Reply to: Mortality Rate in Breast Implant Surgery: Is an Additional Procedure Worthwhile to Mitigate BIA-ALCL Risk?

A retrospective cohort study was performed in Sweden to evaluate the possibility that an individual symptom or constellation of illness symptoms related to silicone occurs in women after breast implant surgery. A random sample (n = 2500) of all women in the Swedish national implant registry who underwent breast augmentation surgery with alloplastic breast implants during the years 1965 through 1993 was compared with a sample (n = 3500) of women who underwent breast reduction surgery during the same period, frequency matched to the implant patients for age and calendar year at the time of surgery. In total, 65 percent of the breast implant patients (n = 1546) and 72 percent of the breast reduction patients (n = 2496) completed a self-administered questionnaire covering 28 rheumatologic and other symptoms and lifestyle and demographic factors. Practically all of the 28 symptoms inquired about were reported more often by women in the breast implant cohort, with 16 (57 percent) significantly more common in breast implant recipients. In contrast, few significant differences or consistent patterns were observed in the length of time since the implant and in the type (silicone or saline) or volume of the implant. Although women with breast implants report a multitude of symptoms more often than women who have breast reduction surgery, the lack of specificity and absence of dose-response relationships suggest that the excess of reported symptoms is not causally related to cosmetic implants.

Concerns about the safety of silicone breast implants have grown since 1988, when the Food and Drug Administration (FDA) designated silicone gel-filled breast implants as devices posing a risk to public safety. Potential risks include the development of connective tissue diseaselike syndromes and rheumatic disease, as suggested by numerous case reports. This study describes the frequencies of physician diagnoses and symptoms of the rheumatic diseases, systemic sclerosis (scleroderma), systemic lupus erythematosus, and rheumatoid arthritis, in 1167 women who have had breast implant surgery and who have reported local implant or systemic problems to the FDA. The investigators used a telephone survey of 820 respondents who were from all of the contiguous United States except Vermont. Among the 820 women, 232 (28%) reported a diagnosis of one of these three diseases after breast implant surgery. Many more met epidemiologic criteria for scleroderma, systemic lupus erythematosus, and rheumatoid arthritis after breast implant surgery. Statistically significant associations (p < 0.05) were breast implant type with scleroderma, breast implant manufacturer with systemic lupus erythematosus, geographic area with rheumatoid arthritis, and breast implant leakage or rupture and reason for implant surgery with each of the three rheumatic diseases. Analysis using a subgroup of women who had implant surgery at least 10 years before the interview and reported a physician diagnosis of or met epidemiologic criteria for at least one of the diseases revealed a higher percentage for scleroderma in the first year after implant surgery and for systemic lupus erythematosus in years 8 through 10. These findings warrant further study.

Breast implant surgery is a popular, globally performed, and frequently requested cosmetic and reconstructive surgical procedure. Breast implant surgery can cause implant-associated systemic symptoms and types of implant-associated cancers, so it is vital to monitor patient outcomes. Most patients who undergo breast implant surgery do not experience health problems. However, patients who do experience health problems as a result of breast implant surgery form a unique patient population. When plastic and aesthetic surgeons, nurses, and other healthcare providers are knowledgeable and experienced in recognizing and treating patients with health problems related to breast implant surgery, the health outcomes of this patient population improve. This article aims to promote informed decision-making and increase patient safety by providing information about the health problems associated with breast implant surgery. This article also highlights recent safety announcements and updates from the United States Food and Drug Administration (FDA). Ensuring the safety of patients undergoing breast implant surgery is a responsibility shared by plastic and aesthetic surgeons, nurses, and other healthcare providers; the general medical community; breast implant manufacturers; and the FDA. These entities must collaborate and coordinate as a united group to accomplish this important goal. The nursing profession can contribute to these collaborative efforts by serving as professional liaisons to these entities and advocating for continued collaborative efforts to increase the safety of patients who have undergone breast implant surgery.

Continuing Medical Education Examination—Breast Surgery: Secondary Surgery and Silicone Implants: One Center’s Experience Before and After the Food and Drug Administration Hearings of 1991 and 1992

Breast implant surgery is a popular plastic surgery procedure performed worldwide. Despite its global popularity, patients undergoing breast implant surgery are at risk for systemic illness and more than one form of cancer. We conducted a nursing workflow analysis at our facility and determined that it is not standard practice to screen patients for the presence or absence of breast implant devices at every health care encounter. This lack of screening for breast implant devices may adversely affect patient safety by hindering the rapid identification of systemic illness or cancer related to breast implant devices and delaying effective medical intervention. Based on the results of the workflow analysis, we initiated a formal call for nursing action. We identified a nursing workflow process to increase patient safety and developed a universal screening tool for implantable devices. We defined universal screening for implantable devices as assessing all patients for the presence or absence of an implantable device, specifically breast implant devices, at every health care encounter. Implementing a universal process for screening patients for implantable devices at every health care encounter can be easily formulated into a policy and procedure and/or an electronic health record (EHR) update or enhancement. This article discusses how we utilized a workflow process map to translate universal screening for implantable devices into an EHR enhancement.

