Image-guided Breast Biopsy
Summary
In a high-profile English legal case, an NHS Trust was found guilty of providing misleading and negligent advice after a breast biopsy in the case of a patient who subsequently died from breast cancer. Dr Gita Ralleigh reviews this case, the image-guided biopsy procedure and the extent to which hospitals should track patients following biopsy.
Key Points
- A patient underwent a breast biopsy which was reported as indeterminate. She declined a further biopsy and failed to attend at two hospital appointments.
- A judge found the hospital in breech of its duty to the patient, as staff had ‘failed to advise her adequately of the risks she faced, the options open to her and their respective merits’.
- Image (ultrasound or X-ray) – guided biopsy is now favoured generally for breast lesions, and in about 2·8% (0·3 8·2%) of cases a cancer is missed.
- Avoiding missed cancer involves using optimal biopsy technique, and correlating clinical, imaging and histological findings to identify likely missed lesions.
- The radiologist doing the biopsy and the referring clinician (usually a breast surgeon) have the duty of informing the patient of the biopsy results and of discussing their implications and any requirements for treatment.
Declaration of interests: No conflict of interests declared
In the autumn of 2004 the case of Helen Cooper vs Royal United Hospital Bath Trust was widely reported in the national press. Mrs Cooper was ruled by Mr Justice Butterfield to have been given ‘negligent’ and ‘misleading’ advice following a breast biopsy procedure in July 2000. The results of the procedure were ‘indeterminate’ and the patient was informed that she would require a further biopsy. The hospital’s plea that Mrs Cooper had declined a further biopsy and had missed two hospital appointments was rejected. The judge ruled that the Royal United Hospital Bath NHS Trust was in breach of its duty towards Mrs Cooper saying staff had ‘failed to advise her adequately of the risks she faced, the options open to her and their respective merits’. Mrs Cooper’s breast cancer was eventually diagnosed in May 2002 and she died in September 2004 with widespread metastatic disease. The judge said the question of whether any breaches he had found were ‘causative of any loss or damage’ sustained by Mrs Cooper and her widower ‘is for another day’. The trust’s chief executive, Mark Davies, responded ‘I am determined that if there are any lessons to be learned we will learn them, but I am confident this was an unusual and tragic one-off case.’
Image-guided percutaneous breast biopsy is increasingly preferred to surgical biopsy for the histological assessment of both non-palpable (usually screen-detected) and palpable (usually symptomatic) breast lesions. Fine needle aspiration cytology has now been replaced by 14-gauge needle automated core biopsy at most centres because of its better characterisation of benign and malignant pathology and lower frequency of insufficient samples.
Ultrasound guidance or X-ray guidance (stereotactic biopsy) may be used to target the lesion depending on the nature of the abnormality. Radiologists perform most breast biopsies, although in some centres breast surgeons, breast physicians or radiographers also undertake these procedures.
The patient care advantages of percutaneous breast biopsy include fewer surgical procedures, less scarring and deformity, ease of performance and low complication rate.1 In follow-up studies the rate of missed carcinomas is low, averaging 2·8% (range 0·3 8·2%) with approximately 70% of missed cancer identified shortly after biopsy (immediate false negatives) and 30% identified subsequently (delayed false negatives). Although this is similar to the frequency of missed cancer at surgical biopsy, which has an average miss rate of 2% (range 0 8%) it is inevitable that some cancers will not be diagnosed at an initial core biopsy. [1, 2]
The radiologist or other breast care professional can take several steps to minimise the likelihood of a false negative diagnosis. Optimal technique ensures that the correct lesion has been adequately sampled. Careful correlation of clinical, imaging and histology findings to identify discordant lesions requiring prompt repeat biopsy (triple assessment) takes place in the context of a multidisciplinary meeting as standard practice in the UK NHS Breast Screening Programme (UK NHS BSP) and most symptomatic breast units also follow these standards.
The radiologist in conjunction with the referring clinician (often a breast surgeon) also has a responsibility to communicate results to the patient as well as explaining the implications of those results and what further management is required.
