US Food Research Articles

Condensation of cellular prion protein promotes renal fibrosis through the TBK1-IRF3 signaling axis.

Cellular prion protein (PrPC), known for its pathological isoform in prion diseases such as Creutzfeldt-Jakob disease, is primarily expressed in the nervous system but has also been detected in the blood and urine of individuals with renal dysfunction. However, the role of PrPC in the development of renal disease is unexplored. Here, we showed that PrPC was up-regulated in fibrotic renal lesions in biopsies from patients with chronic kidney disease (CKD), predominantly in proximal tubular epithelial cells (PTECs). Furthermore, renal expression of PrPC was positively correlated with the severity of renal failure and the decline in estimated glomerular filtration rate in patients with CKD. In mice, tubular-specific deletion of PrPC mitigated renal fibrosis induced by unilateral ureteral obstruction (UUO) or unilateral ischemia-reperfusion injury (UIRI). Mechanistically, PrPC was up-regulated by transforming growth factor-β1-suppressor of mothers against decapentaplegic 3 signaling. PrPC activated TANK binding kinase 1 (TBK1)-interferon regulatory factor 3 (IRF3) signaling through its capacity for liquid-liquid phase separation, which promoted a profibrotic response in PTECs and fibroblasts. Treating mice with amlexanox, a US Food and Drug Administration-approved inhibitor of TBK1, either before the onset of renal fibrosis (in UUO and UIRI models) or after its establishment (in adenine- and aristolochic acid-induced CKD models), mitigated worsening of renal fibrosis and renal function. Collectively, our findings uncovered a mechanism involving phase separation of PrPC underlying renal fibrosis and support further study of the PrPC-TBK1-IRF3 axis as a potential therapeutic target for CKD.

Issues in Clinical Trial Design—Lessons From the FDA’s Rejection of MDMA

This Viewpoint explores potential justifications underlying the US Food and Drug Administration (FDA)’s rejection of methylenedioxymethamphetamine (MDMA) as a treatment for posttraumatic stress disorder, including lack of blinding and issues around the integrity of relevant clinical trials.

Olezarsen for the Treatment of Familial Chylomicronemia Syndrome.

This review aims to evaluate the efficacy and safety of olezarsen (Tryngolza) in treating familial chylomicronemia syndrome (FCS), a rare genetic disorder characterized by severe hypertriglyceridemia. A comprehensive literature search was conducted via PubMed from January 2022 to mid-March 2025, using keywords such as olezarsen, antisense oligonucleotide, triglyceride, hypertriglyceridemia, apolipoprotein C3 (APOC3), and cardiovascular. Relevant English-language studies assessing the pharmacokinetics, pharmacology, efficacy, or safety of olezarsen were included. Data from the US Food and Drug Administration (FDA)-approved package insert were also reviewed. Olezarsen is an antisense oligonucleotide targeting APOC3 mRNA, a key regulator of plasma triglyceride levels. It has been shown to significantly reduce triglyceride levels via APOC3 protein degradation. Clinical trials have demonstrated substantial reductions in triglyceride levels and APOC3, with minimal adverse events. Phase 2 and 3 trials showed consistent efficacy and safety profiles, with common adverse events including COVID-19 infection, abdominal pain, and diarrhea.Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs:Olezarsen offers a targeted and effective treatment for FCS, addressing limitations of traditional therapies such as fibrates, omega-3 fatty acids, and statins. Its novel mechanism of action and once-monthly dosing regimen may improve patient adherence, providing significant advancement in FCS management. Olezarsen represents a new treatment for FCS, offering a targeted approach to significantly reduce triglyceride levels. Its integration into clinical practice has the potential to transform the management of FCS; however, more studies are needed to firmly establish its role.

