Gillian Stokes

Coroner's concerns

AI summary

Insufficient clinical guidance for diagnosing radiation-induced sarcoma in breast implant patients and an inadequate 5-year surveillance period. A crucial follow-up appointment after an aspiration was also not carried out.

View full coroner's concerns

During the inquest, the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths could occur unless action is taken. [BRIEF SUMMARY OF MATTERS OF CONCERN] (1) I am concerned that there is not any or insufficient guidance available to clinicians in regard to possible radiation induced sarcoma, or first line investigations for patients with breast implants to be able to see down to the chest wall. The Radiologist, Surgeon and Nurse advised that they did not have any specific guidance in relation to possible radiation-induced sarcoma, from the Royal Marsden advised in written evidence, that radiation induced sarcomas are increasing in incidence as more primary breast cancer patients are now offered breast conserving surgery with wide local excision and radiotherapy, rather than mastectomy alone (previously there was no radiation). Therefore, in his view the increasing use of radiotherapy leads to increased number of patients developing radiation induced sarcomas. As said from the Royal Marsden, diagnosis requires the treating clinician to recognise that this is a possibility.

Furthermore, as advised in his experience the difficulties in diagnosis are that they are sometimes not recognised by primary and secondary care teams who are the first to see the patient.

In evidence the Radiologist confirmed that the Royal College of Radiologists do not have a protocol for patients who have had previous radiotherapy and implant. Furthermore, Nurse Diagnostician confirmed there was no protocol in the ABS Best Practice Diagnostic Guidelines for radiation induced sarcoma where a patient has had an implant.

(2) I have a concern regarding the current surveillance period of 5 years provided to patients with breast cancer considering the latency period of radiation induced sarcoma is 10 years.

(3) I have concerns regarding the system in place at Ashford Hospital for 2 week follow ups following an aspiration following an initial assessment at the One Stop Clinic. Following the aspiration Mrs Stokes received, the Nurse advised in evidence Mrs Stokes should have had a further review after two weeks, as indicated in the paperwork, but this was not followed through by the hospital and the message was not clearly communicated to the family. This would have allowed for further follow up in case the bulge had increased in size and in pain and could have potentially identified the need to investigate further.

Responses

4 respondents

Department of Health and Social Care Central Government

17 Sep 2024 PDF

Action Planned

The DHSC will explore with MHRA and NHSE raising awareness of angiosarcoma following radiation with patients and clinicians. They note that surveillance guidance for angiosarcoma may do more harm than benefit. (AI summary)

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Dear Krestina,

Thank you for the Regulation 28 report of 8 August 2024 sent to the Department of Health and Social Care about the death of Mrs Gillian Patricia Stokes. I am replying as the Minister with responsibility for Public Health and Prevention.

Firstly, I would like to acknowledge the sad circumstances of Mrs Stokes’ death, and I extend my sympathy and condolences to her family and loved ones at what I am sure was, and remains, a difficult time. Your report rightly raises several matters of concern where you have indicated there is a risk future deaths could occur unless action is taken. I am grateful to you for bringing these matters of concern to my attention.

Your report raises concerns across multiple fronts over the care provided by the Trust and its processes, in particular:

1. That there is insufficient or no guidance available to clinicians regarding possible radiation induced sarcoma, or first line investigations for patients with breast implants to be able to see down to the chest wall.

2. That the current surveillance period of 5 years is provided to patients with breast cancer considering that the latency period of radiation induced sarcoma is 10 years.

3. That Mrs Stokes initial assessment aspiration was not followed up within two weeks as recommended by the nurse, at the Ashford Hospital One Stop Clinic, and that the requirement was not communicated clearly to her family.

In preparing this response, my officials have made enquiries with NHS England (NHSE) and the National Institute for Health and Care Excellence (NICE) to ensure we adequately address the above concerns. NHSE leads and is operationally responsible for the National Health Service in England and is accountable to Parliament and the Department of Health

and Social Care. NICE provide national guidance and advice for clinicians so that they can give the best care to patients to improve health and social care in England and Wales.

Separately, I understand that the Royal College of Radiologists and the Royal College of Nursing as recipients of your report will also be responding directly to your concerns.

