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Journal of Plastic, Reconstructive &... Nov 2023New concerns have been raised by the US Food and Drug Administration regarding breast implant capsule-associated squamous cell carcinoma (BICA-SCC) but very little is... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
New concerns have been raised by the US Food and Drug Administration regarding breast implant capsule-associated squamous cell carcinoma (BICA-SCC) but very little is known about this emerging topic. To gain a better understanding of the disease, a systematic review and individual patient data meta-analysis of patients with BICA-SCC were performed.
METHODS
PubMed, Embase, and Cochrane were searched from inception to 26th February 2023 for studies including patients with BICA-SCC. Individual patient data were extracted and pooled. Risk of bias was assessed using the Joanna Briggs Institute critical appraisal tool.
RESULTS
A total of 16 studies reported 19 patients with BICA-SCC, commonly presented with swelling (84.2%), pain (73.7%), and erythema (21.1%). The median age at SCC diagnosis was 52.0 (interquartile range [IQR] 46.0-60.0) years. The median time from breast augmentation to SCC diagnosis was 20.0 (IQR 15.0-35.0) years. The majority of patients (68.4%) were found to have extracapsular spread at SCC diagnosis. All patients with breast implants in situ underwent implant removal with at least 60.0% of patients undergoing capsulectomy. The mean follow-up period was 17.6 months with 1-year overall survival of 80.8% and 1-year disease-free survival of 53.0%.
CONCLUSION
While rare, surgeons should counsel patients on the risks of malignancy including BICA-SCC before breast implantation and consider the possibility of BICA-SCC when treating patients with late-onset peri-implant changes. A centralized registry is needed to better understand and improve outcomes in patients with BICA-SCC.
Topics: Humans; Middle Aged; Female; Breast Implants; Carcinoma, Squamous Cell; Breast Neoplasms; Breast; Breast Implantation
PubMed: 37666057
DOI: 10.1016/j.bjps.2023.08.002 -
International Journal of Implant... Sep 2023This systematic review aimed to evaluate the incidence of microleakage events (IME) and to identify the potential factors influencing the sealing ability of the... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
This systematic review aimed to evaluate the incidence of microleakage events (IME) and to identify the potential factors influencing the sealing ability of the implant-abutment interface (IAI) under in vitro investigation.
MATERIAL AND METHODS
An electronic search of MEDLINE (PubMed), EMBASE, and Web of Science databases, combined with a manual literature search was conducted up to September 2022. In vitro studies that reported the degree of microleakage at IAI under dynamic loading conditions were included. A meta-analysis was performed to calculate the mean values of the incidence of microleakage events. Subgroup analysis and meta-regression were conducted to further investigate the effect of different variables.
RESULTS
675 studies were identified following the search process and 17 in vitro studies were selected according to the eligibility criteria. The weighted mean incidence of microleakage events was 47% (95% confidence interval: [0.33, 0.60]), indicating that contamination was observed in nearly half of the samples. Concerning possible factors that may influence microleakage (e.g., loading condition, assessment method, implant-abutment connection design, types of abutment material, the use of sealing agents), loading condition (p = 0.016) was the only variable that significantly influenced IME in the meta-regression analysis.
CONCLUSIONS
The results demonstrated that dynamic loading significantly increases the potential of bacterial penetration at the implant-abutment junction. The results should be interpreted carefully due to the data heterogeneity and further well-conducted in vitro studies with homogeneous samples are needed to standardize the methodologies.
Topics: Dental Implants; Databases, Factual; Drug Contamination; Electronics; Eligibility Determination
PubMed: 37733145
DOI: 10.1186/s40729-023-00494-y -
AAPS PharmSciTech Oct 2023Diet-induced obesity and hyperlipidemia are a growing public health concern leading to various metabolic disorders. Capsaicin, a major bioactive compound obtained from...
Diet-induced obesity and hyperlipidemia are a growing public health concern leading to various metabolic disorders. Capsaicin, a major bioactive compound obtained from natural chili peppers, has demonstrated its numerous beneficial roles in treating obesity and weight loss. Current treatment involves either administration of antiobesity drugs or surgical procedures such as Roux-en-Y-gastric bypass or sleeve gastrectomy, both of which are associated with serious side effects and poor patient acceptance. Capsaicin, a pungent molecule, has low oral bioavailability. Therefore, there is a need for the development of site-specific drug delivery system for capsaicin. The present study is aimed at preparing and characterizing 3D-printed capsaicin-loaded rod-shaped implants by thermoplastic extrusion-based 3D printing technology. The implants were printed with capsaicin-loaded into a biodegradable polymer, polycaprolactone, at different drug loadings and infill densities. The surface morphology revealed a smooth and uniform external surface without any capsaicin crystals. DSC thermograms showed no significant changes/exothermic events among the blends suggesting no drug polymer interactions. The in vitro release studies showed a biphasic release profile for capsaicin, and the release was sustained for more than three months (~ 85% released) irrespective of drug loading and infill densities. The HPLC method was stability-indicating and showed good resolution for its analogs, dihydrocapsaicin and nordihydrocapsaicin. The implants were stable for three months at accelerated conditions (40°C) without any significant decrease in the assay of capsaicin. Therefore, capsaicin-loaded implants can serve as a long-acting injectable formulation for targeting the adipose tissue region in obese patients.
