While patients who have had significant blockages in their arteries may not have a choice but to have stents implanted to keep their arteries open and a supply of life-giving blood flowing, there is an unusual amount of risk coming from a source that should be held more accountable. Going back at least six years, Cordis, the manufacturer of the Cypher Stent, was issued a warning that their product was defective and deaths had been reported and more could follow. Unfortunately, to date, this drug-washing stent is still being implanted during angioplasty and even though a significant number of lawsuits have been filed, Johnson & Johnson continues to manufacture and distribute this product, many of which are still being placed in Georgia patients.
When some or all of a patient’s arteries are blocked, it had been the practice prior to the 1990s to do open heart surgery, commonly referred to as bypass surgery. Here is where segments of an artery taken from the patient’s leg would replace that portion of the artery going into the heart. However, with the invention and subsequent approval of heart stents, bypass surgery is becoming increasingly less common.
There are a number of reasons why doctors would opt for stents in lieu of open heart surgery, but primarily because the insertion of stents is considered a non-invasive procedure. Two of the most common reasons to opt for stents would be:
· The overall state of a patient’s health
· Inability to cut through the sternum
Sometimes a patient is not healthy enough to withstand open heart surgery which is one of the most serious and major types practiced today. Other times a patient is not a candidate for open heart surgery due to other factors including previous radiation to the chest. Cancer patients who have been cured or are in remission after radiation to the chest are not good candidates for heart surgery because of the potential for the sternum to disintegrate when cut into. Stents are the obvious alternative in both cases if the arteries are seriously blocked warranting intervention.
Because there are so many defective products still in use and still in question, many doctors, patients and families of patients are asking why. If it is known that these products can lead to death, why are they still being inserted into a patient’s arteries? One of the most common responses is something along the lines of “Without the stents you will almost certainly die. With them at least you have a fighting chance.” That’s not good enough! And, that is why there are so many lawsuits in the courts today.
If you, as a Georgia resident, are being told you need stents to open those clogged arteries, you can find a list of known defective products on the FCA website, listed under 2016 Medical Device Recalls. Unfortunately, this is just the most current list of those products found to have safety issues in the previous year and updated regularly as they are reported. For products such as the safety advisory on the Cordis Cypher Stent, you’d have to go back a few years further. The initial safety advisory which should have prompted a recall was issued sometime during the year 2011. Imagine that! Six years and counting and they are still using these stents in patients to this day.
While you may not be experiencing any problems at the moment, there is always the potential for them to develop at any given moment. Bear in mind that a faulty stent can result in death, worst case scenario. The first thing you should do, if you haven’t already, is get your exact medical records. Ascertain what type of stent was used and if it is on the FDA watch list, there are two people you should contact immediately.
The first person would be your cardiac surgeon to inquire about the possibility of having those stents replaced with a product not found to be faulty. Secondly, contact an attorney to see whether or not you can file a suit against the doctor and/or facility if they knowingly inserted a product found to be potentially defective and life-threatening.
You have the right to expect the best medical care available which includes the use of products and equipment found to be safe for use. If those conditions aren’t met, you have the right to demand compensation. Start with your doctor and lawyer. Don’t wait until your product fails. It just might be now or never.