Infections related to breast implants reported to the Food and Drug Administration, 1977-1997.

The FDA has a surveillance system for monitoring adverse events related to medical devices. Infection reports submitted to the FDA by breast implant manufacturers between 1977 and 1997 are characterized. Two cases of death caused by toxic shock syndrome after mammoplasty reported to the FDA are presented. Overall, 1,971 reports with a principal adverse event of infection were reported in this time frame. There was a large increase in the number of reports on infections related to breast implants between 1992 and 1995 due to the publicity and litigation surrounding breast implants. When an organism was identified in the report, the most common organism reported was Staphylococcus sp. Information on the time between the implantation and the onset of the infection or the explantation of the implant was not always reported. However, in reports that did contain this information, there were differences between the length of time to infection onset reported for saline breast implants (earlier) compared to silicone gel breast implants (later). More than half of the reports (56.6%) asserted only that there was an infection and that breast implants were explanted as a result; the remaining reports asserted that infection and other signs, symptoms, or diagnoses had afflicted the patient.

Mortality after aortic valve replacement: results from a nationally representative database.

BACKGROUND: Nationally representative estimates of in-hospital mortality after aortic valve replacement are needed to evaluate whether results from The Society of Thoracic Surgeons National Cardiac Surgery Database are applicable to other institutions in the United States performing these procedures. METHODS: Data from the 1994 Nationwide Inpatient Sample were used to estimate the patient characteristics and in-hospital mortality rates associated with aortic valve replacements performed in nonfederal hospitals in the United States. Procedural and hospital characteristics were examined for possible associations with in-hospital mortality. RESULTS: An estimated 46,397 aortic valve replacements were performed. In-hospital mortality occurred in 4.3% of first-time isolated aortic valve replacements and 6.4% overall. The highest quartile of procedure-specific hospital volume, compared with the lowest quartile, was associated with lower in-hospital mortality (adjusted odds ratio, 0.58; 95% confidence interval, 0.42 to 0.81). CONCLUSIONS: The in-hospital mortality rates observed in this study are very similar to those reported from The Society of Thoracic Surgeons database. These data provide substantial evidence that results from The Society of Thoracic Surgeons database are representative of those achieved at other institutions. However, procedure-specific hospital volume must be considered in applying these results to individual institutions.

Final-year-of life pacemaker recipients.

BACKGROUND: Older persons who have initial cardiac pacemakers implanted during their final year of life have not been characterized as a group, which makes it difficult to evaluate the suitability of some of their health services utilizations. OBJECTIVE: To help determine how prudently pacemakers are used in this group, we assessed its pacemaker candidates from the perspective of health and ability to perform physical activities of daily living. DESIGN: A retrospective, population-based, cross-sectional study. SETTING: The 1993 National Mortality Followback Survey. PARTICIPANTS: An estimated 1,647,955 persons aged 65 years or older who died in the US in 1993. MEASUREMENTS: Demographic and cause-of-death frequencies obtained by analyzing age, sex, race, and underlying cause-of-death variables in the survey. For persons who had initial pacemakers implanted during their last year of life, we determined the percent of persons, within 10-year age groups, who had no difficulty at any time during their final year of life performing 11 specific physical activities of daily living (e.g., climbing stairs, preparing meals, bathing). These data were obtained from negative responses to questions that asked if the decedents, at any time during their last year of life, had difficulty performing the specific activities. RESULTS: Of the estimated 78,941 persons aged 65 years or older with a pacemaker who died in the US in 1993, 14,158 (18%) had their first pacemaker implanted during their last year of life. Estimated median survival of the final-year-of-life recipients of pacemakers after pacemaker implantation was 5 months. Compared with the general older population that died in 1993, the final-year-of-life recipients of pacemakers group had higher percentages of persons who died of acute disorders (49% vs 19%) and who lived alone in a private home (47% vs 20%), and a lower percentage of persons with Alzheimer's disease (1% vs 7%). The age-stratified means of the percentages of final-year-of-life recipients of pacemakers who had no difficulty performing each physical activity of daily living were all greater than 50. CONCLUSION: Our results suggest that older persons who had initial pacemakers implanted during their final year of life and who died in 1993 were not terminally ill, inactive pacemaker candidates, in general, but relatively independent, physically functional candidates who frequently died abruptly. The physical, mental, and life expectancy factors recommended for consideration by expert guidelines for the implantation of cardiac pacemakers were generally applied to persons in this subgroup.

