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LATEST ARTICLES

Why Post-Market Medical Device Follow-up is Necessary But Ignored or Hidden

As someone who’s had medical issues ranging from chronic pain to infertility, I’m no stranger to being poked, prodded, given a plethora of prescriptions, and feeling more like an alien abduction than a patient being presented solutions to feel better. Sound familiar?

Why Post-Market Medical Device Follow-up is Necessary But Ignored or Hidden

And why do we subjugate ourselves to being guinea pigs to test which therapies, pills, and mechanical parts will torment our bodies? It’s simple. We’re desperate for help and we trust the men and women in scrubs and suits to honestly want to help us. The FDA’s fast tracked 510(k) process,  doctors receiving “gifts” from pharmaceutical companies for prescribing their products, and sky high drug prices are just a few examples of the many parts of the system that are broken at the expense of patient health. Here’s another important flaw with the FDA and Big Pharma: their lack of post-market medical device follow-up.

But why should you take the time to learn about this? Consider these statistics:

  • In 2018, medtech (medical technology) stocks climbed 26%.
  • About 1.4 million hip and knee replacement surgeries were performed in 2017 alone and the number continues to increase each year.
  • The U.S. medical device market was $147.7 billion in 2016 and is projected to grow to $173 billion in 2019.

If you don’t already have a medical device, chances are high that you’ll either have one or you know someone who has one. Plus, this is big money for pharmaceutical companies so a variety of products are probably going to be advertised or recommended to you. Don’t you want to make sure that something this important is proven to help and not harm you?

The FDA’s 510(k) Approval and Post-Market Follow-up Process

The FDA established the 510(k) process to promote medical innovation and approve needed products to market quickly. However, this once “noble” function has now turned into a manipulation of Big Pharma to speed devices to market to for profit and to bypass expensive testing. The 510(k) process allows the FDA to fast-track paperwork through the system as pharmaceutical companies base their devices on previously approved ones… all without human clinical trials.

There are many problems to this practice. First of all, the products that they’re comparing the new one to may have been ineffective or harmful and taken off the market (such as the case involving Protegen transvaginal mesh). Secondly, this is how 70 percent of medical devices are being approved; again, WITHOUT human clinical trials. Is it any wonder why there are so many health complications and recalls concerning medical devices?!? Finally, the FDA is understaffed and underfunded which makes approving, monitoring, and following up on drugs and medical devices a nightmare.

Post market follow-up is critical to patient safety, as the FDA explains that the requirements, “include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and registering the establishments where devices are produced or distributed. Postmarket requirements also include postmarket surveillance studies required under section 522 of the act as well as post-approval studies required at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application.”

Let’s take a closer look at a recent example that hit the news in March 2019. Mentor Worldwide MemoryShape breast implants were approved in 2013. It came to the FDA’s attention that the company failed to enrol the required number of subjects in the post market study, had poor follow-up rates with patients (only 61 percent), and significant data wasn’t consistent.

These studies are particularly important because in 2016 it was determined that breast implants can cause breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL, which is a type of non-Hodgkin’s lymphoma (cancer of the immune system). Post-market surveillance could not only ensure the safety of those in the study, but it can provide valuable information to prevent future patients from suffering from this disease.

Post-market surveillance is a critical part of the FDA’s job and public health depends on it. To quickly approve high risk medical devices and neglect monitoring how they work is not only negligent, but it deliberately disregards the health of the millions of patients that the FDA and pharmaceutical companies claim to be helping. It’s time to put patient health first.

 

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Sources
“FDA warns J&J unit and Sientra over breast implant compliance”. Medical Device Network. Accessed March 25, 2019. https://www.medicaldevice-network.com/news/fda-warns-jj-sientra-breast-implants/
“Robots, DNA And Implantable Devices — Why 2019 Isn’t Your Dad’s Medtech”. Investor’s Business Daily. Accessed March 25, 2019. https://www.investors.com/news/technology/medical-equipment-medtech-2019-preview/
“Defenders: How medical devices are approved by the FDA and why some say it no longer works” KVUE. Accessed March 25, 2019. https://www.kvue.com/article/news/defenders-how-medical-devices-are-approved-by-the-fda-and-why-some-say-it-no-longer-works/269-2a9bfbe6-dd7d-4b2b-a0c1-6bebe24998cb
“Postmarket Requirements (Devices)”. FDA. Accessed April 2, 2019. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/default.htm
“Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)”. FDA. Accessed April 2, 2019. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm

Why Are There So Many Drug and Medical Device Recalls?

As an advocacy group that strives to keep the FDA and big pharmaceutical companies accountable, we’ve seen our share of hundreds of thousands of people angry, disillusioned, and scared because their medicine or medical device has been recalled. They trusted that their doctor or surgeon chose the best decision for their condition. They put their faith in the company that produced their drug or implant to monitor their materials for safety. The believed that the FDA would only approve products that were properly tested and proven safe. Now many of these patients are living in a new normal where they’re worried about whether their pills are safe or they’re in excruciating pain from an implant that can’t be removed. How can this happen? Why does it seem that drugs and medical devices are being recalled more than ever before?

Why Are There So Many Drug and Medical Device Recalls?

