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International Orthopaedics Oct 2014Management of the unexplained, painful large diameter metal-on-metal (MOM) hip replacement is difficult. Although there are guidelines for surgeons, there is no clear...
PURPOSE
Management of the unexplained, painful large diameter metal-on-metal (MOM) hip replacement is difficult. Although there are guidelines for surgeons, there is no clear documented evidence describing the overall threshold for revision surgery. The 2010 product recall of the DePuy Articular Surface Replacement (ASR) and subsequent media coverage may have increased patient and surgeon apprehension, resulting in earlier intervention, i.e. at a greater Oxford hip score (OHS) than expected. Our aim was to investigate whether the threshold for revision using known parameters was affected by the ASR recall. These parameters include poor clinical results (persistent pain or mechanical symptoms), pseudotumour or other progressive soft tissue involvement, osteolysis and high or rising metal ion levels.
METHODS
We used our national referral database of MOM hips, which were revised between 2008 and 2012. Once inclusion and exclusion criteria were applied, we identified 240 patients--71 patients in the pre-recall group and 169 patients in the post-recall group.
RESULTS
The ASR product recall did not seem to affect the threshold for revision of a MOM hip, with no significant difference between the two groups in terms of the functional (median OHS = 17 pre-recall and 20 post-recall; pā=ā0.2109) and radiological (median inclination angle = 50 pre-recall and 48 post-recall; pā=ā0.3221) markers used to guide management. We did however discover that blood metal ion levels were higher in the post-recall group.
CONCLUSION
Issue of a product recall did not change the hip function threshold for revision surgery. The decision to revise a metal-on-metal hip is complex and should follow published guidelines, encompassing metal ion measurement and cross-sectional imaging where appropriate.
Topics: Adult; Aged; Aged, 80 and over; Arthroplasty, Replacement, Hip; Databases, Factual; Decision Making; Female; Hip Prosthesis; Humans; Male; Medical Device Recalls; Metal-on-Metal Joint Prostheses; Middle Aged; Reoperation; Young Adult
PubMed: 24827970
DOI: 10.1007/s00264-014-2369-z -
PloS One 2023Product-harm crises have detrimental effects on firm's sales, reputation, and financial value, requiring crisis managers to promptly adopt appropriate response...
Product-harm crises have detrimental effects on firm's sales, reputation, and financial value, requiring crisis managers to promptly adopt appropriate response strategies to mitigate these impacts. Situational Crisis Communication Theory (SCCT) guides managers to align responsibility attribution with response strategies. Using Chinese listed firms' product-harm crises sample from 2015 to 2021, this study analyzes the stock market's reaction to different response strategies. The event study method reveals that a passive strategy is more effective during the disclosure stage, and accept+no recall and deny+recall are conforming strategies during the initial response stage. Additionally, firms with a crisis history should assume greater responsibility when developing response strategies for product-harm crises, as crisis history amplifies negative effects. The results provide recommendations to help managers formulate appropriate strategies.
Topics: Commerce; Disclosure; Social Perception; Product Recalls and Withdrawals; Consumer Product Safety; Private Sector; Public Opinion; Truth Disclosure; China
PubMed: 37616251
DOI: 10.1371/journal.pone.0290548 -
The American Journal of Gastroenterology Sep 2019
Review
Topics: Adverse Drug Reaction Reporting Systems; Drug Labeling; Drug-Related Side Effects and Adverse Reactions; Gastroenterology; Humans; Safety-Based Drug Withdrawals; United States; United States Food and Drug Administration
PubMed: 31464745
DOI: 10.14309/ajg.0000000000000374 -
JAMA Internal Medicine Feb 2020Timely and complete disclosure of medical device defects is necessary to manage patient care safely and effectively.
IMPORTANCE
Timely and complete disclosure of medical device defects is necessary to manage patient care safely and effectively.
OBJECTIVES
To determine if the manufacturer's recommendations following the recall of a medical device were timely and complete, the follow-up information and data provided to patients and physicians were adequate for managing patient care, and the actions taken by the US Food and Drug Administration (FDA) regarding the recall were appropriate.
DESIGN, SETTING, AND PARTICIPANTS
This single-center retrospective case series included 90 of 448 patients who were implanted with a cardiac resynchronization therapy pacemaker at the Minneapolis Heart Institute from May 2003 through January 2011; this pacemaker was recalled in November 2015. In addition, returned product reports submitted by the manufacturer to the FDA via the Manufacturer and User Facility Device Experience (MAUDE) database from January 2008 through December 2018 were analyzed.
