Breast Lumps and Other Changes
Over her lifetime, a woman can encounter a broad variety of breast conditions. These include normal changes that occur during the menstrual cycle as well as several types of benign lumps. What they have in common is that they are not cancer. Even for breast lumps that require a biopsy, some 80 percent prove to be benign.
Each breast has 15 to 20 sections, called lobes, each with many smaller lobules. The lobules end in dozens of tiny bulbs that can produce milk. Lobes, lobules, and bulbs are all linked by thin tubes called ducts. These ducts lead to the nipple, which is centered in a dark area of skin called the areola. The spaces between the lobules and ducts are filled with fat. There are no muscles in the breast, but muscles lie under each breast and cover the ribs.
These normal features can sometimes make the breasts feel lumpy, especially in women who are thin or who have small breasts. In addition, from the time a girl begins to menstruate, her breasts undergo regular changes each month. Many doctors believe that nearly all breasts develop some lasting changes, beginning when the woman is about 36 years old
Some studies show that the chances of developing benign breast changes are higher for a woman who has never had children, has irregular menstrual cycles, or has a family history of breast cancer. Because they generally involve the glandular tissues of the breast, benign breast conditions are more of a problem for women of childbearing age, who have breasts that are more glandular.
Types of Breast Changes
Common breast changes fall into several broad categories. These include generalized breast changes, solitary lumps, nipple discharge, and infection and/or inflammation.
Generalized Breast Changes
Generalized breast lumpiness is known by several names, including fibrocystic disease changes and benign breast disease. Such lumpiness, which is sometimes described as "ropy" or "granular", can often be felt in the area around the nipple and areola and in the upper-outer part of the breast. Such lumpiness may become more obvious as a woman approaches middle age and the milk-producing glandular tissue of her breasts increasingly gives way to soft, fatty tissue. Unless she is taking replacement hormones, this type of lumpiness generally disappears for good after menopause.
Management of fibrocystic disease
Principles of management for fibrocystic changes include regular examinations, appropriate imaging, and medication as well as excisional biopsy when indicated.
The menstrual cycle also brings cyclic breast changes. Many women experience swelling, tenderness, and pain before and sometimes during their periods. At the same time, one or more lumps or a feeling of increased lumpiness may develop because of extra fluid collecting in the breast tissue. These lumps normally go away by the end of the period.
During pregnancy, the milk-producing glands become swollen and the breasts may feel lumpier than usual. Although very uncommon, breast cancer has been diagnosed during pregnancy.
Solitary Lumps include several types of distinct, solitary lumps. Such lumps, which can appear at any time, may be large or small, soft or rubbery, fluid-filled or solid.
Cysts are fluid-filled sacs. They occur most often in women ages 35 to 50, and they often enlarge and become tender and painful just before the menstrual period. They are usually found in both breasts. Some cysts are so small they cannot be felt; rarely, cysts may be several inches across. Cysts are usually treated by observation or by fine needle aspiration. They show up clearly on ultrasound.
Fibroadenomas are solid and round benign tumors that are made up of both structural (fibro) and glandular (adenoma) tissues. Usually, these lumps are painless and found by the woman herself. They feel rubbery and can easily be moved around. Fibroadenomas are the most common type of tumors in women in their late teens and early twenties, and they occur twice as often in African-American women as in other American women.
Fibroadenomas have a typically benign appearance on mammography (smooth, round masses with a clearly defined edge), and they can sometimes be diagnosed with fine needle aspiration. Although fibroadenomas do not become malignant, they can enlarge with pregnancy and breast-feeding. Most surgeons believe that it is a good idea to remove fibroadenomas to make sure they are benign.
Infection and/or Inflammation
Infection and/or inflammation, including mastitis and mammary duct ectasia, are characteristic of some benign breast conditions. Mastitis (sometimes called "postpartum mastitis") is an infection most often seen in women who are breast-feeding. A duct may become blocked, allowing milk to pool, causing inflammation, and setting the stage for infection by bacteria. The breast appears red and feels warm, tender, and lumpy.
