Malpractice litigation in patients in relation to delivery of breast care in the NHS

Malpractice litigation involving patients with carcinoma of the breast has been evaluated in United States of America (USA). The extent of litigation in breast cancer has not been published in UK and malpractice claims in relation to overall breast care have not been published before. We sought to study and evaluate all the litigation claims in relation to breast care with the National Health Service Litigation Authority (NHSLA) from May 1995 to September 2005. We also studied changes in litigation claims and outcomes in incidents reported before and after January 1, 2000.     

Analysis of malpractice claims in breast care for poor cosmetic outcome

Claims for poor cosmetic outcome account for a large proportion of breast care malpractice litigation in the UK. Detailed analysis of such claims has not been conducted. We sought to analyse National Health Service Litigation Authority (NHSLA) data pertaining to breast care over the period September 2005-April 2008, focussing on claims for poor cosmetic outcome. Data from a medical indemnity organisation detailing similar claims in the private sector were also analysed. Comparison of the NHSLA data with previously obtained NHSLA data (May 1995-September 2005) demonstrated an upward trend in claims for poor cosmetic outcome. The majority of claimants for poor cosmesis had benign disease and the vast majority of claimants with breast malignancy had undergone breast reconstruction. The majority of claims for poor cosmetic outcome were against plastic surgeons. This was more marked in the private sector data than in the NHSLA data, reflecting their workload.     

Breast Cancer Litigation: An Update with Practice Guidelines

▪ Abstract: Cases involving breast cancer are the second most common cause of malpractice litigation. The leading allegation is failure to diagnose, followed by improper treatment. The most common physicians involved are those giving direct care to women: obstetricians/gynecologists, family medicine physicians, and internists. This review addresses frequent areas of litigation, offering practice guidelines for avoidance of malpractice claims. In addition, two new areas of breast cancer management will be reviewed—breast cancer prevention and breast cancer genetic testing—as potential new areas of malpractice litigation. ▪     

Fourteen years of litigation claims in cardiothoracic surgery in the United Kingdom National Health Service

Approximately 36 400 cardiac and 23 100 thoracic operations are carried out in the United Kingdom between 2006 and 2015. National Health Service (NHS) resolution, as known as the NHS litigation authority, is one of the essential bodies of the Department of Health. Its purpose is to provide NHS expertise to resolve concerns fair and square share learning for improvement. We aim to evaluate and increase awareness of medicolegal cases in cardiothoracic surgery. Total numbers and details of claims coded by NHS resolution in cardiothoracic surgery from 2004 to 2017 were requested under the Freedom of Information Act 2000. The data provided in successful claims is further breakdown into damages paid to the claimant, defence cost, claimant cost paid and the sum of the three. In contrast, unsuccessful claims only include the defence cost. Moreover, data provided also includes further analysis of primary causes and primary injuries for Claims Closed/Settled with damages paid. There were 753 claims recorded from 2004 to 2017, of which 415 (55.11%) were successful. The number of claims has been steadily increasing since 2004, with two significant raises from 2009/10 to 2010/11 (37‐55, 48.64% raise) and 2012/13 to 2013/14 (49‐69, 40.82% raise). The mean successful claim ratio was 69.58% (range, 47.56%‐ 83.33%) There is also a steady increase in the successful ratio from 2004 to 2017. In summary, this is the first study published in relation to litigation claims on cardiothoracic surgery in the United Kingdom. The results have provided insight on claims made against cardiothoracic surgery.     

Regional variation in breast cancer treatment throughout the United States

BACKGROUND: It has been proposed that initial treatment for breast cancer varies greatly across the United States. However, one question that has not been answered completely is whether or not geographic location itself is an independent variable with regard to treatment. METHODS: The American College of Surgeons National Cancer Database Benchmark Reports (NCDB) were used to examine initial breast cancer treatment performed throughout the United States during the study period 1999-2003. These data were then stratified with regard to geographic region in accordance with the US Census Bureau classifications. RESULTS: There was a statistically significant relationship between geographic region and initial treatment of breast cancer. Although there were statistically significant relationships between race and geographic region and stage and geographic region, when the data were controlled for stage and race, the regional differences persisted. Stage-for-stage and within each racial cohort, the geographic differences in treatment were still statistically significant. DISCUSSION: This review suggests that geographic location within the United States is an independent variable with regard to breast cancer treatment.     

