The New York Times recently published a story about a lawsuit brought against an orthopedic prosthetic company for distributing their product without appropriate FDA approval. The story calls into question not only the process by which new technology is brought into practice, but the choices the clinician must make when deciding the best options to use on a patient. We need to study every new technology with evidence based means and make critical decisions on the outcomes resulting from those studies. We clinicians strive to always do better.
As I am sure you realize, the FDA and other parties are anxious to have more data, especially when it comes to the newer technologies in Regenerative Medicine. To the best of my knowledge and based on my ongoing scrutiny of the scientific and orthopedic medical literature, Regenexx is the only scientific laboratory to date that has repeatedly met with the FDA and their agents and been allowed to offer regenerative technology under the highest level of scrutiny. My particular targets are arthritis and synovitis. My therapeutic approach to pain, altered function, reduced motion, delaying and even avoiding a joint replacement, and reversing the natural progression of arthritis is mostly based on the research and publications of Regenexx; and in addition more recently, on the outcomes from the continuing monitoring of our own Regenexx Chicago data base.
When it comes to patient care, I explain risks and benefits in generic terms citing percentages from my understanding of the information presented at scientific meetings, that which I read in the medical literature, the publications from Regenexx, and information gleaned from my own investigations. The Decision-Making process should be and at Regenexx is based on registries. The governments of countries outside the United States have required participation in registries for many years; there is no such requirement in the United States. Regenexx for the past seven years has maintained such a registry, and when I joined the Network three years ago, added to the comprehensive nature of those outcome measurements.
Innovation is important to advance patient care. Regenerative Medicine is truly a transformational innovation. We want patients to respect our ability to make decisions about what is in their best interests. This foundation of respect will only result from unbiased decisions and will be strengthened when more recent entries into the field of stem cell care present scientific data and not “this is how I do it” or criticism based on market place competition. Regenexx has introduced a stable and stem cell methodology with a proven track record. This being the case, others should be careful when choosing to forgo that approach. In a spin on the words of the immortal Jerry Maguire, Show Me Your Data.
Tags: arthritis, Benefits and Risk, bone marrow, Bone Marrow Concentrate, Clinical Studies, Hip Replacement, Interventional Orthopedics, joint replacement, Knee, Knee Pain Relief, Mature Athlete, medicine, Orthopedic Care, Orthopedic Surgeon, Orthopedics, Osteoarthritis, Pain Management, Regenerative, Regenexx, Regenexx-SD, stem cells, technology, treatment
Musculoskeletal Care of the Mature Patient
I am receiving daily email blasts in addition to being subjected to a continuum of advertisements from plaintiff attorneys in the media concerning hip and knee replacement recalls. You know how it works; “call us to see if you are a victim of—–, you may be entitled to compensation”. My major interest in stem cell treatment of arthritis is the potential to avoid a joint replacement. On the other hand, I have performed over 20,000 total hips and total knees in my professional lifetime and there is a time and place for a joint replacement. While it is true that about five percent of hip and knee replacements in men and 15% in women are not satisfactory for multiple possible reasons, product liability is way down on the list. The only two recalls of prostheses of which I am aware are the ACS metal on metal hip series manufactured by J&J/Depuy and the Stryker Trident series of acetabular cups manufactured in Cork, Ireland. In spite of the attorney claims, there are no knee prosthetic recalls. I receive inquiries several times a week from patients concerning whether they are entitled to compensation even if there isn’t a problem.
The plaintiff attorney advertisements, for the most part, misrepresent the safety and performance of a joint replacement. As a result Zimmer recently filed a lawsuit to put and end to the inaccurate and misleading statements, for the first time challenging the attorneys’allegations. Surgeons are guided by scientific outcomes; patients should be guided by facts. I have been a clinical investigator of new generations of hip and knee implants and continue to follow many of my patients where possible; both as a standard of my practice and as part of several post FDA approval studies. Reader, be aware, contrary to the statements being made in some advertisements, the Zimmer NexGen knee prosthesis is not and has never been subject to an FDA recall. “Click here, you may be eligible for compensation” When I fish, I practice catch and release. The message in this Blog, don’t get caught and kept, maybe even eaten.
Returning home from a four-day trip, having to do with updates in Regenerative Medicine, I was confronted by numerous inquiries from patients in whom I have performed joint replacements. The issue, prosthetic recalls. Since I have performed in excess of 20,000 hip and knee replacements over my surgical lifetime both here and abroad, communication between my staff and my patients is ongoing but the recent increase in questions concerning these prosthetic recalls prompted me to redirect the Blog this week.
Recently, there has been a marked upturn in advertisements by plaintiff attorneys soliciting patient clients for legal action involving real or alleged recall of products by Zimmer, Stryker, and Johnson and Johnson. Many of these advertisements presumably have been inspired by media coverage and the plaintiff attorney solicitations are increasingly disruptive to my practice and disturbing to patients who have undergone, or are considering undergoing joint replacement surgery. I will try to correct the misleading and false claims in the public domains and educate my patient and my Blog subscriber. While it does appear though that there are situations wherein manufacturers of hip devices have placed profits over patient safety, many of the ads are misleading, and some are deliberately wrong.
Depuy Orthopedics, a division of Johnson and Johnson, recalled two of its hip replacement products, 1) the ASR XL Acetabular System and the ASR Hip Resurfacing System. 12 –13 percent of patients needed a second hip replacement within five years of receiving an ASR implant. I have personally never used an ASR implant.
Similar to Depuy Orthopedics, the Zimmer Durom Cup was recalled in 2008 after hundreds of patient complaints that the product was defective and required early revision surgeries. I have personally never used a Zimmer Durom Cup
I became aware of the early failures of Stryker Trident PSL and Hemispherical Acetabular Cups before the company announced its recall because I had to revise several of my own patients in a relatively short time after implantation. Problems included poor fixation, improper seating of components and bone fracture due to a nonconforming product. Stryker recalled its defective Trident cups in 2008 after numerous warning letters from the FDA; the company new about the defective manufacturing process in Cork, Ireland several years prior to its acknowledgment.
Media coverage describing the negative experience of a single surgeon using the NexGen CR-Flex Porous Femoral Component have prompted an increasing solicitation of potential clients for legal action against Zimmer. What prompted that surgeon to continue using the device when it was quickly apparent they weren’t working is a fair question but beyond the scope of our Blog? There has never been an action involving an alleged recall of products in the Zimmer NexGen category, the FDA has never ordered such recall. I have never personally used a NexGen CR-Flex Porous femur.
You may learn more about a particular orthopedic company or product on the web; access the corporate website: Stryker, Zimmer, Johnson and Johnson, Depuy.