Silicone breast implants.
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Breast Implants↗
Biomedical subjects
Jon P Fryzek
Publications and source records attributed to Jon P Fryzek.
Incidence of silicone breast implant rupture.
HYPOTHESIS: The incidence of silicone breast implant rupture varies with implantation time and type of implant. OBJECTIVE: To measure the incidence of implant rupture by repeated magnetic resonance imaging (MRI) among women with silicone breast implants. DESIGN, SETTING, AND PARTICIPANTS: In 1999, 271 women who had received breast implants at least 3 years before, and who were randomly chosen from a larger cohort of women with cosmetic breast implants, underwent a baseline MRI. A second MRI was performed in 2001; 317 silicone implants (in 186 women) that were intact at the baseline MRI (n = 280) or were intact at baseline but removed before the second MRI (n = 37) were included in the rupture incidence analyses. MAIN OUTCOME MEASURES: Implants were diagnosed with definite or possible rupture. Crude and implant age-adjusted incidence rates were calculated, and implant survival was estimated based on the observed rupture rates. RESULTS: We found 33 definite ruptures (10%) and 23 possible ruptures (7%) during the 2-year period. The overall rupture incidence rate for definite ruptures was 5.3 ruptures/100 implants per year (95% confidence interval, 4.0-7.0). The rupture rate increased significantly with increasing implant age. Double-lumen implants were associated with substantially lower rupture risk than single-lumen implants. For modern implants intact 3 years after implantation, we estimated rupture-free survival of 98% at 5 years and 83% to 85% at 10 years. CONCLUSIONS: The risk of implant rupture increases with implant age. A minimum of 15% of modern implants can be expected to rupture between the third and tenth year after implantation.
Adult↗
Socio-economic status and chronic renal failure: a population-based case-control study in Sweden.
BACKGROUND: Low socio-economic status is associated with the occurrence of several different chronic diseases, but evidence regarding renal disease is scant. To explore whether the risk of chronic renal failure varies by socio-economic status, we performed a population-based case-control study in Sweden. METHODS: All native residents from May 1996 to May 1998, aged 18-74 years, formed the source population. Cases (n = 926) were incident patients with chronic renal failure in a pre-uraemic stage. Control subjects (n = 998) were randomly selected within the source population. Exposures were assessed at personal interviews and relative risks were estimated by odds ratios (OR) in logistic regression models, with adjustment for age, sex, body mass index (BMI), smoking, alcohol consumption and regular analgesics use. RESULTS: In families with unskilled workers only, the risk of chronic renal failure was increased by 110% [OR = 2.1; 95% confidence interval (CI), 1.1-4.0] and 60% (OR = 1.6; 95% CI, 1.0-2.6) among women and men, respectively, relative to subjects living in families in which at least one member was a professional. Subjects with 9 years or less of schooling had a 30% (OR = 1.3; 95% CI, 1.0-1.7) higher risk compared with those with a university education. The excess risk was of similar magnitude regardless of underlying renal disease. CONCLUSIONS: Low socio-economic status is associated with an increased risk of chronic renal failure. The moderate excess was not explained by age, sex, BMI, smoking, alcohol or analgesic intake. Thus, socio-economic status appears to be an independent risk indicator for chronic renal failure in Sweden.
Adolescent↗
Characteristics of women with cosmetic breast implants compared with women with other types of cosmetic surgery and population-based controls in Denmark.
Herein the authors describe characteristics of women with breast implants compared with women with other types of cosmetic surgery as well as population controls. All women who acquired breast implants from 1977 to 1997 were identified from the files of two private plastic surgery clinics in Denmark. Patient characteristics were obtained through a self-administered questionnaire. The magnitude of differences between patient and control groups was estimated using odds ratios and 95% confidence intervals. Women with breast implants had a significantly lower body mass index and reported a two-fold greater incidence of current smoking compared with women from the general population and compared with women with other cosmetic surgery. Women with implants reported a greater number of full-term pregnancies and were less likely than controls to have had their first birth at age 30 years or older. Women with implants were not more likely than women in either control group to report a history of diseases, including connective tissue diseases, cancer, or depression before their implant surgery. Women with cosmetic breast implants differ from women with other forms of cosmetic surgery and from general population controls with respect to characteristics that may importantly influence health outcomes and that need to be addressed in future breast implant studies.
Adult↗
A cohort mortality study among titanium dioxide manufacturing workers in the United States.
