Posts Tagged 'transvaginal mesh'

Consumer group calls for reform of FDA approval process

The independent nonprofit Consumer Reports has undertaken a national campaign to change the process by which the federal Food and Drug Administration approves medical devices, according to a report in the Chicago Tribune.

Consumer Reports says the agency’s approval of metal-on-metal hip implants and transvaginal mesh implants – both of which have led to thousands of reported cases of debilitating health problems — illustrate why reforming the process is necessary.

According to the Tribune, Consumer Reports President Jim Guest sent an email ...

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Medical groups voice concerns about transvaginal mesh implants

The American College of Obstetricians and Gynecologists and the American Urogynecologic Society recently issued a joint statement expressing the organizations’ concerns about the safety and effectiveness of transvaginal mesh implants to treat the condition pelvic organ prolapse.

In the statement, the groups say there’s an “urgent need” for a national registry to track outcomes for all current and future patients who get the procedure.

Pelvic organ prolapse occurs when there’s stretching or tearing of the pelvic floor muscles and connective tissue holding ...

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Medical groups voice concerns about transvaginal mesh implants

The American College of Obstetricians and Gynecologists and the American Urogynecologic Society recently issued a joint statement expressing the organizations’ concerns about the safety and effectiveness of transvaginal mesh implants to treat the condition pelvic organ prolapse.

In the statement, the groups say there’s an “urgent need” for a national registry to track outcomes for all current and future patients who get the procedure.

Pelvic organ prolapse occurs when there’s stretching or tearing of the pelvic floor muscles and connective tissue holding ...

continue reading...

Coalition demands more rigorous FDA screening

A coalition of patient, consumer, and public health groups urged the federal Food and Drug Administration to require more rigorous testing before a medical device used for addressing complications from aneurysm treatments can be sold.

“This decision by FDA sets a bad precedent for approving new devices,” said Lisa McGiffert, Director of Consumers Union’s Safe Patient Project. “Medical devices intended to save lives should require the FDA’s most rigorous safety testing. Bypassing such testing up front can put hundreds of thousands ...

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