Breast Implants Information for women considering breast implants

Breast Implants Information for women considering breast implants The information in this booklet is being provided for women considering the option of breast implant surgery. The aim of the booklet is to assist women in making an informed choice about breast implants before opting for surgery. The information has been compiled by a subcommittee of the Advisory Committee for Medical Devices at the Irish Medicines Board and has included consultation with health professionals and representatives of interested organisations.  Download the PDF

Breast screening: what if I have breast implants?

This leaflet is used to support the Northern Ireland breast screening programme and explains the procedure for women with breast implants

Chronic delivery of antibody fragments using immunoisolated cell implants as a passive vaccination tool.

BACKGROUND: Monoclonal antibodies and antibody fragments are powerful biotherapeutics for various debilitating diseases. However, high production costs, functional limitations such as inadequate pharmacokinetics and tissue accessibility are the current principal disadvantages for broadening their use in clinic. METHODOLOGY AND PRINCIPAL FINDINGS: We report a novel method for the long-term delivery of antibody fragments. We designed an allogenous immunoisolated implant consisting of polymer encapsulated myoblasts engineered to chronically release scFv antibodies targeted against the N-terminus of the Aβ peptide. Following a 6-month intracerebral therapy we observed a significant reduction of the production and aggregation of the Aβ peptide in the APP23 transgenic mouse model of Alzheimer's disease. In addition, functional assessment showed prevention of behavioral deficits related to anxiety and memory traits. CONCLUSIONS AND SIGNIFICANCE: The chronic local release of antibodies using immunoisolated polymer cell implants represents an alternative passive vaccination strategy in Alzheimer's disease. This novel technique could potentially benefit other diseases presently treated by local and systemic antibody administration.

Computer-assisted cup placement techniques in total hip arthroplasty improve accuracy of placement.

Malposition of the acetabular component during hip arthroplasty increases the occurrence of impingement, reduces range of motion, and increases the risk of dislocation and long-term wear. To prevent malpositioned hip implants, an increasing number of computer-assisted orthopaedic systems have been described, but their accuracy is not well established. The purpose of this study was to determine the reproducibility and accuracy of conventional versus computer-assisted techniques for positioning the acetabular component in total hip arthroplasty. Using a lateral approach, 150 cups were placed by 10 surgeons in 10 identical plastic pelvis models (freehand, with a mechanical guide, using computer assistance). Conditions for cup implantations were made to mimic the operating room situation. Preoperative planning was done from a computed tomography scan. The accuracy of cup abduction and anteversion was assessed with an electromagnetic system. Freehand placement revealed a mean accuracy of cup anteversion and abduction of 10 degrees and 3.5 degrees, respectively (maximum error, 35 degrees). With the cup positioner, these angles measured 8 degrees and 4 degrees (maximum error, 29.8 degrees), respectively, and using computer assistance, 1.5 degrees and 2.5 degrees degrees (maximum error, 8 degrees), respectively. Computer-assisted cup placement was an accurate and reproducible technique for total hip arthroplasty. It was more accurate than traditional methods of cup positioning.

Magnetic and in vitro heating properties of implants formed in situ from injectable formulations and containing superparamagnetic iron oxide nanoparticles (SPIONs) embedded in silica microparticles for magnetically induced local hyperthermia

The biological and therapeutic responses to hyperthermia, when it is envisaged as an anti-tumor treatment modality, are complex and variable. Heat delivery plays a critical role and is counteracted by more or less efficient body cooling, which is largely mediated by blood flow. In the case of magnetically mediated modality, the delivery of the magnetic particles, most often superparamagnetic iron oxide nanoparticles (SPIONs), is also critically involved. We focus here on the magnetic characterization of two injectable formulations able to gel in situ and entrap silica microparticles embedding SPIONs. These formulations have previously shown suitable syringeability and intratumoral distribution in vivo. The first formulation is based on alginate, and the second on a poly(ethylene-co-vinyl alcohol) (EVAL). Here we investigated the magnetic properties and heating capacities in an alternating magnetic field (141 kHz, 12 mT) for implants with increasing concentrations of magnetic microparticles. We found that the magnetic properties of the magnetic microparticles were preserved using the formulation and in the wet implant at 37 degrees C, as in vivo. Using two orthogonal methods, a common SLP (20 Wg(-1)) was found after weighting by magnetic microparticle fraction, suggesting that both formulations are able to properly carry the magnetic microparticles in situ while preserving their magnetic properties and heating capacities. (C) 2010 Elsevier B.V. All rights reserved.

