Carcinoma of the breast is the most common cancer in women. The disease is responsible for more than 180,000 new cases and 45,000 deaths annually. Early diagnosis is critical because the cure rate for breast cancer is directly related to the stage of the disease at diagnosis. Localized tumors can be cured 85 percent of the time. The cure rate falls dramatically when four or more lymph nodes are involved.
Breast cancer generates a disproportionate number of liability suits alleging delayed or incorrect diagnosis. Relatively few have to do with the method of treatment. The majority of cases involve primary care physicians in obstetrics/gynecology, family medicine, internal medicine, and general surgery.
An analysis of The Doctors Company's cases revealed the following major causes of missed or delayed diagnosis:
The correct use of mammography is of critical importance in the early diagnosis of breast cancer. That message has been communicated repeatedly. Lapses in this area represent poor physician judgment. Patients and juries cannot be expected to forgive the mismanagement of a screening process—a blunder that can result in a fatal disease.
The problem is stereotypical. Either the patient or the physician becomes aware of a suspicious breast lesion. A mammogram is promptly ordered, but the findings are nondiagnostic for malignancy. The patient is reassured, and a cancer is diagnosed months or years later.
Mammography will fail to detect 10 to 20 percent of breast cancers. Mammography is an inadequate diagnostic tool for characterizing the nature of a mass. The purpose of taking a mammogram on any patient who has a suspicious, palpable breast mass should be to evaluate the remainder of that breast and the contralateral breast—never for any evaluation or diagnosis of the breast mass itself. Instead, this x-ray should be thought of as a technique for screening and as a road map for localization. Do not allow mammograms to delay biopsy of suspicious lesions. To do so represents a serious misunderstanding of the technique’s limitations.
Suspicious breast lesions require histologic evaluations, not x-rays. Thermography and ultrasonography are of no value in diagnosing breast cancer in a patient who has a palpable mass; excisional biopsy, fine-needle aspiration, or core biopsy are necessary. Ultrasound is valuable for confirming that a mammographically detected, round, and smoothly marginated radiodensity lesion is a cyst. The practice of ordering multiple, nonspecific tests for patients—in a futile attempt to avoid a single definitive procedure—must cease.
Physicians should also be aware of an inexorable trend toward holding doctors responsible for screening their patients for treatable disease.
To reduce delays in diagnosing breast cancer and patient injury that can develop into a claim, The Doctors Company recommends using American Cancer Society (ACS) guidelines.*The ACS advocates a cancer-related exam every three years for people ages 20 to 40 and every year for those 40 and older. Specifically, preventive breast cancer guidelines include:
Note: Clinical breast exams should be conducted close to the time of scheduled mammograms.
In addition, The Doctors Company proposes:
Breast cancer is common and requires an aggressive approach to diagnosis. Techniques include frequent self-examination, thorough physical examination by a physician, mammography, needle biopsy and, when necessary, needle localization of positive mammographic lesions. The risk of radiation-induced cancer is very small and should never be used as a reason to deny a patient this necessary procedure. Likewise, a negative mammogram should never be used to delay definitive biopsy of a clinically suspicious lesion.
Mammography is an important x-ray technique. Not only are physicians responsible for knowing when to order the screening and what to do with positive results, they must also understand the deadly limitations of negative studies.
Nipple discharges containing occult blood require open biopsy and removal of the duct, even in the absence of a palpable lesion. Spontaneous, clear nipple discharge from the same ductal opening warrants the same serious consideration. All suspicious lesions require pathologic diagnoses that are based on tissue biopsies. A negative fine-needle aspiration is not adequate.
The Doctors Company intends for these guidelines to motivate our member physicians to follow a systematic approach to early diagnosis of this common malignancy.
*The American Cancer Society, Cancer Facts and Figures, July 1998, Atlanta, Georgia.
Richard E. Anderson, MD, FACP, a medical oncologist, is chairman and chief executive officer of The Doctors Company. A member of the American Society of Clinical Oncology and a fellow of the American College of Physicians, Dr. Anderson was a clinical professor of medicine at the University of California, San Diego, and is past chairman of the Department of Medicine at Scripps Memorial Hospital, where he served as senior oncologist for 18 years. Dr. Anderson is the editor of a book on medical malpractice, and his commentaries on legal reform and defensive medicine have been widely cited. He is the 2004 recipient of the PLUS Foundation Award for Outstanding Leadership in Healthcare Professional Liability.
John K. Cherry, MD, FACS, a retired general surgeon, is a former chief of staff and chairman of the Department of Surgery at Scripps Memorial Hospital in La Jolla, California.
The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.