MD News: Bariatric Surgery Informed Consent Materials: What You Need to Know During COVID-19

MD News: Bariatric Surgery Informed Consent Materials: What You Need to Know During COVID-19

Understand the connections between bariatric surgery, COVID-19 and risk management.

Anthony M. Sola, Esq. and Nicole S. Barresi, Esq.

In 2018, the CDC estimated that 42.4% of the United States population was obese. However, according to the American Society for Metabolic and Bariatric Surgery, less than 1% of people who qualify for bariatric surgery ultimately decide to undergo a procedure each year. To qualify for bariatric surgery, many facilities require that the patient have a BMI of 35–39 with related health issues or a BMI of over 40. A BMI over 40 is considered to be “severe obesity,” which is known to affect approximately 9% of adults and is associated with an increased risk of premature death.

While obesity is known to increase a patient’s risk of many diseases, including cardiac disease and type 2 diabetes, it also has become clear in recent months that obesity is tied to an increased risk with COVID-19. The CDC has advised that an obese patient’s risk of hospitalization due to COVID-19 is triple that of a non-obese person. Further, the risk of death from COVID-19 directly increases with BMI. It is believed that this close relationship is due to the patient’s decreased lung capacity and reserve and the increased difficulty in ventilation.

Due to the increase in health risks from COVID-19, bariatric surgery may become more prevalent as patients who were considering the procedure may ultimately decide to proceed in light of yet another disease linked to statistically significant worse outcomes based on weight. While early in the pandemic many facilities stopped performing bariatric surgery due to identifying these procedures as elective, now nearly all elective surgeries are once again permitted. With the threat of multiple waves of infection, a lack of widespread access to vaccines, and a potential increase in demand for bariatric surgery, it is worth re-examining informed consent practices to ensure all necessary information is provided to patients prior to bariatric surgery.

Pursuant to the New York Public Health Law, to establish a cause of action sounding in lack of informed consent, a patient must prove that: (1) the person providing the professional treatment or diagnosis failed to disclose alternatives thereto and failed to inform the patient of “the reasonably foreseeable risks and benefits” associated with the treatment, that a reasonable medical practitioner would have disclosed under similar circumstances in a manner permitting the patient to make a knowledgeable evaluation, (2) a reasonably prudent patient in the same position would not have undergone the treatment if he or she had been fully informed, and (3) the lack of informed consent is a proximate cause of the injury (Public Health Law §2805-d.).

To avoid lawsuits based on informed consent, it is crucially important that providers document the details of each informed consent discussion with patients, including the anticipated risks, benefits and alternatives, and also including, critically, the alternative of no surgery. Many bariatric practices provide informational seminars and/or written materials to patients. At this time, it is worth considering updating materials and/or discharge instructions to include information regarding the risks of the ongoing pandemic and any additional precautions that patients should take prior to surgery and/or in the post-operative period related to the virus. This may include a patient quarantine and/or COVID-19 testing prior to and after surgery to ensure that the patient and any close care providers are negative. This also may include additional instructions and warnings regarding precautions to take in the weeks following surgery. Bariatric surgery providers must also include these materials or a reference to the same in the patient’s chart so that it is known later the exact materials provided prior to surgery.

While bariatric surgery can be a remedy to what is an expanding health crisis in the United States, it is important from a risk management perspective that informed consent conversations be well documented and updated to include any additional risks/recommendations in light of COVID-19. Therefore, in an effort to mitigate risk, practices should re-examine their informational procedures and providers should consider adding additional commentary to include any additional risks of surgery and/or instructions regarding COVID-19.

Anthony M. Sola, Partner, and Nicole S. Barresi, Associate, are attorneys in the Medical Malpractice Defense Group at Martin Clearwater & Bell LLP.

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Source: MD News April 2021, Long Island Edition