Although titanium dioxide (TiO2) is generally regarded as a nontoxic mild pulmonary irritant, some laboratory studies have reported lung adenomas in rats exposed to high levels of TiO2. Limited data on health effects among humans exist. A retrospective cohort mortality study was conducted among 4241 TiO2 workers who were employed for at least 6 months, on or after January 1, 1960, at four TiO2 plants in the United States. Exposure categories, defined by plant, job title, and calendar years in the job, were created to examine mortality patterns in those jobs where the potential for TiO2 exposure is greatest. Standardized mortality ratios (SMRs) and their 95% confidence intervals (CI) were calculated to compare the mortality pattern of the workers with the general background population. Relative risks were estimated and trend tests were conducted to examine risk of disease among different exposure level groups in internal analyses. Workers experienced a significantly low overall mortality (SMR = 0.8; 95% CI = 0.8-0.9). No significantly increased SMRs were found for any specific cause of death. Deaths from lung cancer were as expected, and SMRs for this cancer did not increase with increasing TiO2 levels. Workers in jobs with greatest TiO2 exposure had significantly fewer than expected total deaths (SMR = 0.7; 95% CI = 0.6-0.9). Internal analyses revealed no significant trends or exposure-risk associations for total cancers, lung cancer, or other causes of death. Results from our study indicate that the exposures at these United States plants are not associated with increases in the risk of death from cancer or other diseases. Moreover, workers with likely higher levels of TiO2 exposure had similar mortality patterns to those with less exposure, as internal analyses among workers revealed no increase in mortality by level of TiO2 exposure.
Adult↗
Self-reported diseases and symptoms by rupture status among unselected Danish women with cosmetic silicone breast implants.
Epidemiologic evidence does not support an association between silicone breast implants and connective tissue or other rheumatic diseases. However, a recent study has suggested that women with ruptured implants may be at increased risk of developing fibromyalgia. An analysis of adverse health outcomes according to breast implant rupture status was conducted in 238 unselected Danish women with cosmetic silicone breast implants. Ninety-two of the women had definite implant rupture, and 146 had intact implants as determined by magnetic resonance imaging. Before undergoing imaging, the women provided blood samples and completed a self-administered questionnaire. Women with ruptured implants overall, and the subgroup with extracapsular ruptures (n = 23), were compared with women with intact implants regarding a number of self-reported diseases and symptoms and the presence of specific autoantibodies, such as antinuclear antibodies, rheumatoid factor, and cardiolipin immunoglobulin G and M antibodies. Overall, there were no differences in the occurrence of self-reported diseases or symptoms or in the presence of autoantibodies between women with intact implants and women with ruptured implants, including extracapsular rupture. The only exception was capsular contracture, which was reported six times more frequently by women with extracapsular ruptures than by women with intact implants (OR, 6.3; 95 percent CI, 1.7 to 23.5). In conclusion, this study of unselected women with silicone breast implants could establish no association between silicone implant rupture and specific diseases or symptoms related to connective tissue disease or other rheumatic conditions, except for an excess of capsular contracture among women with extracapsular rupture.
Adult↗
The Danish Registry for Plastic Surgery of the Breast: establishment of a nationwide registry for prospective follow-up, quality assessment, and investigation of breast surgery.
Although numerous epidemiologic studies have examined the long-term safety of silicone breast implants during the past decade, there is a relative lack of surveillance data on short-term health effects and complications following cosmetic surgery of the breast. The Danish Registry for Plastic Surgery of the Breast, established in May of 1999, provides plastic surgeons with a nationwide system for the collection of preoperative, perioperative, and postoperative data on women undergoing breast implantation, breast reduction, or mastopexy. The purpose of the Registry is to examine short-term and, eventually, long-term local complications and possible health effects, and to contribute to an ongoing evaluation of surgical results and surveillance of the products. Furthermore, the Registry will allow the identification of new areas for research into cosmetic and reconstructive breast surgery. Women accepting registration in the Danish Registry for Plastic Surgery of the Breast complete a self-administered questionnaire focusing on medical history and demographic and behavioral factors. Preoperative blood samples are drawn for storage. Surgical data, postoperative results, and complications are registered following surgery and at postoperative visits. Currently, registration has been initiated at 24 private and public clinics, representing more than 80 percent of the plastic surgery clinics in Denmark. As of November of 2001, a total of 1472 women with breast implants and 560 women with breast reduction were included in the Registry. These figures are expected to increase annually by 1000 women undergoing breast implantation and 500 women undergoing breast reduction or mastopexy. The authors present their experience of establishing the first nationwide comprehensive clinical-epidemiologic database and biological bank for cosmetic and reconstructive surgery procedures.
Breast Implants↗
Incidence and severity of short-term complications after breast augmentation: results from a nationwide breast implant registry.
