Tag Archives: FDA

What if I was Injured by the Mirena IUD

What if I was injured by the Mirena IUD? You are probably asking this question because you are a woman who was injured by the Mirena IUD, and you are wondering if you should pursue a lawsuit to be compensated for your injury.

The letters IUD stand for “intrauterine device.” An IUD is a small, flexible T-shaped plastic device that is inserted into a woman’s uterus by a health care provider to prevent pregnancy. A plastic string tied to the end of the IUD hangs down through the cervix into the vagina.

The maker of the Mirena IUD is Bayer Healthcare Pharmaceuticals. The Mirena IUD is inserted directly into the uterus and can stay in place for as long as five years.

Approved

The Mirena IUD was approved by the U.S. Food and Drug Administration (FDA) in 2000 as a contraceptive device. Later, in 2009, the FDA approved the Mirena IUD for treating heavy menstrual bleeding in women who were using an IUD for birth control.

However, also in 2009, the FDA issued a warning to Bayer for overstating the effectiveness of the Mirena IUD. Up until this time, along with other claims, Bayer was saying that the Mirena IUD would help increase libido (sexual desire). On the contrary, the warning letter from the FDA said, “at least 5 percent of Mirena IUD users reported decreased libido in clinical trials.”

Safe

An IUD has been considered to be a safe, long lasting and effective way of preventing pregnancy. However, the Mirena IUD has been associated with uterine perforation and other serious side effects. As of June 30, 2012, the FDA had received 45,697 reports of a serious Mirena IUD side effect.

Bayer Healthcare has suggested that the risk for perforation of the uterus is mainly an issue when the Mirena IUD is inserted into the uterus. However, a number of women have experienced problems where the Mirena IUD perforated their uterus months or even years after it was inserted into their uterus.

Uterine perforation is potentially life-threatening. For this reason, it is extremely important to watch for warning signs and symptoms of uterine perforation. Some of these are:

Chills
Fever
Nausea
Vomiting
Lower abdominal pain
Rapid heartbeat
Rigidity
Bloating
Heavy vaginal bleeding
Inability to find the Mirena IUD string.

There are three other primary complications of the Mirena IUD. They are expulsion of the device, dislocation of the device and vaginal hemorrhage. More than 6% of women who have had bad side effects with the Mirena IUD have had to have hospitalization or surgery.

There are also other side effects of the device. These include:

Pelvic inflammatory disease (PID)
The device becoming embedded in the uterine wall
Infertility, abscesses, erosion of adjacent areas, such as the vagina
A pregnancy with the device in place (an intrauterine pregnancy)
Group A streptococcal sepsis
Perforation of the cervix or the wall of the uterus.

Again, if you are a woman who has been injured by the Mirena IUD, you should be entitled to compensation for your injury. The wise thing to do is to contact a personal injury attorney and have your case evaluated at no cost or obligation to you.

Article written by James Shugart

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Health Fraud Scams

According to the U.S. Food and Drug Administration (FDA), health fraud scams refer to products that claim to prevent, treat or cure diseases or other health conditions, but they have not been proven safe and effective for those uses. The FDA defines a health product as being fraudulent if it is deceptively promoted as being effective against a condition, but it has never been proven effective or safe for that condition.

English: Source: FDA-OCI

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Have You Been Hurt by Pradaxa

 

Picture of blood clots. Caption: "Macromo...

Medication can be a great blessing. It can help you in many ways. However, the effects produced by medication can sometimes affect you in ways that are harmful.

Pradaxa is a medication that has been frequently prescribed by doctors. Pradaxa is what is referred to as a direct thrombin inhibitor. What this means is that it thins your blood by targeting your blood’s enzymes.

The goal of Pradaxa is to help prevent your blood from clotting (coagulating). In doing so, it is to keep you from having a stroke or a blood clot.

Pradaxa is the brand name for the medication. The generic name of the medication is dabigatran.

Approved by FDA in 2010

The FDA (United Stated Food and Drug Administration) approved the use of Pradaxa in 2010. The medication was developed by Boehringer Ingelheim Pharmaceuticals Inc.. It has been prescribed by licensed doctors all over the world.

Doctors prescribe Pradaxa to people who have an irregular heart rhythm that is known as atrial fibrillation. Doctors prescribe this medication when a person’s atrial fibrillation is not caused by a heart valve problem.

When you have atrial fibrillation, your heart does not beat in a normal rhythm. The result can be blood clots that develop around your heart and travel to other areas of your body, which might result in a stroke. If you already have atrial fibrillation, you have an increased risk for having a stroke. This is due to the fact that blood clots may develop and go to your brain.

Side effects produced by Pradaxa

Like practically all medications, Pradaxa produces side effects. Some of these side effects may be considered less severe than others that are brought about by the medication. Some of the less severe side effects that people have experienced are indigestion, dysfunction of the liver, difficulties with stools, bruising easily, reflux disease, severe abdominal pain, allergic reactions that are serious enough to require hospitalization, increased bilirubin levels and digestive tract ulcers, among other issues.

Pradaxa has also produced some serious, severe side effects in people. These include gastrointestinal problems, anaphylactic reaction and shock, myocardial infarction (heart attack) and severe internal bleeding. It is this internal bleeding that is the most serious side effect produced by Pradaxa.

The life-threatening issue with Pradaxa is that if you have any kind of bleeding event, such as getting cut or a fall, there is almost no way to stop the bleeding. While other blood thinners like Coumadin (which has been used for many years) have a reversal agent or antidote, there is no known reversal agent or antidote for Pradaxa at the present time.

Close to 300 deaths

The medication has been linked to close to 300 deaths all over the world. Pradaxa has also been linked to many cases of internal bleeding that were of a severe, life-threatening nature.

As a result, many personal injury and medical malpractice lawsuits have been brought against the manufacturer of Pradaxa. If you have had life-threatening internal bleeding as a result of using Pradaxa or lost a loved one, you really should let a personal injury attorney evaluate your case.

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