The value of serum procalcitonin level for differentiation of infectious from noninfectious causes of fever after orthopaedic surgery.

BACKGROUND: Early diagnosis of postoperative orthopaedic infections is important in order to rapidly initiate adequate antimicrobial therapy. There are currently no reliable diagnostic markers to differentiate infectious from noninfectious causes of postoperative fever. We investigated the value of the serum procalcitonin level in febrile patients after orthopaedic surgery. METHODS: We prospectively evaluated 103 consecutive patients with new onset of fever within ten days after orthopaedic surgery. Fever episodes were classified by two independent investigators who were blinded to procalcitonin results as infectious or noninfectious origin. White blood-cell count, C-reactive protein level, and procalcitonin level were assessed on days 0, 1, and 3 of the postoperative fever. RESULTS: Infection was diagnosed in forty-five (44%) of 103 patients and involved the respiratory tract (eighteen patients), urinary tract (eighteen), joints (four), surgical site (two), bloodstream (two), and soft tissues (one). Unlike C-reactive protein levels and white blood-cell counts, procalcitonin values were significantly higher in patients with infection compared with patients without infection on the day of fever onset (p = 0.04), day 1 (p = 0.07), and day 3 (p = 0.003). Receiver-operating characteristics demonstrated that procalcitonin had the highest diagnostic accuracy, with a value of 0.62, 0.62, and 0.71 on days 0, 1, and 3, respectively. In a multivariate logistic regression analysis, procalcitonin was a significant predictor for postoperative infection on days 0, 1, and 3 of fever with an odds ratio of 2.3 (95% confidence interval, 1.1 to 4.4), 2.3 (95% confidence interval, 1.1 to 5.2), and 3.3 (95% confidence interval, 1.2 to 9.0), respectively. CONCLUSIONS: Serum procalcitonin is a helpful diagnostic marker supporting clinical and microbiological findings for more reliable differentiation of infectious from noninfectious causes of fever after orthopaedic surgery.

Do orthopaedic shoes improve local dynamic stability of gait? An observational study in patients with chronic foot and ankle injuries.

BACKGROUND: Complex foot and ankle fractures, such as calcaneum fractures or Lisfranc dislocations, are often associated with a poor outcome, especially in terms of gait capacity. Indeed, degenerative changes often lead to chronic pain and chronic functional limitations. Prescription footwear represents an important therapeutic tool during the rehabilitation process. Local Dynamic Stability (LDS) is the ability of locomotor system to maintain continuous walking by accommodating small perturbations that occur naturally during walking. Because it reflects the degree of control over the gait, LDS has been advocated as a relevant indicator for evaluating different conditions and pathologies. The aim of this study was to analyze changes in LDS induced by orthopaedic shoes in patients with persistent foot and ankle injuries. We hypothesised that footwear adaptation might help patients to improve gait control, which could lead to higher LDS: METHODS: Twenty-five middle-aged inpatients (5 females, 20 males) participated in the study. They were treated for chronic post-traumatic disabilities following ankle and/or foot fractures in a Swiss rehabilitation clinic. During their stay, included inpatients received orthopaedic shoes with custom-made orthoses (insoles). They performed two 30s walking trials with standard shoes and two 30s trials with orthopaedic shoes. A triaxial motion sensor recorded 3D accelerations at the lower back level. LDS was assessed by computing divergence exponents in the acceleration signals (maximal Lyapunov exponents). Pain was evaluated with Visual Analogue Scale (VAS). LDS and pain differences between the trials with standard shoes and the trials with orthopaedic shoes were assessed. RESULTS: Orthopaedic shoes significantly improved LDS in the three axes (medio-lateral: 10% relative change, paired t-test p < 0.001; vertical: 9%, p = 0.03; antero-posterior: 7%, p = 0.04). A significant decrease in pain level (VAS score -29%) was observed. CONCLUSIONS: Footwear adaptation led to pain relief and to improved foot & ankle proprioception. It is likely that that enhancement allows patients to better control foot placement. As a result, higher dynamic stability has been observed. LDS seems therefore a valuable index that could be used in early evaluation of footwear outcome in clinical settings.

