Performing an MRI when contraindicated

Presentation

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On October 17, a general surgeon performed a left mastectomy on a 64-year-old woman who had been diagnosed with breast cancer. Following the mastectomy, a plastic surgeon placed a Mentor CPX4 medium-height breast expander.

In November, the patient saw her family physician for right shoulder pain, and he ordered an MRI of the right shoulder.

Physician action

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The patient came to ABC Radiology Center on November 24 for the MRI. On the patient intake forms, she noted that she had breast cancer surgery and that she had implants.

The patient also claimed that she told staff at the ABC Radiology Center that she had an implanted device and that she did not know if it contained metal. She further explained that a plastic surgeon had implanted the device and that they should contact him for more information.

The MRI technologist put the patient in the MRI scanner and began the test. The patient reported that she felt pressure in her left chest wall, and the technologist took her out of the scanner. The technologist then took a chest x-ray ray, which showed the expander.

Radiologist A reviewed the x-ray and told the technologist to proceed with the MRI. The MRI was completed. That afternoon, the patient reported to the plastic surgeon’s office that she was experiencing sharp pain and inflammation on her left chest wall.

On November 30, Radiologist B — who also worked for ABC Radiology Center — read the chest x-ray. He reported, “There appears to be a left breast implant or tissue expander in place with a round valve.” ABC Radiology Center completed an incident report, and Radiologist A noted: “I was asked to look at an x-ray for foreign body. There was a tissue expander in place. I informed the technologist to proceed with imaging as I was unaware of any contraindication.”

The patient returned to the plastic surgeon on November 29. He noted swelling, pain, and redness on the patient’s left chest wall. At another follow-up appointment, the plastic surgeon recommended removal of the expander given the changes since the MRI and that the patient was not responding to antibiotics.

The patient was hospitalized for surgical removal of the left breast expander on December 19. One month later, she underwent left axillary node dissection due to her breast cancer. On January 9, the plastic surgeon noted “s/p left mastectomy and expander reconstruction, removal of expander due to injury/infection and radiation, external beam, now with post radiation changes.” He discussed options for reconstruction with the patient and referred her to another plastic surgeon.

Over the next 12 months, the patient underwent several left breast reconstruction procedures. She was not a candidate for implant reconstruction due to her history of radiation, left breast infection, and prior implant failure.

Allegations

Lawsuits were filed against Radiologist A and ABC Radiology Center. The allegations were:

• improperly performing an MRI on a patient with a tissue expander;
• failure to properly train employees at the radiology center;
• failure to have procedures in place to prevent patients with contraindications from having an MRI; and
• improperly approving the patient for the MRI (Radiologist A).

Legal implications

Radiologists who reviewed this case identified three critical issues. First, the manufacturer of the tissue expander stated on its website that the expander is unsafe for MRI, and that MRI should not be performed in patients with the expander in place. The patient was allowed to undergo the MRI despite the manufacturer’s recommendation.

Second, the MRI technologist’s failure to inquire about the patient’s implant before putting her in the scanner was described as a breach in the standard of care.

Third, Radiologist A’s actions were also described as a breach in the standard of care. Specifically, that she did not recognize that the tissue expander had an integrated magnetic injection (metallic on the x-ray she reviewed). She also did not fully investigate whether the expander was MRI safe by checking the manufacturer’s website, calling the plastic surgeon, or checking the website mrisafety.com.  

Disposition

This case was settled on behalf of Radiologist A and ABC Radiology Center.

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