[Acute Respiratory Failure after Silicone Injection]. / Akutes respiratorisches Versagen durch Silikon-Injektion.

A 35-year-old male patient presented to the emergency department with complains of fever, dyspnea and petechiae. The chest X-ray revealed signs of bipulmonary infiltration. 5 days ago, an illicit silicone injection was performed into the penis for cosmetic reasons. Due to progressive respiratory failure the patient required mechanical ventilation. Bronchoalveolar lavage revealed diffuse alveolar hemorrhage. Silicone pneumonitis with a severe acute respiratory failure based on silicone embolization syndrome was diagnosed. Prone positioning, lung-protective ventilation and corticosteroid therapy were initiated. The patient was discharged from ICU after 19 days. In an outpatient follow up, lung function was fully recovered. CONCLUSION: Silicone pneumonitis should be considered in case of fever, respiratory distress and alveolar hemorrhage linked to cosmetic procedures. High dose corticosteroid therapy and lung-protective ventilation strategies may help for complete recovery of lung function.

Mepitel Film and Mepilex Lite for the prophylaxis and treatment of skin toxicities from breast radiation.

Despite the prevalence of radiation dermatitis in breast cancer patients, current practice guidelines for its treatment are limited. We aimed to discuss the quality of evidence for the barrier-forming Mepitel Film for prophylaxis of radiation dermatitis, and argue for further investigation into evidence-based management of skin toxicities. Two studies assessing Mepitel Film were critically evaluated. Both reported that Mepitel Film decreased radiation dermatitis; moreover, patient-reported outcomes significantly favoured Mepitel Film. However, there has not been global adoption of barrier-forming films such as Mepitel, in part due to the absence of multi-centred randomised trials and the heterogeneity of study designs.

Randomized, single-blinded, crossover study of a novel wound dressing vs current clinical practice after percutaneous collagen induction therapy.

INTRODUCTION: Skin rejuvenation procedures have become common with sophisticated technologies with reduced downtime and related risks. Recently, microneedling has been paired with radiofrequency to create Fractional Radiofrequency Microneedling (FRFM) to induce neocollagenesis. Frequently, topical products are applied immediately after the needling. This procedure is known as percutaneous collagen induction therapy (PCIT). Postoperative topical wound care is critical for prompt rapid and safe healing, with moist wound healing deemed of primary importance for fast and correct scarring process. An ideal dressing enables a moist environment while reducing postprocedural inflammatory responses in the first stages of wound healing. OBJECTIVE: To evaluate whether an innovative silicone-based wound dressing is superior than standard of care therapy in decreasing severity and duration of treatment-site acute inflammatory reactions post PCIT. MATERIALS AND METHODS: Endymed PRO Intensif Handpiece (Endymed, Israel) was used for the full-face FRFM procedure. Subjects (n = 20) applied treatment (Stratacel® -Stratpharma SG, Switzerland) and control (Aquaphor® -Beiersdorf Inc, USA) immediately after the procedure and daily; they were evaluated immediately postprocedure (baseline assessment), at 2, 3 and 7 days postprocedure. Digital and 3D pictures (Antera 3D Camera for Skin Analysis-Miravex, Ireland) were taken at each assessment. RESULTS: All patients healed properly without reporting adverse reactions to any of the studied products. Erythema at each study visit was significantly reduced with the use of the novel wound dressing (P < 0.001). A statistically significant difference in favor of the innovative wound dressing also emerged with respect to the patient-rated product properties (P = 0.008), such as feel on skin, drying time and stickiness. CONCLUSIONS: The novel wound dressing reduced signs of acute inflammation following PCIT when compared to standard of care, without reporting adverse events and resulting in a more favorable outcome from a patient perspective.

ASIA syndrome, calcinosis cutis and chronic kidney disease following silicone injections. A case-based review.

An immunologic adjuvant is a substance that enhances the antigen-specific immune response preferably without triggering one on its own. Silicone, a synthetic polymer used for reconstructive and cosmetic purposes, can cause, once injected, local and/or systemic reactions and trigger manifestations of autoimmunity, occasionally leading to an overt autoimmune disease. Siliconosis, calcinosis cutis with hypercalcemia and chronic kidney disease have all been reported in association with silicone injection. Here, we describe a case of autoimmune/auto-inflammatory syndrome induced by adjuvants, calcinosis cutis and chronic kidney disease after liquid silicone multiple injections in a young man who underwent a sex reassignment surgery, followed by a review of the literature. To our knowledge, this is the first report describing the concomitance of the three clinical conditions in the same patients. The link between silicone and the immune system is not completely understood yet and requires further reports and investigations with long-term data, in order to identify the main individual and genetical risk factors predisposing to the wide spectrum of the adjuvant-induced responses.

