On Nov. 26, 2018, the Food and Drug Administration (FDA) announced that they plan to overhaul the vetting system that has been used to approve medical devices for release on the market for the past few decades. The action comes on the heels of reports showing how many previously approved devices have caused consumer injuries.
Doctors commonly insert inferior vena cava (IVC) filters into the body's largest vein in order to reduce a patient's risk of developing a blood clot after suffering an injury or having a surgery performed on them. They're used as an alternative to prescription blood thinners for those at risk for either deep vein thrombosis (DVT) or a pulmonary embolism (PE).
A five-year study carried out by Stericycle Expert Solutions shows alarming trends when it comes to why medical devices are recalled. Researchers found that 25.7 percent of them in the final quarter of 2017 had software flaws that prevented them from functioning as intended. This wasn't a new trend. This had been the leading reason for recalls for seven quarters.
Alere, a company that manufactures various medical devices including diagnostic machines, settled a $33 million dollar claim with the government over claims it sold hospitals unreliable testing devices. As a result, the hospitals ended up submitting fraudulent claims to Medicaid and Medicare.
Nowadays, doctors aren't always the ones with their hands on the scapel cutting into your body during a surgery, but instead, it's a robot guided by a doctor in another room, city or state instead. This leads many patients to wonder what avenues they can pursue if an autonomous robotic surgical device malfunctions, botches a surgery or otherwise maims or kills them.
If you have suffered from a hernia, you may need surgery to correct the issue. Knowing you need surgery may make you apprehensive, even while you look forward to experiencing relief from your pain and other complications. Unfortunately, if your surgeon uses hernia mesh as part of your operation, you could face further complications.
A lawsuit was filed on Nov. 7 on behalf of 25 patients who had ceramic-coated B. Braun artificial knees implanted. In the filing, the plaintiffs accuse the medical device manufacturer of deliberately concealing the long track record of failures the product had when marketing it to surgeons.
New complaints have emerged against a North Texas spine surgeon accused of having left several patients of his either permanently disabled or dead. According to lawsuits that have been filed against him so far, some of the patients' injuries may be related to doctor's use of titanium surgical devices made in-house.
The Minnesota-based Teleflex Inc., on Thursday, June 22, 2017, issued a voluntary recall of what's estimated to be around 4,000 surgical catheters. The recall, which has been classified as the most critical, Class 1 variety, covers any catheters manufactured by Teleflex's subsidiary Vascular Solutions.
There have been many medical devices invented over the years and people have received these devices. Medical devices are valuable and allow people to do things they could not do before or allow them to do things without pain. However, they need to work as intended to be effective. If the design was defective or faulty, the medical device can actually do more damage than there was before the device was implanted in the body.