Prescription stimulant prescribing, nonmedical use, and shortages: US FDA research and response

Shortages of prescription stimulant medications have been a challenge for patients with attention‐deficit/hyperactivity disorder (ADHD) and other conditions since they began in October 2022. The US Food and Drug Administration (FDA) is committed to understanding and addressing these shortages, which are occurring in the context of significant growth in the dispensing of prescription stimulant medications to adults. Prescription stimulants are Schedule II controlled substances, defined as drugs with “high potential for abuse that may lead to severe psychological or physical dependence.” Questions remain about what is driving increased prescribing of these medications and their potential for misuse; the 2023 National Survey on Drug Use and Health estimated that 3.9 million persons aged 12 years and older in the United States used prescription stimulants nonmedically in the past year. Because the production of Schedule II substances is limited by the Drug Enforcement Administration (DEA), the usual dynamics of supply and demand in the medication marketplace do not apply.

Cell Therapy for T1D Beyond BLA: Gearing Up Toward Clinical Practice.

Type 1 diabetes (T1D) remains a significant global health challenge and patients with T1D need lifelong insulin therapy. Islet transplantation holds transformative potential by replacing autoimmune-mediated destruction of insulin-producing beta cells. This review examines the trajectory of islet transplantation for T1D, focusing on the process and benefits of obtaining biologics license application (BLA) approval for cell-based therapies. Following US Food and Drug Administration (FDA) approval, the authors identify key steps urgently needed to foster islet transplantation as a viable treatment for a broader population of patients with T1D. Furthermore, the authors highlight recent advances in encapsulation technologies, stem cell-derived islets, xenogeneic islets, and gene editing as strategies to overcome challenges such as immune rejection and limited islet sources. These innovations are pivotal in enhancing the safety and efficacy of islet transplantation. Ultimately, this review emphasizes that while BLA approval represents a critical milestone, realizing the full potential of cell therapy for T1D requires addressing the scientific, clinical, and logistical challenges of its real-world implementation. By fostering innovation, collaboration, and strategic partnerships, the field can transform T1D care, offering patients a durable, life-changing alternative to traditional insulin therapy.

Gepotidacin: The first-in-class triazaacenaphthylene antibiotic approved for the treatment of uncomplicated urinary tract infections.

Uncomplicated urinary tract infection (uUTI) is a common bacterial infection in women. While the condition typically has a favorable prognosis, the widespread use of antibiotics has led to increasingly bacterial resistance, reducing the efficacy of traditional antibiotics. On March 25, 2025, the US Food and Drug Administration approved gepotidacin for the treatment of uUTIs caused by susceptible bacteria in female adult and pediatric patients 12 years of age and older weighing at least 40 kg. Gepotidacin is the first triazaacenaphthylene antibiotic approved for clinical use. It selectively binds to and inhibits both bacterial DNA gyrase and topoisomerase IV, disrupting bacterial DNA replication through a unique mechanism and thereby killing the pathogen. Results of clinical trials indicated the non-inferiority of gepotidacin compared to the current standard therapy, nitrofurantoin. The most frequently reported adverse reaction to gepotidacin was mild to moderate diarrhea. The approval of gepotidacin represents a progress in antibiotic innovation, offering novel perspectives on drug development while spurring global efforts to tackle the escalating challenge of antimicrobial resistance.

The antipsychotic drug thiothixene stimulates macrophages to clear pathogenic cells by inducing arginase 1 and continual efferocytosis.

Stimulating efferocytosis, the phagocytic removal of apoptotic cells by macrophages, has been proposed as a method to eliminate dying or dead cells that accumulate and contribute to diseases such as cancer, atherosclerosis, and infection. Toxicity related to the off-target clearance of healthy tissue has led to the premature termination of multiple clinical programs for proefferocytic therapies. To identify potential proefferocytic therapies with established risk profiles, we screened ~3000 US Food and Drug Administration (FDA)-approved drugs and other well-characterized compounds for their capacity to stimulate efferocytosis. We found that the antipsychotic drug thiothixene stimulated efferocytosis of apoptotic and lipid-laden cells by mouse and human macrophages and enhanced the continual efferocytosis of apoptotic cells. Consistent with thiothixene's suppressive effects on dopaminergic signaling, dopamine potently inhibited efferocytosis in a manner that was only partially reversed by thiothixene. The prophagocytic effects of thiothixene in mouse macrophages depended on increased expression of the gene encoding the retinol-binding protein receptor Stra6L, which, in turn, promoted the production of the continual efferocytosis stimulator arginase 1. Our findings demonstrate that dopamine inhibits efferocytosis in macrophages and identify thiothixene, a generic, FDA-approved antipsychotic drug that has been in use for more than 50 years, as a promising candidate for promoting continual efferocytosis and the removal of diseased tissue.

