Robotic Mastectomy
Request that The Commissioner of Food and Drugs Evaluate New Studies and Publish Guidance or Public Information on Robotic Mastectomy for Treatment of Breast Cancer and Update and Make Publicly Available Previous Safety Communications
Symvess
Request that The Commissioner of Food and Drugs Recall all Symvess Products, Suspend Humacyte’s Biologic License, Revoke the Food & Drug Administration’s Approval of the Symvess Biologic License Application, Hold a Public Hearing on Symvess, and Disclose Humacyte/Symvess Data to the Department of Defense
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Hybrid Convergent Approach to Cardica Ablation
Request that the Commissioner of Food and Drugs Issue A Letter to the Centers for Medicare and Medicaid Services, A Letter to Healthcare Providers, and a Communication Letter Confirming that the Off-Label Use of the Da Vinci Robotic System and Video-Assisted Thoracoscopy (VATS) Devices to Perform the “Hybrid Convergent Cardiac Ablation” Protocolin Patients with Isolated Atrial Fibrillation Requires an Food-and-Drug-Administration Approved Investigational Device Exemption for Clinical Investigational Use, and an It Has Come To Our Attention Letter Requesting Additional Information from Intuitive Surgical and VATS Device Manufacturers, including Olympus, About Any Promotion of their Medical Devices for the “Hybrid Convergent Cardiac Ablation” Protocol
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