In its earlier stages, mastitis can be cured by antibiotics. If a pus-containing abscess forms, it will need to be drained or surgically removed.
Benign Breast Conditions and the Risk for Breast Cancer - what women are told:
If You Find a Lump
If you discover a lump in one breast, check the other breast. If both breasts feel the same, the lumpiness is probably normal. You should, however, mention it to your doctor at your next visit.
Nevertheless, if the lump is something new or unusual and does not go away after your next menstrual period, it is time to call your doctor. The sooner any problem is diagnosed, the sooner you can have it treated.
No matter how your breast lump was discovered, the doctor will want to begin with your medical history. What symptoms do you have and how long have you had them? What is your age, menstrual status, and general health? Are you pregnant? Are you taking any medications? How many children do you have? Do you have any relatives with benign breast conditions or breast cancer? Have you previously been diagnosed with benign breast changes?
The doctor will then carefully examine your breasts and will probably schedule you for a diagnostic mammogram, to obtain as much information as possible about the changes in your breast. This may be either a lump that can be felt or an abnormality discovered on a screening mammogram. Diagnostic mammography may include additional views or use special techniques to magnify a suspicious area or to eliminate shadows produced by overlapping layers of normal breast tissue. The doctor will want to compare the diagnostic mammograms with any previous mammograms. If the lump appears to be a cyst, your doctor may ask you to have a sonogram (ultrasound study).
Aspirating a Cyst
When a cyst is suspected, doctors proceed directly with aspiration. This procedure, which uses a very thin needle and a syringe, takes only a few minutes and can be done in the doctor's office. The procedure is not usually very uncomfortable, since most of the nerves in the breast are in the skin.
Holding the lump steady, the doctor inserts the needle and attempts to draw out any fluid. If the lump is indeed a cyst, removing the fluid will cause the cyst to collapse and the lump to disappear. Unless the cyst reappears in the next week or two, no other treatment is needed. If the cyst reappears at a later date, it can simply be drained again.
If the lump turns out to be solid, it may be possible to use the needle to withdraw a clump of cells, which can then be sent to a laboratory for further testing. (Cysts are rarely associated with cancer that the fluid removed from a cyst is not usually tested unless it is bloody or the woman is older than 55 years of age.)
The only certain way to learn whether a breast lump or mammographic abnormality is cancerous is by having a biopsy, a procedure in which tissue is removed by a surgeon or other specialist and examined under a microscope by a pathologist. A pathologist is a doctor who specializes in identifying tissue changes that are characteristic of disease, including cancer.
Tissue samples for biopsy can be obtained by either surgery or needle. The doctor's choice of biopsy technique depends on such things as the nature and location of the lump, as well as the woman's general health.
Surgical biopsies can be either excisional or incisional. An excisional biopsy removes the entire lump or suspicious area. Excisional biopsy is currently the standard procedure for lumps that are smaller than an inch or so in diameter. In effect, it is similar to a lumpectomy, surgery to remove the lump and a margin of surrounding tissue. Lumpectomy is usually used in combination with radiation therapy as the basic treatment for early breast cancer.
An excisional biopsy is typically performed in the outpatient department of a hospital. A local anesthetic is injected into the woman's breast. Sometimes she is given a tranquilizer before the procedure. The surgeon makes an incision along the contour of the breast and removes the lump along with a small margin of normal tissue. Because no skin is removed, the biopsy scar is usually small. The procedure typically takes less than an hour. After spending an hour or two in the recovery room, the woman goes home the same day.
An incisional biopsy removes only a portion of the tumor (by slicing into it) for the pathologist to examine. Incisional biopsies are generally reserved for tumors that are larger. They too are usually performed under local anesthesia, with the woman going home the same day.
Whether or not a surgical biopsy will change the shape of your breast depends partly on the size of the lump and where it is located in the breast, as well as how much of a margin of healthy tissue the surgeon decides to remove. You should talk with your doctor beforehand, so you understand just how extensive the surgery will be and what the cosmetic result will be.
