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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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The Step-By-Step Guide To Taking Action

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

LATEST ARTICLES

As the Race for Presidential Candidates Heats Up, Roundup Becomes Hot Topic

There are many controversial issues that political candidates build their platforms on, and public health and the environment are certainly hot topics. Congresswoman Tulsi Gabbard (D-Hawaii) is the first federal legislator and presidential candidate to call for a ban on Roundup weedkiller and we’re thrilled that she’s bringing this important topic to the forefront of political debate.

As the Race for Presidential Candidates Heats Up, Roundup Becomes Hot Topic

Financial Contributions and Political Support

It’s no secret that mega corporations give financial contributions to political candidates and officials, not to mention lobbyists. In fact, Monsanto’s website even admits:

“Monsanto is committed to participating constructively and transparently in the political process, as such participation is essential to the Company’s long-term success. Our approach on corporate political contributions is driven by the significant impact that public policy decisions can have on our business and on the interests of our stakeholders.”

Fortunately, these political contributions are open to the public to view, so here are some numbers to think about:

Paid to the House of Representatives in 2013

Total paid by Monsanto to Democrats: $72,000
Total paid by Monsanto to Republicans: $190,500

Paid to Senate in 2013

Total paid by Monsanto to Democrats: $37,500
Total  paid by Monsanto to Republicans: $85,000

Contributions to Federal Candidates, 2018 cycle

Total Contributions from this PAC to federal candidates: $315,000 (33% to Democrats, 67% to Republicans)

House: Total to Democrats: $92,500; Total to Republicans: $193,500
Senate: Total to Democrats: $23,500; Total to Republicans: $41,500

When you consider the bills and political decisions that involve adding a warning label to the products, banning glyphosate, use on city property, and more, Monsanto’s contributions are having an impact on government regulations and thereby public health and safety.  

This is precisely why it’s so refreshing to hear that Congresswoman Tulsi Gabbard is standing up against Bayer (who acquired Monsanto in 2018) by stating on Twitter, “I’ve said it before, I’ll keep saying it: Ban roundup! It’s long past time we stopped relying on corrupt corporations with a profit incentive to fund science telling us their chemicals are ‘safe.’ Victims shouldn’t have to go to trial to get the truth.”

Between the two recent California trials that found in favor of the plaintiffs who were diagnosed with cancer due to use of Roundup, new studies that found that Roundup causes a 40% increased risk of cancer, and LA County’s recent ban of Roundup on county property, hopefully more politicians will listen to researchers and their constituents and ban Roundup.

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Sources
“Presidential Candidate Says ‘Ban Roundup!’” Organic Consumers Association. Accessed April 4, 2019. https://www.organicconsumers.org/blog/presidential-candidate-says-ban-roundup#close
“Extensive List of Politicians Paid Off By Monsanto”. Natural Society. Accessed April 4, 2019. http://naturalsociety.com/list-politicians-paid-off-by-monsanto/
“Political Disclosures”. Monsanto. Accessed April 4, 2019. https://monsanto.com/company/governance/political-disclosures/
“Monsanto Co.” Open Secrets. Accessed April 5, 2019. https://www.opensecrets.org/pacs/pacgot.php?cmte=C00042069

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

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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© All Rights Reserved • 2019 • Periscope Group, 4155 Blackhawk Plaza Circle, Suite 100, Danville, CA 94506 Legal Disclaimer

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