The original Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity and the more recent Portsmouth predictor equation for mortality scoring systems were developed to provide risk-adjusted mortality rates in general surgery. The aim of this study was to compare crude and risk-adjusted operative mortality rates among four surgeons using the above scoring systems and assess their applicability for patients scored retrospectively. A total of 505 consecutive patients undergoing major gastrointestinal surgery were analyzed; 65 percent underwent colorectal, 27.5 percent underwent upper gastrointestinal, and 7.5 percent underwent small-bowel surgery. The observed:predicted mortality ratios using the Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity and Portsmouth predictor equation for mortality scoring systems were calculated for each surgeon. The actual overall operative mortality rate was 11.1 percent (elective was 3.9 percent, and emergency was 25.1 percent). The Portsmouth predictor equation for mortality equation predicted a mortality rate of 11.3 percent (P = 0.51). However, the Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity scoring system was found to overpredict death by a factor of two: 21.5 percent (P < 0.001). Mortality rates among the four surgeons varied from 7.6 to 14.7 percent but depended on the proportion of elective vs. emergency surgery. The observed:predicted ratio for Portsmouth predictor equation for mortality was close to unity (0.905-1.067) for all surgeons, but it was 0.45 to 0.56 for Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity. The Portsmouth predictor equation for mortality equation seems to be a more accurate predictor of mortality in gastrointestinal surgery. It would seem to provide the best choice for analyzing operative mortality rates for individual surgeons, taking into account variation in case mix and fitness of patients even when scored retrospectively. This has important implications for the future assessment of surgeons' clinical standards and the assessment of quality of surgical care.

Previous reports showed that in California during the early 1990s, operative mortality rates for esophageal, pancreatic, and hepatic cancers were inversely related to hospital volume. It is unknown whether this information has affected referral patterns or operative mortality rates. Data were analyzed for the 10 years that followed the period covered in the initial studies to determine if: (a) the operative mortality rates had decreased; and (b) a greater proportion of patients with esophageal, pancreatic, and hepatic cancers were treated at high-volume centers. Hospital discharge data were obtained for 8901 patients who had resections for cancer of the esophagus, 2404 patients; pancreas, 5294 patients; and liver, 1203 patients in California between 1995 and 2004. Logistic regression models were used to calculate adjusted mortality rates at high- and low-volume centers by year. The data were compared with the published results for California during the years 1990-1994. Operative mortality rates decreased for esophageal, pancreatic, and hepatic resections during the more recent 10 years. Concomitantly, the proportion of patients treated at high-volume centers increased, as did the number of high-volume centers. There was a substantial increase in the proportion of esophagectomies performed in high-volume hospitals, while the overall number of esophagectomies dropped by 22%. For the other 2 operations, total volume and the volume in high-volume hospitals increased greatly, and the volume in low-volume hospitals was about the same during the 3 periods. The mortality rates decreased at all levels of the volume range. Finally, the performance from one period to the next in individual hospitals was mostly similar, but an occasional outlier was also noted. More resections for esophageal, pancreatic, and hepatic cancer were performed at high volume centers, but mortality rates decreased for all hospital categories. The data suggest that modern hospitals act as complex adaptive systems, whose outputs are determined from the interactions between internal agents and are resistant to analysis by isolating and studying the individual contributions. It is tempting to attribute the desirable changes in these data (eg, more operations being done in high volume centers and better mortality rates at all levels) as consequences of pressures over the past few decades on hospitals to assume greater responsibility for their quality of care and to become more integrated internally.Thus, many factors appear to influence the volume-outcome relationships, and the identity and individual contributions of these influences may be immune to reductionist analysis. There is substantial evidence that high volume should be part of high quality for these complex operations. Nevertheless, measuring outcomes directly, rather than concentrating on their correlates, may be a more reliable index of hospital performance.

Is what's good for the gander good for the goose?