Urological litigation in the UK National Health Service (NHS): an analysis of 14 years of successful claims

What’s known on the subject? and What does the study add? There are no previous studies for urology in the UK but several studies from physician insurance groups in North America. There is anecdotal evidence of common reasons for litigation, e.g. missed testicular torsion. This is the first analysis of the claims data compiled by the NHS litigation authority for the speciality of urology; it provides realistic insight into the areas and procedures of the speciality most commonly affected by litigation. The article identifies areas of high risk, both clinical and medico‐legal.

OBJECTIVES

? To present a summary of the collected data on urological litigation within the UK National Health Service (NHS). ? Knowledge of the main areas of litigation is essential for maintaining good clinical practice as well as risk management procedures in any specialty.

MATERIALS AND METHODS

? Details of all claims closed with indemnity payment pertaining to the specialty of urology as practiced by urologists, general surgeons and paediatric surgeons was obtained from the NHS Litigation Authority (NHSLA) for the years since its creation in 1995 to 2009. ? The data was then classified and analysed.

RESULTS

? In all, 493 cases were closed with indemnity payment with a total of £20 508 686.18 paid. The average payment per claim was £41 599.77. ? Most of the claims were related to non‐operative events (232), followed by postoperative events (168) and intraoperative events (92). ? The most common reason for non‐operative‐related claims was failure to diagnose/treat cancer (69), perforation/organ injury (38) was the highest intraoperative‐related claim and a forgotten ureteric stent (23) was the most frequent postoperative‐related claim. ? The five most commonly implicated procedures were ureteroscopy/ureteric stenting (45), transurethral resection of the prostate (30), nephrectomy (26), vasectomy (19) and urethral catheterisation (15).

CONCLUSIONS

? The present study once again emphasizes the importance of thorough clinical assessment, record keeping and follow‐up as well as informed consent and good communication with patients. ? Recognising the areas of highest risk and improving practice should limit future claims.     

A network data-based survey and analysis of attention towards breast reconstruction after breast cancer surgery in Chinese and American populations

BackgroundBreast reconstruction is an effective technique to rebuild the appearance of the breasts in patients after mastectomy and improves the prognosis. The current study aimed to compare and analyze willingness for breast reconstruction after breast cancer between populations in China and the United States, from the perspective of social concern, using big data analysis. We also aimed to explore factors affecting surgical selection and to identify methods that can improve social cognition and acceptance of breast reconstruction.MethodsUsing Baidu and Google, two representative Internet search engines in China and the United States as research tools, and using big data search volume as the benchmark, we compared and analyzed breast reconstruction willingness and attention characteristics between Chinese and American people, based on search heat, geographical distribution, age and sex, keyword distribution, ethnic group, and social development degree.ResultsIn both the long-term and short-term, Chinese people paid more attention towards searching about breast cancer, but less attention to breast reconstruction after breast cancer surgery. However, in both the short-term and long-term, people from the United States paid more attention towards breast cancer and breast reconstruction with the help of the Internet, showing a synchronous change relationship. There was a large regional difference in the search volume for breast cancer among the Chinese population, while no significant regional differences were noted in the search volume for breast cancer in the United States. However, a large regional difference was observed in the search volume for breast reconstruction between the two countries; people in the coastal and economically developed areas paid more attention to it. Most people who paid attention to breast reconstruction in China were women aged 20–39 years, while the attention among men was low. Search keywords were also limited to breast cancer-related information. However, between Asians and European Americans, Americans paid more attention to breast cancer and were affected by regional development, religious beliefs, and health facilities.ConclusionAttention towards breast reconstruction after breast cancer was lower in the Chinese population than in the American population, and this difference was closely related to the level of regional development. There is insufficient information on breast reconstruction after breast cancer in recent Internet media. In addition to strengthening communication in clinics, media education is important to improve the cognitive level and social awareness of patients and their families, which is conducive to breast reconstruction.     

Effects of Litigation Settlements on Posttraumatic Stress Symptoms in Motor Vehicle Accident Victims

In order to investigate the effects of the initiation of litigation and its settlement on victims of motor vehicle accidents (MVAs), we followed up 132 MVA victims from an initial assessment 1 to 4 months post-MVA for 1 year. Of the 67 who had initiated litigation. 18 (27%) settled within the 12 months, while 49 still had litigation pending; 65 never initiated litigation. Those who initiated litigation had more severe injuries and higher initial levels of posttraumatic stress (PTS) symptoms. All three groups improved in major role function and had reduced PTS symptoms over the 1 year follow-up. Those whose suits were still pending, as well as those whose suits had been settled, showed no reduction in measures of anxiety or depression, whereas the nonlitigants did show improvement on these measures.     