Topics: Humans; Capsaicin; Obesity; Drug Delivery Systems; Printing, Three-Dimensional; Polymers; Drug Liberation
PubMed: 37783858
DOI: 10.1208/s12249-023-02647-z -
Graefe's Archive For Clinical and... Dec 2023For the treatment of macular edema, in addition to the use of antivascular endothelial growth factors, steroids are also used intravitreally and sub-Tenon. Side effects...
PURPOSE
For the treatment of macular edema, in addition to the use of antivascular endothelial growth factors, steroids are also used intravitreally and sub-Tenon. Side effects include among others cataract formation and elevation of intraocular pressure (IOP). The aim of this retrospective study was to elicit the IOP elevation after administration of various steroidal medication, the time of onset, and the efficacy of the administered IOP-lowering therapies.
METHODS
We included 428 eyes with a postoperative (n = 136), diabetic (n = 148), uveitic macular edema (n = 61), and macular edema after retinal vein occlusion (n = 83). These patients were treated with one or more diverse steroidal agents once or multiple times. These drugs included: triamcinolone acetonide (TMC) as intravitreal injection (TMC IVI) or sub-Tenon (TMC ST), as well as dexamethasone (DXM) and fluocinolone acetonide (FA) intravitreally. An increase of IOP of ≥ 25 mmHg was designated as pathological. A steroid response in anamnesis, the time of onset of IOP rise from the first administration, and the therapy administered were documented.
RESULTS
Of 428 eyes, 168 eyes (39.3%) had IOP elevation up to a mean of 29.7 (SD ± 5.6) mmHg, which occurred at a median of 5.5 months. Steroids most frequently leading to rise of IOP included DXM (39.1% of all eyes receiving that drug), TMC IVI (47.6%), TMC ST combined with DXM (51.5%), DXM with FA (56.8%), and TMC IVI with DXM (57.4%). A Kaplan-Meier analysis and the Log Rank test showed a significant difference (p < 0.001). IOP rise was treated as follows: 119 conservatively (70.8%), and 21 surgically (12.5%, cyclophotocoagulation 8.3%, filtering surgery 1.8%, in 4 the steroidal drug implant was removed 2.4%), and 28 eyes received no therapy (16.7%). Sufficient IOP regulation was achieved in 82 eyes (68.9%) with topical therapy. In 37 eyes (31.1%) with persistently elevated intraocular pressure, topical therapy had to be continued over the follow-up of 20 ± 7 months.
CONCLUSIONS
IOP increases after any type of steroid application are not rare. Results of our study let us suspect that especially therapy with intravitreal dexamethasone, either as a monotherapy or in combination with another steroid, tends to increase IOP more than other steroids. Regular IOP checks are necessary after each steroid administration, with possible initiation of long-term conservative and/or surgical therapy if necessary.
