Tag Archives: Safety and Effectiveness

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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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Scientist Calls for Federal Regulations for Fracking Pollution

Hydraulic fracturing (fracking) drilling should be governed by federal regulations because its pollution has no awareness of state boundaries.

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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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Study Links Liquid in E-Cigarette to Viral Infections

Study Links Liquid in Electronic Cigarette to Increased Risk of Viral Infections

The National Jewish Health study, links the liquid used in e-cigarettes to a higher risk of respiratory viral infections, whether the liquid contains nicotine or not.

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E-cigarettes Could Increase Risk of Lung Infections

E-cigarettes Could Increase Risk of Lung Infections

New research suggests the liquid used in electronic cigarettes could increase the risk of viral lung infections, regardless of whether it contains nicotine.

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Actos Bladder Cancer Lawsuits Continue, New Complaint Filed by Tennessee Resident

Actos bladder cancer lawsuits continue, with a new complaint filed by a resident of Tennessee. The national law firm, Parker Waichman LLP, represents the Tennessee man who alleges that Actos caused his bladder cancer.

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Medtronic Infuse Studies Faulted for Downplaying Side Effects

Medtronic Inc.’s published studies for its Infuse bone graft product may have downplayed serious side effects, according to an analysis published last year in The Spine Journal. The study, which drew on U.S. Food & Drug Administration (FDA) documents and other data sources, suggests that up to half of ...

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DeflateGate’s Effects Impact Legal Gambling and the Economy

DeflateGate’s Effects Impact Legal Gambling and the Economy

The NFL has initiated a probe into the New England Patriots following allegations that the team intentionally used overly deflated footballs.

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Smith & Nephew Recalls Metal-on-Metal Hip Implant Component

Medical device maker, Smith & Nephew, just issued a recall for a metal-on-metal hip implant component, a part of one of its all-metal hip replacement systems.

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Older Patients Face Heart Attack Risk Following Surgery

Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery

An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.

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Thousands of Complaints Prompt FDA Panel Meeting about Essure Birth Control

Complaints Prompt FDA Panel Meeting about Essure

In response to more than 5,000 reports of adverse events and side effects of the Essure birth control implant, the Food and Drug Administration (FDA) has scheduled a hearing for September 24 to evaluate the safety and effectiveness device. The … Continue reading

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