University of California, Berkeley researchers have developed a tool to look into the world of bacteria that causes chronic infection in patients and the protective mechanism that makes some immune to antibiotic treatment. Biofilm forms as a reaction to the introduction of bacteria. Using super-resolution light microscopy, which has ten times […]

Cook Medical is once again shipping the Zilver PTX Drug-Eluting Peripheral Stent to doctors and hospitals in Europe, Japan and in the U.S. following a global recall due to at least one fatality. The stent was voluntarily recalled after the company received 13 complaints of a faulty delivery system. Specifically, […]

The entire trial took just 11 days. Donna Cisson sued C.R. Bard Co. of New Jersey, maker of the Avaulta Plus transvaginal mesh implanted in her in 2009 to treat pelvic organ prolapse. Last week, the jury awarded the 55-year-old Cisson $250,000 in compensatory damages and $1.75 million in punitive […]

Hurry up and wait appears to be the word from the U.S. Food and Drug Administration (FDA) when it comes to the safety of medical devices. The agency was supposed to have issued a final proposal by the end of June on a mandate to make it easier to identify […]

The first federal transvaginal mesh trial that names manufacturer C.R. Bard begins this week in Charleston, West Virginia. Plaintiff Donna Cisson was implanted with the Bard Avaulta Plus Posterior on May 8, 2009 in Toccoa, Georgia. Bard Urological, a division of C.R. Bard, Inc. designed, labeled, manufactured and sold the […]

Consumers may not realize it, but the U.S. Food and Drug Administration (FDA) currently has no way to track problems with medical devices and drugs that go wrong other than voluntary reporting. Unlike other countries that have drug and device registries, the FDA has an absolute head-in-the sand approach to […]

The Food and Drug Administration (FDA) held a meeting this week to consider whether the 510(k) approval process for medical devices is keeping the public safe while balancing the need of industry to get innovative products to the market faster and easier. “External stakeholders” were invited and helped set the […]

Public Broadcasting should be commended for trying to explain a very important issue that most Americans do not understand – until it happens to them.  A “Need to Know” broadcast, explores the mysterious world of medical devices. Most Americans imagine their Food and Drug Administration (FDA) is protecting them from […]

Stryker is finally acknowledging that their Rejuvenate and ABG II modular hip product line can cause serious problems in patients – even if they aren’t yet feeling symptoms of metal poisoning or tissue destruction. Since the Rejuvenate product recall on July 4th, Stryker has been telling patients that if you […]

By the end of the year, the U.S. Food and Drug Administration (FDA) had stated it would make sure that high-risk medical devices were approved through the most stringent premarket approval (PMA) review process to assure the safety of consumers. But it looks as though that will not happen. High-risk […]