I regret to hear that Mrs Stokes died of radiation induced sarcoma as a complication of life- saving historic radiotherapy treatment for previous breast cancer in 2013. I would like to acknowledge your concern about insufficient guidance available to clinicians regarding possible radiation induced sarcoma, or first line investigations for patients with breast implants to be able to see down to the chest wall. In 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) published an alert about breast implant associated anaplastic large cell lymphoma which the clinical team followed the appropriate investigations to consider. While angiosarcoma following radiation is rare, I have asked my officials to explore with MHRA and NHSE if more can be done to raise awareness of this side effect with patients and clinicians. Your report raises the concern that patients with breast cancer have a 5-year surveillance period, considering that the latency period of radiation induced sarcoma which affected Mrs Stokes is 10 years. It is my understanding that the rate of recurrence of breast cancer following diagnosis is greatest in the first five years after diagnosis. Current surveillance with annual mammography for 5 years is directed at identifying recurrent breast cancer, which occurs in up to 10% of women post treatment, usually within 5 years. I have been informed that angiosarcoma occurs in 0.1% of women, presenting at around 10 years and is not reliably identified on mammography. Unfortunately, this means that there is currently a lack of evidence about the impact of early diagnosis on survival, and the possibility that regular screening guidance for angiosarcoma may do more harm than benefit cannot be ruled out. Finally, I regret to hear that Mrs Stokes was not invited for a follow up appointment following her initial assessment within two weeks as recommended by the nurse at the Ashford Hospital One Stop Clinic, and that this requirement was not communicated clearly to her family. As this appears to be a local arrangement, I am unable to comment on this point. However, I understand that Ashford & St Peters NHS Trust is also a recipient of your Report and is preparing a full response. I want to again express my deepest condolences to Mrs Stokes family and her loved ones. It is vital that lessons are learnt collectively, and changes are made to reflect where things have gone wrong, which is essential to ensure the NHS provides safe, high-quality care.

I hope this response is helpful. Thank you for bringing these concerns to my attention.

Royal College of Nursing Education

27 Sep 2024 PDF

Noted

The RCN supports the coroner's concerns regarding lack of guidance and pathways for radiation induced sarcoma, implants, and the current surveillance period. However, as a professional body, they do not comment on individual cases. (AI summary)

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Dear Ms Hayes

Prevention of Future Deaths Report – Gillian Patricia STOKES

We respond to your Prevention of Future Deaths (PFD) Report dated 8 August 2024 following the sad death of Mrs Gillian Stokes. We would like to offer our condolences to the family of Mrs Stokes.

The Royal College of Nursing (RCN) is the largest nursing union and professional body, we support over half a million nurses, midwives, nursing support workers and students working together to advance our profession. The RCN is not a regulator and therefore does not comment on individual cases. We support the coroners concerns regarding lack of guidance and pathways for radiation induced sarcoma and individuals with implants. We support the concern regarding an extension to the surveillance period.

The RCN is unable to comment on the system in place for follow-up appointments at Ashford Hospital. However, we can say that a clear process should be in place for organisation of follow-up appointments. The experience of our members would indicate that there is on occasion a lack of administrative support for nurses undertaking specialist or advanced roles, and whilst we do not know if this was the case at this hospital, it is vital that there are the appropriate staff with the requisite knowledge and skills supported by systems and processes to enable timely follow up and progression of clinical recommendations.

Royal College of Nursing 20 Cavendish Square London W1G 0RN

Chief Nursing Officer

We note that you have sought advice from the Royal Marsden Hospital. We consider that they will have the appropriate expertise to be able to assist you further.

Ashford and St Peters Hospitals NHS Foundation Trust NHS / Health Body

30 Sep 2024 PDF

Action Planned

Ashford and St Peters Hospitals NHS Foundation Trust is developing a Standard Operating Procedure (SOP) for the Breast One Stop Shop Clinic that will outline guidelines for patient follow-up care, including accommodating patients requiring earlier follow-up in some circumstances. (AI summary)

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Dear Ms Hayes

Re: Mrs Gilliam Stokes Regulation 28 Report to Prevent Future Deaths

Please find below my responses to your concerns raised in your email received on 29 July 2024 following the inquest into the death of Mrs Stokes. The Regulation 28 report sets out the matters giving rise to concerns numbered 1-3 below.

