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Public Interest Groups Will Leverage ‘Bleeding Edge’ Lessons To Push For Device Safety Changes

 
• By Sue Darcey

Public health organizations including the Facebook group ASHES/E-Sisters, and the National Center for Health Research, are pushing for wider distribution of and a big impact from the "The Bleeding Edge" Netflix documentary. They tell Medtech Insight that they will continued to lobby Congress and US FDA to put more safety regulations and protocols into place for devices.

Angie Firmalino group
Advocating Safety in Healthcare, E-Sisters (ASHES) Founder Angie Firmalino, second from left, joins fellow E-Sisters in lobbying Congress. • Source: ASHES

Health groups including Advocating Safety in Healthcare, Essure-Sisters (ASHES), and the National Center for Health Research (NCHR), led by Diana Zuckerman, say they plan to use the documentary film "The Bleeding Edge," to educate the public on harms that can be caused by medtech.

The film targets four products, among others – Bayer’s Essure sterilization device, Johnson & Johnson’s ASR metal-on-metal hips and ProLift pelvic mesh products, and Intuitive Surgical’s da Vinci surgical robot – in an effortto illustrate how device manufacturers and FDA have leveraged the device regulatory

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