• 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

Is Baby Powder The Next Danger For Women? Ovarian Cancer

Written by Mirena IUD Helpline on . Posted in Baby Powder lawyer, Mirena IUD Lawsuit News, Mirena IUD Updates, Mirena Stories and Sharing, Talcum Powder Lawyer

Baby Powder- Shower To Shower- Talcum Powder – Ovarian Cancer Lawyers

Dangerous Drugs and Devices Harming women- Mirena IUD, Vaginal Mesh and Now Talcum Powder- Johnson’s Baby Powder and Talc Causing Ovarian Cancer. This may be the next big lawsuit as lawyers claim women have gotten ovarina cancer from these products. Talcum Powder – Ovarian Cancer lawsuits are being filed.

Ovarian Cancer Victims Win Talcum Powder Lawsuits Against Johnson & Johnson

Johnson & Johnson has been sued by over 1,200 women who blame the company’s talcum powder products for their ovarian cancer. Not only are U.S. courts beginning to agree with them, juries have started to award victims millions of dollars in compensation.

Talcum powder, a popular moisture absorbing product, is made from talc, the popular name for hydrated magnesium silicate which occurs naturally as a mineral in formations like soapstone. For over 120 years, Johnson & Johnson has marketed talcum powder around the world as a baby powder and for adults to absorb sweat in products like Shower to Shower.

The company has long targeted women to increase sales. “Want to feel cool, smooth and dry? It’s as easy as taking powder from a baby,” was the text in a common Johnson & Johnson ad from the 1960s.

In the 1970s, the first studies emerged showing that talc was deeply embedded into ovarian cancers. Johnson & Johnson introduced corn starch alternatives but it continued to offer talc-based products. In 2014 Johnson & Johnson’s annual talcum powder sales were estimated at $374 million.

In 2007 Deane Berg, an ovarian cancer victim, hired a law firm named Beasley Allen, to sue the company. Johnson & Johnson offered Berg $1.3 million to settle out of court but she was determined to prove her case. In 2013, a North Dakota court ruled in her favor, resulting in 17,000 new claims for Beasley Allen.

A key witness in Berg’s trial was Daniel Cramer of Harvard University who has conducted research into talc and baby powder since the 1980s.
He estimates that talc contributes to 10,000 cases of ovarian cancer a year in the U.S.

“We calculated that (Berg) had had more than 8,000 applications of talcum powder. Tests showed the talc was in her ovaries, her endometrium and lymph nodes,” Dr. Cramer told Lawyers & Settlements. “Only 25 percent of women develop ovarian cancer before menopause. Deane Berg was premenopausal when she was diagnosed with stage-3 ovarian cancer. She had no family history of the disease, and no other risk factors such as the BRAC1 and BRAC2 gene.”

The next major case was Jacqueline Fox, an African-American woman who died of ovarian cancer last October. One of the key documents introduced at the trial was an internal company memo from 1992 that proposed targeting sales at African-American and Latino women to make up for declining sales.

In February, a Missouri jury ordered Johnson & Johnson to pay $72 million to the family.

A third major case of victim Gloria Ristesund is slated to be heard in the same court this month.

The company denies that its talc products have any link to cancer. “We sympathize with the plaintiff’s family but firmly believe the safety of cosmetic talc is supported by decades of scientific evidence,” Carol Goodrich, a J&J spokeswoman, told Bloomberg. “We have no higher responsibility than the health and safety of consumers and we are disappointed with the outcome of the trial.”

The World Health Organization says that talc is “possibly carcinogenic to humans.”
Talc is banned in Europe but regulations are more lax in the U.S.

Consumer advocates say that it is time for the U.S. Congress to take action. “The fact is, many personal care products on store shelves—products we lather in our hair, rub on our skin, and put in our babies’ bathtubs—contain chemicals with known links to health problems, with no warnings at all to consumers,” writes Stacy Malkan, co-founder of the Campaign for Safe Cosmetics, in Time magazine. “We also need to change the laws so that consumers and companies have access to the best information to make the most informed choices about the safest products.”