I understand that the Regulation 28 report has also been sent to the President of the Royal College of Radiologists who will respond to matters of concern 1 and 2.

Matter of Concern 3 I have concerns regarding the system in place at Ashford Hospital for 2 week follow ups following an aspiration following an initial assessment at the One Stop Clinic. Following the aspiration Mrs Stokes received, the Nurse advised in evidence Mrs Stokes should have had a further review after two weeks, as indicated in the paperwork, but this was not followed through by the hospital and the message was not clearly communicated to the family. This would have allowed for further follow up in case the bulge had increased in size and in pain and could have potentially identified the need to investigate further.

With regards to matter of concern 3, the Trust has reviewed the appointments process within the One Stop Shop breast clinic and has found the following:

The normal process for any patient having imaging and any tests during a consultation is for us to wait until all the results have returned to us, this process can take up to four weeks. The results are then discussed at the next Multi-Disciplinary Team Meeting (MDT); following the decision of the MDT the patients will be contacted to arrange their follow-up appointment.

Contact information slips are available and handed to patients who attend breast care clinics. These slips contain details of the Breast Clinic Team telephone number as well as the Patient Navigator Service number for the patients to contact if they have any questions or concerns.

Patients first Personal responsibility Passion for excellence Pride in our team

The Division is in the process of developing a Standard Operating Procedure (SOP) for the Breast One Stop Shop Clinic, which will outline the guidelines for patient follow-up care. The aim of this SOP is to create a follow-up process that is both standardised and tailored to individual patient needs. The process will accommodate patients requiring earlier follow-up in some circumstances. Once the SOP has been finalised, a copy will be provided to the court for information and assurance.

I hope that the measures we have implemented demonstrate our commitment to addressing your concerns and our ongoing efforts to learn from and improve upon the issues highlighted in your report

Please do not hesitate to contact me should you require further details or documentation.

Royal College of Radiologists Education

18 Nov 2024 PDF

Action Planned

The RCR has tasked the authors of their 'Guidance on screening and symptomatic breast imaging' to consider the coroner's concerns during the current review and ensure all modalities are considered. (AI summary)

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Dear Assistant Coroner Hayes, RCR Response to Regulation 28: Prevention of Future Deaths report issued on 8 August 2024 in relation to the death of Gillian Patricia Stokes. I was very sorry to read about the death of Mrs Gillian Stokes and I would like to express my deepest condolences to Mrs Stokes’ family. We take the matters raised in your report very seriously and I hope this reply will be helpful in outlining how we are committed to learning from them and supporting our members and Fellows to develop and maintain excellent medical care. I sincerely apologise for the delay in sending this response. The failure to reply promptly is an isolated incident that we have reviewed and I can confirm that we have put additional measures in place to refine our process when responding to important correspondence such as your report. You have noted that there is a relative lack of guidance in relation to possible radiation induced sarcoma in patients who have had a previous breast implant and also a concern in relation to duration of follow up. Whilst radiotherapy is an effective treatment it is unfortunately associated with radiation- induced sarcoma. Although this is a rare complication it can be devastating and I am saddened to hear that this was a complication of the life-saving radiotherapy Mrs Stokes received for her breast cancer in 2013. The Royal College of Radiologists (RCR) is a charity which works with our members and fellows to improve medical care across the specialties of Clinical Radiology and Clinical Oncology. Clinical Oncologists lead services which deliver radiotherapy and Clinical Radiologists lead diagnostic and interventional services. Both faculties operate across a wide spectrum of practice including in relation to breast pathology. We develop the curriculum in our specialties (which the General Medical Council approves) and the RCR offers support for trainers and trainees and runs the professional examinations in both specialties. We also

