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The U.S. Food and Drug Administration has issued warning letters to Sientra Inc and a Johnson & Johnson unit for failing to comply with the post-approval study requirements for their breast implants.
All patients are reviewed for contraindications prior to MRI scanning. Medical devices and implants are categorized as MR Safe, MR Conditional or MR Unsafe: [6] MR-Safe – The device or implant is completely non-magnetic, non-electrically conductive, and non-RF reactive, eliminating all of the primary potential threats during an MRI procedure.
Tissue expansion is a common technique used for breast reconstruction. [20] This essentially involves expansion of the breast skin and muscle using a temporary tissue expander. [21] Three to four weeks after the mastectomy, a saline solution will be injected into the expander to gradually fill it. This process is supported by a tiny valve ...
Magnetic resonance elastography (MRE) is a form of elastography that specifically leverages MRI to quantify and subsequently map the mechanical properties (elasticity or stiffness) of soft tissue. First developed and described at Mayo Clinic by Muthupillai et al. in 1995, MRE has emerged as a powerful, non-invasive diagnostic tool, namely as an ...
Doctors are warning patients not to wear spandex clothing when coming in for a magnetic resonance imaging (MRI) procedure. Fabrics that use spandex often have metallic threads that could react ...
The company's devices, BioZorb Marker and BioZorb LP Marker, are implanted in soft tissue, including breast tissue, where the site needs to be marked for future procedures, such as radiation for ...
Expert Review of Medical Devices is a monthly peer-reviewed medical journal covering research on the clinical use of devices. It was established in 2004 and is published by Informa . According to the Journal Citation Reports , the journal has a 2013 impact factor of 1.784.
Subcutaneous inflatable balloon expander Accessories and implants Trephine: Cutting instrument Trocar: Access instrument. Used to create an opening into a space without opening the abdominal cavity. A camera is inserted through one to view the interior while instruments are inserted through the others to manipulate the organs. Ultrasonic energy ...