Blood benzene concentrations in workers exposed to oxygenated fuel in Fairbanks, Alaska.

OBJECTIVE: In November 1992 residents of Fairbanks, Alaska became concerned about the potential health effects of an oxygenated fuel program during which 15% (by volume) methyl tertiary butyl ether (MTBE) was added to gasoline. To address those concerns, we earlier completed a survey of occupational exposure to MTBE. We conducted a follow-up survey of workers' exposure to benzene from gasoline in Fairbanks. DESIGN: Cross-sectional exposure survey. METHODS: We examined blood concentrations of benzene from a convenience sample of workers taken in December 1992 during the oxygenated fuel program and from another convenience sample of workers taken in February 1993 after the program was suspended. RESULTS: In December, the median blood benzene concentration of samples taken from four mechanics after their workshift (postshift) was 1.32 micrograms/l (range, 0.84-2.61 micrograms/l), and seven nonmechanics (drivers and other garage workers) had a median postshift blood benzene concentration of 0.27 microgram/l (range, 0.09-0.45 microgram/l). In February, nine mechanics had a median postshift blood benzene concentration of 1.99 micrograms/l (range, 0.92-3.23 micrograms/l), and nine nonmechanics had a median postshift blood benzene concentration of 0.26 microgram/l (range, 0.2-0.46 microgram/l). CONCLUSION: Mechanics had higher blood benzene concentrations than did nonmechanics, but further study is needed to determine the impact of the oxygenated fuel program on exposure to benzene.

Out-of-hospital deaths due to asthma in North Carolina, 1980-1988.

Because deaths that occur outside hospitals have not been well-described, we studied out-of-hospital deaths from asthma in North Carolina from 1980 through 1988. We investigated out-of-hospital deaths from asthma using information from the North Carolina Office of the Chief Medical Examiner. We excluded deaths for which a hospital was listed as the place where the death occurred. For the nine years studied, the Office of the Chief Medical Examiner recorded 89 of 158 investigated deaths from asthma as having occurred out of hospital. Of the 89 deaths, 73% occurred in the decedent's home. The rates of out-of-hospital deaths from asthma increased as the age of the decedents increased, were higher in rural countries than they were in urban counties, and were over three times higher for blacks and American Indians than they were for whites. Racial minorities may warrant special attention in any attempt to prevent out-of-hospital deaths due to asthma.

Methyl tertiary butyl ether in human blood after exposure to oxygenated fuel in Fairbanks, Alaska.

Residents of Fairbanks, Alaska reported health complaints when 15%, by volume, methyl tertiary butyl ether (MTBE) was added to gasoline during an oxygenated fuel program. We conducted an exposure survey to investigate the effect of the program on human exposure to MTBE. We studied 18 workers in December 1992 during the program and 28 workers in February 1993 after the program was suspended. All workers were heavily exposed to motor vehicle exhaust or gasoline fumes. In December, the median post-shift blood concentration of MTBE in the workers was 1.8 micrograms/l (range, 0.2-37.0 micrograms/l), and in February the median post-shift blood concentration of MTBE in the 28 workers was 0.24 micrograms/l (range, 0.05-1.44 micrograms/l; p = .0001). Blood MTBE levels were measurably higher during the oxygenated fuel program in Fairbanks than after the program was suspended.

Surveillance for dust storms and respiratory diseases in Washington State, 1991.

Southeast Washington State, which has a long history of seasonal dust storms, experienced 2 d of dust storms in October 1991, during which PM10 levels exceeded 1,000 micrograms/m3 (i.e., six times greater than the Environmental Protection Agency's 24-h PM10 standard). Three community hospitals in southeast Washington were visited for the purpose of assessing the possible effects of dust storms on respiratory health. During these visits, the number of emergency room visits for respiratory disorders for each day of 1991 were abstracted. These numbers were compared with daily PM10 levels for 1991. Also determined were the observed/expected ratios for the number of emergency room visits for each respiratory disorder category during October 1991. The maximum observed/expected ratio for the respiratory disorders was 1.2. For 1991, we found a 3.5% increase in the number of daily emergency room visits for bronchitis for each 100 micrograms/m3 increase in PM10. In addition, 2 d subsequent to those days on which the PM10 levels exceeded 150 micrograms/m3, there was a 4.5% increase in the number of emergency room visits for sinusitis for each 100 micrograms/m3 increase in PM10. Our results indicate that the naturally occurring PM10 in this setting has a small effect on the respiratory health of the population in general.