More research has come out recently that links testosterone therapy to heart conditions. A study published in early January of this year found that men taking testosterone drugs faced a higher risk of heart attack for men over the age of 65. Men younger than 65 but with a history of heart problems also had higher risks for heart attacks, according to the study tracking 56,000 men.
In recent months, the FDA has begun reviewing more information regarding Essure, a transcervical sterilization procedure for women. Essure is a Class III medical device that, according to the FDA, received a high level of review prior to marketing. The procedure had to be vetted through the pre-market approval process used by the FDA. This process includes reviewing data about product labeling materials and a scientific and regulatory review.
The federal government’s Office of the Inspector General has released their 2014 work plan, and medical device scrutiny features heavily in the goals of the organization. The work plan details all of the hospital-related practices and policies, including quality of care, billing and payments, emergency preparedness, and medical device security.
Doctors doing surgery at a hospital in Maine made a discovery regarding the Cordis Opt-ease Vena Cava Filter that have led to investigation and defective device recalls for the item.
The filter is supposed to catch clotted blood traveling through the Vena Cava to hold it there so that the clot doesn’t travel farther into the heart or lungs. Doctors struggled to remove the filter from a patient who no longer required it, finding that the instructions for insertion and removal were not accurate.
Although medical device manufacturers are supposed to vet their creations extensively before putting them on the market, some products get in the hands of caregivers or patients when there are dangerous consequences or bugs that haven’t been addressed.
Although adult defective medical devices make the news more often, some of the most dangerous devices are those intended for use with children. With so many products and medical devices on the market for children, it can be difficult for parents to stay on stop of which devices are safe to use with infants.
According to Science Daily, “hundreds of thousands of hip and knee replacement surgeries are performed in the United States each year.” While these procedures are generally very effective at reducing pain and restoring mobility, there is a high rate of failure of these devices. There is such a high rate of failure, in fact, that Dr.
Every month the Food and Drug Administration (FDA) recalls several products and devices as unsafe for consumption. Many of these never make news, and very few of these ever make a big splash in the mainstream media. This makes determining whether or not you’ve been affected by a defective product or device difficult.
At the end of 2013, the FDA announced even more Class II recalls for components making up the da Vinci surgical robot system. The robots have already been in the news for numerous errors and concerns shared by patients who have undergone surgeries using these machines. If you have already been injured as a result of a da Vinci surgical robot, you need legal advice from an Illinois defective medical device attorney.
The healthcare field is the latest in a group of industries that can say “There’s an app for that!”. Some of these mobile applications are being scrutinized under the Food and Drug Administration since they can be considered medical devices.