Needle biopsies can be performed with either a very fine needle or a cutting needle large enough to remove a small nugget of tissue.
Fine needle aspiration uses a very thin needle and syringe to remove either fluid from a cyst or clusters of cells from a solid mass. Accurate fine needle aspiration biopsy of a solid mass takes great skill, gained through experience with numerous cases.
Core needle biopsy uses a somewhat larger needle with a special cutting edge. The needle is inserted, under local anesthesia, through a small incision in the skin, and a small core of tissue is removed. This technique may not work well for lumps that are very hard or very small. Core needle biopsy may cause some bruising, but rarely leaves an external scar, and the procedure is over in a matter of minutes.
At some institutions with extensive experience, aspiration biopsy is considered as reliable as surgical biopsy; it is trusted to confirm the malignancy of a clinically suspicious mass or to confirm a diagnosis that a lump is not cancerous. Should the needle biopsy results be uncertain, the diagnosis is pursued with a surgical biopsy. Some doctors prefer to verify all aspiration biopsy results with a surgical biopsy before proceeding with treatment.
Localization biopsy (also known as needle localization) is a procedure that uses mammography to locate and a needle to biopsy breast abnormalities that can be seen on a mammogram but cannot be felt (nonpalpable abnormalities). Localization can be used with surgical biopsy, fine needle aspiration, or core needle biopsy.
For a surgical biopsy, the radiologist locates the abnormality on a mammogram (or a sonogram) just prior to surgery. Using the mammogram as a guide, the radiologist inserts a fine needle or wire so the tip rests in the suspicious area -- typically, an area of microcalcifications. The needle is anchored with a gauze bandage, and a second mammogram is taken to confirm that the needle is on target.
The woman, along with her mammograms, goes to the operating room, where the surgeon locates and cuts out the needle-targeted area. The more precisely the needle is placed, the less tissue needs to be removed.
Sometimes the surgeon will be able to feel the lump during surgery. In other cases, especially where the mammogram showed only microcalcifications, the abnormality could be neither seen nor felt. To make sure the surgical specimen in fact contains the abnormality, it is x-rayed on the spot. If this specimen x-ray fails to show the mass or the calcifications, the surgeon is able to remove additional tissue.
Stereotactic localization biopsy is a newer approach that relies on a three-dimensional x-ray to guide the needle biopsy of a nonpalpable mass. With one type of equipment, the patient lies face down on an examining table with a hole in it that allows the breast to hang through; the x-ray machine and the maneuverable needle "gun" are set up underneath. Alternatively, specialized stereotactic equipment can be attached to a standard mammography machine.
The breast is x-rayed from two different angles, and a computer plots the exact position of the suspicious area. (Because only a small area of the breast is exposed to the radiation, the doses are similar to those from standard mammography.) Once the target is clearly identified, the radiologist positions the gun and advances the biopsy needle into the lesion.
The cells or tissue removed through needle or surgical biopsy are promptly sent (along with the x-ray of the specimen, if one was made) to the pathology lab. If the excised lump is large enough, the pathologist can take a preliminary look by quick-freezing a small portion of the tissue sample. This makes the sample firm enough to slice into razor-thin sections that can be examined under the microscope. A "frozen section" provides an immediate, if provisional, diagnosis, and the surgeon may be able to give you the results before you go home.
The results of a frozen section are not 100 percent certain, however. A more thorough assessment takes several days, while the pathologist processes "permanent sections" of tissue that can be examined in greater detail.
When the biopsy specimen is small--as is often the case when the abnormality consists of mammographic calcifications only--many doctors prefer to bypass a frozen section so the tiny specimen can be analyzed in its entirety.
The pathologist looks for abnormal cell shapes and unusual growth patterns. In many cases, the diagnosis will be clear-cut. However, the distinctions between benign and cancerous can be subtle, and even experts don't always agree. When in doubt, pathologists readily consult their colleagues. If there is any question about the results of your biopsy, you will want to make sure your biopsy slides have been reviewed by more than one pathologist.