Development of a Multiplex TaqMan Assay for Rapid Detection of Groundnut Bud Necrosis Virus: A Quarantine Pathogen in the USA

Groundnut bud necrosis orthotospovirus (GBNV), a tripartite single-stranded RNA virus, poses a significant threat to United States agriculture. GBNV is a quarantine pathogen, and its introduction could lead to severe damage to economically important crops, such as groundnuts, tomatoes, potatoes, peas, and soybeans. For the rapid and accurate detection of GBNV at points of entry, TaqMan reverse transcriptase–quantitative polymerase chain reaction (RT-qPCR) assays were developed and the results validated using conventional reverse transcriptase–polymerase chain reaction (RT-PCR) followed by Sanger sequencing. These assays target highly conserved regions of the nucleocapsid (NP) and movement (MP) proteins within the viral genome. Multiplex GBNV detection assays targeting the NP and MP genes, as well as an internal control plant gene, ACT11, showed efficiency rates between 90% and 100% and R2 values of 0.98 to 0.99, indicating high accuracy and precision. Moreover, there was no significant difference in sensitivity between multiplex and singleplex assays, ensuring reliable detection across various plant tissues. This rapid, sensitive, and specific diagnostic assay will provide a valuable tool at ports of entry to prevent the entry of GBNV into the United States.

Population-level impact of semaglutide 2.4 mg in patients with obesity or overweight and cardiovascular disease: A modelling study based on the SELECT trial.

To estimate the impact of semaglutide 2.4 mg treatment on the risk of major adverse cardiovascular events (MACE) in adults with overweight/obesity in the United States based on the SELECT trial of patients with atherosclerotic cardiovascular disease. Using 2023 census projections and National Health and Nutrition Examination Survey data, we developed Markov population-based predictive models for US adults meeting SELECT inclusion criteria and, separately, for adults eligible for semaglutide 2.4 mg for its MACE risk reduction indication. The 10-year rate of recurrent MACE and deaths was estimated based on the Secondary Manifestations of ARTerial disease 2 risk calculator and estimated semaglutide 2.4 mg treatment effect as per the SELECT MACE hazard ratio. Of 6 164 019 US adults meeting the SELECT criteria, 2 523 218 (40.9%) are estimated to have ≥1 new MACE in the next 10 years with no additional intervention. Semaglutide 2.4 mg may prevent 496 400 events, a 16% relative reduction. An estimated 2 103 630 deaths are predicted over the next 10 years, of which 332 597 deaths (any cause, 16% relative reduction) could be avoided with semaglutide 2.4 mg. Among the estimated 22 653 158 meeting the MACE risk reduction FDA label criteria, 42.7% could experience ≥1 new MACE; treatment could prevent 1 934 493 MACE and 1 231 295 deaths (16% relative reduction for both). Four in 10 individuals in the United States meeting the SELECT criteria are estimated to experience a recurrent CV event without additional intervention. Semaglutide 2.4 mg can potentially prevent between half a million and up to 2 million MACE over the next 10 years in the population meeting SELECT and MACE risk reduction eligibility. What is the context and purpose of this research study? More than 7 in 10 US adults have overweight or obesity, which increases the risk of heart disease. Semaglutide is a medication used to treat type 2 diabetes and obesity. A clinical study called SELECT found that semaglutide reduces the risk of heart attack, stroke, or death by 20% in adults with overweight or obesity and heart disease. What was done? Our research estimated how many people in the United States would meet the criteria for participation in SELECT, how many heart disease events they might have with regular medical care over the next 10 years, and how many could be avoided with semaglutide 2.4 mg treatment in addition to regular medical care. We also estimated how many people would still be alive if they were treated with semaglutide. We estimated the same information for all people eligible for treatment with semaglutide based on the US Food and Drug Administration (FDA) indication of semaglutide 2.4 mg in patients with heart disease. These estimations were based on a large survey of US adults. What were the main results? We found that over 6 million people would meet the SELECT study criteria. Of these, 41% are estimated to have at least 1 new heart disease event in the next 10 years. If treated with semaglutide 2.4 mg, nearly 500 000 heart disease events and more than 300 000 deaths could be avoided. More than 22 million adults would qualify for semaglutide 2.4 mg, according to the FDA indication. If all of these people were treated with semaglutide 2.4 mg, nearly 2 million heart disease events and more than 1 million deaths might be prevented. What is the originality and relevance of this study? Treatment with semaglutide 2.4 mg can reduce the risk of new heart disease events and death in patients with existing heart disease, showing a substantial impact of semaglutide treatment in a real-world setting in the United States. Our study used different analyses to add to the existing research about reducing the risk of heart disease in people with overweight or obesity.