Banff, Alberta, Canada From Banff Plastic Surgery. Received for publication March 8, 2020; accepted May 01, 2020. Disclosure:The author has no conflicts of interest to disclose with respect to this Discussion. Elizabeth J. Hall-Findlay, M.D., Banff Plastic Surgery, 106-75 Dyrgas Gate, Canmore, Alberta T1W 0A6, Canada, [email protected]

Operative mortality is the most important index for assessing operative results, which has rarely been examined in reconstructive surgery. The aims of this study were to establish a representative index of operative mortality after head and neck reconstruction and to consider measures to improve operative results. We reviewed cases of head and neck reconstruction by means of free tissue transfer performed from July 1992 through December 2005 at the National Cancer Center Hospital East, Chiba, Japan. The subjects were 1249 patients with a mean age of 62 years. Operative mortality was evaluated on the basis of the 30-day post-operative mortality rate and the in-hospital mortality rate. Statistical analysis was performed with the Cochran-Armitage test. The 30-day post-operative mortality rate was 0.88% (11 of 1249 patients), and the in-hospital mortality rate was 1.84% (23 of 1249 patients). The 30-day post-operative mortality was significantly correlated with age (P = 0.002), but the in-hospital mortality was not (P = 0.148). Among patients older than 80 years, the 30-day post-operative mortality rate was 8.57%. The most common cause of 30-day post-operative death was cerebral infarction. Of the 23 in-hospital deaths, 13 were due to cancer recurrence. These results indicate that head and neck reconstruction with free flaps is reliable. However, the high 30-day post-operative mortality rate among patients 80 years or older should be considered when deciding whether to operate. To decrease the operative mortality rate, careful perioperative management is needed to prevent complications and shorten the hospital stay.

BACKGROUND: The aim was to determine the true incidence and operative mortality rate of patients with ruptured abdominal aortic aneurysm (AAA) who reach hospital alive in Wales. METHODS: Patients presenting with a ruptured AAA between September 1996 and August 1997 were analysed. The data were collected prospectively by an independent body, observing strict confidentiality. RESULTS: Two hundred and thirty-three patients with confirmed ruptured AAA were identified. One hundred and thirty-three patients (57 per cent) underwent attempted operative repair. Eighty-five (64 per cent) died within 30 days. All 100 patients who received no operation died. Of the 233 patients, 92 were admitted under vascular surgeons (VSs) and 141 under non-vascular surgeons (NVSs). VSs operated on 82 patients (89 per cent) of whom 50 (61 per cent) died; NVSs operated on 51 (36 per cent) of whom 35 (69 per cent) died. CONCLUSION: This study is the only independent prospective study of death among patients with ruptured AAA who reached hospital alive. Some 57 per cent of the patients with a ruptured AAA were operated on. The operative mortality rate was 64 per cent and the overall mortality rate was 79 per cent. VSs were significantly more aggressive (89 per cent) in the management of ruptured AAA (i.e. more likely to operate) than NVSs (36 per cent) (P < 0.0001). Despite this, the operative mortality rate for VSs was 61 per cent, whereas for NVSs it was 69 per cent (P = 0.372). The overall mortality rate (including operated and non-operated patients) for NVSs (89 per cent) was significantly higher than that for VSs (65 per cent) (P < 0.0001). In Conclusion:, ruptured AAA is common in Wales and associated with a high mortality rate even when managed by VSs.

Objective: In recent years much attention has been focused on the rapidly increasing incidence of primary lung cancer in women. The aim of this study was to determine gender differences in patients treated surgically for lung cancer. Methods: We performed a retrospective review of patients who had lung resection for primary lung cancer from January 1994 to December 1998. Results: There were 530 men and 42 women. Women were younger than men (55.6 ± 10 versus 57 ± 9.9). The difference was not statistically significant (p = 0.9). The mean cigarette consumption was greater in men than in women (p < 0.001). We observed a higher operative morbidity and mortality rate in men compared to women (p < 0.05). Men had more squamous cell carcinoma (61.7%). In female patients, squamous cell cancer and adenocarcinoma were found with almost the same incidence (35.7% versus 33.3%). There was a significant difference in the distribution of cell types (p < 0.001). Pathologic stages for women were; I = 38.2%, II = 21.4%, IIIa = 21.4%, IIIb = 9.5%, IV = 9.5% and for men; I = 40.4%, II = 26.6%, IIIa = 24%, IIIb = 6%, IV = 3%. There was no significant difference in the stage distribution between genders (p = 0.2). Median survival for female and male patients were 38 ± 9.2 and 35 ± 3.2 months. Female patients’ survival was longer than male patients but the difference was not statistically significant (p > 0.05). Conclusions: This study emphasizes sex differences in cigarette consumption, operative mortality and the distribution of cell types of patients with primary lung cancer. These initial results should strongly encourage additional studies in different countries on the interaction between sex and lung cancer characteristics to improve clarity.