Deciding To Biopsy
In general, doctors feel it is wise to biopsy any distinct and persistent lump. Although benign lumps rarely, if ever, turn into cancer, cancerous lumps can develop near benign lumps and can be hidden on a mammogram. Even if you have had a benign lump removed in the past, you cannot be sure any new lump is also benign.
In some cases, the doctor may suggest watching the suspicious area for a month or two. Because many lumps are caused by normal hormonal changes, this waiting period may provide additional information.
Similarly, if the changes on mammogram show all the signs of benign disease, your doctor may advise waiting several months and then taking another mammogram. This would be followed by more diagnostic mammograms over the next 3 years.
Biopsy: One Step or Two?
Not too many years ago, all women undergoing surgery for breast symptoms had a one-step procedure: If the surgical biopsy showed cancer, the surgeon performed a mastectomy immediately. The woman went into surgery not knowing if she had cancer or if her breast would be removed.
Today a woman facing biopsy has a broader range of options. In most cases, biopsy and diagnosis will be separated from any further treatment by an interval of several days or weeks. Such a two-step procedure does not harm the patient, and it has several benefits. It allows time for the tissue sample to be examined in detail and, if cancer is found, it gives the woman time to adjust to the diagnosis. She can review her treatment options, seek a second opinion, receive counseling, and arrange her schedule.
The patient could have decided beforehand that, if the surgical biopsy and frozen section show cancer, they want to go ahead with surgery, either mastectomy or lumpectomy and axillary dissection (removal of the underarm lymph nodes). If, on the other hand, the lump proves to be benign, the incision will be closed. The procedure will have taken less than an hour, and the woman may go home the same day or the next day.
A one-step procedure avoids the physical and psychological stress, as well as the costs in time and money, of two rounds of surgery and anesthesia--a particularly important consideration for women who are ill or frail. Women who have symptoms of breast cancer can find the wait between biopsy and surgery emotionally draining, and they may be relieved to have a one-step procedure to take care of the problem as quickly as possible.
Each woman should consult with her doctors and her family, weighs the alternatives, and decides what approach is appropriate. Being involved in the decision-making process can give a woman a sense of control over her body and her life.
Underlying Perioperative Responsibility [by the American College of Surgeons]
The following statement was approved by the College's Board of Regents in February 1996.
The surgeon is responsible for confirming the diagnosis for which surgical care is proposed. This responsibility should include the surgeon's personal review of all pertinent aspects of the patient's case. Appropriate consultation should be requested.
The surgeon is responsible for presenting to the patient the range of options available for the patient's appropriate management, including the surgeon's recommendations and rationale for a specific approach to treatment. Choice of a specific treatment must ultimately be up to the patient; in the event that the patient is not legally competent to express a choice, for whatever reason, the decision of the patient's appropriately appointed surrogate must be substituted for that of the patient.
The surgeon is responsible for obtaining informed consent from the patient, or, if necessary, from the patient's surrogate, after discussion of treatment. The surgeon is responsible for conducting the discussion and for documenting that it took place. The surgeon need not personally obtain the patient's signature on the consent form.
The surgeon is responsible for the proper preoperative preparation of the patient. Minimizing the risk of operation, while providing maximal opportunity for a satisfactory outcome, requires a full appreciation by the surgeon of the patient's condition. Achieving optimal preoperative preparation of the patient will frequently require consultation with other physicians; however, the responsibility for attaining this goal rests with the surgeon.
The surgeon is responsible for the safe and competent performance of the operation. Part of this responsibility includes planning for the operation with the anesthesiologist in order to ensure anesthesia that is best for the patient.
The surgeon is responsible for postoperative care of the patient. This responsibility includes personal participation in and direction of postoperative care, including the management of postoperative complications. The best interest of the patient is thus optimally served because of the surgeon's comprehensive knowledge of the patient's disease and surgical management. Even when some aspects of postoperative care may be best delegated to others, the surgeon must maintain an essential coordinating role. Should complications of operation develop, the surgeon is best able to detect them and to provide or coordinate timely and appropriate therapy. This responsibility extends through the period of convalescence until the residual effects of the surgical procedure are minimal, and the risk of complications of the operation is predictably small. The surgeon is responsible for determining when the patient should be discharged from the hospital.
