Medical Devices
Breast Implants Linked to Rare Cancer Are Recalled Worldwide
By Denise Grady, The New York Times. Textured breast implants made by Allergan that have been linked to an unusual cancer are being recalled in the United States at the request of the Food and… Read More
Widespread Harm From Faulty Heart Device Kept Secret by FDA
By Christina Jewett, for Kaiser Health News. Faced with the possibility that a bout of abnormal heartbeats could end his life, in 2006, Dr. Marc Sicklick had a small device implanted in his chest that… Read More
FDA Hides Information on Dangerous Devices From Patients and Doctors
By Christina Jewett, Kaiser Health News. The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which leave doctors and medical sleuths in… Read More
FDA Finally Orders Halt to Sales of Vaginal Mesh Used in Pelvic Procedures
By Laurie McGinley, The Washington Post. The Food and Drug Administration on Tuesday ordered manufacturers of surgical mesh used for repairing a condition called pelvic organ prolapse to immediately stop selling their products, the latest turn in… Read More
The Da Vinci Surgical Robot: A Medical Breakthrough With Risks for Patients
By Emily R. Siegel, Cynthia McFadden, Kevin Monahan, Andrew W. Lehren and Pauliina Siniauer, for NBC News. Nearly 17,000 events were classified as device malfunctions over the past 10 years in an FDA database, according… Read More
Laparoscopic Power Morcellator Dangerous for Hysterectomy or Myomectomy due to Fibroids
From the FDA. “Since the FDA first issued warnings about the risk of spreading unsuspected uterine cancer from the use of laparoscopic power morcellators, we have continued to review new research to ensure our recommendations… Read More
FDA Warning to Patients With Metal-on-Metal Hip Implants
From the FDA. How do I know if I have a metal-on-metal hip implant? Patients are usually told about the type of implant they are receiving prior to the surgery. If you are uncertain about… Read More
FDA Medical Device Recalls
The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. Use… Read More
Are FDA Approval Processes Causing Medical Device Failures?
By Walkup, Melodia, Kelly & Schoenberger. On the heels of a report from the General Accounting Office criticizing the way the Food and Drug Administration (FDA) handles approvals of medical devices (such as the DePuy… Read More