To provide reliable risk-adjusted morbidity and mortality rates after major surgery to the 123 Veterans Affairs Medical Centers (VAMCs) performing major surgery, and to use risk-adjusted outcomes in the monitoring and improvement of the quality of surgical care to all veterans. Outcome-based comparative measures of the quality of surgical care among surgical services and surgical subspecialties have been elusive. This study included prospective assessment of presurgical risk factors, process of care during surgery, and outcomes 30 days after surgery on veterans undergoing major surgery in 123 medical centers; development of multivariable risk-adjustment models; identification of high and low outlier facilities by observed-to-expected outcome ratios; and generation of annual reports of comparative outcomes to all surgical services in the Veterans Health Administration (VHA). The National VA Surgical Quality Improvement Program (NSQIP) data base includes 417,944 major surgical procedures performed between October 1, 1991, and September 30, 1997. In FY97, 11 VAMCs were low outliers for risk-adjusted observed-to-expected mortality ratios; 13 VAMCs were high outliers for risk-adjusted observed-to-expected mortality ratios. Identification of high and low outliers by unadjusted mortality rates would have ascribed an outlier status incorrectly to 25 of 39 hospitals, an error rate of 64%. Since 1994, the 30-day mortality and morbidity rates for major surgery have fallen 9% and 30%, respectively. Reliable, valid information on patient presurgical risk factors, process of care during surgery, and 30-day morbidity and mortality rates is available for all major surgical procedures in the 123 VAMCs performing surgery in the VHA. With this information, the VHA has established the first prospective outcome-based program for comparative assessment and enhancement of the quality of surgical care among multiple institutions for several surgical subspecialties. Key features to the success of the NSQIP are the support of the surgeons who practice in the VHA, consistent clinical definitions and data collection by dedicated nurses, a uniform nationwide informatics system, and the support of VHA administration and managerial staff.

Introduction: Pancreaticoduodenectomy is the procedure of choice for periampullary neoplasms. It is considered as a major surgical procedure. It is associated with relatively higher postoperative mortality and morbidity rate, however, with development of technology, proper patient selection, meticulous operative technique, appropriate postoperative care, morbidity and mortality rate has decreased subsequently. Up to the 1970s, the operative mortality rate after pancreaticoduodenectomy approached 20% but it has been reduced to less than 5% in recent reports. This study is designed to evaluate the postoperative outcomes of pylorus-preserving pancreaticoduodenectomy procedure in our set up.&#x0D; Objective: To evaluate the outcome of the pylorus-preserving pancreaticoduodenectomy procedure with the intention to measure operation time and per-operative bleeding, observing postoperative anastomotic leakage and gastric emptying time. To find out postoperative wound infection and complications to detect the dumping syndrome.&#x0D; Materials and Methods: A prospective observational study was carried out in the Department of Hepatobiliary Surgery, Combined Military Hospital, Dhaka from July 2013 to January 2017. Fifty patients who underwent pylorus-preserving pancreaticodudenectomy procedure were included in this study.&#x0D; Results: Out of 50 postoperative patients, 12(24%) patients developed complications. Of these patients, 3(6%) developed wound infection, 2(4%) developed bile leakage and 2(4%) developed postoperative haemorrhage. Pancreatic fistula, vomiting, delayed gastric emptying and abdominal collection all were 1(2%) each. Postoperative mortality was 3(6%).&#x0D; Conclusion: The present study demonstrated the development of postoperative complications after pylorus-preserving pancreaticoduodenectomy is as similar as published in different studies. Better outcome can be achieved with meticulous pre-operative evaluation of risk factors and per-operative skill maneuvering.&#x0D; Journal of Armed Forces Medical College Bangladesh Vol.13(1) 2017: 42-45

Vascular rings and other congenital aortic arch anomalies may be major causes of tracheoesophageal obstruction in children. In this report, our diagnostic approach, surgical treatment, and early and late results for 30 patients are reported. During a 20-year period (1982-2002), 30 children underwent surgery for tracheoesophageal compression caused by aortic arch anomalies. The median age at operation was 8 months (range, 36 days to 94 months), and the median patient weight was 8 kg (range, 2.4-16 kg). At 53.3% of cases, double aortic arch was by far the most common encountered cause of compression. Patients were admitted with respiratory distress, stridor, apnea, dysphagia, or recurrent respiratory tract infections. Diagnosis was established by barium esophagogram, computed tomography, magnetic resonance imaging, and angiography. The operative approaches were through a left thoracotomy or a median sternotomy. Operative mortality rate was 3.3%. Follow-up data from 2 months to 10 years (mean follow-up, 34 weeks) were available for all 30 patients. Twenty-six patients (86.7%) were essentially free of symptoms, 3 patients (10%) had residual respiratory problems, and 1 patient (3.3 %) had a gastroesophageal reflux problem. These results suggest that surgical correction of symptomatic vascular rings can be performed with low mortality and morbidity rates.