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Seeking truth, transparency, and resolution for injured consumers

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Periscope Group provides information, resources, and compassionate legal counsel, advocating on behalf of those facing injustice due to prescription drug complications and medical device failures.

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Our in-house legal counsel, Matthew J. Daher, earned his Bachelor of Arts degree from the University of Utah and his law degree from the University of Missouri – Columbia School of Law. Matt has devoted his entire practice to civil litigation, and has spent his career representing the rights of individuals who have been injured by pharmaceuticals, medical devices, medical malpractice, defective products, and motor vehicle accidents. As in-house counsel for Periscope Group, Matt leads our internal legal team and liaises with our external partners.

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Periscope Group provides information, resources, and compassionate legal counsel, advocating on behalf of those facing injustice due to prescription drug complications and medical device failures. Contact us today to see how we can help!

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The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

LATEST ARTICLES

Medical Device Companies Fail to Accurately Report Health Complications to FDA: Are You At Risk?

16,000 complaints involving Essure – a coil-like permanent birth control device- were reported to its manufacturer, Conceptus Inc., between January 2008 and December 2010. However, during that same time period of time, Conceptus (which was acquired by Bayer AG in 2013) filed only 182 reports of patient harm with the FDA. That’s a mere 1.1%. Worse yet, 750,000 Essure implants were sold worldwide until Bayer voluntarily – no, not recalled – pulled it from market in 2018 due to a 70% decrease in sales. So how can a medical device company get away with only reporting a small fraction of complaints to the FDA? Why was Bayer not penalized by the FDA for their negligence in reporting which put hundreds of thousands of women at risk?

Medical Device Companies Fail to Accurately Report Health Complications to FDA: Are You At Risk?

Problems with the FDA Reporting System

According to an intensive study conducted by the International Consortium of Investigative Journalists (ICIJ), there are three major flaws involving device companies and the process of reporting to the FDA:

  1. “FDA inspections have found more than 4,400 violations by device companies of its rules for handling complaints and reporting device problems in the last decade. Each violation can include hundreds or even thousands of mishandled complaints.”
  2. “Manufacturers and others required to report adverse events have classified more than 2,200 episodes in which patients died not as deaths but as injuries, malfunctions or other less severe events in the last five years.”
  3. “The FDA has allowed companies to obscure thousands of injury reports using a program called alternative summary reporting that allows them to keep the information from the public.”

Clearly there are far too many loopholes in the approval and management of medical devices that by far benefit the pharmaceutical companies at the cost of patient health. For example, it can be a grey area to determine if the device itself caused a patient death since the body can shut down at various levels. In the case of the manufacturer Thoratec Corp., a patient had a HeartMate II implant which provides circulatory support to patients with advanced heart disease. When the patient died, two suspected causes of death were reported: “suspected pump thrombus,” a device failure caused by a blood clot that blocks the pump, and multisystem organ failure. Thoratec’s report mentions the patient’s death, but cites the incident as an injury and faults organ failure as the cause of death. The obvious question here is did the mechanical failure cause the organs to shut down? One (of the many) problems is that with hundreds of thousands of complaints reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, it can be an insurmountable task to thoroughly evaluate each reported event. However, pump blockages were a common enough problem with this device that the FDA issued a safety warning for them in 2015.

Foreign Medical Device Companies

While there’s a laundry list of things wrong with the FDA and how it manages the medical device industry, it’s important to mention that it’s the best agency of its kind in the world. In fact,  Europe’s Eudamed adverse events database is accessible only to regulators and industry professionals, in Chile reporting adverse events is voluntary, and in Mexico this data is hidden from the public. So this brings us to another problem: if the U.S. is having trouble managing its own medical device companies, how are we monitoring foreign made products?

Last year in May 2018, 60 Minutes ran an important story exposing Boston Scientific (makers of transvaginal mesh) and how they smuggled counterfeit polypropylene material from a company in China due to a shortage in the U.S. And there are many layers to this story: not only is polypropylene a fragile material that can erode, migrate, shrink and cause many painful health complications, but an unverified foreign product increases the potential for injuries. When Boston Scientific compared the U.S. approved plastic with the foreign one, this is what they found: “They analyzed 11 different parameters, looking at the two plastics side by side, done, the same tests. Nine of those were different,” cites the 60 Minutes program. “Two were the same, nine were different. And of those nine that were different, four of those parameters were very different. And somehow, from that, they concluded that it was the same material.” Boston Scientific denied all allegations, but more than 48,000 lawsuits have been filed against the company on behalf of injured women.

Do You Have a Medical Device?

Not all medical devices are bad nor are they beneficial. As patients, our job is to be our best advocate. Research your surgery procedure and potential medical device online. Visit your doctor with a list of prepared questions or email your doctors to get the answers that you’re looking for. Weigh the risks and benefits to any procedure to determine the best choice for your health. We also need to speak out against bad medical device companies and FDA loopholes… our health depends on it.

