Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, June 30, 2017

The FDA Owes Patients Improved Medical Device Regulation After Dr. Amy Reed's Death

Kirsten Clodfelter  JUN 30, 2017 @ 07:05 AM   FiDA highlight

Dr. Amy Reed, an anesthesiologist and patient-safety advocate, died in May 2017 after a four-year battle with leiomyosarcoma of the uterus. The cancer was spread by a power morcellator, the medical device used for her 2013 hysterectomy.
The surgical tool, released in 1995, was once lauded for facilitating minimally invasive surgery that decreased recovery times and minimized the risk of post-surgical infections. Morcellation, used to remove uterine fibroids or conduct complete hysterectomies, was performed on approximately 50,000 women a year in the U.S. in the early 2010s.
Yet for patients like Dr. Reed, whose uterine fibroids appeared benign but hid an aggressive type of cancer, morcellation can become a death sentence. The device is equipped with a spinning blade, which slices up tissue for removal piece by piece through small incisions. When the blade cuts through a cancerous tumor, it sprays malignant cells around the body, spreading the disease. Following her procedure, Dr. Reed, a mother of six, was left with advanced, Stage 4 cancer.

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