Improper performance of breast biopsy

Presentation

On December 14, a 40-year-old woman came to a breast care center on referral from her ob-gyn. The patient consulted with a surgeon for examination of a mass in her left breast. The patient had a history of breast, colon, and ovarian cancer.

The surgeon’s exam notes reflected nonspecific nodularity, upper outer breast nodularity, and tenderness in the left breast. The surgeon ordered a bilateral breast MRI.

The MRI findings were abnormal with left breast microcalcifications. The surgeon recommended a left breast spot magnification with breast biopsy. The procedure was scheduled to take place in three weeks.

Physician action

On January 4, the patient returned to the center where Radiologist A performed a unilateral left digital diagnostic mammogram. Radiologist A also recommended a stereotactic biopsy for suspicion of malignancy.

On January 10, the patient returned to the center for the stereotactic biopsy at 11:50 a.m. and signed the consent form at 12:50 p.m. According to hospital records, the patient was put on the table in a prone position with her left breast placed in a compression device at 1:28 p.m.

A nine-gauge needle was used for tissue sampling, following local anesthesia with lidocaine and epinephrine. Multiple samples were obtained with partial removal of the calcification. Hospital records reflect that the biopsy specimens were collected at 1:50 p.m. and the needle removed from the patient’s breast and a clip put in to mark the location of the biopsy at 1:52 p.m.

The post-clip film was taken, confirming the removal of the needle and placement of the clip. Radiologist A noted no complications in the operative report.

Tissue samples from the biopsy were received by pathology at 2:48 p.m. A regular mammogram was then performed on the patient at 3:23 p.m. The pathology report noted that the gross exam was completed by 3:35 p.m. Pathology findings were benign.

On January 16, the patient returned to the center for a follow-up appointment with Radiologist B, Radiologist A’s partner. Radiologist B removed the patient’s bandages and noted a 3 cm area in the breast superior to the needle biopsy that represented skin necrosis. A sonogram of the area revealed a probable hematoma with no abscess. An appointment was made for the patient to see the surgeon the next day.

The surgeon’s exam noted a slightly larger area of 5.5 cm x 2 cm of necrosis inferior to the left nipple with no evidence of infection. He noted thick eschar tissue and recommended debridement once the wound had completely demarcated. The surgeon treated the area with silver sulfadiazine cream. The patient was given a prescription for hydrocodone and acetaminophen and a referral to a plastic surgeon.

Over the next year, the patient underwent multiple surgeries to debride necrotic tissue from the left breast and breast reconstruction. She also required several weeks of wound therapy. In the final reconstruction surgery, the operative note indicated that scarring, fibrosis, and fat necrosis was adherent to the fascia of the pectoralis major on the left, all of which was removed.

The patient also began seeing a psychiatrist due to anxiety. She was diagnosed with post-traumatic stress disorder and depression.

Allegations

The patient filed a lawsuit against Radiologist A and the breast care center for improperly performing the left breast biopsy. The patient alleged that her left breast was compressed in a device for approximately two hours during the stereotactic biopsy, causing extensive necrosis to her breast tissue and multiple surgeries to repair the damage.

Legal implications

Consultants for the defense were mostly supportive of Radiologist A. There was no indication in the records to support the plaintiff’s claim that she was left in a compression device for two hours. Records and testimony reflect that the patient was in the compression device for approximately 20 minutes. One consultant felt that the injury may have resulted from a hematoma that developed at the biopsy site, a known complication of the procedure.

Another consultant questioned if the necrosis was a result of the anesthetic used — epinephrine and lidocaine. This consultant also argued that, if the patient had actually been left in the compression device for two hours, there would be necrotic changes on the superior as well as the inferior aspect of the breast.

Two of the consultants stated that they had never seen or heard of necrosis developing at the site of a stereo biopsy. Necrosis was not listed as a complication of the procedure on the informed consent form.

Disposition

This case was settled on behalf of Radiologist A and the breast care center. 

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