The frequency and severity of local complications remain the primary safety issues with silicone breast implants. The Danish Registry for Plastic Surgery of the Breast (DPB), established in 1999, prospectively collects pre-, peri- and postoperative information regarding Danish women undergoing breast augmentation. Through DPB, we conducted a prospective follow-up study of short-term local complications among 1090 women who underwent cosmetic breast implantation from June 1999 through October 2002. Nineteen percent of women who underwent initial implantation developed at least 1 adverse effect. Forty percent of the adverse effects occurred within 3 months of implantation; 79%, within 6 months. Capsular contracture grade II-IV was observed among 4.1% of women in the 2-year follow-up period. Overall, 97 (29%) of the 344 adverse effects among 55 (6%) of the 971 women required surgical intervention. A higher incidence of adverse effects typically occurred after subsequent implantations. According to the DPB experience, we conclude that most short-term postoperative adverse effects following cosmetic implantation are clinically insignificant and do not require treatment and that short-term complications requiring adjuvant treatment are rare.
Adolescent↗
Incidence of cancer among patients with knee implants in Sweden, 1980-1994.
BACKGROUND: As knee implants become more common, it is important to study their potential health risks. We investigated cancer occurrence in a nationwide population-based cohort of 30,011 patients who underwent knee replacement surgery in Sweden from 1980 to 1994. METHODS: Patients were followed from 1 year after the date of their surgery through December 31, 1995, accruing 122,616 person-years of observation. The average follow-up time was 4.3 years, with 2365 patients followed for 10 years or more. RESULTS: Overall cancer incidence was not elevated compared with the general population of Sweden (standardized incidence ratio [SIR] = 1.03; 95% confidence interval [CI] = 0.98-1.08). A reduced rate for all respiratory cancers (SIR = 0.73; 95% CI = 0.59-0.91) and for lung cancer (SIR = 0.73; 95% CI = 0.58-0.91) was found among both men and women. Elevated rates were found for prostate (SIR = 1.20; 95% CI = 1.06-1.34) and bone cancer (SIR = 6.00; 95% CI = 1.24-17.52) in men. The bone cancer excess was based on three observed cases, two of which occurred at a site unrelated to the implant and the site of the third tumor is unknown. Rates of connective tissue cancer and leukemia-lymphoma were not elevated significantly among knee implant recipients. Long-term follow-up (>or= 10 years) did not show a significant excess risk for all cancer (SIR = 1.10; 95% CI = 0.86-1.38) or for any site-specific cancer, including bone cancer, lymphoma, or leukemia. Subgroup analyses for patients with rheumatoid arthritis produced results similar to the overall results. CONCLUSIONS: This epidemiologic study of cancer risk among patients with knee implants is the largest to date. It provides evidence that the incidence of cancer among patients with knee implants is similar to that of the general population. Continued follow-up of this cohort is warranted to evaluate further potential long-term effects of these implants.
Aged↗
The reliability of dietary data for self- and next-of-kin respondents.
BACKGROUND: In case-control studies, recalled dietary data from next-of-kin are sometimes used as a surrogate measure of exposure; however, there is limited evidence comparing the ability of study participants and next-of-kin surrogates for the reliability of their responses with respect to past dietary recall. METHODS: We compared dietary information from 303 subjects who were administered a food frequency questionnaire in 1980 with that from 196 of the same subjects and 107 next-of-kin of deceased subjects 5 years later, but with reference to 1980 diet. Agreement between 1980 and 1985 reporting with respect to food groups, food preparation methods, and adherence to special diets was primarily assessed using the kappa statistic. RESULTS: The concordance between 1980 and 1985 reporting of specific food groups was generally poor. Regarding various methods of cooking meats and the use of different types of cooking fats, next-of-kin respondents showed very poor agreement with the reporting of their deceased relatives, and within-subject agreement was also poor for frying meats, baking meats, and for cooking with margarine and vegetable oil. Subjects and next-of-kin were able to reproduce earlier reporting of a special ulcer diet, but not diabetic or low-salt diets. Overall, subjects tended to have better agreement with their own earlier reporting than did next-of-kin, and spouses were found to be more reliable next-of-kin respondents than other relatives. CONCLUSIONS: Dietary data collected retrospectively from next-of-kin may be unreliable.
Adult↗
A nationwide followup study of autoimmune and connective tissue disease among hip and knee implant patients.
Because implants can provoke varied immune system responses, we assessed whether hip and knee implant recipients had an increased risk of autoimmune/connective tissue diseases (AI/CTDs). Using national registry data from Sweden, we compared hospitalization rates for AI/CTD in 101,771 hip and 23,891 knee implant recipients to rates in the general population. Hip patients were followed up to 22 years and knee patients up to 14 years postimplantation. Our findings indicate that it is unlikely that hip or knee implantation results in any increased risk for most AI/CTDs. After long-term followup, the associations we observed with polyarteritis nodosa and fibrositis could be the basis for future investigations.
Aged↗