A torn meniscus in the knee is one of the most common complaints among professional athletes and amateur weekend athletes alike. The meniscus in the knee is a C-shaped piece of cartilage that acts as the knee’s own shock absorber. Our Deer Park medical device injurylawyers point out that removal of damaged meniscus tissue is a common cause of osteoarthritis. It is also the most common orthopedic surgery across the U.S. But currently such meniscus repairs have limited value.
The current procedure repairs meniscus tears with stitches and might also involve partial removal of damaged tissue. A full 20% of these repairs fail and even successful operations might not last. And patients’ physical abilities might be limited following the repair. A runner used to long distances is likely to find that their physician forbids such activity.
Replacement of damaged meniscus tissue with tissue from a donor can help reduce a patient’s pain and aid in restoration of a normal range of motion. But typically, donor tissue stands in danger of rejection by the patient’s body and is often available in limited supply. Our Deer Park medical device injury lawyers realize that the required anti-rejection drugs are costly and can have side effects in some patients.
Some medical industry players are watching a new development out of York, England. Tissue Regenix Group plc (TRG) has developed a new cellular scaffold derived from pig tissue that shows some promise for facilitating tissue patching and repairs. (Source: Makiko Kitamura, Bloomberg News, businessweek.com, 7/27/2012)
You might already know that pigs bear remarkable similarities to humans in many ways. Pigs’ tissues and cellular material, as well as their reactions to disease, are among the animal kingdom’s most similar to humanity. The similarity to human tissue of porcine tissue leads the human body to accept it much more quickly than tissue repairs derived from other, less similar animals. Unflattering to the more vain among us, but nonetheless true.
TRG “strips” or disinfects the cellular material from the pig tissue that can cause rejection reactions in transplant patients, leaving a cellular “scaffold” which the patient’s body fills in using their own stem cell activity. Prior versions of the cellular scaffold by other companies have used glutaraldehyde as a cellular “disinfectant.” This aldehyde tended to cause calcium buildup that in turn hardened the donor tissue, reducing its effectiveness as a repair designed to encourage a natural range of motion. TRG reportedly uses sodium dodecyl sulfate, which does not cause the usual calcium buildup, leaving the donor tissue more flexible.
Our Deer Park medical device injury lawyers understand that TRG received European approval in August 2010 for its first product based on this new pig tissue technology. That product was a vascular patch to replace tissue removed during open-heart surgery. Some observers say that the TRG pig-derived medical device led to a much quicker cell repopulation by the patient than similar patches derived from bovine tissue.
The company is releasing data from a pre-clinical trial of its pig tissue cellular scaffold medical device this year, with actual clinical trials in humans to follow in 2013. TRG indicates it might file for approval as early as 2014. If approved, the product could lead to better repairs not just for the meniscus, but also for heart valves, and serious wounds.
If successful, the TRG medical device could lead to a reduction in the demand for prosthetic knee replacements and provide valuable data regarding the potential of porcine organ transplants.
Because of its similarity to human tissue, pig tissue is already used in human implants in thousands of procedures each day around the world. But the new TRG process represents new horizons in medical device technology. The FDA requires clinical trial and analysis before it approves such innovations for use in the human body.
And our Deer Park medical device injury lawyers emphasize that the agency should require substantial testing and solid scientific analysis before approving a new medical device for market. A seemingly promising medical device can prove dangerous, even deadly, under conditions of actual usage. The agency is under fire for what critics call lax standards in approving certain drugs and also the notorious metal-on-metal hip replacement and the vaginal mesh medical devices that have caused so many patients so much pain.
You can learn more about the painful hurdles faced by patients injured by defective medical devices in this article by our experienced Deer Park medical device injury lawyers.