Symposium overview: Estrogens and antiestrogens in managing the patient with breast cancer

The prevalence of breast cancer (a hormonally driven neoplasm) in the United States, the potential health benefits of estrogen replacement therapy for postmenopausal women, and the burgeoning research focusing on selective estrogen receptor modulators (SERMs) have resulted in additional complexity in managing breast cancer. In an attempt to clarify existing data, the Society of Surgical Oncology sponsored a symposium entitled “Estrogens and Antiestrogens in Managing the Patient with Breast Cancer” at its 52nd Annual Cancer Symposium. This conference was held in March 1999 and was chaired by Dr. S. Eva Singletary, Professor of Surgery and Chief of the Surgical Breast Section at The University of Texas M. D. Anderson Cancer Center in Houston, Texas. The following is a review of the material presented by the symposium participants.     

Breast sonoelastography: Now and in the future

PurposeThe purpose of this study was to identify practice trends and opinions concerning breast sonoelastography in two different health care systems, one in Europe (France) and the other in North America (Province of Québec/Canada).Materials and methodsWe distributed an 11-item online survey among French and Canadian breast radiologists. The survey comprised of four sections: (i) personal practice characteristics, (ii) breast sonoelastography usage in daily practice and evaluation of its usefulness, (iii) limitations and roles of sonoelastogrpahy in their clinical practice, and (iv) types of elastographic technique and interpretation.ResultsWe found that sonoelastography of the breast appears unpopular among Canadian radiologists, and poorly credible among French radiologists, who perceive it as an unreliable technique. To date, its real impact in clinical practice remains uncertain.ConclusionContinued learning and awareness of the indications, advantages and limitations of breast sonoelastography may motivate breast radiologists to adopt its use.     

Recent trends and predictors in immediate breast reconstruction after mastectomy in the United States

Introduction

Immediate breast reconstruction after mastectomy has increased in frequency during the past decade, but the socioeconomic and patient factors have yet to be fully identified.

Methods

Data were analyzed from the Nationwide Inpatient Sample from 1999 to 2003 using International Classification of Disease-9 codes to identify patients undergoing immediate breast reconstruction. Regression analyses were used to examine predictive variables for immediate breast reconstruction after mastectomy.

Results

Between 1999 and 2003, 469,832 patients underwent mastectomy. Immediate breast reconstruction occurred in 110,878 patients, yielding a 5-year average rate of 23.6% (range of 22.2% to 25.3%). Independent predictors of immediate breast reconstruction after mastectomy include private insurance, hospital in an urban location, teaching hospital, white race, hospital region in the south, age between the 3rd and 6th decades, and low number of comorbidities.

Conclusions

Immediate breast reconstruction after mastectomy is still not commonly performed in the United States. Socioeconomic and geographic factors play a significant role in whether patients undergo immediate reconstruction.     

Reported Litigation Associated With Primary Hip and Knee Arthroplasty

Background

Greater than 75% of arthroplasty surgeons report having been the subject of a malpractice lawsuit. Despite this, few studies have analyzed the causes of litigation following total joint arthroplasty in the United States.

Correlation of targeted ultrasound with magnetic resonance imaging abnormalities of the breast

BACKGROUND: Magnetic resonance imaging (MRI) of the breast is highly sensitive for cancer. However, MRI frequently detects additional lesions that mandate further evaluation. The intent of this study was to assess the ability of targeted ultrasound to identify additional lesions detected on MRI in patients undergoing evaluation for breast cancer. METHODS: Between January 1, 1999, and July 15, 2004, 270 women underwent breast MRI at Grant Medical Center. MRI was obtained in 191 women during evaluation for documented or suspected breast cancer. Fifty-two patients had additional suspicious lesions on MRI, prompting targeted ultrasound; these patients constituted our study population. RESULTS: Seventy-five additional suspicious lesions were detected on breast MRI in 52 women. Two women underwent mastectomy without targeted ultrasound. Targeted ultrasound identified 65 of the remaining 73 lesions (89%). Eight lesions (11%) were not visible on targeted ultrasound. CONCLUSION: Targeted ultrasound can be a reliable method to correlate MRI abnormalities in breast cancer patients.     

