News tagged with 'Medical Devices'

Stryker Biotech LLC and its executives were indicted by a grand jury Wednesday, accused of fraudulently marketing its bone-growth products and covering-up the misconduct. They face prison time and fines.

A review of the process that fast-tracks medical devices into the marketplace without a safety review will be undertaken by the Institute of Medicine. The review will take two years, long overdue say patients hurt by devices that have been fast-tracked.

Universities are often not told about the money their academics receive from device makers as consultants and product developers.

The results of a new study suggests implantable cardioverter defibrillators (ICDs) are not effective in women.

J & J won preliminary approval to market a new ceramic-on-metal hip replacement device that is thought to be an improvement over metal-on-metal.

Two major shakeups at the Food and Drug Administration may be signs of how the agency is remaking itself to become more pro-consumer and less friendly to the industries it tries to regulate.

Kristen Diane Parker, a former Colorado surgery technician accused of stealing syringes filled with pain medication and switching them with used syringes, despite knowing she had hepatitis C, has been denied bail. Parker's actions put nearly 6,000 patients at risk.

A former surgeon at Walter Reed Army Medical Center made false claims about the Infuse bone-growth product sold by Medtronic Inc., a U.S. medical device maker.

A lawsuit filed by Robert Bozicev against Schering-Plough, alleges that the blood clot that led to the death of his wife, Jackie, in December 2007 was caused by her birth control device, NuvaRing.

President Obama will have an opportunity to shape future decisions from the highest court in the land.  Supreme Court Justice David Souter is retiring in June. Souter is one of the more liberal leaning justices and sided with the majority in the case of Diana Levine v. Wyeth and with the majority in the case of Riegel v. Medtronic, both tests of federal preemption.

About 13 million American women experience stress urinary incontinence and the Ethicon TVT vaginal mesh is the gold standard for treatment. While the company reports an 84 to 95 percent success rate, doctors who deal with mesh complications say the number of problems appear to be vastly underreported and a national registry is needed now. 

The FDA is holding an urgent meeting to try and fix the medical device crisis that is putting millions of Americans in danger of defibrillators, hip joints, and spinal screws, among others. Both FDA insiders and a GAO report called for immediate attention and confirmed many devices are marketed without rigorous premarket approval.  Ironically, consumers lost their right to hold device makers accountable under the Riegel decision by the U.S. Supreme Court.

A Colorado company caught in a congressional sting involving oversight of patient safety during clinical trials will voluntarily halt many of its review operations at the request of the FDA.

After more than 30 years, the FDA is pushing to require that manufacturers of 27 medical devices, used to replace hips or make hearts beat, prove they  are safe. 

If you assumed that a medical device that's implanted to help hold up internal organs passed some safety review by the FDA, you'd be wrong.  Synthetic surgical mesh was approved for marketing only. Some in the medical profession suspect there's a problem - some women and men know there is.