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Søren Friis

Publications and source records attributed to Søren Friis.

At least 37 records · Page 2Linked to original sources
PubMed2004

Long-term health status of Danish women with silicone breast implants.

Long-term safety data are important in the evaluation of possible adverse health outcomes related to silicone breast implants. The authors evaluated long-term symptoms and conditions and medication use among 190 Danish women with cosmetic silicone breast implants compared with 186 women who had undergone breast reduction surgery and with 149 women from the general population. Breast implant and reduction surgeries were performed from 1973 to 1988 at one public hospital and one private plastic surgery clinic. Among women with breast implants, the average implantation time was 19 years, 60 percent (n = 114) had only one implantation, and 10 percent (n = 19) had undergone explantation before the time of study (1997 to 1998). The authors found no material differences in self-reported diseases or symptoms among study groups, except for breast pain, which was reported nearly three times as often by women with implants than by women with breast reduction (odds ratio, 2.8; 95 percent confidence interval, 1.4 to 5.3). Approximately 80 percent of women in each study group reported at least one symptom. No consistent differences were observed in the seroprevalences of antinuclear antibodies or other autoantibodies. Self-reported use of psychotropic drugs was higher among women with breast implants than among either control group. The authors conclude that long-term cosmetic breast implantation may cause capsular contracture and breast pain but does not appear to be associated with other symptoms, diseases, or autoimmune reactivity. The authors' finding of excess use of drugs for treatment of depression and anxiety among women with breast implants may warrant further investigation.

Adolescent↗
PubMed2004

Self-reported musculoskeletal symptoms among Danish women with cosmetic breast implants.

BACKGROUND: No epidemiological evidence of an association between silicone breast implants and connective tissue disease has been found. Based on case reports, it has been hypothesized that silicone breast implants may be associated with a unique rheumatic symptom cluster termed "atypical connective tissue disease." MATERIAL AND METHODS: We have evaluated self-reported rheumatic symptoms among women who received breast implants between 1977 and 1997 at 2 private plastic surgery clinics in Denmark. Women with other cosmetic surgery, including breast reduction, as well as women from the general population, were identified as controls. RESULTS: No statistically significant differences in mild (odds ratio [OR] = 0.9; 95% confidence interval [CI] = 0.6-1.3), moderate (OR = 0.7; 95% CI = 0.4-1.2), or severe (OR = 1.1; 95% CI = 0.6-2.1) musculoskeletal symptoms were observed when women with breast implants were compared with women with other cosmetic surgery. Compared with women from the general population, women with breast implants were statistically significantly less likely to have mild or moderate musculoskeletal symptoms (OR = 0.5; 95% CI = 0.3-0.7 and OR = 0.3; 95% CI = 0.2-0.5, respectively); for severe symptoms the deficit was not statistically significant (OR = 0.7; 95% CI = 0.3-1.3). For individual symptom groups, there was no consistent pattern of reporting among women with implants. CONCLUSION: We did not find an excess of rheumatic symptoms or symptom clusters among women with breast implants. In fact, the occurrence of mild, moderate, and severe musculoskeletal symptoms was generally lower among women with implants compared with women with other cosmetic surgery and women in the general population.

Adult↗
PubMed2004

Antipolymer antibodies in Danish women with silicone breast implants.

OBJECTIVE: To use a new immunologic assay to evaluate antipolymer antibody (APA) levels among women with silicone breast implants (SBIs). METHODS: Women (n = 186) were identified through Danish population-based registers and categorized into six groups defined by prior breast surgery (silicone breast implantation/breast reduction/no breast surgery) and by the presence or absence of a prior hospital diagnosis of soft-tissue rheumatism (muscular rheumatism, ICD-8 codes 717.90 and 717.99). The women underwent blood tests, including an APA test, a clinical examination, and an interview focusing on rheumatic complaints. Blood samples were tested blindly. The severity of rheumatic symptoms/signs was scored from 1 (none) to 5 (severe) based on the clinical examination and interview. RESULTS: Women with SBIs did not have higher levels of APA than women without SBIs. The majority of women with SBIs had mild rheumatic complaints, and the severity of their symptoms was not related to APA levels. Among women who had previously been hospitalized because of soft-tissue rheumatism, there were more fibromyalgia cases, and their symptoms were more severe compared with those women without prior soft-tissue rheumatism; however, APA levels were not higher among these women. There was a significant difference in APA measurements resulting from between-kit variation (p less 0.01). CONCLUSIONS: Our data did not demonstrate higher APA levels among women with SBIs compared with controls. The large variation observed between the individual plates in the APA test should be evaluated in future studies.

