bad medical devices blog

The Food and Drug Administration has agreed to team with foreign governments to crackdown on fraudulent medical devices imported to the United States, the Seattle Times reports.
A few weeks ago we reported on these devices when highlighting the newspaper’s investigation into so called “miracle machines” that dupe desperate and often terminally ill patients out of […]

TriMed Inc. won its appeal over Stryker Corp. regarding a patented wrist replacement, Reuters reports.
A U.S. patent court overruled a Federal Circuit Court decision that Stryker infringed upon TriMed’s patent on a wrist replacement that attaches to stable portions of broken bone and holds the fractured portion in place.
The earlier decision favored Stryker. “We hold […]

One of the most commonly performed surgical procedures has an often underreported side effect, according to a report from Reuters.
Patients who get a tonsillectomy are being burned around the lips and mouth by a cauterizing device. These burns can result in long-term complications, reports a study by the Archives of Otolaryngology and Head and Neck […]

The Food and Drug Administration is lax in its inspection of medical device makers, both foreign and domestic, a government investigator told Bloomberg News.
The FDA aims to inspect U.S. manufacturers of high-risk medical devices like heart defibrillators every two years. However, inspections are only conducted every three years and that figure jumps to six years […]

Mentor Corp. is facing a lawsuit after knowingly misleading the Food and Drug Administration about the design, manufacture, safety and efficacy of its ObTape.
According to MarketWire.com, the suit alleges “four women needlessly suffered significant pain and multiple surgeries because Mentor obtained approval to bring ObTape to market.”
ObTape is a transobulator sling used my mostly aging […]

Johnson & Johnson’s Cordis Corporation and the FDA have informed healthcare professionals of a worldwide recall of approximately 132,000 balloon catheters used in angioplasty procedures. The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in […]

The President and CEO of Stryker Corp. says its company has a lot of work to do to erase the memory of two warning letters received from the Food and Drug Administration in the past nine months.
The Kalamazoo (Mich.) Gazette reports Stryker CEO Stephen MacMillan told investors during a conference call that it’s taking the […]

The Wall Street Journal reported yesterday that a new study published in the New England Journal of Medicine says patients with multiple clogged arteries are better off getting bypass surgery than drug coated stents. The study looked at drug coated stents made by Johnson & Johnson and Boston Scientific Corp. in the U.S. Previous […]

Ten years ago you would have been hard-pressed to see any advertisements for prescription drugs. Since the late 1990s, drug makers spend $5 billion annually on direct-to-consumer promotions. Right now, an ad for Valtrex is on the television.
Now, according to The Star Ledger newspaper, some medical professionals fear the same trend is occurring with the […]

Medical devices, or at least pieces of them, are left inside patients about 1,000 times a year, according to a report from the Food and Drug Administration.
This physician foul-up can lead to infection, perforation, blood vessel obstruction and even death. The Colorado Springs Business Journal also reports that an MRI for a patient with a […]