Strap in. This is the first of three posts dedicated to medical device research, global database practices, U.S. FDA approval procedures and pending legislative Bills impacting quality controls over knee replacement devices and their paths to market.
My friend Lindsay and I were having a happy hour one fine fall day and were comparing our experiences with orthopedic surgeons. I became particularly agitated when I began describing my first meeting with a joint replacement specialist to discuss revising my old Total Knee Replacement (TKR). I can still remember my frustration: “He had the temerity to ask me what the make and model of my first knee replacement was! That was fourteen years ago! I hardly remember – and truth be told, it didn’t occur to me to even ask the surgeon back then about make and model. I mean, what kind of expertise could I lend to decision making about a knee model and type? I depend on the surgeon to make that kind of decision. The fact is, I also lost the records in all the moves we made since then and I can’t even guess what kind of knee I have holding me up. I just know it is metal.” Lindsay’s attentive, quiet stance told me I was being heard but her coy smile told me she had a different perspective that I paraphrase here: “You know luv (she is British), that was precisely the first question we asked our surgeon when my husband’s hip had to be replaced: what kind of model, what type of metal and what year of manufacture? I then did my best to research as much as I could about it. Yah! We have all the records about that surgery.” That was a coarse moment, made memorable by the humility, the stupidity that I felt and continue to, because in this case, clearly, what you don’t know CAN hurt you.
The revered Consumer Reports (www.consumer reports.org) agrees with Lindsay. When considering an implant, they recommend these steps, 1) Select an experienced surgeon. 2) Research the ‘Recall’ history of the implant device after selecting a make and model. 2a) Establish a record of your research to have on hand ‘just in case’. 3) Discuss pain treatment plans.
What is ‘Recall’ History and Why is Knowing an Implant Recall History Important?
The recall of a medical device is a term used by the United States Food and Drug Administration (FDA) to describe what, why and how often a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. (www.fda.gov/medical-devices)
The FDA website goes on to explain that a medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a revision knee) is recalled, it does not always have to be explanted (removed) from patients. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place.
Examples of the types of actions that may be considered FDA recalls:
- Inspecting the device for problems
- Repairing the device
- Adjusting settings on the device
- Re-labeling the device
- Destroying the device
- Notifying patients of a problem
- Monitoring patients for health issues
Sometimes a company may be aware that there is a problem with a group of products, but it cannot predict which individual devices will be affected. To appropriately address the concern, the company may recall an entire lot, model, or product line.
Who Recalls Medical Devices?
In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates FDA law, it does two things:
- Initiates a recall (through correction or removal)
- Notifies the FDA.
Legally, the FDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death. However, in practice, the FDA has rarely needed to require a medical device recall (www.fda.gov/medical-devices).
What Does the FDA Do About Medical Device Recalls?
When the FDA learns of a company’s correction or removal action, it reviews the strategy the company proposes to address the problem, assesses the health hazard presented by the product, determines if the problem violates FDA law, offers potential violations of FDA requirements, and if appropriate, assigns the recall a classification (I, II, or III) to indicate the relative degree of risk.
Class I (high risk): A situation where there is a reasonable chance that a product will cause serious health problems or death (i.e. pacemakers).
Class II (medium risk): A situation where a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death. Joint implants are commonly found in this category.
Class III (low risk): A situation where a product is not likely to cause any health problem or injury (i.e. scalpels, bandages).
Once classified, the FDA monitors the recall to ensure that the recall strategy has been effective. Only after the FDA is assured that a product no longer violates the law and no longer presents a health hazard, does the FDA terminate the recall.
How does the FDA Notify the Public about Medical Device Recalls?
When a company initiates a correction or removal action, the FDA posts information about the action in the Medical Device Recall Database. (www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm) This is the site you want to visit when you learn the name of the make and model your surgeon recommends. It is also a site you can visit as you explore for yourself, makes and models you think could be best suited for you.
The FDA updates the Medical Device Recall Database after it classifies the recall and again after it terminates the recall.
In addition, the FDA may post company press releases or other public notices about recalls, market withdrawals, and safety alerts that may potentially present significant risks to consumers or users of the product.
After a recall has been classified, the FDA notifies the public in its Weekly Enforcement Report. In addition, the FDA posts consumer information about recalls in order to ensure that patients are aware of the seriousness of the potential health hazard posed by exposure to the product.
Once classified, the FDA monitors the recall to ensure that the recall strategy has been effective. Only after the FDA is assured that a product no longer violates the law and no longer presents a health hazard, does the FDA terminate the recall (www.fda.gov/medical-devices).
This all seems clear and accountable. What’s the problem?
Being able to quickly bring an implant device to market while avoiding previously required rigorous clinical studies – that is the problem. The advocacy group Consumers Union (within Consumer Reports) reviewed the FDA’s medical device database and found that 708 knee replacement recalls were issued between 2003 and 2018. Drugwatch conducted a separate review in 2018 and identified another 76 recalls. Roughly 97 percent of all recalls in 2018 involved knee replacements from just three manufacturers: Zimmer-Biomet, DePuy and Stryker. (www.drugwatch.com/knee-replacement/recalls/)
Announcing a recall is one step. The actual number of components and patients affected are exponentially more. For example, in 2010, the U.S. FDA issued a Class II recall to Zimmer Inc. (now Zimmer Biomet) for its NexGen Complete Knee Solution MIS Tibial Components, Locking Screw and Stem Extensions, affecting 68,383 devices that had already been implanted. In addition to this recall, the company issued a voluntary recall on an additional 41,180 devices. Al tol, two recalls, one forced and one voluntary, affected over 100K devices of which over half were already implanted in people knees and thus, into their daily lives. (www.lawsuitsettlementnews.com/defective-product/zimmer-nexgen-knee)
How Did This Happen?
