One of the biggest questions people have when they or a family member have suffered side effects such as kidney failure, stroke or a heart attack following open heart surgery is how to find out whether or not Trasylol was used during the surgery. Patients who underwent bypass surgery most often do not know what medications were used during the surgery because their surgeon made the decision of whether to use Trasylol based on the risk of excessive blood loss during the procedure.
Looking at the hospital records associated with the surgery is the best place to find out whether Trasylol was used. Alternatively, you can also look at the hospital billing statement to see if Trasylol (also referred to as “Aprotinin”) is listed under the charges. Under federal law called the “HIPAA Privacy Rule” you have the right to see and receive a copy of your medical records. Typically after requesting your medical records you should receive them within 30 days of the time of request.
Common Questions:
Q: Is there a charge for requesting my medical records?
A: The hospital or medical provider is able under the law to charge a fee for retrieving and copying the requested medical records. Because of this, it is important to initially request only a limited number of surgery records to help lessen the charges associated with the request. In some situations the records can number into several hundred or thousands of pages depending on the specific circumstances. This can translate into a retrieval and copying bill of several hundred to over a thousand dollars since many medical providers charge one or more dollars per page of medical records.
Q: Can I request the medical records on behalf of a family member or friend?
A: Generally, you are only able to request your own medical records. Someone trying to get copies of their medical records is able to grant another person permission to request their records, however his must be done in writing or in certain circumstances a legal guardian must be appointed by the court.
Q: Am I able to request the medical records of a person who has died?
A: Typically, the person who is able to request the medical records of a person who is deceased is the personal representative of the deceased who has been designated by a will or a court has appointed the person. The key to requesting medical records of a person that has died is to include documentation along with request showing you are entitled to access the medical records.
It is a good idea to have the records reviewed by someone who can correctly interpret the records and if there is any doubt contact a medical professional or attorney who can help you in requesting and reviewing the appropriate records.
An attorney at Fields Law Firm is available to answer any questions you may have regarding how to find out if Trasylol was used during heart surgery. We will also request copies of your medical records or family member’s records at no cost to you in order to help find out if Trasylol was used.
Bayer is reviewing the results of the Canadian study of their Trasylol heart medication drug. Trasylol problems including kidney failure, stroke and death have affected thousands of patients across the United States. The Canadian study (referred to as the “BART” study) was a randomized clinical trial involving patients who underwent one of the following procedures: repeat cardiac surgery, isolated mitral-valve replacement, combined valve and CABG surgery, multiple valve replacement or repair, and surgery of the ascending aorta or aortic arch procedures.
The BART study was stopped after a planned periodic data analysis indicated reduced bleeding but also an increase in all-cause mortality for patients in the aprotinin (Trasylol) treatment arm compared to patients who received either of the generic drugs aminocaproic acid or tranexamic acid. Bayer is waiting until more information becomes available following their final data analysis before they take further action regarding Trasylol.
If you or a loved one has had open heart surgery and then experienced Trasylol kidney failure, heart failure or stroke, you may be able entitled to money damages. A Trasylol lawsuit attorney can help evaluate your claim.
In November 2007, Bayer withdrew its heart surgery drug Trasylol from the marketplace. A study based on observations at sixty nine cardiac centers was published that showed Trasylol kidney failure along with other serious side effects such as heart failure and stroke. The observational study raised significant questions regarding the safety of Bayer’s drug.
The study revealed that patients receiving the drug had double the risk of Trasylol kidney problems along with other side effects. It is estimated that as many as 10,000 patients may be on kidney dialysis due to Trasylol. Many patients have suffered from renal failure which can often lead to death. After Trasylol enters the body during bypass surgery it is attracted to the kidneys where, as in many patients, it causes kidney problems including kidney failure. The following video describes the anatomy of the kidneys.
If you or a loved one has had open heart surgery and then experienced Trasylol kidney problems, heart failure or stroke, you may be able entitled to money damages. Trasylol lawsuit attorneys can help evaluate your claim.
The New England Journal of Medicine published an editorial in March 2008 title: Learning from Aprotinin – Mandatory
Trials of Comparative Efficacy and Safety Needed. The authors concluded the problems that have surfaced regarding Trasylol are going to be repeated in other drugs unless the FDA institutes changes in the requirements of postmarketing studies and restrictions on drug distribution and use. The magnitude of Trasylol kidney failure side effects and the potentially fatal consequences that have affected tens of thousands of heart surgery patients are becoming more and more evident.
The FDA first approved Trasylol (aprotinin) in 1993 to help prevent excessive blood loss during bypass surgery. It is estimated that by 2006, around 200,000 heart surgery patients had been prescribed aprotinin. Dr. Dennis Mangano and a group of researchers raised a red flag in 2006 and 2007 regarding the safety of Trasylol. Dr. Mangano published an observational study that showed Trasylol increased the risks of kidney failure, heart attack, stroke and death. The New England Journal of Medicine, in their editorial, asked the important question “What can we learn from the saga of aprotinin, a drug that apparently confers less overall benefit than cheaper alternatives yet has remained on the market for more than 14 years and become the recommended hemostatic agent for high-risk cardiac surgeries?”
