Articles Posted in 510(k) Process

Before you accept a settlement offer, talk to your lawyer, ask all the questions you have, read the settlement documents carefully, and make an informed decision.

I’ve been writing about dangerous medical devices on this site for four years. Over that time I’ve reached thousands and thousands of people injured by these harmful implanted medical products. John Oliver, host of Last Week Tonight, picked up the subject this week, and I am grateful to him and to HBO because he reached…

Let me see if I have this straight: There is a huge medical device manufacturer that earns over $75 billion dollars each year. This corporation decides to market and sell a new medical device. The corporation refuses to do extensive testing on the device because that would take too long and cost too much money.…

At some point in your life, a medical device will likely become a necessary part of your medical care. You may need external items such as hearing aids, blood glucose meters, insulin pumps, or feeding tubes. You may also need the help of surgically implanted medical devices like artificial hips, heart pacemakers, breast implants, spine…

For more than three years I have been writing about the dangers of certain implanted medical devices. These devices include artificial hips, hernia mesh, IUDs, IVC filters, and others. And some have caused massive human suffering: neurological problems, sexual dysfunction, immobility, infertility, headaches, pain, even death. If you are reading this sentence then you discovered…

Victims of C.R. Bard’s IVC filters got some great news two weeks ago. An Arizona jury in the first bellwether trial awarded a woman $3.6 million for injuries she suffered after Bard’s “G2” IVC filter broke into pieces in her inferior vena cava vein, requiring open heart surgery to remove the broken pieces. The plaintiff,…

This is my pitch: People who had to undergo revision surgery because their DePuy ASR artificial hip failed should be compensated for their injuries, even if the revision surgery occurred beyond the ten-year anniversary date of the original implant surgery. Let me admit the obvious: It’s a bit self-serving for me to argue this point.…

It’s nice to see that I may be out in front of a national publication like The New York Times. For two and a half years I have been writing on the dangers of metal-on-metal artificial hips and the deeply-flawed 510(k) medical device approval process. On Saturday Jeanne Lenzer published a very informative piece in the…

Last week I wrote a timeline on the key events surrounding the failure of the Depuy ASR artificial hip. Today I want to take a similar look at the Depuy Pinnacle artificial hip. The Pinnacle was supposed to be the ASR’s more active and athletic brother. But it didn’t turn out that way. 1995: Study…

Hernia mesh is causing problems. People who have been implanted with hernia mesh have suffered adhesions (scar tissue that sticks together), inflammation, pain, allergic reactions, internal bleeding, infections, and many other injuries. One of the hernia mesh products sold for years, Ethicon’s Physiomesh, has caused many of these health problems in patients. In revision or…