Adult↗
PubMed2004

Prolonged culture for mycobacteria in mediastinal lymph nodes from patients with pulmonary sarcoidosis. A negative study.

BACKGROUND: Histological similarity between sarcoidosis and tuberculosis, with epithelioid cell granulomas as the typical finding, suggests that sarcoidosis could be a specific manifestation of infection with mycobacteria. However, convincing evidence for a causal relationship between mycobacterial infection and sarcoidosis has not been produced. OBJECTIVE: To examine whether mycobacteria could be cultured from mediastinal lymph nodes from patients with newly diagnosed pulmonary sarcoidosis using a prolonged culture technique. METHODS: The series comprised 15 patients (10 men) with a median age of 45 years (range 25-61) and chest X-ray showing mediastinal lymphadenopathy. The diagnosis of sarcoidosis was based on biopsy specimens of lymph nodes obtained by mediastinoscopy. Lymph node tissue was processed in a prolonged (12 month duration) culture for mycobacteria. Bronchial washings were obtained by bronchoscopy and examined for mycobacteria using fluorescence microscopy, polymerase chain reaction (PCR) for Mycobacterium tuberculosis (M. tuberculosis) DNA and standard culture (7-week duration). RESULTS: In all lymph node specimens, prolonged culture for mycobacteria was negative. In all bronchial washings, microscopy for mycobacteria, analysis for M. tuberculosis DNA, and standard culture for mycobacteria was negative. CONCLUSION: Our study with prolonged culture failed to demonstrate the presence of mycobacteria in sarcoid tissue, especially M. tuberculosis and M. paratuberculosis, and does not suggest that mycobacterial infection could play a direct pathogenic role in patients with pulmonary sarcoidosis.

Adult↗
PubMed2003

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↗
PubMed2003

A population-based cohort study of mortality among adults prescribed paracetamol in Denmark.

OBJECTIVE: We examined overall and cause-specific mortality in a population-based cohort of individuals prescribed paracetamol. We evaluated rates of death due to liver and renal disease, cancer, and other major causes of death. METHOD: Using the population-based pharmacoepidemiology prescription database of North Jutland County, Denmark, we identified nearly 50,000 persons receiving prescriptions for paracetamol from 1989 to 1995 and evaluated mortality through 1996. Standardized mortality ratios (SMRs) for 18 specific causes of death were computed for persons prescribed paracetamol compared with persons among the general population of the county. RESULTS: SMRs were elevated regardless of cause of death, with a nearly doubled overall death rate among persons prescribed paracetamol. The mortality ratios were highest within 1 year of paracetamol prescription and tended to decline with increasing follow-up, especially for cancers. The magnitudes of the excess mortality risks for liver and renal diseases were not materially higher than for other causes of death. CONCLUSION: Paracetamol is a first-line analgesic for patients with a wide variety of chronic or serious illnesses and therefore is associated with increased rates of nearly all causes of death. The findings are an example of confounding by indication. Paracetamol may be a drug most prone to this form of bias in pharmacoepidemiologic studies. Future observational studies reporting adverse effects of paracetamol must thoroughly evaluate confounding by indication before making causal inferences.

Acetaminophen↗
PubMed2003

Characterization of potassium channel modulators with QPatch automated patch-clamp technology: system characteristics and performance.

Planar silicon chips with 1-2-microm etched holes (average resistance: 2.04 +/- 0.02 MOmega in physiological buffer, n = 274) have been developed for patch-clamp recordings of whole-cell currents from cells in suspension. An automated 16-channel parallel screening system, QPatch 16, has been developed using this technology. A single-channel prototype of the QPatch system was used for validation of the patch-clamp chip technology. We present here data on the quality of patch-clamp recordings and from actual drug screening studies of human potassium channels expressed in cultured cell lines. Using Chinese hamster ovary (CHO) and human embryonic kidney cells (HEK), gigaseals of 4.1 +/- 0.4 GOmega (n = 146) and high-quality whole-cell current recordings were obtained from hERG and KCNQ4 potassium channels. Success rates for gigaseal recordings varied from 40 to 95%, and 67% of the whole-cell configurations lasted for >20 min. Cells were maintained in suspension up to 4 h in a cell storage facility that is integrated in the QPatch 16. No decline in patchability was observed during this time course. A series of screens was conducted with known inhibitors of the hERG and KCNQ4 potassium channels. Dose-response relationship characterizations of verapamil and rBeKm-1 blockage of hERG currents provided IC(50) values similar to values reported in the literature.

