Adverse Event Reporting of Commonly Used Gender-Specific Implantable Medical Devices in the United States.
J Patient Saf
; 19(7): 465-468, 2023 10 01.
Article
em En
| MEDLINE
| ID: mdl-37729644
ABSTRACT
BACKGROUND:
Evidence suggests that more women are harmed by implantable medical devices than men. It is unknown whether this difference includes gender-specific devices.METHODS:
In this study, we examine the differences in reported adverse events between 6 female- and 5 male-specific implantable devices from the Manufacturer and User Facility Device Experience (MAUDE) database from 1993 to 2018. Primary endpoints were injury type (life-threatening, disability, death) and the rate of device evaluation by the manufacturer. Proportions of valid entries across these variables were compared using either the Fisher exact test or χ2 test.RESULTS:
Female-specific devices had higher rates of life-threatening outcomes (1.6% versus 0.3%, P < 0.001), disabilities (5.0% versus 4.3%, P < 0.001), and deaths (0.6% versus 0.1%, P < 0.001) compared with the male-specific devices. Of the 8159 devices that were evaluated by the manufacturer, 56% were female specific while 44% were male specific. Female-specific devices were evaluated far less frequently by the manufacturer (4.5% versus 38.2%, P < 0.001).CONCLUSIONS:
Increased adverse events reports for female-specific devices and associated high-grade complications necessitates improved postmarket surveillance.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Próteses e Implantes
/
Instalações de Saúde
Limite:
Female
/
Humans
/
Male
País/Região como assunto:
America do norte
Idioma:
En
Revista:
J Patient Saf
Assunto da revista:
SERVICOS DE SAUDE
Ano de publicação:
2023
Tipo de documento:
Article