promote excellence in professional practice within our specialties including by producing a range of publications, such as recommendations for the delivery of high-quality radiology services. The RCR itself, however, does not commission or provide any direct clinical care. Training according to the curriculum within both Clinical Radiology and Clinical Oncology covers the nature and effects of radiation, including the potential for developing complications such as radiation induced sarcoma, the steps to minimise the risk of such an occurrence and the possible ways to identify this if it occurs. Risk-benefit is a fundamental concept in therapies involving radiation and is also a relevant consideration in relation to follow-up as many tests, such as CT, themselves carry risks from the radiation they entail. Such considerations are particularly important for rare complications, for conditions where treatment may be challenging whenever the condition is identified and also for conditions separated in time by a long and unpredictable period from an initial exposure. The RCR does not produce the ABS Best Practice Diagnostic Guidelines which were referenced by the clinician who assessed Mrs Stokes, and as the radiologist who gave evidence stated the RCR does not have a dedicated guideline publication on this rare area. The RCR does, however, produce other relevant guidance. In 2019, the RCR published the Guidance on screening and symptomatic breast imaging, fourth edition. This guidance is currently undergoing a review led by the British Society of Breast Radiology, which is an independent organisation and one of several Special Interest Groups with Memoranda of Understanding with which the RCR works. As the next version is developed we have tasked the authors with considering the matters you have raised and also asked that all modalities are considered. I am grateful to you for bringing these matters of concern to our attention and for giving us the opportunity to respond. Once again, I do apologise for the delay in our response and express my deepest condolences to Mrs Stokes’ family and loved ones.

Report sections

Investigation and inquest

On 15th June 2023, I commenced an investigation into the death of Mrs Gillian Patricia Stokes. The investigation concluded at the end of the inquest on 8th July 2024. The conclusion of the inquest was: on 2nd June 2023, Mrs Gillian Patricia Stokes died at the age of 74 years old from sarcoma of the right chest wall at Woking & Sam Beare Hospice, Woking. Sarcoma is a known complication of life-saving historic radiotherapy treatment for previous breast cancer in 2013.

Circumstances of the death

Mrs Stokes died of radiation induced sarcoma, which originated in the chest wall. She had a history of breast cancer confirmed in a referral by Woking & Sam Beare Hospice.

Nine months prior to her death, Mrs Stokes had an investigation into pain in her right breast. She first attended her GP on 26th October who referred her to a Breast Clinic at Ashford Hospital. The radiation induced sarcoma was not found on an ultrasound on 10 November 2022.

She attended a Breast Clinic, and her symptoms were investigated, which was said by the hospital clinicians to be in line with National Guidelines of symptomatic symptoms of patients with breast implants with suspected ALCL (Anaplastic large cell lymphoma). The guidance given on investigations, does not include what investigations need to be carried out on patients with a history of radiation with an implant to ensure the entirety of the chest wall is checked for masses.

Furthermore, there is no guidance for clinicians to consider the rare diagnosis of radiation induced sarcoma, which is said by specialists at the Royal Marsden to be a growing issue, due to the increasing use of radiation combined with reconstructive surgery in the form of implants.

History of Mrs Stokes treatment Mrs Stokes was first diagnosed with breast cancer in 2013 and was given chemotherapy and radiotherapy treatments, which included radiation of the chest wall. She also had a mastectomy followed by reconstructive surgery which included a breast implant.

Between 2013-2018 she returned to the Breast Clinic at Ashford hospital on several occasions, as she was unhappy with the implant. She had complained that it had been positioned too high, was misshapen and too large. She had a breast reduction and a further operation to remove some of the scar tissue and excess skin. Due to the multiple operations she continued to have soft tissue scarring and it remained uncomfortable, but she decided not to have any further surgery.

Mrs Stokes had 5 years of surveillance scanning following her breast cancer diagnosis in case the breast cancer should reoccur. The latency period for radiation induced sarcoma can be up to 10 years. She had an MRI scan on 7th August 2022 to investigate other issues unrelated to the breast cancer, the scan covered the area where the cancer was later found, but at that time no mass was present.

In October 2022, she reported to her GP surgery that she had a swelling in her breast area, which resulted in pain around her breast, down her right arm and armpit. She was referred to the Breast Clinic at Ashford via her GP.

As recommended in National Guidelines, the patient underwent a triple assessment for symptomatic breast disease. The triple assessment consists of 1. Clinical Examination,
2. Imaging; and 3. Biopsy of any abnormal finding. Mrs Stokes was seen at the Breast Clinic within the 2-week period of an urgent referral.

