By Thomas A. Mobilia, Esq. and Daniel L. Freidlin, Esq.
Monday, July 29, 2019
Category: Legal
Specialty: Women's Health
Mammography is generally considered a low-risk diagnostic test that plays an important role in the early detection of breast cancer. Risks associated with mammography include pain and exposure to low-dose radiation. The risks are increased in women with breast implants. Breast implants obscure the visible breast tissue and decrease the sensitivity of mammography, resulting in the potential for delayed detection of cancer. Another adverse event is rupture of the implant, which requires surgical removal of the implant shell, and potentially escaped silicone.
Notwithstanding these additional risks, it is still recommended that women with breast implants undergo screening mammograms. The question then arises as to whether informed consent in women with breast implants is required prior to performing mammography. To answer this question, it is important to understand the law of informed consent. Informed consent is a legal doctrine that dictates when a patient, under most circumstances, has a right to decide whether to undergo medical treatment. In New York, informed consent is required by statute before a patient undergoes a nonemergent treatment, procedure or surgery, or “a diagnostic procedure which involves invasion or disruption of the integrity of the body.” As a mammogram is not an invasive diagnostic study, informed consent is not required. However, there remains a valid question as to whether women with breast implants should be provided with an informed consent detailing the additional risks associated with undergoing mammography, even though not required.
Case Example
We successfully defended a case involving a patient’s breast implant that was found to be ruptured on a mammogram. The plaintiff claimed that the breast implant rupture was due to excessive compression force applied by the technologist during the mammogram, and that she was not advised of the risk of implant rupture in advance.
At trial, the technologist who performed the mammogram testified that she informs all patients with implants about the additional views that would be performed (displacement views) to image the breasts, that implants obscure some of the breast tissue, making it more difficult for the radiologist to detect cancer, and of the risk of rupturing the implant. The plaintiff denied this conversation took place, and there was no documentation to prove it did. The jury decided this factual dispute in favor of the technologist and rendered a defense verdict. This “he said she said” situation could have been avoided had the patient been required to sign a consent form documenting that she was informed of the risk of undergoing mammography in the presence of breast implants. Our experience is that many of our clients inform their patients of the risk of implant rupture during mammography, but surprisingly this conversation is not always documented in writing.
Implant rupture is a rare complication that may occur during mammography. When it occurs, it is likely related to the age and integrity of the implant as opposed to excessive compression force as was claimed by the plaintiff in our case. However, lawsuits often arise after a medical complication occurs. Appropriate documentation is crucial to the defense of the medical complication case at trial. In the context of mammography in patients with breast implants, patients should be advised that the purpose of the procedure is aimed at the early detection of breast cancer, that additional views are performed when implants are present, that compression will be required to adequately perform the test and why, and that there is a small risk of implant rupture as a result of the compression that is necessary to image the breast tissue. Most importantly, this conversation should be documented with a detailed consent form signed by the patient. The document signed by the patient becomes a powerful exhibit at trial and may prevent the lawsuit from being brought in the first place.
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