Ruptured breast implants missed on multiple occasions

This case is based on a real scenario, with some facts altered to preserve confidentiality.

Ms P was 20 years old when she had bilateral silicone breast implants. Unfortunately, she was never completely satisfied, and for many years afterwards complained of her breasts “not feeling right”. 

Initially, she found reassurance from her GP, who repeatedly and thoroughly examined her and could find nothing untoward. However, four years after the procedure, with increasing anxiety, she asked her GP to refer her for a mammogram. She had the investigation done at private hospital A. This was reported back to the referring GP as normal.

For a few years after this, Ms P took further reassurance from this report, albeit she later said she still did not think her breasts “felt right”, and returned to her GP asking for further investigation. This time the GP referred her for an MRI scan, which was carried out at private hospital B. The report stated that there was no intracapsular rupture and that the left breast showed what was described as a herniation. The report did not suggest the need for any further action for the referring GP. Both the GP and Ms P took reassurance from the report of no rupture.

More years passed and Ms P had a child. After this, she thought her left breast in particular was “odd”, but put it down to weight changes during pregnancy. However, she asked her GP for a second MRI scan. This was done at private hospital A. The referring GP noted on the request that Ms P had previously had an MRI scan, which did not show a rupture. This second MRI scan was reported as showing no extracapsular rupture, but it did not make any comment about any intracapsular rupture. Again, both the GP and Ms P were reassured by the report of no rupture.

Two years later, Ms P felt a lump in her left breast. Her GP referred her for a third MRI scan, again at private hospital A. Again, no rupture was reported.

Ms P was not reassured this time as three MRI scans and a mammogram had reported nothing of note, but she now had a breast lump and longstanding anxiety about her implants. Her GP referred her to a breast surgeon. He suggested that her implants be removed. Ms P underwent this procedure. During the operation, it was found that both implants had ruptured, and so were replaced.

Ms P brought a claim against the four radiologists who had carried out her one mammogram and her three MRI scans over a number of years. She alleged that they had failed to identify implant rupture, despite her on-going concerns and symptoms, and that this had led to much anxiety over several years. 

How did Medical Protection assist?

Medical Protection instructed an expert in clinical radiology to consider the case and the four radiological images. The expert commented on a number of vulnerabilities for the different reporting radiologists. These were as follows:

1. The first radiologist should have advised the GP that while the mammogram was indeed normal, an intracapsular silicone implant rupture would be very difficult to see on one, and so if there were continued concerns in this regard, Ms P should have been referred back for an MRI scan. This was noted to be an omission in the mammogram report.
2. The second radiologist should have advised the GP that the bulging of the implant contour on the first MRI scan, which they had correctly identified and then described as a herniation, should have been caveated with an acknowledgement that this sign could suggest an intracapsular rupture. The expert opined that the report should have then gone on to suggest further evaluation and assessment of Ms P in light of this possibility. This was noted to be an omission in the first MRI report.
3. The third radiologist should have made a comment on whether or not there was an intracapsular rupture. Their report was silent on this point. Additionally, they were silent on any reference to Ms P’s previous MRI scan, despite knowing she'd had one. It was noted that the first and second MRI scans were done at different private hospitals, so the radiologist may not have had access to it. But the expert advised they should have then suggested to the GP that some comparison with the previous imaging could be warranted, as they had not been able to do this. These were noted to be omissions in the second MRI report.
4. The fourth radiologist should have identified the intracapsular rupture that was now evident. The expert opined that they had confused the finding of multiple folds of the implant shell layering on itself – the linguine sign which is highly indicative of an intracapsular rupture – with the normal radial folds of the implant. Additionally, it was noted they had access to previous imaging (the second MRI scan) but failed to make reference to it. If they had done so, it would have been obvious that there were changes in Ms P’s left breast. These were noted to be omissions in the third MRI report.

Outcome

Overall, the expert considered that the reports back to the referring GP could have been better worded to help direct them, particularly as a non-breast specialist, in their management of Ms P. It followed that there had been missed opportunities to investigate and identify the implant rupture earlier and that this had led to several years of anxiety for Ms P.

Taking these vulnerabilities into account, it was recommended that the claim should be settled.

Learning points

Clarity of communication in radiology reporting and the value of adding clinical value to managing patients has been previously documented.¹ Indeed, a survey of GPs found the overwhelming majority valued the radiologist's opinion outside the remit of imaging, when recommending further treatment, referral, and non-radiological investigation.²

The Royal College of Radiologists has produced clear standards for reporting and interpreting imaging investigations.³ Standards one to three are particularly relevant to this claim. In summary, these are that reports should include:

• a range of opinions when an abnormality is identified
• relevant negative observations where pertinent
• wording that takes into account the professional background of the referrer
• suggestions for further investigations or specialist referral where these could contribute to patient management
• a review of prior studies when reporting a new image.

You cannot underestimate the reliance that may be placed on a radiologist’s report in the management of a patient, so careful attention to the wording could pay dividends in protecting yourself

¹ Brady AP. Radiology reporting—from Hemingway to Hal? Insights into Imaging 2018;9:237–46. doi:10.1007/s13244-018-0596-3 

² Grieve FM, Plumb AA, Khan SH. Radiology reporting: A general practitioner’s perspective. The British Journal of Radiology 2010;83:17–22. doi:10.1259/bjr/16360063 

³ Standards for the reporting and interpretation of imaging investigations. Second. London: Royal College of Radiologists 2018.