Dr Ken Harvey has provided links to the following investigations
- Everything you need to know about, “The Implant Files”
- Medical Devices Harm Patients Worldwide As Governments Fail On Safety
- Medtech Giant Pushes Boundaries As Casualties Mount And Sales Soar
- Breast Implant Injuries Kept Hidden As New Health Threats Surface
- Experts Warn Expanded Heart Valve Use Risks Patient Safety
- The Implant Files reveal how breast implants linked to rare cancer set off alarm bells
- The Implant Files reveal defibrillators pulled from market still being used in emergencies
- Controversial vaginal mesh implants banned because of risk to prolapse patients
- Pelvic mesh implants: How tracking vehicle parts is easier than medical devices
- Patient Hopes Rise And Fall As An Industry Balances Progress And Profit
- What is TAVR? Five takeaways from our investigation into a new heart valve device
- BMJ – How lobbying blocked European safety checks for dangerous medical implants
Resources for patients and frequently asked questions
See also: The Bleeding Edge: Netflix documentary about the U.S. $400bn medical device industry
Review: https://www.theguardian.com/film/2018/jul/25/the-bleeding-edge-netflix-documentary-medical-devices
Devices covered in “The Bleeding Edge”:
- Essure contraceptive device
- Hip Implants
- Transvaginal mesh
- Da Vinci Robotic surgical system
U.S. Regulation:
- Medical Devices — Balancing Regulation and Innovation
- Regulation of Medical Devices in the United States and European Union
- Medical Devices in the Real World
- Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D. November 20, 2018.
Australian perspective:
- ABC background Briefing: The Implant Files: Deadly devices
- ABC Background Briefing (Part 1) Podcast N.B. Sawyer Extractor™ Pump for Snake Bite complaint mentioned at 34 minutes.
- ABC Background Briefing (Part 2)
- The Implant Files reveal how Australians were used as guinea pigs in medical device trial
- Medical device regulation in Australia: safe and effective?
- Increased scrutiny of medical devices by TGA
- Australian Orthopaedic Association’s National Joint Replacement Registry
- Australian Breast device registry and TGA information about Breast Implant Associated Anaplastic Large Cell Lymphoma
- Pelvic mesh implants ‘one of the biggest medical scandals’ involving Australian women
- Specific types of transvaginal (urogynaecological) surgical mesh cancelled by TGA
- Secret pacemaker payments boosting private hospital coffers but costing the health system
- Young doctors struggle to learn robotic surgery
- CHF: Future of medical devices a challenge for society