The surgeon is responsible for disclosing to the patient information related to the conduct of the operation, operative and pathologic findings, the procedure performed, and the expected outcome.
When the time comes that the surgeon will no longer be involved in follow-up of the patient, he or she is responsible for ensuring appropriate long-term follow-up for continuing problems associated with the patient's surgical care. All information necessary to provide care for those problems should be made available.
Reprinted from Bulletin of the American College of Surgeons
Vol. 81, No. 9, Page 39, September 1996
The current standard today is the Doctor should Suspect, Suspect, Rule Out, Rule Out breast cancer.
The Physician Insurers' Association of America (PIAA) Breast Cancer Study, Civil litigation Study and ACOG Professional Liability Survey can be used to construct a risk profile for patients and physicians likely to be involved in the delayed diagnosis of breast cancer In many cases the physician believes some action on their part could have prevented a lawsuit and 25% of the cases substandard care on the part of physician was actually admitted. The physician most likely involved in the delayed diagnosis of breast cancer on survey will meet the following criteria: (1) an ob-gyn will evaluate a woman under age 40; (2) despite the presence of a mass, the physician will be unimpressed with the potential for breast cancer; (3) a needle aspiration, needle biopsy or ultrasound will not be performed;(4) mammogram will be ordered, will return negative and will be accepted as providing a benign diagnosis, despite the presence of the breast mass; (5) no consultation regarding the mass will be obtained;(6) the mass will be labeled as fibrocystic diseases or as another benign breast condition; (7) the physician, insured, and defense counsel will support a settlement if a lawsuit if filed; (8) the physician may believe some action could have prevented the lawsuit, the most likely being referral for consultation regarding evaluation of an apparently benign breast mass or abnormality.
Errors in the diagnosis of breast cancer are a significant source of medical malpractice claims. More than 78,000 insurance claims conduction by PIAA, delayed diagnosis of breast cancer was documented as the most common type of medical delayed diagnosis (1503 claims). In this survey, misdiagnosed breast cancer also was the cause of the greatest number of ongoing litigation claims, the largest number of paid claims and the greatest overall expense in litigation. The delayed diagnosis of breast cancer accounted for $100, 508,220 in indemnity payment or approximately 5% of the $2.6 billion paid to litigants annually. A delay in diagnosis of breast cancer was a factor in 37.5% of the cases of breast cancer. The delayed diagnosis of breast cancer is the major cause leading to medical malpractice claims with the general surgeon. The liability payment awarded by specialty in delayed diagnosis of breast cancer: General surgery $885,528.00 per case; Obstetrical and gynecology $704,000.00 per case, Family practice and internal medical $437,000.00 per case.
Potential solutions to reduce the risk of delayed diagnosis of breast cancer tie in directly with the goals of good communication about risk management. Because women under age 40 are consistently found to be the focus of the misdiagnosed breast cancer, one belief of physicians leading to errors must be related to the incidence of breast cancer in young women. Surprisingly, nearly one quarter of all breast cancer deaths occur in women whose age is not usually associated with the presence of breast cancer. A recent study of rates of breast cancer in women 36 years of age or younger with breast masses found the incidence of cancer was 2.5%. A doctor must anticipate, evaluate and diagnose no matter if the patient is young and pregnant.
Every three minutes some woman in the United States hears the words - Breast Cancer. This life altering diagnosis resonates with graphic images of mastectomies, vivid scars, hairlessness, nausea illness and pain. Suspecting the worst (as all women do) when patient goes to her doctor after finding the lump, she was relieved to be told she had nothing to worry about. Being an informed, intelligent woman - don't ignore the lump, and again seek life-saving medical attention. Avoid misinterpretation of mammograms and ultrasound, and being told "nothing to worry about."
