• The Mirena IUD is Manufactured by Bayer...
    ...the same company that has indicated to shareholders that it will reserve an additional $262.5 million to settle Yaz and Yasmin lawsuits over blood clots
  • Call the Mirena IUD Helpline and speak to a female medical social worker and a Mirena IUD lawyer
  • The Mirena IUD has had serious complications
    • Perforation of the uterus
    • The IUD can gravitate and become embedded in the uterus or abdomen
    • Pregnancy even with the Mirena inserted
    • Gravitation of the IUD, change in position
    • Ectopic pregnancy
    • Group A streptococcal sepsis
    • Infertility when the IUD becomes embedded
    • Need for surgical removal of the Mirena
  • The Mirena IUD is a flexible intrauterine device that is placed into the uterus through the vagina by a GYN. Mirena releases a continuous dose of hormones (levonorgestrel) to prevent pregnancy for up to five years.
  • Over 2 million women in the U.S. have used Mirena IUD for birth control.
    Mirena is one of the most common IUDs currently on the market.
  • Uterine Perforation Symptoms From the Mirena: If you have these symptoms see a physician immediately.
    • Lower abdominal pain
    • Heavy vaginal bleeding
    • Inability to locate the Mirena IUD string
    • Bloating, rigidity and pain in the abdomen
    • Nausea, Vomiting, Chills, Fever, Rapid heartbeat

Yaz Also Manufactured By Bayer Has Serious Complications

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News

Bayer the manufacturer of Yaz and the Mirena IUD appears to target women for birth control  drugs and devices that turn out to cause serious complications. Both Yaz and the Mirena IUD are the central focus of lawyer T.V ads and lawsuits

By LAUREN PEARLE, OLIVIA KATRANDJIAN, CHRIS CUOMO (@ChrisCuomo) and GLENN RUPPEL

Dec. 6, 2011

 

Yaz was pitched as the blockbuster birth control pill with benefits, the choice for women desperate for relief from severe PMS and acne. But now, several new independent studies have found that Yaz carries higher blood clotting risks than other leading birth control pills, leading to new scrutiny from safety regulators.

 

Former FDA Commissioner Dr. David A. Kessler, who is now working for lawyers suing Bayer, which makes Yaz, accusing the drugmaker of concealing the contraceptive’s health risks.

 

“Bayer violated its duties under FDA regulations and state law by selectively presenting data as to [blood clotting] events,” Kessler said in court documents, citing studies that Bayer itself conducted but allegedly misreported to regulators.

 

He indicated that if he had been head of the FDA in 2000 and knew what he knows now, he may not have approved the drug.

 

“In my opinion, had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted,” he wrote.

 

Citing conflicting safety studies, the The FDA is holding hearings Thursday to determine whether new safety measures, like package label changes, are warranted.

 

Bayer maintains that Yaz is safe.

 

“Based on a thorough assessment of the available scientific data, Bayer believes that its drospirenone-containing products are safe and effective and have a favorable benefit-risk profile when used in accordance with U.S. product labeling,” Bayer spokeswoman Rose Talarico told ABC News.

 

Yaz was the best-selling birth control pill in the United States for 2008 and 2009. Tens of millions of women switched to Yaz since it was launched a decade ago.

PHOTO: Yaz birth control is pictured in this handout photo.

Bayer

Yaz birth control is pictured in this handout… View Full Size

Yaz Birth Control Investigation Watch Video

 

 

ABC News investigated whether these women switched to a more potentially risky pill that, as it turns out, was never proven to treat common PMS.

 

In 2007, Carissa Ubersox, 24, was fresh out of college and starting her dream job as a pediatric nurse in Madison, Wis. On Christmas day, while working the holiday shift, her boyfriend surprised her at the hospital with a marriage proposal.

 

Wanting to look and feel her best for her wedding day, Ubersox said she switched to Yaz after watching one of its commercials that suggested this pill could help with bloating and acne.

 

“Yaz is the only birth control proven to treat the physical and emotional premenstrual symptoms that are severe enough to impact your life,” claimed the ad.

 

It “sounds like a miracle drug,” Ubersox said she remembers thinking.

 

But just three months later, in February 2008, Ubersox’s legs started to ache. She didn’t pay much attention to it, assuming, she said, that it was just soreness from being on her feet for a 12-hour shift.