According to the editorial, a crucial piece of the drug approval and monitoring process that is missing is the requirement for more information on infrequent but serious complications and performance relative to alternative drugs. In their opinion, the major lesson to be learned from the current Trasylol problems is that there needs to be head-to-head comparative trials when a new drug has alternatives. This needs to be done before a drug such as Trasylol is routinely administered for a large number of patients. Furthermore, they state that we cannot rely on the drug manufacturers to perform these studies on a voluntary basis because it is not in their commercial or financial interest to do so.
If you or a loved on has suffered from Trasylol kidney failure side effects or has died following heart surgery where Trasylol was used please contact our Trasylol attorneys for a free consultation or help finding out if Trasylol was used during surgery.
Thousands of heart surgery patients throughout the United States who were given the Trasylol heart medication during bypass surgery have kidney failure and are on dialysis or have died as a result of renal failure. You need dialysis when you develop end stage kidney failure – usually by the time you lose about 85 to 90 percent of your kidney function.
The following video describes hemodialysis that many patients suffering from Trasylol kidney problems have to undergo three times per week following their heart surgery.
Healthy kidneys clean your blood by removing excess fluid, minerals, and wastes. They also make hormones that keep your bones strong and your blood healthy. When your kidneys fail, harmful wastes build up in your body, your blood pressure may rise, and your body may retain excess fluid and not make enough red blood cells. When this happens, you need treatment to replace the work of your failed kidneys.
In hemodialysis, your blood is allowed to flow, a few ounces at a time, through a special filter that removes wastes and extra fluids. The clean blood is then returned to your body. Removing the harmful wastes and extra salt and fluids helps control your blood pressure and keep the proper balance of chemicals like potassium and sodium in your body.
One of the biggest adjustments you must make when you start hemodialysis treatments is following a strict schedule. Most patients go to a clinic-a dialysis center-three times a week for 3 to 5 or more hours each visit. For example, you may be on a Monday-Wednesday-Friday schedule or a Tuesday-Thursday-Saturday schedule. You may be asked to choose a morning, afternoon, or evening shift, depending on availability and capacity at the dialysis unit. Your dialysis center will explain your options for scheduling regular treatments.
Researchers are exploring whether shorter daily sessions, or longer sessions performed overnight while the patient sleeps, are more effective in removing wastes. Newer dialysis machines make these alternatives more practical with home dialysis. But the Federal Government has not yet established a policy to pay for more than three hemodialysis sessions a week.
Several centers around the country teach people how to perform their own hemodialysis treatments at home. A family member or friend who will be your helper must also take the training, which usually takes at least 4 to 6 weeks. Home dialysis gives you more flexibility in your dialysis schedule. With home hemodialysis, the time for each session and the number of sessions per week may vary, but you must maintain a regular schedule by giving yourself dialysis treatments as often as you would receive them in a dialysis unit.
Even in the best situations, adjusting to the effects of kidney failure and the time you spend on dialysis can be difficult. Aside from the “lost time,” you may have less energy. You may need to make changes in your work or home life, giving up some activities and responsibilities. Keeping the same schedule you kept when your kidneys were working can be very difficult now that your kidneys have failed. Accepting this new reality can be very hard on you and your family. A counselor or social worker can answer your questions and help you cope.
Many patients feel depressed when starting dialysis, or after several months of treatment. If you feel depressed, you should talk with your social worker, nurse, or doctor because this is a common problem that can often be treated effectively.
Arteriovenous fistula. One important step before starting hemodialysis is preparing a vascular access, a site on your body from which your blood is removed and returned. A vascular access should be prepared weeks or months before you start dialysis. It will allow easier and more efficient removal and replacement of your blood with fewer complications. For more information about the different kinds of vascular accesses and how to care for them, see the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) fact sheet Vascular Access for Hemodialysis.
When you first visit a hemodialysis center, it may seem like a complicated mix of machines and people. But once you learn how the procedure works and become familiar with the equipment, you’ll be more comfortable.
The dialysis machine is about the size of a dishwasher. This machine has three main jobs:
Structure of a typical hollow fiber dialyzer. The dialyzer is a large canister containing thousands of small fibers through which your blood is passed. Dialysis solution, the cleansing fluid, is pumped around these fibers. The fibers allow wastes and extra fluids to pass from your blood into the solution, which carries them away. The dialyzer is sometimes called an artificial kidney.
Dialysis solution, also known as dialysate, is the fluid in the dialyzer that helps remove wastes and extra fluid from your blood. It contains chemicals that make it act like a sponge. Your doctor will give you a specific dialysis solution for your treatments. This formula can be adjusted based on how well you handle the treatments and on your blood tests.