Did your Mom use Talcum powder for years. Does she have a diagnosis of Ovarian Cancer? It may very well be from years of using Talc products to dry off. The particles travel up to the ovaries and remain there for years. Then- Ovarian cancer develops. Call Now

Talcum Powder Lawyers | Baby Powder Lawyers | Ovarian Cancer

Written by Mirena IUD Helpline on . Posted in Baby Powder lawyer, Mirena IUD Lawsuit News, Mirena Stories and Sharing, Talc ovarian cancer lawyer, Talc Ovarian Cancer Lawyers, Talcum Powder Lawyer

Talc Ovarian Cancer Lawyers

Baby Powder and Shower To Shower  Alert  for Ovarian Cancer
Studies have  linked  talcum powder to ovarian cancer.  Women are reporting ovarian cancer from years of using talc products like Johnson and Johnson Baby Powder  and Shower to Shower talc powder. The American Cancer Society estimates that in 2016, about 22,280 new cases of ovarian cancer will be diagnosed and 14,240 women will die of ovarian cancer in the United States. How many of these women will have used Talcom Powder products for years and have no idea that their ovarian cancer diagnosis is related to their use of Talc products.

Talcum Powder Lawsuit High Verdict

Johnson & Johnson (JNJ.N) was ordered to pay $72 million  to the family of a woman whose death from ovarian cancer was linked to her use of the company’s talc-based Baby Powder and Shower to Shower for several decades. A Talc victim was awarded  $10 million of actual damages and $62 million of punitive damages, according to the family’s lawyers and court records.

 

What Is Talcum Powder ?

Talcum powder is derived from talc, which is a hydrated magnesium silicate. Talcum powder is made from talc, a mineral made  of magnesium, silicon, and oxygen. It has been used by women over the years on genital areas because  it absorbs moisture and helps cut down on friction.

Dangers Of Johnson and Johnson Baby Powder and Shower To Shower  Powder

Use of  talc products over the years may increase the risk of women developing ovarian cancer. When these talc products are is applied  the talc may migrate into the fallopian tubes, uterus and ovaries resulting in cancer.

Ovarian Cancer Symptoms

Swollen or bloated abdomen.
Bloating
Pressure or pain in the abdomen or pelvis
Difficulty eating or feeling full quickly
Urinary urgency or frequency
Change in bowel habits with  constipation and/or diarrhea

Speak To A  Talcum Powder Ovarian Cancer Lawyer

Talcom Powder Ovarian Cancer Lawyers are  accepting nationwide lawsuits for  talcum powder products like Johnson’s Baby Powder and Shower-to-Shower Body Powder.

Letter To Bayer Regarding the Mirena IUD, Mirena IUD Complications

Written by Mirena IUD Helpline on . Posted in Mirena Stories and Sharing

Did you suffer  Injury because of Your Mirena IUD device? The Mirena IUD Helpline and Mirena IUD lawyers are here for you.The Mirena IUD Helpine Is always looking for information for our readers. We thought you would find this interesting.

Letter to Bayer from the FDA; DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration Silver Spring, MD 20993

Dear Dr. Almanakly:

The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a script for a live consumer-directed program (program) entitled “Mirena Simple Style Statements Program” (150-74-0002-09) for Mirena® (levonorgestrel-releasing intrauterine system) (Mirena), submitted by Bayer HealthCare Pharmaceuticals Inc. (Bayer) under cover of Form FDA-2253. The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. Thus, the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(n), and FDA’s implementing regulations. See 21 CFR 202.1(e)(3)(i), (e)(5) & (e)(6)(i).

Background

According to the DESCRIPTION section of its FDA-approved product labeling (PI),1 “Mirena® (levonorgestrel-releasing intrauterine system) consists of a T-shaped polyethylene frame (Tbody) with a steroid reservoir (hormone elastomer core) around the vertical stem.” The steroid reservoir contains the progestogen levonorgestrel, which is secreted slowly into the uterus over time upon the insertion of Mirena by a trained healthcare provider. According to the INDICATIONS AND USAGE section of its PI, Mirena is approved for the following indication:

Mirena is indicated for intrauterine contraception for up to 5 years. Thereafter, if continued contraception is desired, the system should be replaced. Mirena is recommended for women who have had at least one child.

The PI for Mirena also includes numerous contraindications, including “[u]ntreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled,” and “[c]onditions associated with increased susceptibility to pelvic infections.”

1 The most current version of the FDA-approved PI as of the dissemination date indicated on Form FDA-2253 was the July 21, 2008, version, and that is the version referred to in this letter. We note that the PI for Mirena was updated on October 1, 2009.