Topics: Humans; Intraocular Pressure; Glucocorticoids; Macular Edema; Incidence; Retrospective Studies; Ocular Hypertension; Triamcinolone Acetonide; Retinal Diseases; Glaucoma; Fluocinolone Acetonide; Intravitreal Injections; Dexamethasone
PubMed: 37432451
DOI: 10.1007/s00417-023-06163-5 -
Clinical Breast Cancer Apr 2024Neoadjuvant chemotherapy (NAC) is a standard modality of treatment for breast cancer. The exposure of patients to drugs that effect the cells and processes involved in... (Meta-Analysis)
Meta-Analysis Review
Neoadjuvant chemotherapy (NAC) is a standard modality of treatment for breast cancer. The exposure of patients to drugs that effect the cells and processes involved in healing prior to reconstructive surgical procedures is a source of concern for reconstructive surgeons. The reported effects of NAC on autologous and tissue expander to implant-based breast reconstruction vary from study to study and have not been comprehensively reviewed on a large scale. There is also significant variation from study to study regarding which outcomes are evaluated. The primary aim of this systematic review and meta-analysis is to evaluate the effect of neoadjuvant chemotherapy (NAC) on common and significant outcomes including total complication, reconstruction loss, and SSI (Surgical Site Infection) rates in breast reconstruction. The second aim of this study is to evaluate whether NAC has differing effects on implant-based reconstruction compared with autologous flap reconstruction. A systematic review of the literature published from 1991 to 2019 in the PubMed and Scopus library database was performed to identify studies reporting outcomes of breast reconstruction in patients receiving NAC. A meta-analysis was then performed. Primary outcomes reviewed included overall complication rates, SSI rates, and total loss of reconstruction (flap necrosis or premature tissue expander or implant removal). Outcomes were analyzed using a random effects model and chi-square statistical test. Our literature search yielded 22 manuscripts with a total of 3680 patients that fit our inclusion criteria, of which 12 reported on reconstruction loss, 14 reported on SSI rates, and 10 reported on overall complication rates. There was no significant difference in overall breast reconstruction loss rate (OR 1.30, P = .35), complication rate (OR 1.21, P = .06), and rate of SSI (OR 1.28, P = .85) between NAC vs. non-NAC groups. In patients undergoing autologous flap reconstruction there were no significant differences in complication (23.4% vs. 17.7%, P = 0.076), loss of reconstruction (3.1% vs. 4.4%, P = .393), or SSI (5.3% vs. 3.4%, P = .108) rates in patients who were treated with NAC compared to those who were not. Likewise, in patients undergoing TE/implant-based reconstruction there were no significant differences in complication (19.6 vs. 24.2 P = .069), loss of reconstruction (17.4% vs. 13.3%, P = .072), or SSI (7.9% vs. 5.1%, P = .073) rates in patients who were treated with NAC compared to those who were not. NAC was not associated with any significant differences in overall complication, reconstruction loss, or SSI rates in patients receiving implant-based or autologous flap breast reconstruction. Additionally, the lack of effect of NAC on overall complication, reconstruction loss or SSI rates did not differ with or depend on the type of reconstruction.
Topics: Humans; Female; Mastectomy; Breast Implants; Breast Neoplasms; Neoadjuvant Therapy; Mammaplasty; Retrospective Studies; Postoperative Complications
PubMed: 38228449
DOI: 10.1016/j.clbc.2023.12.004 -
Drugs Jan 2024A randomized, double-masked, multicenter, phase 2 trial to evaluate the long-term safety and efficacy of travoprost intraocular implant, an extended-release drug... (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
A randomized, double-masked, multicenter, phase 2 trial to evaluate the long-term safety and efficacy of travoprost intraocular implant, an extended-release drug delivery system designed to provide uninterrupted sustained intraocular pressure (IOP)-lowering therapy, thereby reducing patient treatment burden and improving adherence with IOP-lowering medication.
METHODS
Patients with open-angle glaucoma or ocular hypertension were administered a fast-eluting implant (FE implant, n = 51) and received twice-daily (BID) placebo eye drops, a slow-eluting (SE implant, n = 54) and received BID placebo eye drops, or underwent a sham surgical procedure and received BID timolol 0.5% (n = 49). IOP was measured at baseline, day 1-2, day 10, week 4, week 6, month 3, and every 3 months thereafter through 36 months. Efficacy was evaluated by mean change from 8:00 AM unmedicated baseline IOP through month 36, and the percentage of patients receiving the same or fewer topical IOP-lowering medications as at screening (pre-study). Safety was evaluated by adverse events and ophthalmic parameters.
RESULTS
Clinically and statistically relevant IOP-lowering treatment effects were observed through month 36 after a single administration of the travoprost implant compared with BID timolol with mean IOP reductions ranging from 7.6 to 8.8 mmHg for the FE implant group, from 7.3 to 8.0 mmHg for the SE implant group, and from 7.3 to 7.9 for the timolol group at the 8:00 AM timepoint (P < 0.0001 for all treatment groups at all visits). At months 12, 24, and 36, a greater percentage of FE and SE implant patients versus timolol patients were well controlled on the same or fewer topical IOP-lowering medications compared with screening with 63 and 69% for the FE and SE implants groups, respectively, versus 45% for the timolol group at month 36. The safety profile of the implant was favorable; there were no dislodgements, no explantations, no adverse events of conjunctival hyperemia or periorbital fat atrophy, no discontinuations due to study eye adverse events, nor any serious adverse events in the study eye. Comparable changes from baseline in corneal endothelial cell counts were observed in the three treatment groups over the 36 months.