 

By the next evening, she was gasping for air. Blood clots in her legs had traveled through her veins to her lungs, causing a massive double pulmonary embolism.

 

Her fiance called 911, but on the way to the hospital Ubersox’s heart stopped. Doctors revived her, but she slipped into a coma for almost two weeks.

 

Ubersox’s only memory of that time is something she refers to as an extraordinary dreamlike experience. She said she remembers a big ornate gate and seeing a recently deceased cousin.

 

That cousin, Ubersox said, told her, “You can stay here with me or you can go back.”

 

But, she recounted, he told her if she goes back she’ll end up blind.

 

“I just remember waking up in the hospital and I was like, ‘Oh, I guess I chose to stay,'” Ubersox told ABC News.

 

Like her cousin in her dreamlike experience foretold, she actually did wake up blind, and remains blind to this day.

 

No one can say for sure whether Yaz caused Ubersox’s blindness, but Yaz contains a unique hormone called drospirenone that some experts say may trigger more blood clots than other birth control pills. Clots can cause serious breathing problems, a stroke or even death.

 

All birth control pills come with some risk. Two to four women per 10,000 on the pill will suffer blood clots, and some will die as a result. But with Yaz, several new independent studies have put that risk two to three times higher.

 

“It’s a disappointing finding,” said Dr. Susan Jick, author of one of those independent studies involving almost a million women. “As a public safety concern that’s not what one wants to find.”

About The Mirena IUD, Contraindications, Medical Review

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News

 

Mirena IUD Helpline is your resource about the Mirena IUD and the Mirena IUD lawsuits. We receive calls daily from women seeking a Mirena IUD lawyer for complications.

 What is the Mirena IUD?

The Mirena IUD (intrauterine device), also known as the Mirena coil, is a hormonal device for controlled contraception. It is fitted under the uterus (the womb) and releases very low doses of a progesterone hormone called levonorgestrel.

Clinical uses of the Mirena IUD

 

The Mirena IUD is predominantly associated with contraception, but it has also been advised for women with the following conditions:

  • Endometriosis.
  • Chronic pelvic pain.
  • Heavy periods (menorrhagia).
  • Anaemia.
  • Dysmenorrhoea.

Fitting the Mirena IUD

The Mirena IUD must be put into place by a qualified and certified doctor, who will follow the manufacturer’s instructions using an aseptic technique to prevent bacterial infection. Women who have a high risk of endocarditis (an inflammatory condition that affects the heart) are normally given antibiotics before the IUD is fitted, to lower potential infection risks.

During the fitting procedure the cervix is widened or dilated, to enable doctors to determine the size of the uterus and then insert the device. Some women often find the dilation aspect of the procedure painful and it may be worthwhile to take pain-relief medication beforehand. There may be less discomfort if you have the device fitted mid-cycle, as this is the time when the cervix is dilated naturally.

 

Once the Mirena IUD has been fitted it will provide contraceptive protection for up to 5 years, and the 5 year rate of pregnancy for a Mirena IUD is approximately 0.7 percent.

Mechanisms of contraception

 

The Mirena IUD releases a daily 20 microgram dose of the hormone levonorgestrel. There is some debate around how the coil works exactly, but it is known to have a number of effects on the body in preventing pregnancy. These include:

 

Reducing the frequency of ovulation.

Changing the consistency of cervical mucus to reduce the possibility of sperm reaching the egg through the cervix.

Encouraging the release of prostaglandins and leukocytes from the endometrium (the lining of the womb), which creates a hostile environment for the eggs and sperm. This response is produced by the insertion of an unknown or foreign body into the uterus.

Thinning the endometrium to make it more difficult for eggs to implant.

Removing the Mirena IUD

The procedure to remove the Mirena IUD is usually more straightforward if carried out at the latter end of the natural cycle. The procedure involves using forceps to gently pull the IUD thread and remove the coil. If the thread cannot be found this is known as a ‘lost coil.’ If this is the case, forceps or thread-collecting devices may be used to locate the thread or to pull the IUD out of the cervix. In rare cases, when it is not possible to grasp the IUD, ultrasound scans may be carried out to locate the IUD. In very rare cases a hysteroscopy may be required, which involves using an endoscope to inspect the uterus.

Within a few months of the IUD being removed, fertility will return to normal and around 80 percent of women conceive within a year of having the Mirena IUD taken out.