The use of Mirena is associated with a number of risks, including warnings regarding the increased risk of pelvic inflammatory disease (PID), ovarian cysts, and irregular bleeding and amenorrhea. Additional warnings include the risk of Mirena embedding in, perforating, or being expelled from the uterus, as well as the increased risk of ectopic pregnancy, and the risks to an intrauterine pregnancy that occurs with Mirena in place. Should a woman become pregnant while using Mirena, serious risks include pregnancy loss and a permanent loss of fertility.

In addition to the warnings noted above, the PI details the common adverse reactions that were observed during the clinical trials for Mirena. According to the PI, “Very common adverse reactions” (>10% of clinical trial patients) included “uterine/vaginal bleeding (including spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea), and ovarian cysts.” Adverse reactions that were reported by 5% or more of clinical trial patients include, among others, abdominal/pelvic pain, nausea, headache, nervousness, back pain, weight increase, breast pain/tenderness, acne, decreased libido, and depressed mood.

The PI also includes precautions that patients should be counseled that Mirena does not protect against HIV infection (AIDS) or other sexually transmitted diseases, and that patients should be instructed to check that the threads attached to Mirena are still in place after each menstrual period, as there is no contraceptive protection if Mirena is displaced or expelled.

Additionally, in regards to patient follow-up following the insertion of Mirena, the DOSAGE AND ADMINISTRATION, Patient Follow-up section of the PI states (in pertinent part):

Patients should be reexamined and evaluated 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.

Overstatement of Efficacy/Unsubstantiated Claims

Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience. The Mirena program is a live presentation designed for a consumer audience of “busy moms.” The program is presented in a consumer’s home or other private setting (e.g. private restaurant party) by a representative from Mom Central (a social networking internet site) and a nurse practitioner (Ms. Barb Dehn).2 The script of this program submitted to FDA includes an introduction from the Mom Central representative, a presentation given by Ms. Dehn regarding the use of Mirena, and a “post-party” questionnaire for the audience.

The script includes the following statements to be delivered by the Mom Central representative (emphasis added):

“This party was brought to you by Mom Central in partnership with Bayer HealthCare Pharmaceuticals’ Mirena which may help couples keep life simple!”

2 The Mirena program submitted to FDA also references a presentation given by a fashion stylist (Ms. Angela Hastings) that immediately follows Ms. Dehn’s presentation regarding the use of Mirena. The script of Ms. Hastings’ presentation regarding fashion tips was not submitted to FDA.

Fadwa Almanakly, Pharm.D. Page 3

Bayer HealthCare Pharmaceuticals Inc.

NDA 21-225 / MACMIS 18166

“Barb Dehn is a practicing Women’s Health Nurse Practitioner, award-winning author and nationally recognized health expert from San Francisco. Barb is going to kick things off with a discussion about romance and how to find simple ways to reconnect with our partners.”

The script also includes the following statements to be delivered by Ms. Dehn (emphasis added):

“. . . And, let’s face it, when we feel good about the way we’re put together, we feel better about approaching the romance in our lives.”

“What we’re here to talk about today – is how to find those simple ways to reconnect with ourselves and our partners.”

Following the introduction of the program, the script states that “Barb [Dehn] will begin presentation with an icebreaker – an interactive Q&A – which will touch upon issues such as busy schedules, barriers to intimacy and contraception” (emphasis added). The “icebreaker” questions include the following (in pertinent part; emphasis added):

“How many of you feel so busy that you often can’t find time to take care of yourself? And do you think this impacts your level of intimacy?”

“Do you ever feel so overwhelmed by your schedule that intimacy is much more of a “to do” on a list than a desire?”

“If you didn’t have to worry about contraception, do you think you would be more likely to be intimate with your partner?”

“Do you think if you didn’t have to worry about taking your birth control everyday, it would help you be more intimate?”

Immediately following the “icebreaker” questions, the script for Ms. Dehn states (emphasis added):

“So you mentioned that convenience and reliability are among the most important benefits of your birth control method. One strategy that I recommend for busy couples is choosing a birth control method that allows for spontaneous intimacy and which you don’t have to think about every day, such as the intrauterine contraceptive Mirena®.”The above statements clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena. Mirena has been proven to be an effective intrauterine contraceptive device. While we note that Mirena does not involve a daily routine and is not a barrier method of contraception, FDA is not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance, or intimacy with their partners. Claims that state or suggest such quality of life outcomes, such as those described above, must besupported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated patient assessment instruments to measure the outcomes of interest. If you do, in fact, have data to support these claims, you should submit them to FDA for review.