Rehabilitation outcomes for orthopaedic trauma individuals as measured by the INTERMED.

PURPOSE: Bio-psychosocial characteristics of patients after orthopaedic traumas may be a strong predictor of poor outcome. The objective of this prospective study was to assess whether the INTERMED, a measure of bio-psychosocial complexity, identifies complex inpatients during rehabilitation including vocational aspects with a poor outcome 1 year after discharge. METHOD: At entry, the INTERMED scores of 118 inpatients were used to assign patients to the high or low complexity group. A questionnaire evaluated 1 year after discharge whether patients: (1) returned to work, (2) still have therapies, (3) take psychoactive drugs, (4) take medication against pain and (5) were satisfied with vocational therapy. Univariate logistic regressions identified which variables predict INTERMED case complexity during hospitalisation as well as predictors (i.e. INTERMED case complexity, French as preferred language, duration of the disability, accident at work, work qualification, severity of the injury, psychiatric co-morbidities, pain) of the five measured outcomes 1 year after discharge. RESULTS: During hospitalisation, the high complexity group was associated with a high prevalence of psychiatric co-morbidities, a higher level of pain and a weaker perception of treatment effects. One year after discharge, the INTERMED was the sole variable to predict all outcomes. CONCLUSION: The INTERMED identifies complex patients during vocational rehabilitation after orthopaedic trauma and is a good predictor of poor outcome 1 year after discharge.

Modelling the effect of minor orthopaedic day surgery on patient mood at the early post-operative period: a prospective population-based cohort study.

OBJECTIVE: The effect of minor orthopaedic day surgery (MiODS) on patient's mood. METHODS: A prospective population-based cohort study of 148 consecutive patients with age above 18 and less than 65, an American Society of Anaesthesiology (ASA) score of 1, and the requirement of general anaesthesia (GA) were included. The Medical Outcomes Study - Short Form 36 (SF-36), Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI) were used pre- and post-operatively. RESULTS: The mean physical component score of SF-36 before surgery was 45.3 (SD=+/-10.1) and 8 weeks following surgery was 44.9 (SD=+/-11.04) [n=148, p=0.51, 95% CI=(-1.03 to 1.52)]. For the measurement of the changes in mood using BDI, BAI and SF-36, latent construct modelling was employed to increase validity. The covariance between mood pre- and post-operatively (cov=69.44) corresponded to a correlation coefficient, r=0.88 indicating that patients suffering a greater number of mood symptoms before surgery continue to have a greater number of symptoms following surgery. When the latent mood constructs were permitted to have different means the model fitted well with chi(2) (df=1)=0.86 for which p=0.77, thus the null hypothesis that MiODS has no effect on patient mood was rejected. CONCLUSIONS: MiODS affects patient mood which deteriorates at 8 weeks post-operatively regardless of the pre-operative patient mood state. More importantly patients suffering a greater number of mood symptoms before MiODS continue to have a greater number of symptoms following surgery.

Dexamethasone-loaded poly(epsilon-caprolactone) intravitreal implants: a pilot study.

