The One Percent Nobody’s Talking About: How Medical Paternalism is Failing the Informed Consent Test (original) (raw)

Abstract

The standard of informed consent is being violated. With more than 38 million American women utilizing birth control each year, both the expected success rate and consequent implications of failure are significant. Most patients understand the approximate pregnancy rate to be around one percent for popular options like hormonal birth control pills and intrauterine devices, and they are told that the rare event of failure usually results from inconsistent usage or slippage of the device, respectively. Most birth control decisions center on variables like ease of use, cost, and reliability, for obvious reasons. What is left out of the doctor-patient discussion, however, are the consequences of being amongst the one percent whose birth control fails. Research on potential harm to the fetus exposed to estrogen and progesterone — the hormones typically found in oral contraceptives — is inclusive. Nevertheless it is easy enough for a woman to stop taking the pills once she discovers she is pregnant. With IUDs the potential harm to the fetus and even to the woman herself is significant. As many as half of IUD pregnancies are ectopic, a life-threatening condition usually necessitating an abortion (compared to just one percent of pregnancies overall). Furthermore, hormone-releasing devices like Mirena® and even non-hormonal IUDs like ParaGard® significantly increase the risks of miscarriage, premature birth, and infection in otherwise normal uterine pregnancies. The IUD literature disclosed to patients mentions such possibilities in the small print attachments included in the packaging — which the patient may or may not see, as most gynecologists directly order and insert the devices. Information-seeking patients might find this information on their own, such as through the manufacturers’ websites, which heavily emphasize an impressive success rate and gloss over the FDA-required warnings of serious harm. ParaGard® attempts to remove themselves from responsibility for such tragedies, assuring readers that nothing printed there can serve as a substitute for advice given by one’s medical doctor. As in many situations, the issue of informed consent rests with the information that is exchanged between doctor and patient: does the patient fully understand the potential harm to herself, and in the event of pregnancy, to potential others? I propose that at least in some cases, this standard is not being met. Furthermore, IUDs pose a problem oral contraceptives do not. In the event that the device cannot be located or otherwise removed, continuing a pregnancy is incredibly dangerous both to the fetus and the mother. One might say that a woman using birth control wasn’t interested in having another child, anyway, implying that aborting should be a reasonable if not simple solution. Because of increased risk for sterility following infection as a result of an IUD, use is typically only suggested for women who already have children. Once removed, an IUD’s birth control properties cease, so not surprisingly, the reversibility aspect is a heavily-marketed feature — suggesting that women using IUDs may be interested in having more children in the future (thus they might not be inclined to abort if accidentally pregnant, despite the preference not to become pregnant at the moment). All of this is to say becoming pregnant, with an IUD in place is a far more complicated matter than a game of chance, betting on being in the 99 percent. When a woman who is already a mother becomes pregnant with an IUD that doctors are unable to remove, there are greater considerations than those accurately represented in downplaying the likelihood of the risks becoming reality. She might be disinclined to abort, impacted by the positives of the experience of already having children. She might not be prepared emotionally for the heartbreak that could result in deciding to continue a pregnancy that ends tragically. She could unintentionally be inflicting the hazards of a life with severe disabilities on her child if born prematurely. She could be threatening her own life with an infection that turns septic in an effort to maintain the life of the offspring that was conceived despite 99 percent odds. The doctor-patient conversation needs to focus more on these one percent possibilities — even at the risk of the patient ultimately deciding against the IUD as a form of birth control so highly touted for its success rate. This is by no means intended to be representational of the inclinations of women in general; but because any woman could potentially be thus affected, the onus is on physicians to discuss such possibilities. Without this discussion, the ethical standard has not been met for informed consent.

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