Psychological assessment of postdisaster class action and personal injury litigants: A case study

The case study method is used to describe psychological assessments undertaken with victims of a combined natural/technological disaster for litigation purposes. A class action suit was filed in which the authors determined levels of traumatic stress in 27 plaintiffs as a group and relative to each other. The process was effective—the case was settled out of court in favor of the litigants. Individual litigants were satisfied with monetary awards received.     

Surgeon variability in treating nonpalpable breast cancer: Surgical oncology as a value-added specialty

Background: Several studies have demonstrated a relatively low rate of breast conservation surgery (BCS) in the United States. Few have analyzed the impact of individual surgeon variability on the outcome of the procedure, and none have contrasted surgical oncologists versus general surgeons in the treatment of nonpalpable breast cancer. Methods: A blinded review was done of 409 excisions for nonpalpable breast cancer performed by 11 board-certified general surgeons (GS, n=221) and one surgical oncologist (SO, n=185) in a teaching institution. We compared surgical margins, need for reexcision, and breast conservation rates. Results: Although there were no significant differences in patient and tumor characteristics, there were surprising differences between the GS and SO, especially related to surgical margins and final treatment. The SO has a significantly higher rate of frozen section compared to GS (81% vs. 64%,P<0.01) and a lower rate of positive margin at the time of original biopsy (25% vs. 41%,P<0.01). These differences translated into lower necessity for reexcision of tumor (18% vs. 48%,P<0.01) and higher rate of BCS (88% vs. 70%,P<0.01). Conclusion: This study demonstrates marked differences among trained general surgeons. The additional experience of a surgical oncologist is valuable, because fewer positive margins lead to a higher likelihood of breast preservation and decreased costs related to fewer additional operative procedures.Presented at the 50th Annual Cancer Symposium of the Society of Surgical Oncology, Chicago, Illinois, March 20–23, 1997.     

Contribution of breast density to the volume of the augmented breast: A preliminary study

BACKGROUND:

Prediction of soft tissue contribution to the shape, volume and texture of the augmented breast proves to be an ever-challenging, uncontrollable variable. Similarly, the understanding of the contribution of breast density in breast augmentation has been elusive and, generally, not well studied.

OBJECTIVE:

With the aid of three-dimensional photographic analysis, the present preliminary study examined the contribution of differing breast densities to the overall volume of the augmented breast.

METHODS:

All patients undergoing primary augmentation over a six-month period were included in the study. To standardize technique and implant type, all patients received saline-filled moderate-profile implants, which were placed partially underneath the pectoralis muscle through a lower pole approach. Photographic analysis of the breast volume was completed preoperatively and, subsequently, at a minimum of six months postoperatively. Preoperatively, each breast was also assigned to one of four classes of increasing mammographic density, as judged by the mammographic radiologist (fatty, moderately dense, heterogeneously dense and extremely dense). Postoperative breast volumes were, subsequently, correlated to mammographic densities.

RESULTS:

Thirty-eight augmented breasts in 21 patients were examined. The average volume gain based on the implant size used was 92.7%. Heterogeneously dense breasts comprised 68% of the total breasts and showed an average volume gain of 100.67%, extremely dense breasts comprised 26% of the total breasts and showed an average volume gain of 97.3%, and moderately dense breasts comprised 5% of the total breasts with an average gain of 100.04%. There was no significant difference between the augmented breast volumes and the respective expected volumes (combined preaugmented breast volumes and implant volumes; P=0.3483). Additionally, no statistical difference was found between the density classes and the expected augmented volumes.

CONCLUSION:

No statistical difference was found between expected and actual augmented breast volumes among or between four different breast density classes. Thus, one would expect that the soft tissue compression or the response of the impression of the implant on the parenchyma, would not be statistically different among classes. Additionally, compressive atrophy, as seen with atrophy of the breasts over time, would be expected to be multifactorial and not uniquely independent to breast density. However, longitudinal analysis is needed to study the durability of breast shape relative to breast density.     