The impact of cigarillo text warning presence and size on young adults' cigarillo risk beliefs, knowledge, appeal and use intentions.

Cigar warning labels can serve as health communication tools; yet current cigar warnings in the United States can be small or absent, and efforts to standardize them have met industry resistance, partly due to limited research. In 2021, we conducted an online 3x2x2 factorial experiment with 1352 young adult (aged 18-34) past 12-month cigar users. Participants viewed a cigarillo pack image that varied by: text-only warning size (none; small 15%-of-pack label; larger 30%-of-pack label); warning color (white; black); and brand (Swisher Sweets; White Owl). We compared group means on risk perceptions, knowledge and intentions. Packs with any warning label (vs. none) elicited higher endorsement that the packs made participants think about health risks of smoking cigarillos (p<.001), as did packs with larger 30%-of-pack versus 15%-of-pack warnings (p<.001). Packs with a warning label (vs. without) elicited greater absolute perceptions of cigarillo harm (p<.001), as did 30%-of-pack versus 15%-of-pack warnings (p<.001). Risks referenced in the stimuli warning (mouth and throat cancer) were more frequently mentioned in an open-ended knowledge item by participants in conditions with a warning label versus the no-warning condition (p<.05). Packs with 30%-of-pack warnings were also rated as less attractive and elicited lower use intentions than packs without a warning or with the 15%-of-pack warning (p<.05). Results provide evidence that cigar text-only warning labels, particularly larger ones, can facilitate some cigar risk knowledge and beliefs, reduce pack appeal and discourage product interest, supporting policy efforts to strengthen cigar warning requirements. Our results suggest that use of the small text warnings on cigarillo packs (~15% of pack size), as currently still found in the United States based on existing Federal Trade Commission agreement guidelines, is better than having no warnings at all, but that larger warnings sized at 30% of pack (as proposed by the US Food and Drug Administration and voluntarily used by some brands/manufacturers) could have significant benefits across a range of outcomes. Study findings lend support for the cigar warning requirements proposed by the US Food and Drug Administration through the Deeming Rule.

Assessing variation in US payer coverage of anti-vascular endothelial growth factor therapies for the treatment of age-related macular degeneration, diabetic retinopathy, and diabetic macular edema.

