Tag Archives: St. Jude

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Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

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Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.

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Trial over Ethicon Transvaginal Mesh Begins in California

Pelvic mesh devices have become the subject of safety concerns in recent years amidst reports that they can cause serious, sometimes permanent injuries.

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Exposure to Common Pesticide May Increase ADHD Risk

Exposure to Common Pesticide May Increase ADHD Risk

A new study has found that exposure to a common household pesticide may increase the risk of attention deficit hyperactivity disorder (ADHD) in children.

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Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices

Stryker’s recent recall of two metal hip implant components, the Rejuvenate Modular and ABG II modular-neck hip stems, may have dealt a serious blow to one of the key arguments medical device manufacturers have made to defend their metal-on-metal hip replacements. Facing thousands of lawsuits, the makers of ...

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Fracking Boom Changing Way of Life in Pennsylvania's Northern Tier

In just a few years, the impact of hydraulic fracturing (fracking) drilling on northeastern Pennsylvania is hard to miss. Thousands of natural gas wells have been opened in that area specifically in the last five years as companies look to exploit the vast Marcellus shale formation about two miles below the ...

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FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.

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Johnson & Johnson Facing More Metal-on-Metal Hip Implant Woes, as DePuy Pinnacle Complaints Rise

Having already spent around $3 billion on its DePuy Orthopaedics ASR hip implant recall, Johnson & Johnson is facing another potential debacle involving a metal-on-metal version of its Pinnacle Hip Replacement System. According to a report from Reuters, Johnson & Johnson and its DePuy unit already face some 1,600 metal-on-metal ...
FDA Questions Device Makers about Duodenoscope Cleaning Procedures

Following Deadly Outbreaks, FDA Questions Device Makers about Duodenoscope Cleaning Procedures

In light of a recent outbreak linked to contaminated duodenoscopes, the U.S. Food and Drug Administration (FDA) is questioning manufacturers about their methods for cleaning the devices, the New York Times reports. The specialized scopes, which have been linked to several outbreaks in recent years, most recently infected seven patients ...

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British Health Agency Strengthens Warnings about Valproate

British Health Agency Strengthens Warnings about Valproate Risk in Pregnancy

Statement issued urging healthcare professionals to give women information on birth defects when Depakote and other valproate medicines are used during pregnancy.

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St. Jude ICD Recall Is Deemed a Class I by Federal Regulators

St. Jude ICD Recall Is Deemed a Class I

St. Jude recently reported two patient deaths tied to early depletion of lithium batteries in St. Jude Medical Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D). The U.S. Food and Drug Administration (FDA) and St. Jude issued an … Continue reading

Posted in Defective Medical Devices, Product Recalls, Recalled Medical Devices, St. Jude Defibrillators | Tagged , , , , |

Premature Battery Depletion of Defibrillator Caused Two Deaths

Premature Battery Depletion of Defibrillator Caused 2 Deaths

On October 11, 2016, the U.S. Food and Drug Administration (FDA) issued a safety warning for premature battery depletion of the St. Jude Medical Implanted Defibrillator. The St. Jude products in question were manufactured before May 2015 and are ICD and CRT-D … Continue reading

Posted in Defective Medical Devices, Health Concerns, St. Jude Defibrillators | Tagged , , , , |

Investigation of St. Jude Medical Devices Now Includes FDA

Investigation of St. Jude Medical Devices Now Includes FDA

The U.S. Food and Drug Administration (FDA) has now joined the investigation into security claims that devices made by St. Jude Medical can be hacked remotely. These claims are still being defended by St. Jude. Muddy Waters Capital, an investment … Continue reading

Posted in Defective Medical Devices, Health Concerns, St. Jude Defibrillators | Tagged , , , , , , , , , |

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