MAIN OUTCOMES AND MEASURES
Clinical outcomes were serious adverse clinical events that occurred before and after the November 2015 recall notifying physicians and patients that the device's battery could fail unexpectedly because of high internal impedance. Technical outcomes were signs and causes of failure.
RESULTS
Five of 90 patients observed during 2015 experienced syncope when their pacemakers stopped pacing owing to battery or wire connection defects prior to the recall. Of the 90 patients, 37 (41%) were men, and the median (interquartile range) age at implantation was 71.3 (66.1-78.2) years. Analysis of the MAUDE data revealed that battery failures prior to the recall were associated with serious adverse events that included 1 death, 1 cardiac arrest, 5 syncopal attacks, and 6 heart failure exacerbations; 3 additional prerecall syncopal events were caused by wire connection defects. The manufacturer and the FDA were aware of the battery and wire connection defects for 19 months before issuing the recall, yet the wire connection problem was not included in the advisory and physicians were not informed that interrogating the pacemaker could result in loss of pacing. The FDA classified the recall as class II rather than the more critical class I.
CONCLUSIONS AND RELEVANCE
This case series study of patients implanted with a defective pacemaker found that the pacemaker recall was delayed and that subsequent communications did not include all critical information needed for safe and effective patient care. These findings should prompt reforms in how the medical device industry and the FDA manage future medical device recalls.
Topics: Aged; Cardiac Resynchronization Therapy Devices; Disclosure; Disease Progression; Equipment Failure; Female; Heart Arrest; Heart Failure; Humans; Information Dissemination; Male; Medical Device Recalls; Mortality; Retrospective Studies; Syncope; Time Factors; United States; United States Food and Drug Administration
PubMed: 31860011
DOI: 10.1001/jamainternmed.2019.5171 -
Journal of Medicinal Chemistry Mar 2021A product recall is the outcome of a careful pharmacovigilance; and it is an integral part of drug regulation. Among various reasons for product recall, the detection of...
A product recall is the outcome of a careful pharmacovigilance; and it is an integral part of drug regulation. Among various reasons for product recall, the detection of unacceptable levels of carcinogenic impurities is one of the most serious concerns. The genotoxic and carcinogenic potential of -nitrosamines raises a serious safety concern, and in September 2020, the FDA issued guidance for the pharmaceutical industry regarding the control of nitrosamines in drug products. The FDA database shows that >1400 product lots have been recalled from the market due to the presence of carcinogenic -nitrosamine impurities at levels beyond the acceptable intake limit of 26.5 ng/day. The drugs that were present in recalled products include valsartan, irbesartan, losartan, metformin, ranitidine, and nizatidine. This perspective provides a critical account of these product recalls with an emphasis on the source and mechanism for the formation of -nitrosamines in these products.
Topics: Carcinogens; Drug Contamination; Drug Industry; Drug Recalls; Humans; Nitrosamines; Pharmaceutical Preparations; United States; United States Food and Drug Administration
PubMed: 33706513
DOI: 10.1021/acs.jmedchem.0c02120 -
JAMA Oct 2022
Topics: Humans; Continuous Positive Airway Pressure; Sleep Apnea, Obstructive; Positive-Pressure Respiration; Ventilators, Mechanical; Medical Device Recalls
PubMed: 36255436
DOI: 10.1001/jama.2022.15478 -
Medecine Et Maladies Infectieuses Jun 2017Already used in various countries, trimethoprim (TMP) was withdrawn from the French market in 1990, but should be soon available again. This article reviews the... (Review)
Review
Already used in various countries, trimethoprim (TMP) was withdrawn from the French market in 1990, but should be soon available again. This article reviews the experience of TMP use around the world and its current use in Europe. Label use and guidelines only recommend the use of TMP for the treatment of urinary tract infections (UTI). Compared with co-trimoxazole (Co-T), a combination of TMP and sulfamethoxazole (SMX), TMP has (a) a similar resistance rate among Escherichia coli strains (estimated between 10 and 20% in uncomplicated cystitis), (b) a similar clinical efficacy for cystitis prevention and treatment, (c) a lower toxicity (as severe toxicity adverse effects of Co-T come from its sulfonamide component), (d) limited data for the treatment of pyelonephritis and male UTIs, and (e) an important impact on the microbiota. TMP should thus be indicated in the third-line empirical treatment of acute uncomplicated cystitis (sparing fluoroquinolones and nitrofurantoin), in the prevention of recurrent acute cystitis when an antibiotic prophylaxis is required (possibly in first line), and in the treatment of documented acute cystitis at risk of complications. Updated data on the epidemiology of resistance to TMP per clinical pictures is now required. The bactericidal effect of TMP should also be confirmed on recent strains (although limited recent data suggests a bactericidia similar to that of Co-T) and its clinical efficacy should be evaluated in pyelonephritis and male UTI.