Animals↗
PubMed2003

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↗
PubMed2003

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↗
PubMed2003

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↗
PubMed2003

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↗
PubMed2003

Nonaspirin nonsteroidal anti-inflammatory drugs and risk of hospitalization for intracerebral hemorrhage: a population-based case-control study.

BACKGROUND AND PURPOSE: Nonsteroidal anti-inflammatory drugs (NSAIDs) have effects on hemostasis and have been associated with an increased risk of bleeding. However, data relating the use of nonaspirin NSAIDs and risk of intracerebral hemorrhage (ICH) are sparse. METHODS: Using data from the County Hospital Patient Register and the Civil Registration System of North Jutland County, Denmark, we identified 912 cases of first-time ICH and 9059 sex- and age-matched population-based controls in the period of 1991 to 1999. All prescriptions for nonaspirin NSAIDs before the date of admission for ICH were identified through a population-based prescription database. Conditional logistic regression was used to adjust for potential confounding factors, including previous discharge diagnoses of hypertension, chronic bronchitis and emphysema, alcoholism, liver cirrhosis, diabetes mellitus, and prescriptions for insulin or oral hypoglycemic agents, antihypertensive agents, lipid-lowering agents, low-dose aspirin, high-dose aspirin, and oral anticoagulants. RESULTS: No overall association was found between prescription for nonaspirin NSAIDs in the preceding 30, 60, or 90 days and risk of ICH; ie, odds ratios ranged from 0.92 (95% CI, 0.70 to 1.21) to 1.13 (95% CI, 0.81 to 1.58). Furthermore, there was no increased risk of ICH associated with prescription for nonaspirin NSAIDs when the study population was stratified by age, sex, and a previous discharge diagnosis of hypertension. CONCLUSIONS: Patients prescribed nonaspirin NSAIDs were not at an overall increased risk of being hospitalized for ICH. This reassuring finding was seen in all examined subgroups, including the elderly and patients with a previous discharge diagnosis of hypertension.

Adult↗
PubMed2003

Confounding by indication: implications for implant research.

When studying potential adverse effects of medical and surgical treatments, including prosthetic implants, it is essential to be able to isolate the effect of the treatment from that of the underlying illness in order to draw conclusions about cause and effect. Treatment involving surgical implants is typically not assigned randomly, but stems from a clinical indication related to underlying medical problems. When undertaking a research study comparing implant recipients to other groups ofsubjects (who often do not have the same underlying problems), it is of critical importance to account for these inherent differences between the study groups. Confounding by indication is the bias that arises in the observational study of treatment effects, which stems from the differing baseline risks, comorbidities, and prognostic factors between patients who receive treatment and those who do not. In this article, we examine several observational epidemiologic studies that have noted associations between prosthetic implants and subsequent connective tissue disease. However, it can be demonstrated that none of these studies has been able to adequately account for confounding by indication, resulting in findings that are likely biased. Because of the increasingly widespread use of implants at younger ages and the growing importance of studying their potential long-term effects, a thorough understanding of this bias is necessary in order to properly conduct and interpret implant research studies.

Bias↗
PubMed2003

Upscaling and automation of electrophysiology: toward high throughput screening in ion channel drug discovery.

Effective screening of large compound libraries in ion channel drug discovery requires the development of new electrophysiological techniques with substantially increased throughputs compared to the conventional patch clamp technique. Sophion Bioscience is aiming to meet this challenge by developing two lines of automated patch clamp products, a traditional pipette-based system called Apatchi-1, and a silicon chip-based system QPatch. The degree of automation spans from semi-automation (Apatchi-1) where a trained technician interacts with the system in a limited way, to a complete automation (QPatch 96) where the system works continuously and unattended until screening of a full compound library is completed. The performance of the systems range from medium to high throughputs.

Animals↗
PubMed2002

Cancer risk in persons receiving prescriptions for paracetamol: a Danish cohort study.

