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What They Knew

Attune Knee Systems are made by DePuy Synthes, a subsidiary of Johnson & Johnson, and were  introduced to the worldwide market in 2011. The Attune Knee System is comprised of the following components: Attune Gradius Curve, Attune Rotating Platform Knee, and the Anatomic Patella. The problem with this popular knee replacement product is with the bonding system; parts have been reported to come loose and patients have been required to have further knee surgeries to replace the defective pieces. Many times these revision surgeries are more painful and difficult due to scar tissue and tissue damage.

When They Knew It

By 2013, problems started being reported about this defective medical device. According to The Journal of Knee Surgery, early on doctors began noticing that the devices were becoming unglued from tibial bone attachments. In certain cases, it was reported that the device never bonded to the bone at all! Furthermore, 10-20% patients have stated that they were not completely satisfied with this newer procedure. Unfortunately, even with these reports to the FDA, Johnson & Johnson failed to warn patients about this flaw in their product.

If you were one of the 650,000 patients who had an Attune Knee System surgery, here are some signs to look for if you suspect that your medical device has come loose:

  • Constant and consistent pain
  • Limited range of motion
  • Swelling and inflammation
  • Awkward range of motion in the knee including if the knee moves sideways or backwards
  • Loss of stability (such as trouble walking down stairs)

If you had an Attune Knee System surgery after 2013 and your device became loose causing you to undergo an additional surgery, call Periscope Group today. Johnson & Johnson knew early on that their device was problematic and yet the FDA didn’t recall this product until July 2015. Tens of thousands of people were given this device and many are reporting problems to the FDA. You may be eligible for compensation to help pay for your medical bills and time off work. Contact us today. We want to hear your story.

Attune Knee System Warnings In The News

2/27/18: Lawsuit Over Alleged “Cebonding” Hits Depuy’s Attune Knee

Johnson & Johnson’s DePuy’s orthopedics business is in court defending itself against charges that the company sold implants which it allegedly knew, or should have known, would result in higher than average rates of revision surgery.

Read Full Article

1/3/18: Attune Knee Replacement Failures and Consequences

A recent study published in the Journal of Knee Surgery reviewed a number of reports submitted to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database regarding DePuy Orthopaedic’s Attune Knee System, and found more than 230 reports about device failures.

Read Full Article

9/18/17: First U.S. Lawsuit Filed Against DePuy-Synthes for Attune Knee Replacement Failure

DePuy Synthes markets the Attune Knee System as having “patented technologies” that improve range of motion and give patients “the confidence of a stable knee replacement.” However, in recent months, DePuy Synthes has filed dozens of reports with the Food and Drug Administration documenting premature failures of the Attune Knee System that have resulted in the destabilization of patients’ knee replacements and painful revision surgeries.

Read Full Article

6/7/17: Unusually High Rate of Early Failure of Tibial Component in Attune Total Knee Systen

A novel design total knee arthroplasty (TKA) system has been introduced to improve patient outcomes and increase longevity. However, we have encountered a high rate of debonding of tibial implant–cement interface. In addition, multiple reports have been filed in Manufacturer and User Facility Device Experience database (MAUDE) with the same mechanism of failure.

Read Full Article

GET YOUR FREE Attune Knee System CASE REVIEW TODAY

Attune Knee Systems cases are now being reviewed, but there is a limited window to pursue help. If you think you, a friend, or a family member may qualify, get your free case review today… before it’s too late!

  • * Submit now to learn if you may be eligible for a cash settlement or call (800) 511-3838 now.

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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LATEST ARTICLES

Sling Vs. Mesh: What’s the Difference?

Talking about transvaginal mesh (TVM) can be confusing. There are words like “polypropylene,” “mesh migration,” and “pelvic organ prolapse” that can be difficult to understand. Additionally, sometimes words seem interchangeable like “sling” and “mesh.” Here are a few things that you need to know if you have or are thinking about having a TVM implant.

Sling Vs. Mesh: What’s the Difference?

Slings vs. Mesh

First of all, transvaginal mesh – commonly abbreviated to TVM – covers both slings and mesh. TVM is usually made out of a plastic called polypropylene. It looks somewhat like a window screen and the plastic itself is many times used to make fishing line.

Slings are mainly used for stress urinary incontinence (SUI) and are commonly referred to as “tapes.” This is because the mesh is cut into a long, thin strip much like a piece of scotch tape. SUI occurs usually in women who have given birth and in women who are 44 years old and older. SUI is when a woman laughs, coughs, or sneezes and then experiences urine leakage. The sling supports the tube that urine passes through (called the urethra) and the neck of your bladder (where your bladder connects to your urethra) to help prevent leaks.

There are also two types of slings: pubovaginal and suburethral. A pubovaginal sling has a minimally invasive surgery involving a small vaginal incision where the sling is placed under the urethra to support the organ. A suburethral sling sits around the urethra and is actually attached to the abdominal wall. This is a more invasive procedure and requires a couple of days in the hospital following the surgery.

Now let’s talk about mesh which is primarily used for pelvic organ prolapse (POP). POP is when some of the vaginal walls are weakened and then the bladder, rectum, small bowel and/or uterus sag near or in the vaginal opening. As you can imagine, it’s going to take a bit more than a skinny tape-like device to hold all these organs back where they belong. Mesh can be used to support these organs like a hammock.

Mesh Complications

Slings and mesh sound great, right? I mean, who wants to leak pee or have their organs protruding from their vagina? However, tens of thousands of complications have been reported among TVM patients including mesh erosion (when the mesh breaks apart), migration (when the mesh moves around in the body), tissue and organ damage (which happens when the sharp edges slice surrounding areas), and dyspareunia (where the mesh lodges in the vagina and causes painful sex). There are other procedures and devices – such as colporrhaphy and pessaries – that don’t have these harmful lasting adverse effects. When you think about it, women have been having babies and have been aging for thousands of years without using harmful TVM. Why is this dangerous device being put in women at all?!

TVM is truly a crime against women. This defective plastic breaks, slices, and creates irreparable damage causing women to no longer be able to work or function in daily tasks due to the excruciating pain. It also harms relationships because of the physical and mental stress it imposes and due to the lack of physical intimacy resulting from broken mesh (if it moves into the vagina, the sharp edges can slice the penis). These women are suffering, embarrassed, angry, and have lost so much… all so that big pharmaceutical companies can make a lot of money.

If you had complications that needed mesh removal, please contact Periscope Group today. We would love to hear your story and we want to help you if we can. TVM is a dangerous product that was never fully tested and has ruined tens of thousands of women’s lives around the world. It’s time that your voice is heard!

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Sources
“Talking about Slings and Meshes. There is a difference!”. Central Florida Urogynecology. Accessed July 30, 2018. http://www.cfurogyn.com/articles/prolapse/SlingsAndMeshes.html
“Sling vs. Mesh: What You Need to Know”. Urogynecology University of Colorado. Accessed July 30, 2018. https://urogyn.coloradowomenshealth.com/blog/sling-vs-mesh
“Colporrhaphy”. Encyclopedia of Surgery. Accessed August 6, 2018. http://www.surgeryencyclopedia.com/Ce-Fi/Colporrhaphy.html

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/

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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