Informed consent has always been the center of ethical healthcare. It helps patients fully understand the benefits, risks, and alternatives to a particular treatment. This becomes more important for women, especially when dealing with reproductive health.
Historically, women have always been underrepresented across clinical trials and research. As more cases of patient safety come to light, gender bias is making way for poor outcomes and safety. Take hormonal treatments, for instance, leaving behind unfavorable side effects. For many women, it’s a serious condition that they didn’t see coming.
This article discusses informed consent, its anomalies, and the need to prioritize it for women’s healthcare. Read on!
Informed Consent and Its Anomalies
Informed consent in US healthcare dates back to 1914. The landmark case of Schloendorff vs. the Society of New York Hospital firmly established the principle of patient autonomy. This led to healthcare providers disclosing all treatment-related information to a patient, including benefits, risks, alternatives, and consequences of refusal.
Yet, data suggests a poor satisfaction rate for informed consent across patients, the highest reported for emergency surgeries. Considering a critical condition that requires life-saving surgery, informed consent is often not a practical protocol.
However, in other cases, patients feel the compulsion to accept a prescribed treatment without understanding the potential side effects. Here are some data-backed findings from multiple studies.
- Over 60% of patients were unaware of the implications of informed consent.
- A study showed that only 24% of patients had signed the consent form themselves.
- Only 54.3% of informed consent forms included full details of a medical procedure.
- 0.9% of informed consent forms mentioned the potential risks.
Hormonal Treatment in Women: Lack of Informed Consent Leading to Dangerous Side Effects
Hormonal treatments for women are often a preferred choice for multiple ailments. They can relieve menopause symptoms, prevent osteoporosis, treat menstrual migraines, and even improve sex life. Despite the positive outcomes, the treatment leaves behind a significant impact on a woman’s body. What’s interesting to note is that the side effects are precisely the opposite of the intended treatment.
A woman undergoing hormonal replacement therapy can experience dramatic mood swings and changes in menstrual cycles. It can also negatively impact her reproductive health. What’s upsetting is that most patients are less informed about the potential side effects, whether it’s short or long-term.
In recent times, hormonal contraceptives have been the center of criticism. While they are prescribed for millions of women globally, they come with a fair share of risks. Studies have confirmed how the use of hormonal contraceptives adds to the risk of blood clotting, depression, and weight gain, among other side effects.
Earlier this year, Pfizer, the makers of a popular hormonal contraceptive Depo Provera, came under the radar. Reportedly, a woman who’s been on Depo Provera for years was diagnosed with meningioma.
In her Depo Provera lawsuit, the plaintiff slammed Pfizer with severe allegations of concealing information regarding potential side effects, like brain tumors. Similar allegations followed suit. Soon after, the biopharmaceutical giant revised the drug label, which is currently warning against a long list of possible side effects.
- Loss of bone mineral density
- Thromboembolic disorders
- Cancer
- Ectopic pregnancy
- Anaphylaxis and anaphylactoid reactions
- Menstrual irregularities (including bleeding or spotting)
- Abdominal pain or discomfort
- Dizziness
- Nervousness
- Decreased libido
- Liver malfunction
- Impaired carbohydrate metabolism (especially for diabetic people)
According to TruLaw, an individual diagnosed with meningioma or other forms of tumor due to Depo Provera birth control injections can file for personal injury. With sustainable evidence, they stand a chance to seek adequate compensation.
Such lawsuits are a stark reminder of the importance of informed consent. When patients aren’t told about the possible aftermath of a treatment or taking a drug, the consequences can be life-altering.
Challenges in Ensuring Informed Consent and the Way Forward
One of the major challenges in ensuring informed consent is rapidly progressing medical research. While new studies are always eye-opening, they can cloud one’s perceptions about an accepted treatment.
Here, a healthcare provider’s role is paramount. They must stay up to date with relevant research data and incorporate it into their very first patient consultation. For example, there’s no denying the effectiveness of progestogens in preventing pregnancy. However, a 2024 study on the use of progestogens and the risk of intracranial meningioma has been a game changer.
After the study came to light, many healthcare providers are reconsidering the use of progesterone. Patients are also paying more attention to the potential side effects. In this context, healthcare providers should uphold the right to informed consent, checking the boxes for ethical healthcare.