Timely anti-vascular endothelial growth factor (anti-VEGF) therapy is recommended to preserve vision in age-related macular degeneration (AMD), diabetic retinopathy (DR), and diabetic macular edema (DME). Coverage of anti-VEGF agents for the treatment of retinal diseases varies, resulting in administrative burdens for providers and treatment delays for patients. To examine how US commercial and Medicare Advantage (MA) health plans cover anti-VEGF therapies for the treatment of retinal diseases using information from the Tufts Medical Center Specialty Drug Evidence and Coverage Database. This descriptive study evaluated coverage of US Food and Drug Administration (FDA)-approved anti-VEGF drugs for AMD, DR, and DME current as of April 2024 using the Specialty Drug Evidence and Coverage Database from 18 of the largest US commercial health plans and MA offerings from a subset of 6 of these plans. Substantial variation exists in commercial coverage across FDA-approved anti-VEGF therapies for AMD, DR, and DME. Descriptive assessment showed that approximately 65% of commercial coverage decisions and approximately 52% of MA decisions included restrictions beyond the FDA label. Coverage decisions for originator products were more likely to include restrictions compared with those for biosimilar products. Step therapy protocols were found in up to 75% of plans but were variable by drug, with most requiring a first-line trial of bevacizumab. Evidence cited to support coverage restrictions was likewise variable. Descriptive data show that US commercial and MA coverage and step therapy protocols vary substantially across health plans, which may potentially contribute to administrative burdens and treatment delays.

Adverse drug reaction patterns of GLP-1 receptor agonists approved for obesity treatment: Disproportionality analysis from global pharmacovigilance database.

This study aims to compare adverse drug reaction patterns of liraglutide, semaglutide and tirzepatide-glucagon-like peptide-1 receptor agonists (GLP-1 RAs) approved for anti-obesity medications-to evaluate their real-world safety. This disproportionality analysis utilized a case-control design with VigiBase. The study focused on reports of adverse events associated with liraglutide, semaglutide and tirzepatide, selected based on warnings in the US Food and Drug Administration approval labels for each drug. Data were restructured using unique identifiers to differentiate individuals affected by adverse drug reactions. Multivariable logistic regression models estimated adjusted reporting odds ratios (aRORs) with 95% confidence intervals (CIs) to assess the association between various adverse events and GLP-1 RAs, adjusting for age, sex, region, reporter qualification, reporting year and concomitant medication. The information component (IC) was analysed, and signals of adverse drug reactions were considered significant only when both aROR and IC were statistically significant. Our analysis of targeted adverse drug reactions included 24 725 individuals using liraglutide, 21 454 using semaglutide and 11 538 using tirzepatide. Tirzepatide had fewer reports of adverse drug reactions compared with the other two drugs, and its pharmacovigilance association strength was the lowest. Semaglutide, however, was significantly associated with several unusual adverse events, including suicidal ideation and behaviour (IC, 1.53 [IC025, 1.28]; aROR, 2.52 [95% CI, 2.18-2.93]), hair loss (IC, 0.78 [IC025, 0.63]; aROR, 1.42 [95% CI, 1.30-1.55]) and vision loss (IC, 1.27 [IC025, 1.13]; aROR, 1.80 [95% CI, 1.66-1.97]). Our findings emphasize the need for cautious prescribing and further research to ensure the safe use of these medications.

Infection toxicity assessment of tumor necrosis factor α inhibitors in the treatment of IBD: a real-world study based on the US food and drug administration adverse events reporting system (FAERS)

ABSTRACT Background Tumor necrosis factor α (TNF-α) inhibitors are widely used to treat inflammatory bowel disease (IBD), but systematic risk assessment of infectious toxicity is still lacking. Research design and methods We used disproportional analysis to calculate infection-related risk signals for four TNF-α inhibitors and compared them with infection-related signals for seven other therapies. Results There were 55,379 reports of infection-related adverse events (AEs) with TNF-α inhibitors as a ‘primary suspect (PS)’ therapy. The median time to onset of infection-related AEs was 113 days (interquartile range [IQR] 14–612). TNF-α inhibitors present the strongest infectious toxic signal than interleukin 12/23 (IL-12/23) inhibitors, integrin blockers, Jak inhibitors, and S1P receptor modulator. Compared with infliximab, certolizumab pegol, and adalimumab, golimumab showed the strongest signal. The strongest signal corresponding to appendicitis, pulmonary tuberculosis, pneumonia, sepsis, urinary tract infection, otitis media and herpes zoster is golimumab, infliximab, golimumab, natalizumab, certolizumab pegol, infliximab, and infliximab. Conclusions Compared with other control therapies, TNF-α inhibitors have the strongest infectious toxicity signal. Compared with other TNF-α inhibitors, golimumab has the strongest infectious toxicity signal. When using TNF-α inhibitors to treat IBD, infection-related AEs should be vigilant.