Cutaneous Application of Silicone Wafers Containing Carbon Microcoils: Efficacy in Relieving Chronic Muscle Tension and Pain.

BACKGROUND: Chronic musculoskeletal pain is highly prevalent worldwide. PRIMARY STUDY OBJECTIVE: The aim of this study was to evaluate the efficacy of Helical(®) microcoils, a new, noninvasive treatment for chronic musculoskeletal pain. DESIGN: This was a prospective, observational study. SETTING: The study was conducted at the main author's private clinic, in São Paulo, Brazil. PARTICIPANTS: We evaluated 20 physicians, from 2 different hospitals, who suffered from chronic musculoskeletal pain and volunteered to participate in the study. INTERVENTION: The Helical(®) microcoils were applied to the skin over the affected areas. Before and after the intervention, the physician-patients completed questionnaires and a visual analog scale. PRIMARY OUTCOME MEASURES: We quantified postintervention improvement or worsening of pain and muscle tension. RESULTS: Significant improvements in pain and muscle tension were observed in 95% of the physician-patients evaluated. The only side effect reported was mild pruritus at the application site, which occurred in 5 of the 20 cases. CONCLUSION: The use of Helical microcoils was found to be safe and efficacious in relieving muscle tension and pain.

Management of scars: updated practical guidelines and use of silicones.

Hypertrophic scars and keloids resulting from surgery, burns, trauma and infection can be associated with substantial physical and psychological distress. Various non-invasive and invasive options are currently available for the prevention and treatment of these scars. Recently, an international multidisciplinary group of 24 experts on scar management (dermatologists; plastic and reconstructive surgeons; general surgeons; physical medicine, rehabilitation and burns specialists; psychosocial and behavioural researchers; epidemiologists; beauticians) convened to update a set of practical guidelines for the prevention and treatment of hypertrophic and keloid scars on the basis of the latest published clinical evidence on existing scar management options. Silicone-based products such as sheets and gels are recommended as the gold standard, first-line, non-invasive option for both the prevention and treatment of scars. Other general scar preventative measures include avoiding sun exposure, compression therapy, taping and the use of moisturisers. Invasive treatment options include intralesional injections of corticosteroids and/or 5-fluorouracil, cryotherapy, radiotherapy, laser therapy and surgical excision. All of these options may be used alone or as part of combination therapy. Of utmost importance is the regular re-evaluation of patients every four to eight weeks to evaluate whether additional treatment is warranted. The amount of scar management measures that are applied to each wound depends on the patient's risk of developing a scar and their level of concern about the scar's appearance. The practical advice presented in the current guidelines should be combined with clinical judgement when deciding on the most appropriate scar management measures for an individual patient.

Development of transdermal therapeutic formulation of CNS5161, a novel NMDA receptor antagonist, by utilizing pressure-sensitive adhesives II: improved transdermal absorption and evaluation of efficacy and safety.

The aim of this study was to prepare a transdermal therapeutic formulation of CNS5161, an NMDA receptor antagonist developed as a drug for neuropathic pain. Since a silicone pressure-sensitive adhesive (PSA) was found to be the best PSA for CNS5161 among six different PSAs examined in our previous study, the effects of the loading concentration of CNS5161 on release and rat skin permeability were investigated using silicone PSAs. The release of CNS5161 was elevated with an increase in the drug concentration from 1% to 14%. The transdermal flux at the steady state reached a plateau at 8% and over, while crystallization of CNS5161 was not observed for any formulation even at high drug concentrations. The drug concentration in rat skin at the steady state was also saturated at 8% and over, which correlated well with the transdermal flux at the steady state. Therefore, skin permeation clearance defined to the skin concentration at the steady state was almost constant at 0.21/h from 2% to 14% of CNS5161, which suggests that drug concentrations in the skin would be a driving force for transport of the drug to the receptor side. Since increasing the concentration of CNS5161 in the PSA patch was not able to elevate the transdermal flux, 12 formulations containing several permeation enhancers were examined to improve the transdermal transport of CNS5161. Among them, the formulation containing propylene glycol, diisopropyl adipate, and polyvinylpyrrolidone significantly increased the transdermal flux by approximately 1.8-fold by improving the diffusivity of CNS5161 in the skin, and also significantly enhanced the analgesic effect of CNS5161. This formulation caused only slight skin irritation, which indicated that it would be a promising transdermal therapeutic system for CNS5161.

Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld's syndrome): clinical and immunological spectrum.

