What You Need to Know to Stay Safe
If you are in the market to have a knee replacement any time soon, you owe it to yourself to read this post and take note.
You may have recently read a headline like this…
“Otismed Corporation and Former CEO Plead guilty to distributing FDA-Rejected Cutting Guides for Knee Replacement Surgeries”
After significant research, I found the underlying story about the knee implant industry and key players like Stryker, Depuy and the FDA, far more surprising and disturbing yet thoroughly papered over by most of the major news organs allowing Stryker the parent company to dodge a major public relation snafu, while the media gladly pin the tail on the donkey-Otismed and its’ disgraced former CEO.
On Oct. 2, 2008, OtisMed submitted a pre-market notification to the FDA seeking clearance to market the OtisKnee that was eventually denied approximately one year later. Pre-market notification is a fast track approval process when a medical device is deemed “similar” to those already on the market and therefore does not represent a high risk to the population.
The focus of recent publicity has been almost exclusively over the CEO of Otismed who blatantly disregarded the FDA denial, and knowingly shipped off 218 units to surgeons to empty the warehouse.
Selling the Theory
In May 2006, Otismed a software company that created and patented custom cutting guides for surgeons (Trademark is ShapeMatch) began to sell the software to surgeons through the co-promotion of Stryker. Of course who would not want a custom knee? The theoretical proposition that a custom fit knee would work and feel better than an off the shelf product is almost irresistible logic.
The problem, as described by Dr. Stefan Kreuzer MD, is that the theory runs counter to the traditional method of positioning knee implants. Mechanical alignment is the gold standard boasting long-term results with 90 % success rates 10-20 years after implantation.
The new kid on the block is kinematic alignment or what Otismed refers to as Shape Matched Technology allowing for a “custom fit”. Surgeons take an MRI of the diseased knee, represent it in a healthy state model then create custom cutting guides that would recreate the person’s natural kinematic axis. The theory sounds promising but is essentially untested. While early studies appeared promising, Dr. Kreuzer was waiting for more research and stated, “the jury is still out on the Otismed principle”.
Meanwhile, Otismed and Stryker rushed headlong into the market undaunted by the common sense need for comprehensive research and testing when tampering with such an important element of surgical success. Sales reps took to the surgeons’ offices claiming FDA approval was not needed. Eventually 18,000 of these cutting guides were sold and used in surgeries.
On January 12, 2008, The Journal of Arthroplasty published a study on the OtisMed knee suggesting that patients might experience early implant loosening or wear and eventual failure due to gross limb malalignment. Some surgeons reported aborting the surgery and using traditional techniques due to concerns emerging during surgery.
The Marketing Gold Rush Takes Precedence Over Safety
“THE BAYLOR REGIONAL MEDICAL CENTER AT PLANO OFFERS CUSTOM FIT KNEE™ REPLACEMENT”, ran the title of the press release put out by one of the largest hospital systems in Dallas on Feb 28, 2008, only one month after warning signs emerged.
The hospital boasted:
New Technology Allows Surgeons to Customize Implant Fit and Placement for Each Individual Patient. OtisMed’s initial offering is the OtisKnee, a groundbreaking new product that enables surgeons to offer custom fit total knee replacement. With OtisKnee, surgeons can for the very first time match the size and placement of the implant to the patient’s unique and normal (non-diseased) knee anatomy.
Of course the fact that this was only theory and had not been proven was of no consequence to the marketing specialists at Baylor Plano. Undoubtedly many other hospital systems eagerly jumped on the bandwagon to cash in on the unproven technology.
Finally, eight months after this press release, on Oct. 2, 2008, OtisMed submitted a pre-market notification to the FDA seeking clearance to market the OtisKnee.
Where On Earth Is The FDA?
In a relatively small market like knee implants, it is surprising that Otismed could market a product with impunity for approximately 3 years before being told to stop. It took the FDA one year (Sept, 2, 2009) before deciding that Otismed should be denied clearance to market the cutting guides.
Interestingly, Stryker acquired Otismed in November 2009 despite knowing that the device had not been approved.
Then in 2010, Stryker received a subpoena from the Department of Justice related to sales and marketing of the Otisknee.
Despite the ongoing investigation, the FDA granted approval to Stryker in May 2011 for the ShapeMatch Cutting Guide through 510(k) clearance. By the end of the month, Stryker had offered 33 million to the DOJ to settle allegations of violations of federal laws related to The Otisknee, not cleared by the FDA.
Depuy, was marketing a similar custom knee-Trumatch without FDA approval. The FDA issued a warning letter to Depuy orthopedics, Inc. on August 19, 2010 that stated that the marketing of the TruMatch Personalized Solutions System was illegal. The company was ordered to halt marketing on the device, until the situation was resolved. TruMatch, had not been approved for use in the U.S according to the letter. The FDA claims Depuy never told them it intended to commercially distribute the product.
And Finally The Train Wreck We All Knew Was Coming
In January 2013, just 18 months after being approved, Stryker’s ShapeMatch Cutting Guide was formally recalled by the FDA with a Class I recall.
This type of recall is the most serious of recalls responses that can be issued by the FDA. It is reserved for a situations in which there is a reasonable probability that the use of or exposure to the product will cause a serious adverse heath consequences or death. It was found that a software glitch resulting in the creation of cutting guides that did not match the parameters set by the surgeons and led to misalignment of the implants.
Is There Anyone Looking Out For You?
The FDA does not have your back. According to the Consumer Union, Safe Patient Project, the reality is that
Instead of pre-market safety testing, the FDA primarily relies on “post-market” reporting to Medwatch, a system for physicians and patients to report problems with implants. When enough problems or “signals” are reported, FDA may send out notice to the companies and the companies can choose to voluntarily recall their products. This means virtually every hip and knee implant patient is an unwitting participant in a giant, “post market” test to see which products are actually safe and which ones turn out to harmful or ineffective.
Who is in charge of policing a careless and reckless industry from throwing patients under the bus for profits? The answer- no one!
My hope is that your day of blithely trusting healthcare professionals and taking opinions and marketing claims at face value is over. Now more than ever you must do your own due diligence. Ask your doctor what implants he is using. Do your own research. Find out about the existing track record of a device. If there is no track record, run-you are about to be used as a guinea pig.
Consumer Union Report
Dr Stefan Kreuzer MD
Department of Justice
Gibson and Dunn
Depuy FDA Action