Olmesartan Restores LMNA Function in Haploinsufficient Cardiomyocytes.

Gene mutations are responsible for a sizeable proportion of cases of heart failure. However, the number of patients with any specific mutation is small. Repositioning of existing US Food and Drug Administration-approved compounds to target specific mutations is a promising approach to efficient identification of new therapies for these patients. The National Institutes of Health Library of Integrated Network-Based Cellular Signatures database was interrogated to identify US Food and Drug Administration-approved compounds that demonstrated the ability to reverse the transcriptional effects of LMNA knockdown. Top hits from this screening were validated in vitro with patient-specific induced pluripotent stem cell-derived cardiomyocytes combined with force measurement, gene expression profiling, electrophysiology, and protein expression analysis. Several angiotensin receptor blockers were identified from our in silico screen. Of these, olmesartan significantly elevated the expression of sarcomeric genes and rate and force of contraction and ameliorated arrhythmogenic potential. In addition, olmesartan exhibited the ability to reduce phosphorylation of extracellular signal-regulated kinase 1 in LMNA-mutant induced pluripotent stem cell-derived cardiomyocytes. In silico screening followed by in vitro validation with induced pluripotent stem cell-derived models can be an efficient approach to identifying repositionable therapies for monogenic cardiomyopathies.

Evaluation of Gadolinium-Based Contrast Agents in Juvenile Non-Human Primates Including Behavioral Evaluations Such as Learning and Memory.

The US Food and Drug Administration (FDA) requested the four Gadolinium-Based Contrast Agents (GBCA) New Drug Application (NDA) holders to investigate the effects of gadolinium (Gd) retention on fetal and neonatal development in mice and juvenile non-human primates (NHP) as well as the effects of repeated GBCA administrations on behavioral, neurological, and histopathological endpoints. Two linear (gadodiamide and gadobenate dimeglumine) and one macrocyclic (gadobutrol) GBCA, intended to be representative of linear non-ionic, linear ionic, and macrocyclic GBCAs, were investigated in a juvenile toxicity study in the cynomolgus monkey. Clinical observations, body weight, food consumption, clinical chemistry, full histopathology, and behavioral/neurological parameters including learning and memory were assessed. Additionally, Gd was quantified in the brain and other selected organs/tissues. A total of 84 juvenile animals (n = 12/group) were intravenously dosed every 4 weeks from postnatal day 28 for a total of 8 administrations over 29 weeks. Evaluation at the end of dosing, or after a recovery phase, was conducted to assess the reversibility of any observed effects. Necropsy was performed on Day 198 of the dosing phase for four animals/group and Day 365 of the recovery phase for the remaining eight animals/group. No GBCA-related adverse effects were observed in juvenile cynomolgus monkeys either at the end of the dosing or recovery periods. The no-observed-effect-levels (NOEL) for gadobutrol and gadodiamide administration were 0.9 mmol/kg and, for gadobenate dimeglumine, 0.3 mmol/kg (due to a non-adverse difference in learning during the recovery phase in the high dose group). The no-observed-adverse-effect-level (NOAEL) for all GBCAs was established as at least 0.9 mmol/kg. Gd levels observed in brain tissue of cynomolgus monkey after juvenile exposure to multiples of equivalent clinical doses of all GBCAs tested did not correlate with any adverse morphological or functional findings. This study showed no evidence that exposure to GBCA during development presents a potential risk for long-term effects such as behavioral, neurological, or histopathological findings in the brain, and/or impaired learning or memory.