The FDA established the FDA 501 (k) 3 Clearance Process which allows the fast-tracking into a surgeon’s office new implant designs that are deemed “substantially similar” to previously approved models. This fast-track allows devices to avoid undergoing what would have been typical but time consuming and rigorous clinical testing. As Jeanne Lenzer (Gloopman, The New Yorker, April 2020) explains, most (i.e. Class II) devices are “exempt from clearance or approval and can simply be registered with the FDA” (through the 501 (k) 3 Clearance Process); more invasive or complex devices in these classes also face minimal hurdles, requiring only that a manufacturer give the FDA ninety days’ advance notice before marketing a device. Unlike drugs, these items do not need to be tested in clinical trials, and they are said to be “cleared” rather than “approved.”
Reality can be harsh: Under the FDA Fast-Track System, patients become the research subjects. Patient use and feedback on recover (aka of a make and model) creates the ‘clinical study’. My, your, our feedback provides the data and marketing language. In addition, you and your insurance company pay for a company to improve its products while you risk suffering the consequences of hosting a defective device.
Still, the FDA 501(k) 3 clearance process still actively exists despite rendering “…thousands who receive (implants) (to) serve as unofficial test subjects.” (SurgicalWatch.com). A growing percentage of this group suffer the unacceptable consequences of chronic pain, immobility and a premature need for revision surgery – and so goes the reality of revision repair as this blog site has been describing.
A quick overview (DrugWatch.com) of the leading lawsuits to date showcases how people are truly suffering from fast-tracked models that have not completed slower paced, rigorous clinical studies reliant on the combination of computer simulations and alternative test subject (i.e. dogs):
Manufacturers, Models, Problems
Arthrex, iBalanced Knee, Loosening/defective tibial tray
B. Braun, Adv. Surface Ceramic Coated Knees, Loosening/cement failure
DePuy, Attune Knee System, Loosening/ Instability
Exactech, Optetrack Knee, Excessive wear/premature failure
Zimmer Biomet, NexGen, Premature loosening
Zimmer Biomet, Persona, Loosening/Defective screws
Stryker, Duracon Uni. Knee System, Pain/Instability/Limited ROM
WHAT YOU DON’T KNOW CAN HURT YOU.
Much, much to my chagrin, my revised knee structure is the Zimmer Biomet NexGen system – a zippy, wow name that would appeal to me if I didn’t know any better. It was first introduced in 1995, with most of its components later approved, without extensive trials thanks to the 510K fast-track approval program. How difficult it was to learn that this make and model of implant is prone to fail within a few years. Needless to say that as (and still) the most popular design on the market, Zimmer Biomet faces the largest lawsuit on record for knee replacements. (www.aboutlawsuits.com/zimmer-nexgen-knee-settlement-140107/ )
What Could I Have Done Differently?
I could have asked my surgeon these questions among others:
- What device are you planning to use?
- Why this device?
- Does it have a reasonable track record of use (minimum of 5-10 years) (verywellhealth.com/what-type-of-knee-replacement-implant-is-best-2549614)
- How often have you implanted this device?
- Given my age, medical profile, lifestyle, resilience capacities, and future needs, describe how this device appropriate for me?
- What is its recall history and why?
- How do you square its recall history with your reliance on it now?
- What database(s) do you rely on to determine which implant device to use? (more on this in Blog 16)
- What do your previous patients think are this device’s strengths and weaknesses?
- May I talk to ( i.e. three of) your patients who have the same device?
- What are some decent alternatives? What are their strengths and weaknesses?
- If I wait, what device improvements might be ‘just around the corner’?
Asking any combination of these questions could have also helped me assess more astutely, no, responsibly, if this surgeon was as good as hi/her website testimonies, research papers and hospital rates claimed and clarified if s/he was a good match for me?
I could have embarked, from the start, on a physical therapy routine that factored in the weaknesses of the make and model. Recently, I redesigned some of my PT routines now that I know I live with a vulnerable device. I have accepted that I must regulate my getting up and sitting down, amount of walking, avoidance of stairs and sudden movements.
In the meantime, I now do have a resource file that I update periodically with information pertinent to my make and model. I use a very green neon tab.
I continue to take deep breaths when I feel despair crawling out from under the metal. I consciously tamper it down into a low-grade awareness and return to core muscle exercises. I also returned to doing shoulder-stands, thus shifting stress from my knees to my shoulders where the weight of responsibility more ably rests.
WHAT YOU DON’T KNOW CAN HURT YOU. WHAT YOU DO KNOW CAN ONLY EMPOWER YOU.
Blogs #16-17 will review how newer databases are improving information gathering on currently implanted devices, and on current legislative Bills to secure patient safety and close the FDA 501 (k) 3 Fast Track loopholes.
Blog #15 resources:
Lindsay T.; Rome, Italy/Manchester, England