Claims relating to percutaneous image-guided breast biopsy may relate to radiology or pathology errors. Diagnostic pathology errors involve either over- or under-diagnosis resulting in unnecessary surgery or delayed diagnosis. UK NHS BSP guidelines for pathology reporting categorise results as B1 (normal tissue), B2 (benign lesion), B3 (uncertain malignant potential), B4 (suspicious) and B5 (malignant). This classification recognises that although most core biopsy samples can be characterised as normal, benign or malignant, a small proportion (less than 10%) of samples cannot. In general, a diagnostic category of B3 or B4 should lead to percutaneous or surgical repeat biopsy in order to obtain a definitive diagnosis.
Where the radiologist performing breast biopsy is concerned, there are three primary areas of negligence: the acceptance and performance of the procedure itself, the obtaining of informed consent and the responsibility for follow-up communication and recommendations for further management.3 Proof of negligence requires expert opinion to establish standard of care and the likelihood of departure from that standard of care and is related to injury to the patient. If a defendant breaches a recognised duty and if it bears a substantial relationship to injury, then negligence will be found.
With regard to stereotactic core biopsy, a joint task force of the American College of Radiology, American College of Surgeons and College of American Pathologists stated ‘The performance of a stereotactically guided CNB carries with it the obligation to inform the patient of the results of the biopsy and the potential implication of these results…’4
As stated by Berlin in 1998, ‘…responsibilities to track patients after percutaneous core biopsies are clearly being imposed on radiologists by society and the radiological community itself. Whatever the extent of these responsibilities, they are greater today than they were yesterday and are likely to be greater tomorrow than they are today.’5
Legal Commentary
by John Griffiths, Partner, Shepperd & Wedderburn (Solicitors), Edinburgh, Scotland
The weight of Dr Ralleigh’s article is directed to the increasing preference for image-guided percutaneous breast biopsy to surgical biopsy. The issue in the case of Cooper was whether it was negligent for the treating clinician to allow the patient to believe either a further mammogram or a further biopsy was the appropriate next procedure. The patient opted for a mammogram which was delayed. The patient claimed she had been advised that a repeat biopsy or a further mammogram were of equal diagnostic value in the determination of malignancy in her breast tissue. Her account was accepted by the court and the expert evidence was to the effect that the patient should have been advised that a repeat biopsy was the correct course - hence the treating clinician was negligent.
This was therefore an issue of consent; the patient was not given proper disclosure of information or advice on which to make an informed choice.
The case also raises the complication of patients who miss appointments or who do not respond to follow-up letters. Negligence can also arise in cases where follow-up communication appears to fail. In the UK, there have been a number of successful claims where errors have been made in notifying patients of abnormal cervical smear tests, with tragic consequences. Where an error has arisen in a hospital or GP practice system, fault is not difficult to apportion and a judge will not need to hear expert evidence in relation to a failure on systems.
But what of cases where the abnormality is correctly identified and the patient written to and requested to return? If they fail to respond, how many letters should be sent and how explicit should those letters be? At what point does patient autonomy override the duty of the doctors to seek to persuade the patient to return?
The courts have not provided a definitive answer to these, not uncommon, questions.
References
- Liberman L. Percutaneous Imaging-Guided Core Breast Biopsy: State of the Art at the Millennium. Am J Roentgenol 2000; 174:1191–9.
- Lee CH, Philpotts LE, Horvath LJ et al. Follow up of Breast Lesions Diagnosed as Benign with Stereotactic Core-Needle Biopsy: Frequency of Mammographic Change and False Negative Rate. Radiology 1999; 212:189–94.
- Dershaw, David D (editor). Imaging-Guided Interventional Breast Techniques. New York: Springer Verlag; 2003.
- Bassett L, Winchester DP, Caplan RB et al. Stereotactic Core-Needle of the Breast: A report of the Joint Task Force of the American College of Radiology, American College of Surgeons and College of American Pathologists. CA Cancer J Clin 1997; 47:171–90.
- Berlin L. Tracking for breast cancer (commentary). Am J Roentgenol 1998; 170:93–5.
