An Analysis of the FDA MAUDE Database and the Search for Cobalt Toxicity in Class 3 Johnson & Johnson/DePuy Metal-on-Metal Hip Implants

Conclusions We were not able find in the FDA MAUDE database meaningful warning signs to support the contention that chromium-cobalt–containing Class 3 J&J and DePuy hip implants caused systemic neurological or thyroid symptoms in patients. The incidence of reported cardiomyopathy was rare but frequent enough to be cause of concern. The redaction of most patient data along with the nonstructured nature of data entry would be expected to hinder the identification of warning signs. Even identification of the type of device could not be consistently carried out. In addition, the FDA needs to implement a methodology to identify and group all reports from a single device implanted into a patient, so duplication of event counting would not occur. Of 83,550 J&J/DePuy KWA Reporter File records, we found only two physician reports sent directly to the FDA. Almost all reports are submitted by manufacturers and are most commonly authored by attorneys. A standard of care needs to be set for physicians to report medical device adverse events to the FDA.
Source: Journal of Patient Safety - Category: Health Management Tags: Original Articles Source Type: research

Related Links:

OBJECTIVES: The aim of the study is to investigate the views of adolescents aged 16-19, attending public high schools in Warsaw, on effectiveness of suicide prevention. METHODS: The studied population covered adolescents aged 16-19 back in 2015 (M ...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
BACKGROUND: Bullying victimization among school-aged children is an important public health issue that may affect their well-being and mental health. However, few studies have been conducted on left-behind children in rural China, who are defined as the ch...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
Social media (SM) use is widespread among adolescents, and many SM outlets lend themselves to cyberbullying and its consequences, including anxiety, depression, and even suicide. The purpose of this study is to determine the current prevalence of bullying ...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
BACKGROUND: Surveillance of youth suicide attempts presents many challenges. To assess common data sources that capture information about youth suicidal behavior, we compared counts of high school students who reported (a) a suicide attempt and (b) an inju...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Adolescents Source Type: news
ABSTRACTObjectives:Late-life depression, falls, and fall worry are public health problems. While previous research confirms the cross-sectional relationship between depression and fall worry, few longitudinal studies have examined whether changes in fall w...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Age: Elder Adults Source Type: news
This study evaluated psychache and...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Suicide and Self-Harm Source Type: news
This study hypothesized that a higher diet quality...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Suicide and Self-Harm Source Type: news
PURPOSE: There is scant research on depressive symptoms (DS), suicidal ideation (SI), and mental health care-seeking in Mozambique. METHODS: Generalized estimating equations were used to assess factors associated with DS, SI, and mental health care...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Suicide and Self-Harm Source Type: news
BACKGROUND: To determine the prevalence of suicidal ideation and behaviour - and their correlates - in patients with persecutory delusions. METHODS: 110 patients with persecutory delusions in the context of non-affective psychosis were assessed for...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Suicide and Self-Harm Source Type: news
IVF patients who have a poor ovarian response are often not sure what to do. When they grow very few follicles inspite of taking lots of injections, they are understandably depressed and upset. Few follicles = few  eggs = few embryos, which means their chances of success are not very bright.One option is to cancel the cycle. However, the problem with this is that it's very unlikely that the next cycle will be any better , because poor ovarian response is often biologically determined. And unless they've gone to a clinic which is bad,  or if they feel that their doctor was incompetent and did not do...
Source: Dr.Malpani's Blog - Category: Reproduction Medicine Source Type: blogs
More News: Amnesia | Brain | Cardiology | Cardiomyopathy | Chromium | Cobalt | Databases & Libraries | Depression | Heart | Medical Devices | Neurology | Study | Thyroid | Toxicology | Warnings