PURPOSE: Poly(epsilon-caprolactone) (PCL) is a biodegradable and biocompatible polymer that presents a very low degradation rate, making it suitable for the development of long-term drug delivery systems. The objective of this pilot study is to evaluate the feasibility and characteristics of PCL devices in the prolonged and controlled intravitreous release of dexamethasone. METHODS: The in vitro release of dexamethasone was investigated and the implant degradation was monitored by the percent of mass loss and by changes in the surface morphology. Differential scanning calorimetry was used to evaluate stability and interaction of the implant and the drug. The short-term tolerance of the implants was studied after intravitreous implantation in rabbit eye. Results: PCL implant allows for a controlled and prolonged delivery of dexamethasone since it releases 25% of the drug in 21 weeks. Its low degradation rate was confirmed by the mass loss and scanning electron microscopy studies. Preliminary observations show that PCL intravitreous implants are very well tolerated in the rabbit eye. CONCLUSION: This study demonstrates the PCL drug delivery systems allowed to a prolonged release of dexamethasone in vitro. The implants demonstrated a strikingly good intraocular short-term tolerance in rabbits eyes. The in vitro and preliminary in vivo studies tend to show that PCL implants could be of interest when long-term sustained intraocular delivery of corticosteroids is required.

INTERMED predicts non-return to work in an occupational rehabilitation setting for individuals with orthopaedic trauma-Part I

Introduction.- Knowledge of predictors of an unfavourable outcome, e.g. non-return to work after an injury enables to identify patients at risk and to target interventions for modifiable predictors. It has been recently shown that INTERMED; a tool to measure biopsychosocial complexity in four domains (biologic, psychologic, social and care, with a score between 0-60 points) can be useful in this context. The aim of this study was to set up a predictive model for non-return to work using INTERMED in patients in vocational rehabilitation after orthopaedic injury.Patients and methods.- In this longitudinal prospective study, the cohort consisted of 2156 consecutively included inpatients with orthopaedic trauma attending a rehabilitation hospital after a work, traffic or sport related injury. Two years after discharge, a questionnaire regarding return to work was sent (1502 returned their questionnaires). In addition to INTERMED, 18 predictors known at baseline of the rehabilitation were selected based on previous research. A multivariable logistic regression was performed.Results.- In the multivariate model, not-returning to work at 2 years was significantly predicted by the INTERMED: odds-ratio (OR) 1.08 (95% confidence interval, CI [1.06; 1.11]) for a one point increase in scale; by qualified work-status before the injury OR = 0.74, CI (0.54; 0.99), by using French as preferred language OR = 0.60, CI (0.45; 0.80), by upper-extremity injury OR = 1.37, CI (1.03; 1.81), by higher education (> 9 years) OR = 0.74, CI (0.55; 1.00), and by a 10 year increase in age OR = 1.15, CI (1.02; 1.29). The area under the receiver-operator-characteristics curve (ROC)-curve was 0.733 for the full model (INTERMED plus 18 variables).Discussion.- These results confirm that the total score of the INTERMED is a significant predictor for return to work. The full model with 18 predictors combined with the total score of INTERMED has good predictive value. However, the number of variables (19) to measure is high for the use as screening tool in a clinic.

Raman scattering and photoluminescence analysis of silicon on insulator structures obtained by single and multiple oxygen implants

An analysis of silicon on insulator structures obtained by single and multiple implants by means of Raman scattering and photoluminescence spectroscopy is reported. The Raman spectra obtained with different excitation powers and wavelengths indicate the presence of a tensile strain in the top silicon layer of the structures. The comparison between the spectra measured in both kinds of samples points out the existence in the multiple implant material of a lower strain for a penetration depth about 300 nm and a higher strain for higher penetration depths. These results have been correlated with transmission electron microscopy observations, which have allowed to associate the higher strain to the presence of SiO2 precipitates in the top silicon layer, close to the buried oxide. The found lower strain is in agreement with the better quality expected for this material, which is corroborated by the photoluminescence data.