing and legally (but not necessarily physically) safe consumer of a product” (Page 98). The informed consent system, in addition to placing the legal burden on the individual, also allows doctors to take advantage of their patients trusting that they are “informed.”
The misrepresentation of health information to women seeking IUDs is a purposeful tactic to take advantage of both their trust and the legalese that frees doctors from accountability for users’ struggles. Takeshita describes anti-abortion and anti-contraceptive doctors misconstruing the function of an IUD to purposefully steer them away from use. These doctors purposefully frame the IUD as an abortive device. They argue that IUDs don’t actually prevent pregnancy, just prevent the fertilized egg from attaching to the wall. By choosing not to disclose that the process is not so clear-cut the patient is, as Takeshita writes, “put in a position where she is asked to make a moral choice rather than choose a contraceptive method” (Page 124). In practice, this behavior pushes women not to consider their own health but rather the moral value judgment of ending a purely theoretical pregnancy. Takeshita continues, arguing that such a behavior “functions as a form of governance over women’s bodies against IUD insertion” where women are “caught off guard and made to feel judged by their healthcare providers” (Page 124-125). Even today, the protocol for informed consent to the IUD is a tension for women looking to explore contraceptive options.
In exploring contemporary informed consent, I needed to assess two things. First, I needed to look into publicly accessible marketing info. Paragard’s “What is Paragard” page, for example, does not even list associated health concerns and risks on the main page. They advise women not to use Paragard if they are experiencing a pelvic infection or certain cancers. However, if you scroll past the main information, you can find an explanation of potential risks including IUD attachment, lost pregnancies, and infertility. In some ways, I found Paragard’s marketing website more helpful than I expected. Each page actually includes this safety warning along with advice telling patients experiencing any concerning issues to speak to the FDA as well as their doctor(s). Paragard’s website was more accessible than most, however. Reproductive Access, for example, has much less information on their breakdown of the IUD. The pamphlet their website hosts lists “Yes. Serious problems with the IUD are rare, and most happen the first few days” in response to concerns about safety and very limited listings of side-effects, with a focus on the benign. Information available on the risks and procedures is only the first step of the process of informed consent.
The second piece is that of the actual consent forms. The Women’s Health Center of Lebanon in Pennsylvania has their full IUD informed consent form available online. Their form features both a detailed explanation of the procedure, including potential warning signs that women should be able to detect through their own follow-up examination of the strings at the IUD’s base. In addition to this explanation, their consent form has a detailed explanation of potential side effects, from the simple to the severe, alongside the steps that these women should following unintended side effects. The form then asks these women to list alternative contraceptive methods, risks of alternatives, as well as an agreement that their doctor has fully informed them of the other risks I listed above. While Lebanon’s facility is one of many in the country, I believe it demonstrates the ways in which an informed consent form can encourage women to be truly informed and safe with their use of contraceptives and the IUD. What must happen now is that all centers providing insertion services need to adopt similar practices, especially where it pertains to informing without trying to sway women away from methods without informing them fully.
If you're interested in learning more, please check out Chikako Takeshita's The Global Biopolitics of the IUD and if you're interested in learning more about the IUD on your own check out pages such as Planned Parenthood's IUD Page,
References:
Pace, Eric. "P. G. Gebhard, 69, Developer Of the Term 'Informed Consent'" The New York Times. The New York Times, 26 Aug. 1997. Web.
Takeshita, Chikako. The Global Biopolitics of the IUD: How Science Constructs Contraceptive Users and Women's Bodies. Cambridge, MA: MIT, 2012. Print.
"What Are the Legal Requirements of Informed Consent?" American Cancer Society. Web.
"What Is PARAGARD® (intrauterine Copper Contraceptive) IUD ? | Hormone-Free IUD Birth Control." Paragard. Web.
http://www.reproductiveaccess.org/wp-content/uploads/2014/06/IUD_facts.pdf
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