We note that, according to the Mirena PI, at least 5% of clinical trial patients reported decreased libido as a side effect of Mirena use. Patients also experienced abdominal/pelvic pain, nausea, headache, nervousness, and depressed mood, which could adversely affect a woman’s feelings relating to romance or intimacy.

The script also includes the following statements, to be presented by Ms. Dehn (emphasis added):

• “But what this party is really about is looking at the whole picture and figuring out steps to take to simplify your lifestyle while still looking and feeling great. One of those ways is finding a birth control that is compatible with your busy lifestyle.”

The above statement goes beyond the suggestion of increased intimacy to suggest that Mirena can help patients “look and feel great.” Again, FDA is not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great. Patients using Mirena may experience various side effects, such as irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness, and acne, in addition to the side effects indicated above. The experience of these side effects can prevent patients from “looking and feeling great.” Such claims of improved patient-reported outcomes must be supported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated instruments to measure these outcomes of interest. If you do, in fact, have data to support these claims, you should submit them to FDA for review.

Omission and Minimization of Risk Information

Promotional materials are misleading if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. The script includes the following risk presentation, to be presented by Ms. Dehn (emphasis in original):

• Only you and your healthcare professional can decide if Mirena is right for you. Mirena does not protect against HIV or STDs. Candidates for Mirena have had a child, and do not have certain cancers or acute pelvic inflammatory disease. In rare cases, perforation or embedment may occur. Mirena may become completely or partially dislodged. In the uncommon event you think you’re pregnant, contact your healthcare professional without delay. Ovarian cysts may occur and typically disappear. Changes in bleeding are common in the first few months followed by shorter, lighter periods. Periods, however, may remain irregular.

The risk presentation omits the contraindications regarding untreated lower genital tract infections and conditions associated with increased susceptibility to pelvic infections, and does not adequately convey that should a woman become pregnant while using Mirena, she may lose her baby or her fertility.We refer you to the December 17, 2008, advisory letter from DDMAC to Bayer, regarding the promotion of Mirena. This advisory letter includes a change of opinion regarding the risk presentation for Mirena. The letter states (in pertinent part, emphasis added):

Because this constitutes a change in our position, you will be provided a reasonable period of time to revise any Mirena promotional materials currently in use that omit this important risk information. Accordingly, the revisions should be completed within 90 days of receipt of this letter or at the next production of new promotional materials, whichever comes first.

The promotional program at issue here was newly developed, and as stated on the Form FDA-2253 accompanying the materials, it was disseminated on February 28, 2009, after the change of opinion letter was issued. We also refer you to your January 5, 2009, response to the change of opinion letter, stating that you intend to comply with our request.

Additionally, the script minimizes the risks associated with Mirena. Specifically, the “looking and feeling great” statement referenced above, in the context of the program as a whole, minimizes the risks associated with the use of Mirena. As stated in the Background section above, the PI for Mirena includes “very common” (experienced by >10% of clinical trial patients) adverse reactions, in addition to other serious warnings, precautions, and safety issues associated with the use of Mirena. The suggestion that Mirena will help patients “feel great” minimizes the side effects that patients may experience as a result of using the drug.

False/Misleading Statements

The script includes the following statements to be presented by Ms. Dehn (emphasis added):

• “. . . Mirena has no daily, weekly, or monthly routines to comply with as compared to the negatives associated with other birth control methods.”

The above claim that Mirena has “no . . . monthly routines” directly contradicts information contained in Mirena’s PI. According to PRECAUTIONS, Continuation and Removal section (repeated in the DOSAGE AND ADMINISTRATION, Patient Follow-up section) of the PI for Mirena, “[Patients should be] reexamine[d] and evaluate[d] . . . 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.” The PRECAUTIONS, Patient Counseling Information section of the PI also states that patients should check that the threads attached to Mirena are in place after each menstrual cycle (thus on a monthly basis), to ensure that Mirena has not become displaced or expelled, which would result in a loss of contraceptive efficacy. Therefore, the claim that there is no “monthly routine to comply with” is a false statement.

We note that the script includes instructions to check the Mirena threads monthly in a separate part of the presentation; however, this does not correct the false statement highlighted above.

Fadwa Almanakly, Pharm.D. Page 6

Bayer HealthCare Pharmaceuticals Inc.

NDA 21-225 / MACMIS 18166

Conclusion and Requested Action

For the reasons discussed above, the program is misleading in violation of the Act, 21 U.S.C. 352(n), and FDA implementing regulations. See 21 CFR 202.1(e)(3)(i), (e)(5) & (e)(6)(i).

