Whenever you are injured or ill, you want to be sure the technology the doctors are using will help save you- not hurt you. The Food and Drug Administration (FDA) is devoted to making sure the medications and devices in the medical field do just that. Recently, they have come up with a concern about a blood pump put out by HeartWare International Inc. The pump is used to help people who have a severe heart failure, and does that job well. Yet medical device reviewers claim that the pump also heightens patient's clotting rates and possibilities of a stroke.
The HeartWare Ventricular Assist Device (HVAD) was tested in a clinical trial by the FDA. Unfortunately, the test may have missing data that is hard to compare with the registry of patients that have used the machine. In the clinical trials, the HeartWare company compared patients who used the HVAD machine to those who used a mechanically assisted circulatory support. No blood pump manufacturer has ever used this type of comparison/registry data to prove the effectiveness of their product.
Because of the obscure way of testing, the FDA is concerned the HeartWare may have skewed their numbers in favor of the HVAD. The FDA reports that 16 of the 250 people who received the HeartWare device had a blood clot-related pump failure, and 15 of the patients needed to replace their pumps- which requires a surgery. When dealing with the cardiovascular area, it is very important that machines are fool-proof have no chance of causing a terrible heart failure problem.
Though many of the people involved in the experiment are defending HeartWare and the HVAD, the FDA still wants to take the issue to a panel. They say that the fact that 15 people needed a device exchange is a relevant consideration and may suggest that the HVAD is not safe or effective. The FDA postponed a meeting with outside experts who were due to vote on the device on April 25th. The HVAD's main purpose is to aid people with heart problems by pumping blood in failing hearts. It is usually installed in patients to preserve their lives while they await a heart transplant.
According to NBC News, about 50,000 worldwide are awaiting heart transplants, but only about 5,000 people receive one each year. The HeartWare blood pump is intended to preserve those people who are hoping for a heart transplant but are not sure when their opportunity for the surgery will arise. Right now, there is only one blood pump which can be installed in a person with heart failure while they are awaiting a transplant. It is known as the HeartMate II, and was invented the Thoratec Corp. This pump was approved for use in 2008, and is used in many surgeries now to help sustain the heart's functions. If the HVAD is approved, many doctors believe that it will eventually eclipse the HeartMate II, since it is smaller and takes less time to implant.
The FDA does not intend to approve the new device if it has too many side-effects would could be fatal to heart failure patients. Eight percent of the men and women who were issued a HVAD in the control group for research suffered an ischemic stroke. This is a condition when a blood vessel that supplies blood to the brain is blocked by a clot. The dangers of clotting, and pump-associated thrombosis are also main concerns that the FDA will continue to research with the device.
It is important to make sure that the devices used in your hospital are FDA approved. While it is illegal for hospitals to use any devices that have not been approved by a health department, you may want to research products before consenting to any sort of treatment or implant surgery. When negligent medical staff implant a device in your body that is dangerous, unapproved, or has severe side-effects, you may want to contact a medical malpractice attorney, especially if you did not consent to the operation.