At the Breast clinic, Mrs Stokes initial clinical examination was conducted by a Nurse Diagnostician. The Nurse confirmed in evidence that her examination of Mrs Stokes chest wall was limited by her breast implant. If she had not had a breast implant, she would have been able to palpate the mastectomy area and rub it. This was not possible due to the implant.

Mrs Stokes was referred for a mammogram on her left breast, as cancer can often appear in the other breast following first diagnosis of breast cancer. This was clear.

She was also referred for an ultrasound of her right breast, this was in line with the national guidance called ABS Best Practice Diagnostic Guidelines Symptomatic Breast.

The concern by all three clinicians following Mrs Stokes Presentation at One Stop Clinic, following the clinical examination by the Nurse, an ultrasound by the Radiologist and the Surgeon, was that Mrs Stokes may have an issue regarding ALCL (Anaplastic large cell lymphoma – a fast and rare growing cancer). This was because liquid was found surrounding the breast implant. Some fluid was taken for testing and no malignant cells or makers or ALCL were found. This is in accordance with the Royal College of Radiologists Guidance on screening and symptomatic breast imaging 4th edition, breast specialists must be aware of the possibility of this rare complication of implant breast augmentation.

Radiation induced sarcoma was not considered as a possible diagnosis, as the cases that the Nurse, Radiologist and the Surgeon have experienced present with focal mass or skin change, clinically with a focal mass abnormality associated on imaging which was not found on ultrasound with Mrs Stokes.

In evidence and confirmed at the inquest, the radiologist who carried out the examination in November 2022 confirmed that the examination normally should include examination of the skin down to the chest wall (which lies posterior to the implant) for focal masses. In Mrs Stokes case, the position of the implant meant that the radiologist could not see posteriorly to the breast implant with ultrasound imaging, as the image cannot go beyond the implant and therefore not down to the chest wall.

The Radiologist confirmed that she could see the surface of the implant and around the implant, where there was a moderate amount of fluid, but no mass in the breast tissue and no nodularity related to the surface of the implant. There was therefore in the clinicians view no suspicion of a sarcoma because no mass was visible on the surface of the breast tissue or around the implant. The implant capsule demonstrated a smooth contour with no irregularity or nodule surrounding the implant.

I asked both the Nurse and the Radiologist if the fact that they could not carry out a full examination down to the chest wall was raised at MDT when deciding what management steps to take next. I was advised it was not, as it was not a consideration that there was a focal mass behind the implant. The patient wanted the implant out and she had not tested positive for ALCL.

At inquest, I was told by the surgeon that they could not MRI all patients who were in this position. Furthermore, they confirmed that the guidance did not require them to. Whereas there is specific guidance for ALCL cases which are also very rare in number but can be tested by a cytology test (by taking a sample of fluid).

In written evidence doctors from the Royal Marsden, who considered Mrs Stokes case at MDT after the sarcoma was diagnosed, wrote in written evidence that sarcomas are very fast growing and it is evident in this case that Mrs Stokes was as it was not present in the MRI in August 2022.

I had further written witness evidence from a colleague of the Radiologist from Ashford Hospital who advised whilst they were unable to see anything on ultrasound to suggest a focal mass was present in November 2022, given the size of the mass on 27 January 2023, there is a possibility that it may have been present if an MRI scan was used in November 2023, but it is impossible to say. Royal Marsden also advised that it was not possible to say.

After the One Stop Clinic following the aspiration the Nurse advised in evidence Mrs Stokes should have had a further review after two weeks, as indicated in the paperwork, but this was not followed through by the hospital and the message was not clearly communicated to the family. This would have allowed for further follow up in case the bulge had increased in size and in pain, but Mrs Stokes was not seen again until January 2023, as she was reclassed as a cosmetic case following the negative ALCL tests.

Mrs Stokes attended again for an operation on 26th January 2023 and the staging CT scan on 15th March 2023 her sarcoma was classed as inoperable by Royal Marsden. Mrs Stokes was treated palliatively and passed away on 2nd June 2024.

I had invited Ashford Hospital for submissions, but have not received any before completing this report.

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