CONCLUSION
The travoprost intraocular implant demonstrated robust IOP-lowering and substantially reduced topical IOP-lowering medication burden for up to 36 months following a single administration, while maintaining a favorable safety profile. The travoprost intraocular implant promises to be a meaningful addition to the interventional glaucoma armamentarium by addressing the key shortcomings of topical IOP-lowering medications, including low adherence and topical side effects while controlling IOP for up to 36 months.
TRIAL REGISTRY
ClinicalTrials.gov identifier NCT02754596 registered 28 April 2016.
Topics: Humans; Travoprost; Glaucoma, Open-Angle; Intraocular Pressure; Timolol; Antihypertensive Agents; Cloprostenol; Ocular Hypertension; Glaucoma; Ophthalmic Solutions; Double-Blind Method; Treatment Outcome
PubMed: 38060092
DOI: 10.1007/s40265-023-01973-7 -
Biomaterials Advances Oct 2023Alternative engineering approaches have led the design of implants with controlled physical features to minimize adverse effects in biological tissues. Similar efforts...
Alternative engineering approaches have led the design of implants with controlled physical features to minimize adverse effects in biological tissues. Similar efforts have focused on optimizing the design features of percutaneous VAD drivelines with the aim to prevent infection, omitting however a thorough look on the implant-skin interactions that govern local tissue reactions. Here, we utilized an integrated approach for the biophysical modification of transdermal implants and their evaluation by chronic sheep implantation in comparison to the standard of care VAD drivelines. We developed a novel method for the transfer of breath topographical features on thin wires with modular size. We examined the impact of implant's diameter, surface topography, and chemistry on macroscopic, histological, and physical markers of inflammation, fibrosis, and mechanical adhesion. All implants demonstrated infection-free performance. The fibrotic response was enhanced by the increasing diameter of implants but not influenced by their surface properties. The implants of small diameter promoted mild inflammatory responses with improved mechanical adhesion and restricted epidermal downgrowth, in both silicone and polyurethane coated transdermal wires. On the contrary, the VAD drivelines with larger diameter triggered severe inflammatory reactions with frequent epidermal downgrowth. We validated these effects by quantifying the infiltration of macrophages and the level of vascularization in the fibrotic zone, highlighting the critical role of size reduction for the benign integration of transdermal implants with skin. This insight on how the biophysical properties of implants impact local tissue reactions could enable new solutions on the transdermal transmission of power, signal, and mass in a broad range of medical devices.
Topics: Animals; Sheep; Skin; Epidermis; Biophysics; Body Fluids; Drug-Related Side Effects and Adverse Reactions
PubMed: 37591177
DOI: 10.1016/j.bioadv.2023.213568 -
Journal of Plastic, Reconstructive &... Dec 2023The impact of neoadjuvant chemotherapy (NACT) on the complication rate after implant-based and autologous breast reconstruction remains unclear. The aim of this study... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The impact of neoadjuvant chemotherapy (NACT) on the complication rate after implant-based and autologous breast reconstruction remains unclear. The aim of this study was to systematically review and perform a meta-analysis of previously published studies on immediate breast reconstruction (IBR) in breast cancer patients treated with NACT compared with controls.
METHODS
PubMed and EMBASE were searched to identify studies assessing the impact of NACT on major and minor complications after IBR. The primary effect measures were relative risk (RR), 95% confidence interval (95% CI), and p-value.
RESULTS
Eight studies comprising 51,731 patients were included in the meta-analysis. Of these, 5161 patients received NACT and 46,570 patients did not receive NACT. In regard to major complications, NACT did not statistically significant increase the rate of reconstructive failure (RR = 1.35, 95% CI = 0.96-1.91, p = 0.09), the rate of mastectomy skin-flap necrosis (RR = 1.39, 95% CI = 0.61-3.17, p = 0.44), or the rate of reoperation (RR = 1.09, 95% CI = 0.87-1.37, p = 0.45). Regarding minor complications, NACT did not significantly increase the rate of wound complications (RR = 1.05, 95% CI = 0.87-1.28, p = 0.62). In a subgroup analysis of implant-based breast reconstruction following NACT, single-stage direct-to-implant (DTI) had a significantly lower implant failure rate compared with two-staged tissue expander/implant (TE/I) (RR = 0.43, 95% CI = 0.26-0.71, p = 0.0011).
CONCLUSION
NACT did not increase the major or minor complication rate after IBR with either autologous tissue or implants. Thus, NACT and IBR should be considered safe procedures. The review of studies describing patients undergoing implant-based breast reconstruction following NACT could indicate that single-stage DTI was a safer procedure than two-staged TE/I. However, the association requires further evaluation.