Many people find the needle sticks to be one of the hardest parts of hemodialysis treatments. Most people, however, report getting used to them after a few sessions. If you find the needle insertion painful, an anesthetic cream or spray can be applied to the skin. The cream or spray will numb your skin briefly so you won’t feel the needle.
Most dialysis centers use two needles-one to carry blood to the dialyzer and one to return the cleaned blood to your body. Some specialized needles are designed with two openings for two-way flow of blood, but these needles are less efficient and require longer sessions. Needles for high-flux or high-efficiency dialysis need to be a little larger than those used with regular dialyzers.
Some people prefer to insert their own needles. You’ll need training on inserting needles properly to prevent infection and protect your vascular access. You may also learn a “ladder” strategy for needle placement in which you “climb” up the entire length of the access session by session so that you don’t weaken an area with a grouping of needle sticks. A different approach is the “buttonhole” strategy in which you use a limited number of sites but insert the needle back into the same hole made by the previous needle stick. Whether you insert your own needles or not, you should know these techniques to better care for your access.
NIH Publication No. 07-4666
December 2006
If you or a loved one has had open heart surgery and then experienced Trasylol kidney problems, heart failure or stroke, you may be able entitled to money damages. Trasylol lawsuit attorneys can help evaluate your claim.
The number of Trasylol kidney failure lawsuits is growing as the public becomes
more aware of Trasylol side effects such as renal failure and strokes. Trasylol has recently been linked to a higher risk of kidney damage, heart attack, and death in the five years following a patient undergoing bypass heart surgery. Trasylol studies continue to show that the drug causes serious problems in bypass patients.
In 1993 Trasylol (Aprotinin) was approved by the Federal Drug Administration (FDA). Aprotinin is manufactured by Bayer under the brand name Trasylol. Over the past several years Trasylol sales continued to increase even though studies indicated serious Trasylol kidney damage side effects until late in 2007 when Bayer finally withdrew their heart surgery drug from the market.
Most heart surgery patients are unsure if they were given Trasylol during their open bypass surgery. Many patients suffering from Trasylol kidney damage side effects don’t know if they were given Trasylol during their surgery because the surgeon made the decision whether to administer the drug to help prevent bleeding during surgery.
Trasylol affects the way in which blood clots. It is administered to open heart surgery patients to help stop excessive bleeding. Trasylol is mainly used during repeat coronary artery bypass surgery to reduce the amount of bleeding both during and after surgery. The drug had been in use for 13 years and a million patients had received it before it was pulled from the market. One of the most serious complications for bypass surgery patients is excessive bleeding. Clotting medications such as Trasylol reduced the amount of blood transfusion needed during surgery.
In 2006 The New England Journal of Medicine (NEJM) published a study that reported Trasylol problems with an increased risk of developing heart failure, kidney damage, myocardial infarction, and stroke in bypass heart surgery patients. This study was followed by an increasing number of Trasylol studies that confirmed the findings of the 2006 NEJM study.
If you or a loved one has had open heart surgery and then experienced Trasylol kidney problems, heart failure or stroke, you may be able entitled to money damages. Trasylol attorneys can help evaluate your claim.
We are a Law Firm that is dedicated to helping people who have been affected by Trasylol side effects.
Personal Injury Law Firm
Bayer HealthCare Pharmaceuticals, Inc. has been facing an increasing number of patients who have filed a Trasylol lawsuit over its Aprotinin heart surgery drug. The lawsuits allege that Bayer is liable for manufacturing and failing to warn Trasylol users of its dangerous side effects. The Trasylol lawsuits allege that Bayer knew Trasylol increases patients’ risk [...]
Until recently, Bayer’s anti-bleeding drug was used on a regular basis during heart surgery. Trasylol (Aprotinin) is widely used to decrease bleeding risk during coronary artery bypass graft (CABG) surgery. There are some common side effects that persist or become bothersome following use, including: constipation, diarrhea, difficulty urinating, infection (fever, chills, sore throat), lightheadedness, sleeplessness [...]
We represent all Trasylol lawsuits clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Trasylol lawyer will contact you to answer any of [...]
Trasylol Aprotinin Side Effects Study
Another study reveals an increased risk of serious Trasylol side effects leading to a higher mortality rate in aprotinin bypass patients. A recent study published in The New England Journal of Medicine on February 21, 2008 shows an increased risk of death for patients receiving aprotinin (Trasylol) during coronary-artery bypass grafting [...]
Trasylol Heart Surgery Drug Information
What is aprotinin injection?
APROTININ (Trasylol) is a drug that affects the way blood clots. It was given to heart surgery patients during bypass procedures. Aprotinin was mainly used during repeat coronary artery bypass surgery to reduce the amount of bleeding before and after surgery. Trasylol and other clotting medications help to [...]