Articles Posted in FDA

FDA CPAP Recall
I’ve written extensively about problems with some Philips CPAP and BiPAP machines, including alleged injuries, affected machines, recalls, and potential litigation. That litigation is ramping up, but a new concern has arisen over the FDA’s inadequate and delayed recall process.

Specifically, governmental safeguards designed to protect the public from faulty or dangerous medical devices may not be working properly. Using the Philips recall situation as a prime example, let’s examine what going on with the U.S. Food and Drug Administration (FDA) and why there might be room for improvement in how it handles potentially dangerous medical devices.

The FDA’s Role in Keeping Consumers and Patients Safe

Image of the ECHELON FLEX ENDOPATH StaplerDuring the course of surgery, a doctor may need to find a way to connect sections of organs or close wounds. One way to do this is through the use of sutures, a special type of thread. Another way is with the use of surgical staples. The Ethicon surgical stapler is pictured at right.

Doctors commonly use staples over sutures during surgery because they offer several advantages, including:

  • Lower risk of infection

Zantac and cancer-causing NDMA
Many of us suffer from heartburn, and one of the most popular ways to treat it is by taking Zantac. Until recently, Zantac was considered a very safe medication and was available without a prescription.

Given how well it worked, along with its affordable price and the perception of safety, hundreds of thousands of people, if not millions, took Zantac. In the fall of last year, the US Food and Drug Administration (FDA) reported that this popular drug might contain N-Nitrosodimethylamine (NDMA), a likely cancer-causing substance.

The past few months have resulted in mass voluntary recalls and a rush of FDA updates and reports about the possible dangers of taking Zantac and what it means for consumers. This blog post will attempt to summarize what’s going on and briefly discuss what happens next.

Young woman vapingLike many parents, vaping and e-cigarettes caught my wife and me by complete surprise. Two years ago we asked our oldest child how many kids he knew in his high school who were vaping. He said, “it will be much faster to list the kids who aren’t vaping.” We were stunned. We knew very little about vaping, and at the time I assumed it was some kind of fringe product used by adults already addicted to nicotine.

Unfortunately, studies indicate that one in five high school kids have tried vaping, but in my unscientific observation I believe the number is higher. Still, there are more than fifteen million kids in enrolled in public high schools in this country, so even if the number is “only” one in five, this means over three million public high school children have either tried or are currently using vaping products like JUUL.

What we do know is that e-cigarettes are extremely popular and profitable for the companies selling the devices. The primary manufacturer, marketer, and seller of these vaping devices is a company called JUUL Labs, Inc.

Harmful Medical Devices on HBO's Last Week Tonight with John Oliver

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 more people in twenty minutes than I have in four years. I want more people to get the word out about the serious problems with medical devices rushed to market and “cleared” through the 510(k) loophole because it’s a public health crisis. Too many companies are pushing too many untested medical devices to market, and the FDA is not doing enough to protect the public from these devices. John Oliver talks about all of this on the latest episode of his show. It’s funny (and profane), but he lays out accurately the way massive profits have driven companies to push harmful medical devices on to an unsuspecting public. You can check it out at the link below:

Warning: This is HBO. Oliver speaks freely: the language is salty and the subject matter adult. Companies and people other than me own the content linked above. The show is the property of HBO and whoever owns HBO. Neither HBO nor John Oliver has any affiliation with my website.

 

FDA Considering Changes to 510(k) Process
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 screws, rods, artificial discs, intrauterine devices, metal screws, pins, plates and rods, artificial knees, or coronary stents. No matter what type of medical device you need, you deserve safe devices of only the best quality that are responsive to technological updates. As a patient, you should have the right to make a fully informed decision about whether you want to use a newer or older version of a particular medical device. The FDA is now considering making changes to its (infamous) 510(k) medical device approval process.

FDA Pressures Medical Device Manufacturers to Utilize Newer Technologies 

You only have to look at the evolution of cell phone technology to appreciate the abundance of technological changes that have occurred over the past decade. So, why should you be provided with the medical device equivalents of flip phones? That’s one of the key focuses of the proposed new changes to the 510(k) Approval Program the U.S. Food and Drug Administration (FDA) which would be incorporated in 2019. The 510(k) Approval Program, put in place originally in 1976, has provided an approval “short-cut” for medical devices which are based on medical devices currently on the market. I have written about the 510(k) process often on this site. The medical device currently on  the market, upon which the new product is based, is known as a “predicate device.” Historically, there have been no restrictions concerning the age of the predicate device. This is about to change.

On November 27, 2018, Teva Pharmaceuticals announced a huge recall of all products containing the medication valsartan. The prescription medications containing valsartan may contain chemicals that are considered possible carcinogens.

So What is Valsartan?

Valsartan RecallValsartan is a drug used to treat hypertension, high blood pressure, congestive heart failure, and other conditions. It also improves health outcomes in people who have suffered a heart attack. Valsartan is part of a group of drugs called angiotensin receptor blockers (ARBs). The drug works in part by relaxing blood vessels to permit easier blood flow, which leads to lower blood pressure. Lower blood pressure leads to fewer strokes, heart attacks, and kidney problems.

MRI with gadolinium-based contrast agentI’ve been representing people injured by defective medical devices and harm drugs for many years. Because I study these types of products on a daily basis, I have become leery about putting anything inside my body, whether it is an artificial joint like a hip or knee, or a prescription medication. As I often tell people–mostly joking but not completely–these days I am uncomfortable taking a baby aspirin.

Of course that’s not rational. Please hear me: there are important, helpful drugs and medical devices which improve lives, extend lives, and save lives. Paranoia is not your friend when you are facing a serious health issue. That said, it is always prudent to double check anything put into your body when a medical procedure is performed. Read about the product, get a second or third opinion.

In the past few years studies have identified troubling health problems in patients following the administration of gadolinium-based contrast agents (GBCAs) used during MRIs. Some people have gotten debilitating symptoms from these GBCAs. Let’s take a look:

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 my site because of your interest in medical devices and the problems they can cause. And if you are interested in this subject, you must see the new Netflix documentary The Bleeding Edge.

The Bleeding EdgeThe Bleeding Edge is a remarkable film investigating the public health crisis caused by our current medical device industry. It examines the two main causes permitting the manufacture and sale of defective medical devices: corporate greed and inadequate FDA oversight. It is a tragic story, particularly when the film takes a close look at many of the actual victims of these harmful medical devices. It’s one thing to hear that the Essure birth control device has injured thousands of women; it’s quite another when you see a woman on screen explain how she has given up on her hope to find love because she can no longer have intercourse due to permanent internal injuries. It is deeply sad to hear these stories. And it may have you writing your member of congress. Which you should.

I urge you to check out the film. Here are a few key takeaways:

Woman in pain with Essure birth control device
Bayer’s Essure birth control device is coming off the market, thanks to a public campaign aimed at raising awareness about its dangers. After years of silence, in which women were told that their pain wasn’t real, and years of incident reports that went unheeded, the U.S. Food and Drug Administration (FDA) finally agreed that Bayer needed to do more to warn patients about the risks of the birth control device.

Now that women are making informed decisions, use of the birth control device has dropped off so precipitously that Bayer is ending its production. Let’s look at what Essure is and why it’s so dangerous.

The Essure Birth Control Implant

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