Contraindications

Intrauterine devices or systems are sometimes unsuitable for certain women and the Mirena IUD should not be fitted in the following circumstances:

  • If a woman is pregnant.
  • If a woman has sepsis (an infection) after giving birth or having an abortion.
  • If a woman has an active sexually transmitted infection.
  • If a woman has PID (pelvic inflammatory disease) or has had a PID infection within the last 3 months.
  • If a woman has uterine abnormalities.
  • If a woman has cervical, ovarian or endometrial cancer and is waiting for treatment.
  • If a woman has pelvic tuberculosis.
  • If a woman has malignant trophoblast disease.

 

Complications and side-effects of the Mirena IUD

Once the IUD has been inserted into the uterus it is possible for the device to be rejected and expelled from the cervix. According to the trial research carried out by the manufacturer the expulsion rate is approximately 4 percent, with 3 percent occurring within the first 12 months of the coil being fitted. Rates of expulsion are higher with women who haven’t had children, women within a younger age bracket, and if an IUD is fitted shortly after giving birth or having an abortion.

Uterine perforation is a rare complication but it can be potentially serious. It may occur during insertion or after the coil has become embedded in the wall of the uterus (myometrium) and migrated into the abdominal cavity. Perforation can contribute to internal scarring, damage to surrounding organs and infection, and surgery may be required to repair any damage. The rates of perforation are estimated to vary between 1 and 2.6 per 1000 insertions; however, the actual figure may be higher as many perforations go unreported.

Perforation and expulsion inhibit the contraceptive qualities of the IUD, and it is important for women to check the location of the IUD thread on a regular basis to ensure its right location. Most doctors recommend self-checking once per cycle.

In some cases the string can be felt by males during sexual intercourse. If this is a problem the thread can be shortened, tucked behind the cervix or cut in line with the cervix. It is worth noting that cutting the threads will make it more difficult to check the location of the IUD and make removal of the IUD more complex.

Sexually transmitted infections (STIs) and Pelvic inflammatory disease

Pelvic inflammatory disease (PID) is often the result of a sexually transmitted infection. PID can cause infertility and is considered a serious condition. Having an IUD fitted will raise the risk of a woman getting PID if she has an STI. This is why it is not advisable for women with an STI or those with a high risk of developing them to have an IUD fitted.

 

A study carried out using animals suggested that the risk of contracting HIV was slightly higher when using progestin-only hormonal contraceptives, because the walls of the vagina become thinner. However, studies carried out with humans have not found an elevated risk.

The IUD does not offer any protection against STIs. Only barrier types of contraception, such as a condom, can protect against both infections and unwanted pregnancies.

Post-abortion and post-partum insertion

An IUD can be fitted within 48 hours of post-partum (giving birth). After this period of time the risk of perforation is higher, as uterine involution is incomplete. Involution usually takes around 4-6 weeks after giving birth. Doctors will make special considerations for women who are breastfeeding.

IUDs are not advisable for those who have undergone a second trimester abortion within the last four weeks. If this is the case the woman will be advised to wait in order to enable complete uterine involution. IUDs are also unadvised for women who have undergone a medical abortion and have not had an ultrasound to make sure that the procedure was successful. Rates of expulsion are higher when IUDs are fitted shortly after abortion and childbirth.

Source Medic M.D

The Mirena IUD Lawsuits Update, Mirena IUD Lawyers Expect 1000’s

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News

The Mirena IUD Helpline and Mirena Lawyers have Mirena IUD Lawsuit Updates As The Lawsuit Proceeds

Efforts to consolidate the Mirena Lawsuit in 2012 into a Mirena Class Action Lawsuit or Mirena Lawsuit Multidistrtict Litigation continues.

Plaintiffs have petitioned the Judicial Panel on Multidistrict Litigation to create a centralized docket for all federal lawsuits alleging injury caused by the intrauterine contraceptive device Mirena.

The Jan. 16 petition urges the JPML to consolidate eight pending federal lawsuits, as well as any future Mirena claims, before a single U.S. District Judge in the Northern District of Ohio. The filing comes just one week after the New Jersey Supreme Court denied a motion by Mirena manufacturer Bayer Healthcare Pharmaceuticals Inc. to consolidate nearly a dozen lawsuits filed recently in New Jersey state court. However, Bayer Healthcare filed a request to centralize the New Jersey Mirena litigation in its home state, the company headquarters.

