A recall of Thoratec’s HeartMate II Left Ventricle Assist System (LVAS) that was first announced in February has been designated Class I, the U.S. Food & Drug Administration’s (FDA) most serious type of recall. The HeartMate II LVAS is a heart pump which is used as a bridge to transplantation in heart transplant candidates at …
Nowadays, after a heart catherization proves a patient has a clogged artery, it is customary for a stent to be done immediately to prop open up the cartery. They have become the norm here in the United States. But, what if what we have been thinking is the best option, ultimately is not? According to …
The Wingspan Brain Stent marketed by Stryker Corp. may be doing more harm than good, according to a report authored by U.S. Food & Drug Administration (FDA) staff. The Wingspan system has been on the market since 2005 and is used to open blocked arteries in the brain when clot-dissolving drugs do not work. It …
The timing of DePuy Orthopaedics’ 2009 decision to phase-out its now-recalled ASR hip implant devices is now being questioned. According to a report published in The New York Times, based in information obtained under the Freedom of information Act, the decision on the hip implant phase out was made just weeks after the company received …
How is a medical device on the market for 2 years without the FDA being aware of it? According to a report from Bloomberg News, Johnson & Johnson’s Gynecare Prolift transvaginal mesh device product was brought to market in 2005, but the U.S. Food & Drug Administration (FDA) was not even aware that the device was …
According to recent studies, heart stents are being overused, causing unnecessary complications. When a patient has heart trouble, I believe one of the worst fears would be open heart surgery. And, although many don’t ever get to that point, there are some patients that need help keeping their arteries open therefore requiring a nonsurgical procedure, …
And yet another study has confirmed that metal-on-metal hip implants are more likely to fail compared to other types of hip replacement devices, therefore researchers are calling for the controversial medical device to be banned, after reviewing the world’s largest database on hip replacements. The Lancet Study, being called the most comprehensive study to date, …
Failing metal-on-metal hip implants have caused hundreds of thousands of patients all over the world exposure to dangerously high levels of toxic metals. This disturbing news was brought about in a recent report published in the British Medical Journal (BMJ), which questioned the way regulars in the U.S. and abroad responded to increasing evidence of …
The top FDA administrator stressed that the agency must possess more control in barring faulty products in order to put a stop to lawsuits that resulted from flawed hip implants and vaginal mesh. But since the FDA currently does not have the power to reject a medical device rushed through the fast-track system, even if …
The recent controversy surrounding Medtronic Inc.’s Infuse bone graft is having some question what the future will hold for the company, and for the spinal fusion market. First approved by the U.S. Food and Drug Administration (FDA) in 2002, Medtronic’s Infuse bone graft has been cleared for use in a type of spine surgery called …