The use of paracetamol has been associated with increased risks for urinary tract cancers and decreased risk for ovarian cancer, although results have been inconsistent. We conducted a population-based cohort study using data from the Prescription Database of North Jutland County and the Danish Cancer Registry. Cancer incidence among 39,946 individuals receiving prescriptions for paracetamol was compared with expected incidence based on the North Jutland population who did not receive paracetamol prescriptions, during a 9-year follow-up period. Standardized incidence ratios (SIRs) with corresponding 95% confidence intervals (95% CIs) were calculated for cancers overall and at selected sites. Overall, 2,173 cancers were observed with 1,973 expected, yielding a SIR of 1.10 (95% CI, 1.06-1.15). Significantly elevated SIRs were found for cancers of the esophagus (1.9; 95% CI, 1.3-2.8) and lung (1.6; 95% CI, 1.4-1.7). Nonsignificantly increased SIRs were observed for cancers of the liver (1.5; 95% CI, 0.96-2.2), renal parenchyma (1.3; 95% CI, 0.9-1.7) and renal pelvis/ureter (1.6; 95% CI, 0.96-2.6), whereas the SIR for cancer of the urinary bladder was close to unity (1.1; 95% CI, 0.9-1.4). For ovarian cancer, the SIR was close to expectation (0.9; 95% CI, 0.6-1.2) with no evidence of trends with duration of follow-up or number of prescriptions. A similar risk pattern was observed after exclusion of person-time experience following prescription for aspirin or other nonsteroidal antiinflammatory drugs in the study cohort and reference population. Our results do not support a major role for paracetamol in the development of cancers of the urinary tract, and we found little evidence of a protective effect of paracetamol against ovarian cancer. The elevated risks for cancers of the esophagus, lung and liver are most likely a result of confounding variables, but may warrant further investigation.

Acetaminophen↗
PubMed2002

Epidemiological investigation of local complications after cosmetic breast implant surgery in Denmark.

Concern has been raised recently regarding the absence of information on the occurrence and severity of local complications after cosmetic breast implantation. The authors evaluated the occurrence of local complications in a large epidemiological retrospective cohort study of women with cosmetic breast implants in Denmark. All women with breast implants were identified from the files of two private clinics of plastic surgery in Denmark. Information on implant characteristics, surgical procedure, as well as short- and long-term complications was obtained through medical record review. Patient characteristics were obtained through a self-administered questionnaire. A total of 754 women (1,572 implants) had at least one cosmetic implantation performed at the study clinics. Average age at implantation was 32 years. Implant types included silicone double lumen with textured surface, 31.2%; silicone single lumen with textured surface, 27.8%; silicone single lumen with smooth surface, 24.5%; silicone double lumen with smooth surface, 0.8%; and other or missing information, 15.7%. Average implant size was 247 ml (range, 110-630 ml). Placement was submuscular for 91.3% of implants, subglandular for 2.6%, and 6.1% had no available information. Overall, 77.8% of implantations were not followed by complications, 17.8% were followed by one complication, 3.6% were followed by two complications, and 0.8% were followed by three or more complications. In 94.6% of implantations, no additional hospitalizations were recorded as a result of complications. Forty-seven of 57 explantations/reimplantations were secondary to postoperative complications. General complications such as hematoma and infection were rare, occurring in 2.3% and 2.0% of implantations respectively. Capsular contracture remains the most common complication, occurring in 11.4% of implantations. In this investigation, among the first epidemiological studies of local complications, the authors found cosmetic breast implant surgery to be associated with a low frequency of normal surgical complications such as infection, hematoma, and wound dehiscence. Most complications were mild and did not lead to additional hospitalization. The complication that led most frequently to the need for additional surgery/hospitalization was capsular contracture. Kjøller K, Hölmich LR, Jacobsen PH, Friis S, Fryzek J, McLaughlin JK, Lipworth L, Henriksen TF, Jørgensen S, Bittmann S, Olsen JH. Epidemiological investigation of local complications after cosmetic breast implant surgery in Denmark.

Adult↗
PubMed2002

Health outcomes in offspring of Danish mothers with cosmetic breast implants.

To assess whether maternal breast implants are related to adverse health outcomes in offspring, the authors conducted a retrospective cohort study of esophageal disorders, rheumatic disease, and congenital malformations among 2,854 children born to women with breast implants and among 5,805 children born to a comparison group of women who underwent breast reduction or other plastic surgery. Rates were calculated using both hospitalization and outpatient data. Significantly higher rates of esophageal disorders were observed (O) than were expected (E) for children born before (O/E, 2.0; 95% CI, 1.3-2.8) but not after (O/E, 1.3; 95% CI, 0.5-2.9) maternal breast implant surgery. Risk of rheumatic disease was similar among children born before (O/E, 1.4; 95% CI, 0.7-2.6) and after (O/E, 1.4; 95% CI, 0.2-5.0) maternal breast implant surgery. A marginally significant excess of congenital malformations of the digestive organs was observed among children born after maternal implant surgery (O/E, 1.8; 95% CI, 1.0-3.1), with a similar finding among children born to women in the comparison group (O/E, 1.9; 95% CI, 1.4-2.4). The risk of malformations overall was not statistically significantly higher than expected among children born after maternal breast implant surgery. The elevated risks of adverse health outcomes appear unrelated to breast implants per se, because similar findings were observed among children born both before and after the mother's implant surgery, as well as among children born to mothers in the comparison cohort.

Adolescent↗