DDMAC requests that Bayer immediately cease the dissemination of violative promotional materials for Mirena such as those described above. Please submit a written response to this letter on or before January 14, 2010, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Mirena that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials. Please direct your response to me at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD 20705-1266; facsimile at 301-847-8444. In all future correspondence regarding this matter, please refer to MACMIS # 18166 in addition to the NDA number for Mirena. We remind you that only written communications are considered official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Mirena comply with each applicable requirement of the Act and FDA implementing regulations.

Women”s Dangerous Drug snd Devices Helpline Update

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News, Mirena Stories and Sharing

 

Over 45,000 adverse events from Mirena have been reported to U.S. health regulators since Mirena’s introduction to the market. The most serious Mirena risks and side effects include:

The Mirena IUD Helpline has observed many drug and device lawsuits for products harming women over the past years. Our T.V screens are inundated with lawyer ads targeting these injured women. The vaginal mesh is perhaps the largest multi district litigation since the  Silicone Breast Implant Class Action. Other drugs have moved into settlement stages like Yaz and Fosamax.  There are so many specifically targeting women. Now we have the Mirena IUD causing uterine perforation s as the IUD literally tears through the cervix or the wall of the uterus.

Uterine perforation is no joke.  We speak to callers where the Mirena has moved thru the uterine wall, ripped through the cervix or entered  the abdominal cavity years after the IUD was  inserted with no initial complications. Over 45,000 adverse events from Mirena have been reported to U.S. health regulators since Mirena’s introduction to the market.  We expect 1000’s of lawsuits.

If you have been injured by the Mirena, we want to hear from you. Share your stories with others on our comments section. You are not alone.

 

 

Another Bayer Birth Control Method Is Causing Deaths In France

Written by Mirena IUD Helpline on . Posted in Mirena Stories and Sharing

 

Another Bayer Birth Control Pill With Problems, Dianette Is Causing Deaths

 

Written by lisaspitzer on January 28, 2013. Posted in Yaz Helpline News

Diane-35 acne drug linked to deaths, prompting French investigation Published January 28, 2013 France’s health regulator has opened an inquiry into acne drug Diane-35, which is also used as a contraceptive, after four deaths linked to the drug in the past 25 years. Health regulator ANSM said on Sunday that Diane-35, produced by German drugmaker Bayer, is authorized in 135 countries and sold in more than 116. Last year about 325,000 women in France used the drug, ANSM said, adding it would publish its report next week. ANSM said the four deaths were due to thrombosis linked to the use of Diane-35. Three other deaths possibly connected to the drug, reported by the media, were linked to other health issues, the agency said. Diane-35, also sold as Dianette in some countries, reduces acne for women by regulating hormones, according to several medical websites. The drug is also used as a contraceptive. Earlier this month, ANSM said it was studying the possibility of limiting the use of third- and fourth-generation contraceptive pills after a woman sued Bayer over alleged side-effects such as embolism, or blood clots.

Even More On the Mirena IUD, Mirena Victims Share Stories

Written by Mirena IUD Helpline on . Posted in Mirena Stories and Sharing

At the Mirena IUD Helpline we are always seeking information to share. Mirena IUD victims call us daily with sad stories about how the Mirena IUD ruined their lives. We found this on a site called fertility gal and wouls like to share it with our readers. The Mirena IUD has some very severe complications and Mirena IUD lawyers are filing lawsuits. There has been 1000’s of adverse incident reports submitted to the FDA and an MDL consolidated Mirena IUD class action is in the beginning stages.

Mirena IUD Stories

 

So if you have had any bad experiences with Mirena please let us know,it will help others with their problems, hopefully. I just wish I never got Mirena and my advice is DONT its not Worth the risk,if the Doctors had of told me about the BAD side effects I would NEVER of had it put in. Sorry about going on so long, Good Luck to you all,

I had the Mirena IUD inserted in Feb. 2007. It was a very painful experience and I cramped and bled for several weeks after the insertion, which I was told, was completely normal (yeah right). For months I would have pains and cramping and irregular bleeding, all of which was supposed to be normal.

