When you are ill or experiencing a medical problem, you turn to your trusted family physician or medical provider. Depending on your ailment, your doctor will recommend a course of treatment. While some patients may have questions regarding a prescribed treatment most patients do not question the treatment itself. In other words, patients have a tendency to assume that if a doctor prescribes a particular medical intervention that he or she has a good reason to believe it will work. However, is this always the case?
A recent New York Times article examined how patients are hurt or even die because some of the medical devices on the market are not adequately screened or monitored by the Food and Drug Administration (FDA). It is estimated that in the past decade alone, there have been close to 2 million injures and greater than 80,000 deaths as a result of faulty medical devices. It was revealed that some of these faulty devices were approved for use with little to no clinical data. Put another way, some of these same products that were used to treat a medical problem had clinical proof that they were either safe or effective.
One of the biggest examples in history of a medical device gone wrong is pelvic mesh also known as transvaginal mesh. Pelvic mesh is a synthetic product implanted surgically into a woman to repair a condition known as pelvic organ prolapse, where a woman’s pelvic floor muscles are weakened and organs including the uterus or bladder can sag into the vaginal area. It is a common affliction especially with women who have given birth vaginally. Approximately 1 in 8 women have surgery to treat pelvic organ prolapse.
For over a decade, more than 100,000 patients, who had suffered varying degrees of life-altering injuries, made claims against seven companies responsible for making the mesh. The craziest part about the product responsible these 100,000 women’s injuries and close to 80 deaths is that it was never clinically before being approved by the FDA to treat pelvic organ prolapse. Instead, it was approved by what is known as a “510k clearance” loophole which allows a product to be approved more quickly and cheaper because the product is similar to an existing approved product.
The good news, if there is any, is that the FDA in April finally pulled the remaining pelvic mesh products from the market saying that it could not guarantee the long-term safety of the product. This after advocates had to tried to persuade the FDA for years of the dangers of the product. The bad news, of course, is that there were so many innocent people suffered far greater harm (and even death) by a medical device to solve a medical problem caused. The pelvic mesh litigation is one of the largest mass tort cases in the nation’s history in terms of the number of corporate defendants, the number of claims filed, and settlement dollars of approximately 8 billion dollars.
If you believe you or a loved one suffered an injury due to medical negligence or due to a faulty medical device, the law firm of Hubbard & Kurtz, L.L.P. can help. The seasoned Kansas City Personal Injury Attorneys at Hubbard & Kurtz, L.L.P. know what it takes to prove all the elements of a medical malpractice case a defective medical device case. Our attorneys have helped countless families, in both Kansas and Missouri, fight to obtain just compensation. Trust our team of skilled Kansas City Medical Malpractice and Personal Injury Attorneys to provide you with considerate and compassionate service. Contact Hubbard & Kurtz, L.L.P. today at (816) 472-4673 to schedule an initial consultation.