Familial chylomicronemia syndrome and treatments to target hepatic APOC3 mRNA.

Familial chylomicronemia syndrome and treatments to target hepatic APOC3 mRNA.

Computation screening for incorrectly determined cocrystal structures.

Pharmaceutical solid forms, like salts and cocrystals, play a crucial role in drug formulation. Despite differing mainly by a single hydrogen atom, the regulatory requirements set by the US Food and Drug Administration for these forms vary significantly. We previously developed a DFT-based computational method to distinguish salts from cocrystals. This method, validated on 95 structures, performed well for systems where hydrogen bonds were longer than 2.613 (16) Å. Here, benefits of the rSCAN functional over the PBE functional are discussed. We expand the dataset to 404 cocrystal models. Analysis confirms that 301 of these forms are indeed cocrystals. Additionally, 87 salt-cocrystal continuum forms are identified and 16 cocrystals are classified as possible salts. These 16 problematic structures are further investigated and for seven of them, single crystals were grown and their structure determined using single-crystal X-ray diffraction. Among the phases exhibiting salt-like behaviour, five of them are identified as salts. In some cases, rSCAN alone gives unreliable results for strong hydrogen bonds, but these discrepancies are often corrected using better-renormalized or hybrid functionals (i.e. r2SCAN, PBE0 and PBE50). For future calculations, we recommend using the r2SCAN functional for salt-cocrystal differentiation, as it provides reliable results for O-H...N bonds longer than 2.554 (5) Å. The r2SCAN functional offers a good balance between accuracy and computational efficiency for systems with longer O-H...N bonds.

Intestinal bacteria-derived extracellular vesicles in metabolic dysfunction-associated steatotic liver disease: from mechanisms to therapeutics.

Intestinal bacteria-derived extracellular vesicles in metabolic dysfunction-associated steatotic liver disease: from mechanisms to therapeutics.

Double preloaded internal up-and-over technique for total transfemoral four vessel thoracoabdominal multibranch endoprosthesis with temporary aortic balloon occlusion for ruptured complex abdominal aortic aneurysm.

Double preloaded internal up-and-over technique for total transfemoral four vessel thoracoabdominal multibranch endoprosthesis with temporary aortic balloon occlusion for ruptured complex abdominal aortic aneurysm.

Evaluating Breast Implant Screening Guidelines in Breast Cancer Reconstruction.

In 2020, the US Food and Drug Administration updated its surveillance recommendations for breast implant rupture to ultrasound screening or magnetic resonance imaging (MRI) 5-6 years following silicone implant placement, with repeat screening every 2-3 years thereafter. This study evaluates the risk of implant rupture and assesses the utility of routine surveillance MRIs in diagnosing implant rupture. We performed a retrospective review of patients with implant-based reconstruction for breast cancer with a single surgeon between 2012 and 2017. Inclusion criteria included a 5-year minimum follow-up period. Analysis was performed to elucidate rupture rate and associated factors. A total of 376 patients underwent reconstruction with saline (13%) and silicone implants (87%). Seventy-five (20%) underwent routine MRI screening within 5-6 years of surgery. Implant rupture occurred in 26 patients (7%). Average time from implant placement to rupture was 5.9 ± 4.0 years. Fifty-nine percent of silicone implant ruptures were diagnosed by MRI screening. Thirty-eight percent of silicone implant ruptures presented without clinical symptoms and were identified on routine MRI screening. All saline implant ruptures presented with clinical symptoms. On imaging, ruptures were classified as intracapsular (81%) or extracapsular (12%). Seventy-three percent of ruptures were confirmed intraoperatively during implant replacement. Median time for rupture diagnosis to implant removal/replacement was 3 months (range, 0.5-21 months). MRI screening for silicone implant rupture in implant-based breast reconstruction had a 59% detection rate, with relatively low patient adherence (20% within 5-6 years after surgery), highlighting the challenges of screening. Patients should be counseled on the risk of implant rupture and the likelihood of needing replacement during their lifetime.