Mirena IUD Facts

  • The Mirena IUD is  effective for five years.
  • The Mirena IUD  IUDs by blocks semen from pasting the cervix.
  • The Mirena IUD contains a slow release birth control chemicals

 The Real Facts About Complications

  • The Mirena IUD  is becoming dislodged and migrating to other organs in the female.
  • The Mirena is causing perforations in the Uterus and other organs.
  • The Mirena is becoming embedded in the uterus of many women and the result is perforation.
  • The Mirena now must be surgically removed.
  • The result for many women is infertility
  • The Mirena has resulted in abnormal pregnancies
  • Other serious complications

Mirena Adverse Incident Reports Are Coming In To The FDA Daily

The FDA received 108884 reports of reactions related to the use of Mirena from December 2000 to September 2011 . These reports described 3124 types of complications

If you or a loved one has been injured or died as a result of the Mirena IUD call our helpline today.

 

 

 

More About The Mirena IUD, Mirena IUD Helpline Resources

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News

At the Mirena IUD helpline we are always looking for information online to share with our readers. We get calls daily from women with Mirena IUD complications interested in the Mirena IUD lawsuits. We found this and would like to share it with our readers on a forum run by ” Alice”

Despite the popularity of long-acting birth control methods in other parts of the world, relatively few American women use intra-uterine devices (IUDs) like Mirena. This may be due to several misconceptions about IUDs and who should use them. Today, the American College of Obstetricians and Gynecologists (ACOG) and the World Health Organization (WHO) both approve IUDs, including Mirena, for women who have never given birth. However, the decision to use Mirena is you and your health care provider.

 

In the past, IUD use in younger women without children was mistakenly linked to complications like pelvic inflammatory disease (PID), infertility, and other side effects related to the placement of the IUD. However, recent research debunks these claims and concludes that the IUD is a safe and highly effective birth control option for women of all ages, with and without children. One concern about the IUD is that sometimes it can slip partially out of the uterus, a process known as expulsion. If this happens, the IUD is no longer effective and a woman can become pregnant. Expulsion is more likely in women who have never had a pregnancy — even women who have had a miscarriage or abortion appear to have better IUD retention rates compared to those who have never been pregnant. The possible risk of expulsion is not a contraindication for Mirena in women who haven’t had children, but it is something to keep in mind and discuss with your health care provider.

 

Another worry about IUD use in women without children is the increased risk of PID. According to current research, higher rates of sexually transmitted infections (STIs), not IUD use, are to blame for the increased risk of PID in this group. Women who have not had children tend to be younger and generally have higher rates of STIs like chlamydia and gonorrhea, which can lead to PID. Contrary to popular belief, Mirena and other hormonal contraceptives may actually protect against PID by thickening the cervical mucus and decreasing menstrual flow. On the other hand, Mirena does not protect against STIs so condoms are still a good idea. Your provider will need to make sure that you don’t have any STIs before inserting an IUD.

 

Like most contraceptives, Mirena does have some side effects. Side effects of using Mirena may include:

 

Cramping, pain, or infection after insertion

Expulsion (your health care provider can reposition the IUD properly)

Peforation of uterus (rare, and in most cases, happens upon insertion)

Reduced menstrual cramps

Light or absent menstrual flow (some women may welcome this change while others might worry about a possible pregnancy)

 

A common belief has been that an IUD can increase the risk of having an ectopic pregnancy (a pregnancy where the fertilized egg implants in the fallopian tube, which can be dangerous for the woman). In fact, IUDs do not increase the risk of ectopic pregnancy. However, the IUD is better at preventing a pregnancy in the uterus than it is at preventing pregnancy in the fallopian tubes, meaning that ectopic pregnancy is somewhat less likely to be prevented by this method of birth control than a uterine pregnancy.

 

If you are looking for progestin-only birth control, the “mini-pill” is another option. For more information about the mini-pill, check out What are the differences among birth control pills? and Norplant vs. progestin-only pill. In addition, you might consider the copper-T IUD, which functions similarly to the Mirena, but uses no hormones. A health care provider can help you choose a suitable birth control method. At Columbia, students can call x4-2284 or log on to Open Communicator to make an appointment with a clinician at Primary Care Medical Services (PCMS). Off-campus, some health professionals are still reluctant to prescribe IUDs to women without children, so you may need to ask around to find a provider who is familiar with the new safety guidelines.