When you introduce a medical device into your body, there’s always the chance that things could go awry: For example, a breast implant could shift, leak, or otherwise interfere with your health. Now, after years of studying the issue, the U.S. Food and Drug Administration says there appears to be a connection between breast implants and a rare form of cancer that has claimed at least nine lives. [More]
Two weeks after being told by the FDA that it needed to stop marketing its at-home genetic testing kits, and several days after it stopped marketing the disease-diagnosing aspects of the product, Google-backed 23andMe is finally letting customers who had paid for the $99 kit know what is going on. [More]
Most new products, from cheapo wristwatches to new cars, often come with manufacturers’ warranties. But that isn’t the case for most hip and knee implants, meaning that a growing number of Americans are having expensive devices put in their bodies without any written assurance from the manufacturers. [More]
The best infomercial/direct-response ad products solve problems that you had no idea you had. The Chia Pet? The Topsy Tail? The Shake Weight? The Snuggie? The Comfort WipeAll things that your life would have continued just fine without, but they make so much sense that you simply must have them. We’re not sure that’s the case with the Wax Vac, which combines the glamor of an ear thermometer with all of the fun of sticking an electric sucking machine in your ear while grinning. [More]
It seems almost silly to think that anyone would want to scale back the amount of regulatory control on the safety of medical devices, and a new poll shows that an overwhelming number of Americans believe in strong oversight of these products. Yet members of the House and Senate are considering legislation that could allow potentially unsafe items to hit the market.
When it comes to approving medical devices for patients to use, the Food and Drug Administration is handcuffed by conflict of interest rules that it says slow the process. A bipartisan trio of senators have introduced a bill that would ease the rules in favor of getting devices approved quicker, possibly at the expense of medical ethics.
A letter to President-Elect Obama from nine FDA scientists makes alarming charges of mismanagement at the FDA, alleging incompetence, intimidation, and inappropriate industry influence.
Medtronic is “recalling” its latest heart defibrillator models because of faulty wiring, which could lead to either it not working when you most need it, or it shocking you randomly in the heart with painful electric jolts. “The company is urging all of the roughly 235,000 patients with the lead, known as the Sprint Fidelis, to see their doctors to make sure it has not developed a fracture that can make the device misread heart-rhythm data.”