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Medical Device Safety

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Kavanagh KT, Kraman S. An Analysis of the FDA MAUDE Database and the Search for Cobalt Toxicity in Class 3 Johnson & Johnson/DePuy Metal-on-Metal Hip Implants. Journal of Patient Safety: October 10, 2018 - Publish Ahead of Print

Letter In Support regarding the CDC's Action Regarding the High Incidence of Occult Cancer in Hysterectomy Specimens.   "Review of Pre-operative Evaluation of Women Undergoing Hysterectomy and Myomectomy" Health Watch USA Position Letter.  May 9, 2018    View Letter

Sarah Robinson, PA.  Although there is no existing test to rule out Sarcoma, if caught early without spread, Sarcoma is curative. Do say "NO" to your GYN surgeon who offers you a cosmetic "bikini incision" laproscopic hysterectomy, a surgery which uses the power morcellator tool to grind your uterus into smaller pieces removed from "keyhole" incisions. Your life may depend on it". Health Watch USA Meeting April 18, 2018. 

Madris Tomes CEO of Device Events discusses shortcomings of the FDA's MAUDE Database along with the need for better and more timely post market monitoring of medical device safety. Health Watch USA Conference - Nov. 3, 2017.

Stephen S. Tower, MD reports on 28 patients with cobalturia and encephalopathy associated with cobalt chromium hip implants. Health Watch USA Conference. Nov. 3, 2017.

Robert Bridges, MD discusses the PET Scan changes in patients with encephalopathy associated with cobalt chromium hip implants. Health Watch USA Conference. Nov. 3, 2017.

Joleen Chambers from FiDA (FAILED Implant Device Alliance) discusses several dangerous medical devices along with the lack of sufficient testing and post-market follow-up. Health Watch USA Meeting.  Jun. 21, 2017.

Evidence Mounts That Some Hip Implants Are Toxic to The Brain.  News Relesase.  June 6, 2017.  View Release

Amanda Rusmisell, The Essure Problems Group and Dangers Associated With the Essure Contraceptive device.   Health Watch USA Meeting.  Jan. 18, 2017.  YouTube Video:

Dr. Stephen Tower, Complications of Wear or Corrosion of Chromic-Cobalt Hip Implants.   Health Watch USA Conference.  Nov. 4, 2016.    YouTube Video:    Presentation Slides

Without more monitoring, medical devices will keep harming patients   Lexington Herald Leader.  Aug. 14, 2015.  We all need to encourage Congress to amend the 21st Century Cures Act to assure effective pre-market testing and post-market monitoring of medical devices.   View Op-Ed

Dr. Hooman Noorchashm & Dr. Amy Reed on Uterine Morcellation and The Spreading of Cancer:   Jack Pattie Radio Show / Webcast.     May 12, 2015.   YouTube Video

Lawrence F Muscarella, PhD  on the Prevention of Transmission of the ‘Superbug’ Carbapenem-Resistant Enterobacteriaceae (CRE) during Gastrointestinal Endoscopy.  2015, May 15.
LFM Healthcare Solutions, LLC.   View Presentation

Dr. Stephen Tower, on the epidemiology and mechanisms of failure of total hip arthroplasty and associated heavy metal poisoning.   Health Watch USA Conference.  Nov. 7, 2014.    You Tube Video:   presentation slides

Collage of Patients Developing Advanced Stage Cancer from Uterine MorcellationDr. Hooman Noorchashm and Dr. Amy Reed on the dangers of Uterine Morcellation:   Health Watch USA Meeting.  June 25, 2014.  (Picture to the right shows a collage of patients who developed advanced stage cancer from uterine morcellation.  Those with a ribbon have died.) 

  • Segment 1:   Hooman Noorchashm MD, PhD on the morcellation disaster: A root cause analysis and perspective. YouTube Video:

  • Segment 2:   Amy J. Reed MD, PhD on the morcellation disaster: A physician, patient, and mother of six, gives her personal perspective.  YouTube Video: 

  • Segment 3:  Dr Noorchashm presents his research and perspective leading to a plan of action to ban the procedure of morcellation and revising the 510K medical device approval process.   YouTube Video: 

Dr. Stephen Tower, presenting on adverse events associated with Metal-on-Metal Hip Implants
HW USA Meeting.  Apr. 2, 2014  
YouTube Video

Lisa McGiffert from Consumer Union on the Safety of Medical Devices
Webcast/Radio.   Oct. 22, 2013   
Listen to Webcast of Radio Show (Jack Pattie) Presentation

Joleen Chambers from FiDA on the Safety of Medical Devices      Failed Implant Device Alliance
HW USA Conference.  Nov. 1, 2013