Medicolegal Issues

Who is liable when a surgical error occurs?
The answer can depend on whether it is a true error and your prevention strategy. These experts discuss how to develop a safety culture that...
In this quarterly column, these medical and legal experts and educators present a case-based* discussion and provide clear teaching points and takeaways for your practice.
Dr. Sanfilippo is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, and Director, Reproductive Endocrinology and Infertility, at Magee-Womens Hospital, Pittsburgh, Pennsylvania. He also serves on the OBG Management Board of Editors.
Mr. Smith is Professor of Law and Dean Emeritus at California Western School of Law, San Diego, California.
The authors report no financial relationships relevant to this article.
*The “facts” of this case are a composite, drawn from several cases to illustrate medical and legal issues. Eliminated from this statement of the case are all of the issues related to breast implants and product liability.
In the end, the patient decided not to pursue the lawsuit.
Breast cancer is the most common female malignancy, with 232,340 cases occurring annually in the United States. It is the second leading cause of cancer-related death in US women.1 For this case discussion, we review the role of breast cancer screening, including breast self-examination and mammography.
Recently, medical care has evolved from “breast self-examination” (BSE) to “breast self-awareness.”2 The concept of BSE and concerns about it stem in part from “the Shanghai study.”3 In this prospective randomized trial, 266,064 female textile workers were randomly assigned to “rigorous and repetitive training in BSE” versus no instruction and no BSE performance. The former group had twice as many breast biopsies than the latter group (2,761 biopsies in the BSE group vs 1,505 in the control group). There was no difference in the number of breast cancers diagnosed among the groups—864 in the BSE group and 896 in the control group (relative risk [RR], 0.97; 95% confidence interval [CI], 0.88–1.06; P = .47). Other studies also support lack of efficacy regarding BSE.4
The potential for psychological harm, unnecessary biopsy, and additional imaging in association with false-positive findings is a concern2 (TABLE). The American College of Obstetricians and Gynecologists (ACOG) states, “breast self-examination may be appropriate for certain high-risk populations and for other women who chose to follow this approach.”2,5,6 The US Preventive Services Task Force (USPSTF) guidelines say that there is “insufficient evidence to assess risks vs benefits, including harms,” and recommends against teaching BSE.7 The American Cancer Society puts BSE in the “optional” category.2,8
Is there a middle of the road strategy? Perhaps. The concept of breast-awareness was developed so that women understand how their breasts look and feel.2,5 The concept does not advocate monthly BSE. The Mayo Clinic reported that, of 592 breast cancers, 57% were detected following abnormal screening mammography, 30% by BSE and 14% by clinical examination by a clinician. Furthermore, 38% of women with a palpable abnormality had a normal mammogram within the preceding 13 months.9 McBride and colleagues aptly addressed this: “Healthcare providers can educate their patients that breast awareness, in essence, is a two-step process. First, it requires that women be familiar with their breasts and aware of new changes and, second, have an understanding of the implications of these changes which includes informing their health care provider promptly.”10 The concept of “know what is normal for you” as conveyed by The Susan G. Komen Foundation succinctly encourages communication with patients.2,11
The latest technique in mammography is digital or 3D mammography, also known as tomosynthesis. The technique is similar to 2D mammography with the addition of digital cameras. A study published in the radiology literature noted that the 2 methods were equivalent.12 One possible advantage of 3D mammography is that the 3D images are stored in computer files and are more easily incorporated into the electronic medical record.
While breast augmentation is not associated with an increase in breast cancer,13 mammography following breast augmentation can be more difficult to interpret and may result in a delay in diagnosis. In a prospective study of asymptomatic women who were diagnosed with breast cancer, 137 had augmentation and 685 did not. Miglioretti and colleagues noted that the sensitivity of screening mammography was lower in the augmentation cohort.14 To enhance accuracy, breast implant displacement views (in which the breast tissue is pulled forward and the implant is displaced posteriorly to improve visualization) have been recommended.15 A retrospective review provides data reporting no effect on interpretation of mammograms following augmentation.16 The American Cancer Society recommends the same screening for women with implants as without implants, starting at age 40 years.17
Paget disease of the breast was first described by Sir James Paget in 1874. He also defined Paget disease of extramammary tissue, bone, vulva, and penis. Paget disease of the breast is a rare type of cancer in which the skin and nipple are involved frequently in association with DCIS or invasive breast cancer. The skin has an eczema-like appearance. Characteristic Paget (malignant) cells are large with clear cytoplasm (clear halo) and eccentric, hyperchromatic nuclei throughout the dermis. Assessment includes mammography and biopsy with immunohistochemical staining. Treatment varies by case and can include lumpectomy or mastectomy and chemotherapy and/or radiation therapy. Medications, including tamoxifen and anastrazole, have been recommended. Prognosis depends on nodal involvement. The disease is more common in women older than age 50.18
The answer can depend on whether it is a true error and your prevention strategy. These experts discuss how to develop a safety culture that...
Communicating with patients in the online world is quite beneficial, but these interactions require constant attention to potential privacy,...
Be careful what you say, it may come back to haunt you