Topics: Humans; Female; Mastectomy; Neoadjuvant Therapy; Breast Neoplasms; Mammaplasty; Postoperative Complications; Treatment Outcome; Breast Implants; Retrospective Studies
PubMed: 37804643
DOI: 10.1016/j.bjps.2023.09.048 -
Safety and effectiveness of intravitreal dexamethasone implant in patients with ocular toxocariasis.The British Journal of Ophthalmology Jan 2024To evaluate the safety and effectiveness of intravitreal dexamethasone (DEX) implant in patients with active uveitis due to ocular toxocariasis (OT).
AIMS
To evaluate the safety and effectiveness of intravitreal dexamethasone (DEX) implant in patients with active uveitis due to ocular toxocariasis (OT).
METHODS
Seventy-eight patients with OT were recruited in this retrospective study, including 51 patients in DEX group treated with intravitreal DEX implant and 27 patients in control group without intervention. The reduction of vitreous haze scores (VHS), the best-corrected visual acuity (BCVA) changes, intraocular pressure (IOP) and cataract progression and formation were recorded at baseline (V0), 1 (V1), 3 (V3) and 6 months (V6) after treatment in DEX group, and V0 and V6 in control group.
RESULTS
There was no change in VHS and BCVA in control group between V0 and V6. Better VHS (p=0.001) and BCVA (p=0.022) was achieved in DEX group; the rate of VHS=0 was 0%, 67.4%, 42.9% and 44.9% at V0, V1, V3 and V6, respectively (p<0.001), and the mean BCVA was improved from logMAR 1.5±0.9 to 1.2±0.9 at V1, 1.4±1.0 at V3 and 1.4±1.2 at V6. A favourable BCVA at V1 was associated with older age (p=0.038) and uninvolved macula (p=0.000) in DEX group. No significant difference in IOP elevation ≥10 mm Hg, cataract progression and formation between groups. More eyes needed retinal surgery in control group (p<0.001).
CONCLUSIONS
This was the first study to investigate use of intravitreal DEX implant in OT patients, which can efficiently reduce ocular inflammation and improve BCVA in macular uninvolved patients.
Topics: Humans; Animals; Dexamethasone; Glucocorticoids; Retrospective Studies; Nijmegen Breakage Syndrome; Toxocariasis; Macular Edema; Treatment Outcome; Retinal Vein Occlusion; Cataract; Intravitreal Injections; Drug Implants
PubMed: 36596664
DOI: 10.1136/bjo-2022-322244 -
International Journal of Gynaecology... May 2024The etonogestrel-releasing implant is a long-acting reversible contraception that is recommended by the Food and Drug Administration for 3 years and has been proven to...
OBJECTIVE
The etonogestrel-releasing implant is a long-acting reversible contraception that is recommended by the Food and Drug Administration for 3 years and has been proven to be highly effective and convenient. Adverse effects including irregular bleeding patterns, weight gain, and acne are reported to be the main reasons for treatment discontinuation. The aim of this study is to learn the association between body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters) and the incidence of side effects and adherence to treatment.
METHODS
This is a retrospective cohort study, conducted at a single university-affiliated medical clinic, including all women who underwent etonogestrel-releasing implant (Nexplanon®; New Jersey, USA, Organon USA Inc., Merck and Co) insertion between January 2019 and December 2021. Cases where abnormalities were reported during the insertion procedure or missing data were excluded from the study. Information on patients' demographic, medical history, obstetric and gynecological history, and follow-up was collected from electronic medical files. The primary outcome was defined as the rate of implant removal in the different obesity classes. Data are presented as median and interquartile range. The study was approved by institutional review board.
RESULTS
The study population included 1318 women, of whom 466 (35%) requested early removal of the implant. Women's demographic and clinical characteristics were comparable between women who requested early removal and those with full-length treatment. The median time for early removal was 12 (6-20) months from insertion. Irregular bleeding was the most frequent reason for early removal in both groups and was more than twice as prevalent in the early removal group (239 [51.29%] vs 193 [22%], P = 0.001). The early removal group had fewer obese women (BMI ≥30) compared with women who had full-length treatment (163 [31.8%] vs 350 [68.2%], P = 0.03), with comparable rates of class 3 obesity women (BMI ≥40) (P = 0.68). Multi-regression logistic analysis including age, BMI, parity and side effects found that the presence of side effects is the only independent predictor significantly associated with early implant removal (B = 1.74, P = 0.04).
CONCLUSIONS
Continuation of etonogestrel-releasing implant contraception treatment was associated with the presence of side effects that were more often reported in non-obese women. BMI was not found to be a significant factor influencing adherence to treatment.
PubMed: 38712353
DOI: 10.1002/ijgo.15590