Expeditious diagnosis and treatment of malignancies can prevent lost opportunities for cure or effective palliation. When treatment was delayed, it resulted in needing more extensive surgery, radiation therapy and chemotherapy - all of which were unnecessary had treatment had been rendered when patient first presented with this mass had it been excised when first discovered, would have been only in situ (precancerous) and the malignancy would have been completely avoided. With so many diagnostic techniques available, it is inexcusable for a physician with a symptomatic patient to fail to diagnose or rule out breast cancer.
Physicians define causation in these cases as a change in the characteristics or state of the tumor as a result of the delay. These changes result in more extensive or invasive treatment and reduce the patient's change of long-term survival. There is clear evidence that when diagnosis after their first symptoms is delayed more than three months, cancers tend to be larger and more aggressive. Large tumor size, the presence of metastasis in the axillary lymph nodes and advanced clinical stage are all associated with a poor prognosis (Jay R. Harris et al., Diseases of the Breasts, chs. 12, 16 (1996).
Delay in Diagnosis of Breast Cancer Medical/Legal Issues
Delay in diagnosis of breast cancer is one of the most expensive malpractice allegations against physicians
Failure to Diagnose Breast Cancer Cases
· Can elicit much jury sympathy
· May also generate second case (e.g., a wrongful death action following a successful trial of the personal injury action)
· Widespread public belief that early diagnosis equals "cure"
Primary Care Physicians (Family Practitioners and Internal Medicine)
· Failure to screen and/or follow up on patient complaint
· Failure to follow up on a questionable mammogram result
· Error/delay caused by miscommunication between providers
· System problems resulting in negligence (record-keeping, follow-up, transmitting test results)
· Failure to refer
Breast Cancer Facts
· Breast cancer is the second most common cancer among women (skin cancer being number one)
· Breast cancer is second leading cause of cancer deaths in women, after lung cancer
· Over 200,000 women in the United States will be diagnosed with invasive breast cancer in 2004
· Over 40,000 women will die from breast cancer in 2004
· Gender, age, positive family history, age at first term pregnancy, nulliparity, early menarche and late menopause are all risk factors with relative importance
· Other risk factors include use of hormone replacement therapy, previous breast pathology, weight, level of physical activity end alcohol use
· Absence of any of these risk factors does not exclude the possibility that a women may develop cancer
Effective Risk Management Strategies:
Conscientious follow up
Accurate and objective documentation
· Communication breakdown between physicians and patients is often a primary factor prompting litigation
Risks minimized by clear communication between.
· clinicians and patients
· clinicians and other members of the healthcare team, i.e. consulting physician
Communication with Patients
· Clinical findings
· Recommended tests/plan
· Test results
· Follow-up procedure
· Patient education
Communication with Other Providers
o Communication gaps between consulting and referring physicians can have a negative impact on patient care and physician credibility
o Clear, concise communication
o Telephone call may be appropriate and necessary
MAMMOGRAPHY QUALITY STANDARDS ACT (MQSA)
Requires all facilities to meet certain standards to become accredited and certified. One provision of MQSA requires mammography facilities to establish an effective system for communicating written test result to patients. Since April 28, 1999, mammography facilities have been required to notify all patients, in writing, of mammography test results
Notification to Referring Physician Required:
Unless the patient is self-referred, test results must also be serif to the referring physician. 'Suspicious or highly suggestive of malignancy' test results should be communicated to the referring physician and to the patient as soon as possible. While this can and should be done orally, the written report is still required.
Most claims in failure to diagnose cases allege either a delay in follow up or a failure to follow up
A thorough follow-up system encompasses not only tracking of test results, but also referral to specialists, appointments and telephone calls that require follow-up
Keep in mind the following "rules of thumb":
· Every patient with positive or suspicious findings must be contacted, preferably by telephone
· Do not allow reports to be filed until you have reviewed and signed or initialed them
· Physicians must have a thorough follow-up System
Accurate and thorough documentation is key to defensibility of a claim
Documentation should include:
· Pertinent personal and clinical history
· Physical findings, drawing and diagram
· Advice given to patient including recommended follow up
· Patient education