 

On or around December 17, 2007 I was having terrible pain that would not stop, I became nausaus and I starting vomiting uncontrollably. I told my husband that something was wrong and that I needed to go to the hospital, but before he could get my kids ready and in the car, I was on the floor in pain. The worst pain of my life (and I have given birth twice). My husband called the ambulance and I was rushed to the hospital. When I arrived at the hospital we still did not know what was wrong but they thought I has a stomach virus or a ruptured appendix. They completed an MRI and found that the MIRENA was lodged in my fallopian tube and I needed emergency surgery to have it removed. The MIRENA IUD has hormones in it and that was probably the cause of my pain and nausea. The hospital I was in was over-booked with surgeries and my doctor (who inserted the MIRENA) was unable to come to the hospital to perform the surgery, so I had to just wait in pain and agony. A colleague of my doctor’s performed the surgery the next day to have the MIRENA removed. At the time, I had lost my medical benefits, due to a layoff, so now I am now stuck with a stack of medical bills.

 

This was a terrible experience and I want a lawsuit filed against Bayer. They do not tell you all of the terrible side effects and I feel they lie about the risk being less than .1. This company is terrible and I have called them and made a complaint. Now that I have told people my story it seems that everyone knows that IUD’s are dangerous and that is why they were taken off the market before. Somthing needs to be done NOW before more women fall victim of the dangers of this product. (www.lawcash.com/complaint/732/mirena-iud-complaint.asp)

 

What are the possible side effects of using Mirena?

The following are serious but uncommon side effects of Mirena:

• Pelvic inflammatory disease (PID). Some IUD users get a

serious pelvic infection called pelvic inflammatory disease. PID

is usually sexually transmitted. You have a higher chance of getting

PID if you or your partner have sex with other partners. PID

can cause serious problems such as infertility, ectopic pregnancy

or constant pelvic pain. PID is usually treated with antibiotics.

More serious cases of PID may require surgery. A hysterectomy

(removal of the uterus) is sometimes needed. In rare cases,

infections that start as PID can even cause death.

Tell your healthcare provider right away if you have any of

these signs of PID: long-lasting or heavy bleeding, unusual

vaginal discharge, low abdominal (stomach area) pain, painful

sex, chills, or fever.

• Life-threatening infection. Life-threatening infection can occur

within the first few days after Mirena is placed. Call your

healthcare provider if you develop severe pain within a few

hours after placement.

• Embedment. Mirena may adhere to the uterine wall. This is

called embedment. If embedment occurs, Mirena may no

longer prevent pregnancy and you may need surgery to have

it removed.

• Perforation. Mirena may go through the uterus. This is called

perforation. If your uterus is perforated, Mirena may no longer

prevent pregnancy. It may move outside the uterus and can

cause internal scarring, infection, or damage to other organs,

and you may need surgery to have Mirena removed.

Common side effects of Mirena include:

• Discomfort during placement. Dizziness, faintness, bleeding

or cramping may occur during placement. This is common. Let

your healthcare provider know if the cramping is severe.

• Expulsion. Mirena may come out by itself. This is called expulsion.

You may become pregnant if Mirena comes out. If you

notice that Mirena has come out, use a backup birth control

method like condoms and call your healthcare provider.

• Missed menstrual periods. About 2 out of 10 women stop

having periods after 1 year of Mirena use. The periods come

back when Mirena is removed. If you do not have a period for

6 weeks during Mirena use, contact your healthcare provider.

• Changes in bleeding. You may have bleeding and spotting

between menstrual periods, especially during the first 3 to 6

months. Sometimes the bleeding is heavier than usual at first.

However, the bleeding usually becomes lighter than usual and

may be irregular. Call your healthcare provider if the bleeding

remains heavier than usual or if the bleeding becomes heavy

after it has been light for a while.

• Cyst on the ovary. Approximately 12% (12 out of 100) of

women using Mirena develop a cyst on the ovary. These cysts

usually disappear on their own in a month or two. However,

cysts can cause pain and sometimes cysts will need surgery.

This is not a complete list of possible side effects with Mirena.

For more information, ask your healthcare provider.

Call your doctor for medical advice about side effects. You may

report side effects to the manufacturer at 1-888-842-2937, or

FDA at 1-800-FDA-1088

(http://berlex.bayerhealthcare.com/html/products/pi/mirena_patient_insert.pdf?C=&c=) THIS IS THE COMPANY’S WEBSITE – BAYER

If you have had Mirena IUD complications please share it on the Mirena IUD Helpline comments section.

The Mirena IUD Helpline has a goal.It  is to reach all women with a uterine perforation to be part of the Multi District litigation class action. WE must seek justice against manufacturers that target women with a goal toward profits and not appropriate warnings.