Topics: Anti-Bacterial Agents; Cystitis; Drug Resistance, Bacterial; Drug Utilization; Escherichia coli; Escherichia coli Infections; Fosfomycin; France; Humans; Practice Guidelines as Topic; Product Recalls and Withdrawals; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Urinary Tract Infections
PubMed: 28043762
DOI: 10.1016/j.medmal.2016.12.001 -
Nutrients Sep 2023The range of gluten-free food products available to consumers is steadily expanding. In recent years, recalls of food products have highlighted the importance of...
The range of gluten-free food products available to consumers is steadily expanding. In recent years, recalls of food products have highlighted the importance of accurate labeling of food products for the presence of wheat, other gluten-containing cereals, or gluten itself as refined ingredient. The purpose of this study was to gain more insights into recent food recalls related to undeclared gluten/wheat contamination and consumer experiences with these recalls. Recalls of products triggered by gluten contamination are relatively scarce and are not often triggered by a consumer complaint. The impact of these recalls on consumer trust was evaluated through an online survey that was distributed among supporters of Celiac Canada (CCA) and covered (i) strategies to adhere to a gluten-free diet, (ii) experiences with gluten-free recalls and their impact on consumer trust, and (iii) demographic information. Consumer concern regarding gluten-free product recalls is significant, but the concern regarding recalls is not heightened after experiencing a recall. Companies pursuing transparency in the process, identification of the source of contamination, and mitigation strategies going forward are likely to retain consumer trust in their product and brand. Based on the survey results, further efforts focusing on consumer education regarding interpreting nutrient labels, identifying sources of information on product recalls, and understanding procedures to follow upon suspected gluten contamination of a gluten-free product are recommended.
Topics: Humans; Diet, Gluten-Free; Food Labeling; Trust; Glutens; Product Recalls and Withdrawals; Celiac Disease
PubMed: 37836454
DOI: 10.3390/nu15194170 -
The Journal of Arthroplasty Aug 2023Orthopaedic devices comprise nearly 20% of devices on the market and 12% to 20% of these devices undergo a recall within 10 years. More than 95% of these devices are...
BACKGROUND
Orthopaedic devices comprise nearly 20% of devices on the market and 12% to 20% of these devices undergo a recall within 10 years. More than 95% of these devices are approved without supporting clinical data through the Food and Drug Administration's 510(k) pathway. The risk of recall of orthopaedic arthroplasty devices approved through the 510(k) pathway has not been previously studied.
METHODS
The FDA 510(k) database was queried for orthopaedic devices approved between January 01, 2008 and December 31, 2018 and subsequently codified to hip and knee arthroplasty devices using product codes. The database included 904 arthroplasty devices during the study period, with hip and knee making up 53.7% (485) and 46.3% (419) of devices, respectively. Information regarding numbers, dates, and reasons for recall were recorded. Cumulative incidence function was conducted to compare the risk of recall between hip and knee arthroplasty.
RESULTS
In total, 94 (19.4%) hip and 85 (20.3%) knee devices were recalled. The hazard of recall by 10 years for hip and knee arthroplasty devices was approximately 24%, with no statistical differences between each region. The most common causes of recall were process control and device design, accounting for 29.6% and 26.3% of recalls, respectively, with no significant difference between study groups.
CONCLUSION
The risk of recall for arthroplasty devices is more than that previously understood. Improved postmarket surveillance strategies along with increased physician participation in detecting and reporting device safety issues are necessary to strengthen patient safety.
Topics: United States; Humans; Medical Device Recalls; United States Food and Drug Administration; Product Surveillance, Postmarketing; Patient Safety; Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip
PubMed: 36773660
DOI: 10.1016/j.arth.2023.01.068 -
American Journal of Therapeutics 2010
Topics: Humans; Hypotension, Orthostatic; Midodrine; Product Recalls and Withdrawals; Product Surveillance, Postmarketing; Sympathomimetics
PubMed: 20844343
DOI: 10.1097/MJT.0b013e3181f7e4ea