Reasons for Recalls

Drug and medical device recalls can either be required by the FDA based on reports they’ve been receiving or it can be voluntary on behalf of the company when their product(s) are potentially unsafe. Here are the main reasons for recalling a medical product:

  • Health Risks – If a medicine or implant is found to harm patients and causes a high potential for injury, then it could be recalled. For example, phenylpropanolamine (PPA), a drug that was used in decongestants and weight loss medicines, was recalled because it was found to increase the risk of hemorrhagic stroke (bleeding in the brain).
  • Poor labeling or packaging – If the dosing instructions are confusing, if the dosing device is faulty, or perhaps the packaging proves not to be childproof, then it could be recalled.
  • Mislabeled – Let’s say that you purchased a generic medication that was labeled gluten free but it in fact did contain gluten, then the company would have to rectify this error.
  • Compromised Manufacturing – This has been in the news a lot lately. Recently (January 2019) it was found that the popular blood pressure medication Valsartan was contaminated with N-nitrosodimethylamine, or NDMA, a possibly cancer-causing substance and an additional contaminant called nitrosodiethylamine, or NDEA.  

2018 – The Year of the Recall

Let’s look at some of the stats for 2018 from R&D Magazine to see how they were broken down into the above categories:

Pharmaceuticals (percentage of total drug recalls)

  • Failure to meet product specifications: 25%
  • Deviations from current Good Manufacturing Practice (cGMP): 23.9%
  • Sterility: 12%
  • Mislabeling: 10.9%
  • Foreign Materials: 7.6%

Medical Devices (number of recalls per cause)

  • Software issue: 79
  • Mislabeling issue: 43
  • Quality issue: 36
  • Sterility issue: 27

A Few of the Top Drug and Medical Device Recalls of 2018:

Other Important Facts to Know

  • Five companies reported ten or more recalls in the quarter. This is the highest number since Q3 2016 and the second highest since Q3 2013.
  • You can check the FDA’s website to see if your medication or implant has been recalled by clicking here.

Why Are There So Many Drug and Medical Device Recalls?

There are many reasons why the number of recalls are increasing. First of all, we’ve talked a lot about how the FDA and pharmaceutical companies fast-track medical devices to market without testing using the 510(k) process. Another problem is that many products and drugs are produced overseas (learn more here).  A third broken part in the system is that Big Pharma funds not only the FDA, but politicians who monitor this appendage of the government. An additional glitch is that the FDA is overworked and underfunded; they can’t keep up with all the applications, adverse effect reports, and follow-up documents causing many issues to fall into the cracks.

Clearly the FDA is broken at the cost of innocent patients and their health. It’s time we voice our concerns, educate ourselves about our health, and hold the FDA and Big Pharma accountable for harming millions of people.

 

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Sources
“Drug Recalls Increased, Medical Device Recalls Decreased in Q3”. R&D Magazine. Accessed April 2, 2019. https://www.rdmag.com/news/2018/11/drug-recalls-increased-medical-device-recalls-decreased-q3
“What Is a Drug Recall?”. WebMD. Accessed April 2, 2019. https://www.webmd.com/a-to-z-guides/what-is-a-drug-recall#1

IVC Filter Use is Declining; What Does This Mean for Patients?

There are many drugs and medical devices that start out innocent enough: they are designed to help patients address difficult medical conditions and the benefits outweigh the risks in these specific situations. However, a common problem has occurred in which products become overused, over-marketed, and either used off-label or not according to manufacturer’s directions. This is certainly the case for IVC filters. Not only were they overused, but many times they were left in patients causing added risks to patient health.

IVC Filter Use is Declining; What Does This Mean for Patients?

Fortunately, a study published in the American Journal of Roentgenology found that IVC filter sales have dropped drastically over the past decade. “Between 2009 and 2015, IVC filter utilization across the United States declined by 36.3% in the Medicare population and by 26.6% in the privately insured population,” explained a statement from the Harvey L. Neiman Health Policy Institute.

This decline in sales is a win for patients due to the overuse and risks that these devices pose. IVC filters are prongs that form a tent-like structure to trap blood clots in the inferior vena cava, a large vein that carries blood to the heart. If a blood clot enters the heart or lungs, irreparable damage could take place.

IVC filters were supposed to be used in patients who were diagnosed with blood conditions that would be harmed from use of anticoagulants. “Filters should be considered for patients who cannot be anticoagulated and for those who fail anticoagulation for proximal DVT [deep vein thrombosis] or PE [pulmonary embolism],” states Akhilesh Sista, MD, FSIR, section chief and associate professor at New York University Langone School of Medicine.

IVC filters should only be used in these extreme circumstances due to the added risk they bring to patients. IVC filter prongs may break and migrate causing tissue damage and can even lodge in the heart. It has also been found that even though these medical devices have been labeled “retrievable” – meaning they should be removed after 29 to 54 days in most cases – many doctors fail to take these devices out of their patients putting them in danger.

Clearly the decline of IVC filter sales is a win for patients. These new statistics mean that doctors are carefully analyzing patient health verses the danger of using this device. If you have one of these medical devices or have an upcoming surgery which may involve an IVC filter, be sure to discuss any questions you may have with your doctor to ensure that this is the best option for your health.

 

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Sources
“The decline of state-level IVC filter utilization”. EurekAlert!. Accessed April 8, 2019. https://www.eurekalert.org/pub_releases/2019-04/hlnh-tdo040419.php
“IVC filter overuse declining, but retrieval rates remain low”. Healio. Accessed April 8, 2019. https://www.healio.com/cardiac-vascular-intervention/venous/news/online/%7Bc384ddb8-e89b-4c26-9ee4-f514e48567da%7D/ivc-filter-overuse-declining-but-retrieval-rates-remain-low

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

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