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Recent Posts in Defective Medical Device Category

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West Virginia Trans-Vaginal MDL Running Smoothly

According to recent reports, the U.S. District Court for the West Virginia transvaginal mesh MDL is underway and running smoothly. This case was consolidated in February of this year and includes four ...
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FDA has no Monitoring System for Medical Devices

Five years ago, the Food and Drug Administration (FDA) received permission from Congress to set up a unique identifier system to monitor medical devices after they were approved for entry into the ...
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What Doctors aren't Telling you about Cellulaze

Cellulaze is a new laser treatment for cellulite removal. It was approved by the Food and Drug Administration (FDA) for the improvement of cellulite for up to three months. While doctors and some ...
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Trial Date Set for First Federal Vaginal Mesh Trial

The first of approximately 600 federal cases related to C.R. Bard Inc's dangerous vaginal mesh implant is set for February 5, 2013. More than 75,000 women have vaginal mesh devices inserted each ...
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How the FDA Intervenes

After any assessed risk with a product, the FDA will then intervene in some way. This may take on a number of different forms. One thing they will do is regulate product labeling. Products such as ...
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How the FDA Assesses Risk

The Food and Drug Administration has a process by which they assess and manage the possible risk of products. This goes for products that are both on the market and those that have not yet entered the ...
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Boston Scientific Defibrillator May Malfunction

Boston Scientific Corporation's Cognis and Teligen defibrillators may be at risk for malfunction. These defibrillators are used to restart a stopped heart. The device has been linked to one known ...
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St. Jude Medical to Stop Sales of Faulty Heart Device Wires

St. Jude Medical Inc. has decided to stop selling two different types of heart device wires after they were discovered to come out of insulation and cause problems for patients. The wires were ...
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Dental X-Rays Increase Risk of Brain Tumor

A new study published in the American Cancer Society's Cancer journal shows that patients who received certain kinds of dental x- rays are at a much higher risk of developing meningioma, one of ...
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St Jude's Handling of Recent Recalls Raises Questions About Heart Device Industry

Seven years ago, medical device manufacturer Guidant failed to warn doctors about potentially fatal flaws in the design of their heart defibrillators. In the wake of that incident, the entire heart ...
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News of Defective Heart Implants Troubles Medical Manufacturers

St. Jude Medical is facing serious concerns after news that their heart implants contain defects that are injuring many of their patients. Allegedly, what is happening is that the lead wire that ...
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Retraction Sought by St. Jude on Riata Death Study

St. Jude Medical Inc. is calling for the retraction of a study of its Riata heart leads, which were recalled in 2010 for safety issues, saying it contained a biased account of deaths attributed to the ...
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FDA Issues Notice Regarding Thoratec's HeartMate II Pump

The Food and Drug Administration (FDA) issued a notice of Thoratec Corporation's HeartMate II Pump on April 4, ordering the company to send new instructions on the correct procedure for implanting ...
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Recall of Some Vitamin B12 Injections

Cyanocobalamin is the scientific term for vitamin B12. Some people are prescribed cyanocobalamin injections for conditions such as anemia, infections and strict vegan diets. Recently, American Regent ...
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New Senate Bill Proposes Changes to Medical Device Approval Process

We previously discussed concerns with the Food and Drug Administration's (FDA) 510(k) approval process, which provides fast-tracked approval if a device it is similar to an already-approved ...
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Panel of Experts to Review Safety of Metal on Metal Hip Implants

The Food and Drug Administration (FDA) will hold a two day review panel in June to definitively rule on the safety of metal-on-metal (MoM) hip implants. The June 27-28 gathering will bring together ...
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Public Calls for Additional Oversight of Implanted Medical Devices

While Congress attempts to speed up the approval process for medical devices, a recent survey shows that the general public wants the opposite to happen. Results from a new Consumer Reports poll ...
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Wright Medical Technology Joins the Multidistrict Litigation Club

Wright Medical Technology is being brought to multidistrict litigation (MDL) by federal lawsuits because of their defective hip replacements. The injuries are similar to those who have suffered from ...
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Final Word on Metal-on-Metal Hip Implants: Don't Use Them

A new report issued in the UK has unequivocally warned against implanting metal-on-metal hip devices due to their extremely high failure rate. Patients particularly at risk include women, younger ...
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Reports Say Johnson & Johnson Knew of DePuy Failure Long Before Recall

According to reports, Johnson and Johnson knew that their DePuy hip implants were defective a year before they were recalled. The New York Times published a story including the contents of an email ...
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Penalty for Medical Device Manufacturer that Sold Unapproved Devices

The manufacturer of a spinal implant will pay the U.S. Food and Drug Administration (FDA) a $1 million penalty for marketing an unapproved medical product. The penalty was agreed upon in a settlement ...
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Unclean Surgical Instruments Put Patients at Risk

A new investigation conducted by MSNBC and the Center for Public Integrity has revealed that improperly sterilized surgical instruments are making their way into operating rooms across the country. As ...
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New Information Further Calls DePuy's Ethics into Question

More evidence is emerging that senior DePuy officials were aware of problems with their hip replacement and resurfacing devices, but continued to market them for over a year before implementing a ...
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New Efforts to Limit State Inspections of Drugs and Medical Devices

Lately, it seems like there is a discovery of a dangerous drug or medical device each week, yet a state representative from California just introduced legislation to limit individual states' right ...
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Medical Apps for Smartphones May Be Considered Medical Devices

A recent slew of medical applications intended for smart phones have caused the FDA to take notice. There are currently numerous free or almost free apps available to download, used for everything ...
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30 results found. Viewing page 1 of 2. Go to page 1 2   Next
Pain Experts in Unethical Relationship with Makers of Painkillers
Two senators have opened an investigation into financial ties between the producers of prescription painkillers and pain experts in the medical field.... Read More [+]
How Thorough Patient Counseling Can Help Reduce Drug Injuries
Many drug injuries can be avoided by a number of factors, some not controllable by the consumer. But one way they can be reduced is by thorough patien... Read More [+]
Proposed Bill for FDA to Block Devices Tied to Recalls
Currently there is a loophole in the law that allows products to be put on the market even if they are connected to a similar product that has been re... Read More [+]