Aesthetic Remodeling of the Healthy Breast in Breast Reconstruction Using Expanders and Implants

Background  Breast reconstruction using expanders and implants still is the most common surgical procedure in many hospitals. The most important factor in obtaining a satisfactory aesthetic result for both the patient and the surgeon is to achieve the greatest symmetry possible between the healthy breast and the reconstructed breast. To get a good result, it is necessary to make an exhaustive preoperative examination that facilitates selection of the most suitable technique for remodeling the healthy breast and to choose the most suitable expander for placement on the side to be reconstructed. Methods  A retrospective study investigated 60 patients submitted to breast reconstruction between October 2005 and January 2008. The study analyzed the characteristics of the healthy breast (e.g., volume, ptosis), which is treated in the first part of the first operation. These characteristics are used later as a model for reconstructing the mastectomy side. The most adequate technique for remodeling the healthy breast based on its characteristics is indicated, as well as techniques not recommended for obtaining the desired symmetry. Results  This study aimed to determine the basis for selecting the most appropriate technique to use in managing the healthy breast and obtaining the most aesthetic result in breast reconstruction. The healthy breast analysis allows an algorithm of indications to be elaborated based on the volume and degree of ptosis exhibited by the healthy breast. The healthy breast should resemble the reconstructed breast with its anatomic implant. In this study, the technique used most often to remodel the healthy breast was reduction surgery with a superomedial pedicle, and glandular flap (autoimplant) (30%). The results were highly satisfactory for both the patient and the surgeon. Conclusions  Aesthetic remodeling of the healthy breast is the first surgical treatment in breast reconstruction in two stages using expanders and implants. The expander for reconstruction of the other breast then is selected according to the measurements of the healthy modified breast. This reproducible and simple model of breast reconstruction, with its detailed preoperative plan, allows clinicians to obtain a good aesthetic result for breast reconstruction patients.     

Mammographic breast density and the risk of breast cancer: A systematic review and meta-analysis

ObjectivesMammographic density is a well-defined risk factor for breast cancer and having extremely dense breast tissue is associated with a one-to six-fold increased risk of breast cancer. However, it is questioned whether this increased risk estimate is applicable to current breast density classification methods. Therefore, the aim of this study was to further investigate and clarify the association between mammographic density and breast cancer risk based on current literature.MethodsMedline, Embase and Web of Science were systematically searched for articles published since 2013, that used BI-RADS lexicon 5th edition and incorporated data on digital mammography. Crude and maximally confounder-adjusted data were pooled in odds ratios (ORs) using random-effects models. Heterogeneity regarding breast cancer risks were investigated using I² statistic, stratified and sensitivity analyses.ResultsNine observational studies were included. Having extremely dense breast tissue (BI-RADS density D) resulted in a 2.11-fold (95% CI 1.84–2.42) increased breast cancer risk compared to having scattered dense breast tissue (BI-RADS density B). Sensitivity analysis showed that when only using data that had adjusted for age and BMI, the breast cancer risk was 1.83-fold (95% CI 1.52–2.21) increased. Both results were statistically significant and homogenous.ConclusionsMammographic breast density BI-RADS D is associated with an approximately two-fold increased risk of breast cancer compared to having BI-RADS density B in general population women. This is a novel and lower risk estimate compared to previously reported and might be explained due to the use of digital mammography and BI-RADS lexicon 5th edition.     

A Prospective Longitudinal Study of Cosmetic Outcome in Immediate Latissimus Dorsi Breast Reconstruction and the Influence of Radiotherapy

Background Immediate breast reconstruction may result in superior cosmetic outcomes as a result of the preservation of the skin envelope. The impact of implant use and radiotherapy (RT) on the cosmetic outcome of latissimus dorsi (LD) breast reconstruction, however, has never been prospectively evaluated with adequate long-term follow-up. Methods Women undergoing immediate LD breast reconstruction from January 2000 to February 2007 underwent photographic assessment and clinical evaluation for breast retraction analysis (BRA) at 3, 6 and 12 months postoperatively and on the anniversary of their surgery. The resulting photographs were subject to panel cosmetic assessment. A patient-reported cosmetic outcome questionnaire and the body image scale (BIS) were administered to each woman at a single time point to coincide with the anniversary of their surgery. Multilevel linear regression modelling was used to analyse the results. Results Seventy-three women underwent 53 implant-assisted LD breast reconstructions and 20 autologous procedures with a mean follow-up of 2.71 years. The incidence of radiotherapy in this cohort was 43%. RT over time adversely influenced overall cosmetic outcome as assessed by the panel (P = 0.0002), and BRA (P = 0.033), both of which were significantly worse in the implant-assisted group (P = 0.020). Patient reporting of overall cosmetic outcome and BIS, however, did not differ significantly between the LD groups or following RT. Conclusion Radiotherapy may adversely affect the cosmetic outcome of latissimus dorsi breast reconstruction, particularly if an implant is used, but this is not universal. Patient assessment of their cosmetic outcome may, however, differ significantly from the clinician’s view. Financial support: Allergan Medical UK, United Bristol Healthcare Trust Charitable Trustees