An adjuvant is a substance that enhances the antigen-specific immune response, induces the release of inflammatory cytokines, and interacts with Toll-like receptors and the NALP3 inflammasome. The immunological consequence of these actions is to stimulate the innate and adaptive immune response. The activation of the immune system by adjuvants, a desirable effect, could trigger manifestations of autoimmunity or autoimmune disease. Recently, a new syndrome was introduced, autoimmune/inflammatory syndrome induced by adjuvants (ASIA), that includes postvaccination phenomena, macrophagic myofasciitis, Gulf War syndrome and siliconosis. This syndrome is characterized by nonspecific and specific manifestations of autoimmune disease. The main substances associated with ASIA are squalene (Gulf War syndrome), aluminum hydroxide (postvaccination phenomena, macrophagic myofasciitis) and silicone with siliconosis. Mineral oil, guaiacol and iodine gadital are also associated with ASIA. The following review describes the wide clinical spectrum and pathogenesis of ASIA including defined autoimmune diseases and nonspecific autoimmune manifestations, as well as the outlook of future research in this field.

Spherical headed silicone intubation in the treatment of 26 cases (31 eyes) of chronic dacryocystitis under nasal endoscopy.

PURPOSE: To observe the clinical efficacy of spherical headed silicone implantation in the treatment of chronic dacryocystitis under nasal endoscopy. METHODS: Twenty six patients (31 eyes) with chronic dacryocystitis were subjected to spherical headed silicone implantation under topical anesthesia (lacrimal passage and nasal mucosal surface). Lacrimal passage irrigation was performed daily throughout the first postoperative week , and once each month thereafter. RESULTS: All spherical headed silicone tube placements were successfully performed. The operative time ranged from 6 to 11 minutes. Symptoms of epiphora were immediately ameliorated post-operatively, and irrigation demonstrated patency of the lacrimal system in all patients. All patients were followed from 7 to 24 months, during which symptoms of tearing were improved. The lacrimal ducts of 27 eyes (87.7%) were normal. The lacrimal ducts of 4 others (12.3%) were still blocked. Lacrimal passage irrigation was open and secretion disappeared in 28 eyes (90.3%). Tearing was observed in 3 eyes (9.68%). CONCLUSION: Spherical headed silicone tube implantation under nasal endoscopy is successful in relieving symptoms of tearing.

Effects of combined intralesional 5-Fluorouracil and topical silicone in prevention of keloids: a double blind randomized clinical trial study.

Keloids are aesthetically disfiguring and severely disabling. The optimal treatment remains undefined. This clinical study, evaluate the efficacy and side effects of combined topical silicone and 5-Fluorouracil on the prevention of keloids. In this double blind randomized clinical trial, fifty patients with keloids were randomly allocated in two groups. The control group were treated by perilesional surgical excision of keloids combined with topical silicone and the trial group were treated with adjuvant treatment of intralesional 5-Fluorouracil. All patients were examined and assessment was done by an independent observer. the data collected were analyzed by SPSS statistical software with using tables and χ square tests. 75% of the cases in the trial group were keloid free 21% have keloid partially improvement and 4% have keloid recurrence, compared to patients in the control group respectively: 43%, 35% and 22%, findings suggest that efficacy of 5-Fluorouracil combined with topical silicone used for the prevention of keloid is comparable to other modality. The lack of any serious side effects and the evidence of recurrence at one year of follow-up make this an effective tool for the prevention of keloids.

A comparative study evaluating the tolerability and efficacy of two topical therapies for the treatment of keloids and hypertrophic scars.

BACKGROUND: Onion extract gel (OE) and 0.5% hydrocortisone, silicone and vitamin E lotion (HSE) are two over-the-counter preparations used to enhance the cosmesis of keloids and hypertrophic scars. OBJECTIVE: To determine the tolerability and efficacy of OE versus HSE versus placebo in subjects with keloids and hypertrophic scars. METHODS: Thirty subjects (> or =18 years) with keloids or hypertrophic scars were randomly assigned to one of three study preparations for 16 weeks. Scar volume was measured at baseline and weeks 4, 8, 12 and 16. Subjects and blinded investigators assessed scar parameters (induration, erythema, pigmentation alteration, pain, itching, tenderness and cosmetic appearance) and patient satisfaction at each visit using a visual analog scale (VAS). Data analysis included: mean percentage change (MPC) for subjects completing the study (n = 15); the mixed model test to determine differences between the groups over time; and the Kruskal-Wallis test for the analysis of differences in subjects' satisfaction within the three groups over 16 weeks for subjects who completed at least one follow-up visit (n = 21). RESULTS: All three preparations were well tolerated with the exception of a mild acneiform-like eruption in one OE patient. Significant improvements were obtained with OE in volume, length, width and induration and with HSE in volume, length, induration, erythema and pigmentation alteration. There was a trend showing that a higher percentage of subjects were satisfied with OE than with HSE or placebo. The Mix Model Analysis (MMA) showed significant improvements with OE over placebo in investigator cosmetic assessment, lesion induration, pigmentation and tenderness and with HSE over placebo in investigator cosmetic assessment, lesion induration, pigmentation and erythema. Improvements in erythema and pigmentation were significantly greater in HSE than in OE. CONCLUSION: Both OE and HSE were more effective than placebo in the management of hypertrophic scars and keloids.