 

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Sources
“How medical device harm is concealed”. ICIJ. Accessed January 30, 2019. https://www.icij.org/investigations/implant-files/how-medical-device-harm-is-concealed/?fbclid=IwAR0IfmV3sL4dcf7KWT_gP5Ta5XGtjfj-_UD1SVdE6TcKNIrj2ouLPxLGK9c
“Women sounded alarm on Essure birth control device. Now the FDA is cracking down.”. NBC News. Accessed January 30, 2019. https://www.nbcnews.com/health/womens-health/women-sounded-alarm-essure-birth-control-device-now-fda-cracking-n865531
“CBS News’ 60 Minutes Interviews Dr. Duane Priddy for Gynecological Polypropylene Mesh Investigation”. MarketWatch. Accessed January 30, 2019. https://www.marketwatch.com/press-release/cbs-news-60-minutes-interviews-dr-duane-priddy-for-gynecological-polypropylene-mesh-investigation-2018-05-17

Important Information You Should Know About Medical Implants

From knee replacements to breast implants to IVC filters, there are countless medical devices that are being implanted into millions of people every year. (Kind of reminds me of the 1970’s show The Six Million Dollar Man with Lee Majors.) Even though these types of procedures seem almost commonplace, every surgery is nerve wracking and comes with a certain amount of risk. It’s also important to realize that every medical device and implant comes with benefits and risks beyond the actual surgery itself. Here are some common questions and answers that patients have concerning these devices.

Tens of millions of Americans have medical implants, but what do we really know about these devices? If you have one or are planning to have surgery, read more here.

Is there a difference between a medical implant and medical device?

It seems that these two words are interchangeable, but they can mean different things in the medical world. Generally speaking, a medical implant is something that goes inside your body or connects to your body such as a hip replacement or a mechanism that internally delivers medicine such as a chemotherapy port.

A medical device is the general term that can include implants, but may also be used when referring to medical tools that are used in surgery, bandages to cover wounds, and a wide variety of other medical equipment.

Additionally, drugs are NOT included in either category (although an implant may deliver a drug into the body). If you visit the FDA’s website, you’ll notice a distinct tab for “drugs” and another for “medical devices.” This separation could help you if you plan to research your procedure or if you have to file a complaint down the road.

I’m considering getting a device. What should I research?

Before getting an implant, ALWAYS do your research. It seems simple enough to take your doctor’s advice, because after all, he’s the one with the medical degree and experience, but you are your best advocate and you need to know the benefits and risks to your procedure. For example, millions of women had vaginal mesh put in them and have had to undergo repeated surgeries to fix complications. The mesh is made out of polypropylene which can erode, break apart, migrate, shrink, and cause other painful complications. Equally alarming is that it wasn’t properly tested before becoming the “gold standard” for repairing pelvic organ prolapse or stress urinary incontinence. Knowing these facts could have prevented women around the world from unnecessary pain and devastation.

So here are a few ways to research the safety and effectiveness of your implant:

  • The FDA’s website is a good place to start. At the top right corner you’ll see a search box that says “Search FDA.” Type in the type of implant you’re planning on having (like breast implant, hip implant, vaginal mesh, etc.) and you’ll see a list of topics pop up. Choose the overview page first. If there are any warnings or FDA safety notifications about the product, you’ll see red highlighted text at the top of the page discussing the risks and problems that this device may be having. Scroll down and you’ll usually find what types of implants are available (such as metal, plastic, biologic, etc.), how to prepare for surgery, what risks and adverse effects to be aware of, and how the surgery will be done. But here’s a big problem: The FDA is underfunded and overwhelmed, so the website isn’t always up-to-date!!!!
  • Talk to your surgeon ahead of time and ask what specific brand and model of implant he or she is planning on using, then look it up. Find out how long it’s been on the market, if it was properly tested, can the device be removed if needed, how long will it last, how long did it take for others to start experiencing problems, and if there are lawsuits or recalls on it. You may also want to look into whether there are other options available that are safer and have less risks. Write down all of your questions and concerns and make an appointment to discuss them with your doctor.
  • Check out social media – As you may or may not know, there are specialized groups on social media and where you can ask people who have gone through the procedure about their outcomes. For instance, on Facebook you can type in “hip replacement” and you’ll see links to videos, groups, articles, and photos. You can even join a group and ask questions about recovery time, complications, and more.

My medical device is having a negative effect on my health. How do I report it?

First of all, call your doctor right away if you have any concerns at all. Fever, vomiting, increased pain and other symptoms may the start of a bigger problem. The sooner you address the issue, the better chance you have at recovery. Secondly, ALWAYS get a copy of your medical records whether you’re having complications or not. Not only will they detail your procedure, but it will have a card in it stating exactly what medical device you have including the brand, model, and serial number.

The FDA has a program called MedWatch where you can file a complaint form online. Click the button that says “Consumer/Patient” and you will be guided through a set of questions to share what implant you had and the complications you experienced. This is so important not only to track your own injuries, but to inform the FDA so that they can potentially analyze the data to protect others from harm.

