How To Find Out If Trasylol Was Used During Heart Surgery

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.

Lessons From Trasylol Side Effects And Safety Studies

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.

Trasylol News Video | Trasylol Heart Surgery Attorney CABG Lawyer | Kidney Failure Problems

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.

When Your Kidneys Fail

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.

How Hemodialysis Works

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.

Hemodialysis.

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.

Adjusting to Changes

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.

Getting Your Vascular Access Ready

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.

Equipment and Procedures

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.

 
Graft.

Dialysis Machine

The dialysis machine is about the size of a dishwasher. This machine has three main jobs:

• pump blood and watch flow for safety
• clean wastes from blood
• watch your blood pressure and the rate of fluid removal from your body

Dialyzer

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.

• Reuse. Your dialysis center may use the same dialyzer more than once for your treatments. Reuse is considered safe as long as the dialyzer is cleaned before each use. The dialyzer is tested each time to make sure it’s still working, and it should never be used for anyone but you. Before each session, you should be sure that the dialyzer is labeled with your name and check to see that it has been cleaned, disinfected, and tested.

Dialysis Solution

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.

Needles

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.

Arterial and venous needles.

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.

Trasylol Kidney Problems | Kidney Failure After Heart Surgery Lawsuits

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.

Bayer Pharmaceutical facing 78 Trasylol lawsuits in U.S.

COLOGNE, Germany - Bayer’s CEO stated that Bayer AG is facing 78 Trasylol lawsuits in the United States as a result of its heart surgery drug. “We are not aware of any lawsuit outside the United States,” Werner Wenning told a shareholders’ meeting.

Each year approximately one million patients undergo surgery following a heart attack. Prior to Trasylol being withdrawn from the marketplace, the majority of patients who were at increased risk of bleeding during surgery had the option of one of three antifibrinolytic drugs to limit blood loss: Trasylol (Aprotinin), Amicar (aminocaproic acid), or Cyklokapron (tranexamic acid). These drugs work by inactivating an enzyme called plasmin so it stops from breaking down blood clots which helps prevent bleeding.

Bayer’s Trasylol heart surgery side effects have recently been linked to an increased rate of kidney failure, heart attack, and death in the five years following a patient undergoing heart surgery.

In November 2007, Bayer withdrew Trasylol from the marketplace following a Canadian study that associated Trasylol with an increased risk of death and kidney failure. Bayer plans on defending Trasylol claims vigorously, however time will tell how they deal with potentially thousands of claims from individuals and families throughout the country as litigation continues.

Trasylol Recall Follows Kidney Failure Problems

On November 5, 2007, the U.S. Food and Drug Administration (FDA) announced that Bayer Pharmaceuticals Corporation agreed to a “marketing suspension” of its Trasylol drug. Trasylol is a drug that was designed to control bleeding during heart surgery. Two weeks before the FDA’s announcement, researchers from the Ottawa Health Institute notified the FDA that they had stopped a study on Trasylol because it appeared to increase the risk of death for patients, compared to two other drugs used in the study.

Prior to the Trasylol recall, Dr. Dennis Mangano, a medical researcher, published a study in the New England Journal of Medicine in January 2006 that patients who had been given Trasylol had twice the rate of kidney failure and an increased risk of strokes, heart attacks and encephalopathy (a type of brain disease).

After the Trasylol recall, two studies published on February 28, 2008 in the New England Journal of Medicine confirmed that patients who were given Trasylol had an increased risk of death. The release of these studies follows an interview of Dr. Dennis Mangano on the TV show 60 Minutes. Dr. Mangano contended that the FDA should have pulled Trasylol from the market after his study was released in January 2006. It is estimated that approximately 413,000 patients received Trasylol between the time of his study and the time of the recall. According to Dr. Mangano, 22,000 lives could have been saved if the drug had been taken off the market in January 2006.

For more Trasylol news please visit our Trasylol lawsuits news and information website.