The International Consortium of Investigative Journalists (ICIJ) latest investigation: The Implant Files.
- 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
JAMA Perspective: Mesh Implants forWomen: Scandal or Standard of Care?
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.
- US Halts Sale of Vaginal Mesh Blamed for Thousands of Injuries
- Moving From Substantial Equivalence to Substantial Improvement for 510(k) Medical Devices
- FDA recommends boxed warning for breast implants
- FDA recommends tough warnings for breast implants
- FDA challenged over metal implants ‘public health travesty’
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?
- Australian Orthopaedic Association’s National Joint Replacement Registry
- Australian Breast device registry
- Breast Implant Associated Anaplastic Large Cell Lymphoma
- Vaginal mesh controversy shows collective failure of the TGA and Australia’s specialists
- Pelvic mesh implants ‘one of the biggest medical scandals’ involving Australian women
- Increased scrutiny of medical devices by TGA
- 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
- TGA latest:
- Cut private health insurance costs by fixing how we pay for hip replacements and other implants
- Pelvic mesh maker Johnson and Johnson loses Australian class action suit
- Where were the regulators? How authorities failed pelvic mesh victims
- Cosmetic doctors keep using suspended breast implants
- ‘Outrageous’: Banned breast implant maker flouts TGA and safety concerns
- TGA response: What you need to know about unapproved breast implants
- Pacemaker-defibrillator device shocks patient 60 times, but manufacturer Biotronik denies problem
- Johnson & Johnson to pay $2.6m to women with faulty pelvic mesh implants
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