 

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Sources
“Implant Files: Frequently asked questions and resources for readers”. https://www.icij.org/investigations/implant-files/resources-for-patients-and-frequently-asked-questions/

How to Safely Change Your Diabetes Medication

There are a variety of reasons why type 2 diabetics want to change or get off of their medications: 1) the high drug prices and the monthly investment that some require. 2) The FDA has put out scary warnings concerning certain drugs like Invokana and the increased risk of amputation. Maybe this has got you thinking about either changing your medication or getting off of it entirely or 3) perhaps you’ve gotten your levels under control through diet and exercise and feel like you no longer need to take all of those pills. Regardless of your reason, you should definitely talk to your doctor FIRST before taking any drastic steps to stop the meds your taking and create a plan together. Here are a few things that your doctor might suggest…

How to Safely Change Your Diabetes Medication

Change Up Your Medication

Each year you should evaluate the medications that you’re on and evaluate how they’re working. Your body changes and sometimes you may need to up a dose or try a medication that works in a different way. According to Diabetic Connect, “If your A1C result is not good, it may well be related to a change in your underlying diabetes, rather than to anything you did ‘wrong’; it may simply be a clue that it’s time to update your diabetes medications.”

The most important thing you can do after discussing with your doctor your new diabetes management plan is to constantly monitor your levels for about two weeks. Diabetes Forecast shares that diabetic medications don’t work right away and could take a few days to fully react in your body. “In the first few days after you start a new medication, you may start to see lower blood glucose readings. That dip happens before the drug hits its maximum blood glucose–lowering potential… This has to do with the medication reaching what’s called its ‘steady state’—when the amount of drug entering the body equals the amount leaving it. When the drug reaches this point in the bloodstream, you’ll start to see the greatest blood glucose drop, but the size of the effect depends on how each medication works in the body and how each person metabolizes drugs.”

During this process, it would be helpful to keep a journal of what you eat, your exercise routine, any minor side effects you may be experiencing (call your doctor immediately for any dangerous complications) and your blood levels. Your doctor will find this incredibly helpful as he or she tries to find the perfect drug combination for your unique situation.

Checklist for Weaning Off a Medication

NEVER stop taking a medication without being monitored by your doctor. It could be that the medication is working and that’s why your glucose levels are where they’re supposed to be. Just stopping a medication could create havoc in your body. When you DO go to the doctor, he may ask you these three questions:

  1. Is your A1C is less than 7 percent?
  2. Is your fasting morning blood glucose under 130 milligrams per deciliter (mg/dL)?
  3. Is your blood glucose level at random or after a meal is below 180 mg/dL?

If you answer yes to all three of these questions, your doctor may lower or stop your doses. However, there are other factors to consider – lifestyle, diet, stress, overall health – that influence this decision, so give your doctor a complete and accurate picture of your health profile.

“Some drugs can lower the blood sugar levels below the normal range, causing symptoms of hypoglycemia. These drugs, which include insulin and those in the sulfonylurea family (which are common in patients on more than one kind of diabetes pill) need to be reduced or discontinued by the clinician as required to avoid hypoglycemia, so these are typically the first drugs to be discontinued,” explains Dr. Michael Dansinger on WebMD. “It is important that patients who take these medications check their blood sugar levels regularly, particularly while making lifestyle changes. Doing so lets us know the risk of future hypoglycemia and guides the decision about when to decrease or discontinue such medications.”

Changing your medications or weaning off of them takes time, careful instruction from your doctor, and consistently monitoring your shifting glucose levels especially at the start of this process. Remember that your health management is a collaboration between you, your doctor, and often a family member or someone close to you who helps care for you. Your plan should be customized and doable for you to succeed. “Sometimes providers forget that and prescribe a regimen that is so difficult that somebody just can’t reasonably do it,” Evan Sisson, PharmD, MHA, CDE,Sisson says. “It’s up to the provider to say, ‘What’s reasonable for you?’ ”

 

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Sources
“Stopping Metformin: When Is It OK?”. Healthline. Accessed January 25, 2019. https://www.healthline.com/health/stopping-metformin
“Stopping Diabetes Medicines”. Diabetes Self-Management. Accessed January 25, 2019. https://www.diabetesselfmanagement.com/blog/stopping-diabetes-medicines/
“How To Wean Off of Diabetes Medication”. WebMD. Accessed January 25, 2019. https://blogs.webmd.com/life-with-diabetes-2/2010/12/how-to-wean-off-of-diabetes-medication.html
“When to Update or Change Your Diabetes Medications”. Diabetic Connect. Accessed January 25, 2019. http://www.diabeticconnect.com/diabetes-information-articles/general/30-when-to-update-or-change-your-diabetes-medications
“Type 2 Medications: How Long Do They Take to Work”. Diabetes Forecast. Accessed January 30, 2019. http://www.diabetesforecast.org/2016/jan-feb/type-2-medications-how-long.html

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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