Effect of adhesive matrix composition and terpinolene on indomethacin bioavailability in rats from transdermal therapeutic system.

Drug-in-adhesive matrix-type transdermal therapeutic systems for indomethacin (IND) were formulated and evaluated. Silicone and two types of polyacrylates were used as the bases of matrices. Terpinolene was used as a penetration enhancer. The physicochemical properties of matrices were determined. The bioavailability study of IND was performed in rats. The presence of IND in blood was demonstrated for each system. The calculated pharmacokinetics parameters for IND mainly depend on the solubility of IND in the adhesive layer. The positive influence of a penetration enhancer on IND bioavailability was observed only for one type of polyacrylate matrices.

The history of injectable silicone fluids for soft-tissue augmentation.

BACKGROUND: The debate over the legitimacy of silicone as a safe tool for soft-tissue augmentation has spanned well over half a century. Proponents concede that injections of questionable purity and/or of massive quantities have produced unfavorable outcomes. They assert that in experienced hands with "injectable-grade" silicone, there are very few problems. Despite these claims, the literature is replete with disastrous outcomes following silicone fluid injection, often many years after the initial treatment. METHODS: An extensive review of the English-language literature was conducted using MEDLINE. RESULTS: A comprehensive review of injectable silicones was completed, revealing the origins, misuses, early clinical trials, and support for and against the injection of silicone fluids for the augmentation of soft tissues. CONCLUSIONS: A better understanding of the history of injectable silicone fluids for soft-tissue augmentation can give insight into the pitfalls and complications surrounding its use. There has been an evolution in the technique and type of products used for soft-tissue augmentation. In its current use, silicone oil for permanent soft-tissue augmentation could be a very powerful tool. There is some literature that supports the use of a small amount of purified, high-viscosity silicone oil; however, there has not been a single longitudinal study to date with appropriate follow-up data. The unanswered question remains: Are the risks worth the potential benefits of silicone oil as a permanent filler?

The effects of onion extract on hypertrophic and keloid scars.

OBJECTIVE: To evaluate the therapeutic activity of topical onion extract in gel form on hypertrophic and keloid scars, focusing on problems such as elevation, redness, hardness, itching and pain. METHOD: This comparative prospective study assigned 60 patients to three groups. Group I was treated with onion extract alone, group 2 with silicon gel sheet alone and 3 group with a combination of onion extract and silicon gel sheet. RESULTS: In the group comparisons, a significant difference was observed at the end of six months in the colour parameter between group I and group 2 and in the height parameter between group I and group 3 (ANOVA post-hoc Tukey's test, p<0.01 and p<0.05 respectively). The onion extract was more effective in relation to scar colour, while the silicon gel sheet was superior in decreasing the height of scar (paired sample t-test, p<0.001). In addition, the most effective therapeutic results were obtained when the silicon gel sheet treatment was combined with onion extract in group 3. CONCLUSION: Onion extract improved hypertrophic and keloids scars via multiple mechanisms. However, it was statistically ineffective in improving scar height and itching. For this reason, onion extract therapy should be used in combination with an occlusive silicon dressing to achieve a satisfying decrease in scar height.

[Injectable therapy for urinary incontinence: a review]. / Blasenhalsinjektionen zur Therapie der Stressinkontinenz: Eine Ubersicht.

Trans- or periurethral bladder neck injections are minimal invasive therapies for stress urinary incontinence which can be performed under local anaesthetic as an outpatient procedure. So far the best documented substance is collagen of bovine origin but other substances as silicone, autologous fat, chondrocytes and ethylenevinylalcohol are available. Success rates are between 60 and 80% with deteriorating long term results of approximately 30% requiring reinjection usually after 18 to 24 months.

Lip silicone granulomatous foreign body reaction treated with aldara (imiquimod 5%).

We report a case of a lip granulomatous reaction after injection of silicone being treated successfully with topical Aldara (Imiquimod 5%). Silicone granulomas and the inflammatory foreign body reaction that can occur are some of the complications that arise from using silicone for cosmetic enhancement. The inflammatory reaction of this patient first appeared shortly after silicone injection of both the upper and lower lips. Histopathologic examination revealed a foreign body inflammatory reaction that is consistent with silicone granuloma. Although this reaction has been described extensively in the dermatologic literature as one of the disfiguring side effects of silicone injection, its treatment has plagued cosmetic dermatologists. We report the use of an immunomodulatory cream Aldara (Imiquimod 5%) to treat this type of reaction.