• 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

Posts Tagged ‘Yaz birth control pills lawyer’

New Bayer Mirena IUD Approved, While Mirena IUD Lawsuits Are Underway

Written by Mirena IUD Helpline on . Posted in Birth Control Central News

While women are filing lawsuits for Mirena IUD injury a new Bayer IUD is approved.  We receive calls daily from women suffering with side effects from Bayer’s Mirena IUD and yet science moves on and a new Bayer IUD is approved.

FDA Approves Bayer HealthCare (BAY)’s First New IUD in 12 Years

WAYNE, N.J., Jan. 9, 2013 /PRNewswire/ — Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg, a new hormone-releasing system that is placed in the uterus for the prevention of pregnancy for up to three years.[1]

“Research shows that nearly 50 percent of pregnancies in the U.S. are unintended,2 which emphasizes the need for increased education and access to effective birth control options,”said Anita L. Nelson, M.D., Professor of Obstetrics and Gynecology at Harbor-UCLA Medical Center, Torrance, CA. “Skyla is more than 99 percent effective at preventing pregnancyand may be appropriate for women who want a birth control method that they do not have to take daily. Further, Skyla may be used by women whether or not they have ever had a child, representing an important new choice for women who don’t want to become pregnant for up to three years.”

Skyla is a small, flexible plastic T-shaped device containing 13.5 mg of a progestin hormone called levonorgestrel.The size of the Skyla T-body is 28mm x 30mm and the outer diameter of the placement tube is 3.8mm. Because Skyla slowly releases levonorgestrel into the uterus, only small amounts of the hormone enter the blood. During the first three to six months of using Skyla, women may experience irregular periods and an increase in the number of bleeding days. Women may also have frequent spotting or light bleeding. Some women may have heavy bleeding during this time. After using Skyla for a while, the number of bleeding and spotting days is likely to lessen, and there is a small chance that periods may stop altogether.1,3

Women can have Skyla placed by a healthcare provider during an in-office visit. Skyla is intended for long-term use for up to three years but may be removed by a healthcare provider at any time. Women could become pregnant as soon as Skyla is removed, so they should use another method of birth control if they do not want to become pregnant. About 77% of women who want to become pregnant will become pregnant sometime in the first year after Skyla is removed.3

“The approval of Skyla expands Bayer’s IUD portfolio and highlights our continued commitment to empower women with a variety of birth control options at different reproductive stages of their lives,” said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. “We are pleased to bring the first new IUD to market in the U.S. in 12 years, and to provide women who are seeking contraception with an important new and effective option to consider with their healthcare providers.”

Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg will be available by prescription the week of February 11.

About the Clinical Trial for Skyla1

The approval of Skyla is supported by data from a Phase 3 trial that included 1,432 women aged 18-35 who received Skyla, of which 38.8% (556) had not yet had a child. The trial was a multicenter, multinational, randomized open-label study conducted in 11 countries in Europe, Latin America, the U.S. and Canada. Women less than six weeks postpartum, with a history of ectopic pregnancy, with clinically significant ovarian cysts or with HIV or otherwise at high risk for sexually transmitted infections were excluded from the trial.

The pregnancy rate calculated as the Pearl Index (PI) in women aged 18-35 years was the primary efficacy endpoint used to assess contraceptive reliability. The PI was calculated based on 28-day equivalent exposure cycles; evaluable cycles excluded those in which back-up contraception was used unless a pregnancy occurred in that cycle. Skyla-treated women provided 15,763 evaluable 28-day cycle equivalents in the first year and 39,368 evaluable cycles over the three-year treatment period. The PI estimate for the first year of use based on the five pregnancies that occurred after the onset of treatment and within seven days after Skyla removal or expulsion was 0.41 with a 95% upper confidence limit of 0.96. The cumulative three-year pregnancy rate, based on 10 pregnancies, estimated by the Kaplan-Meier method was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.

Of Skyla-treated women, 21.9% discontinued the study treatment due to an adverse event. Most common adverse reactions (occurring in greater than or equal to 5% users) were, vulvovaginitis (20.2%), abdominal/pelvic pain (18.9%), acne/seborrhea (15.0%), ovarian cyst (13.2%), headache (12.4%), dysmenorrhea (8.6%), breast pain/discomfort (8.6%), increased bleeding (7.8%) and nausea (5.5%).

Other serious adverse reactions were also observed, including ectopic/intrauterine pregnancy, life-threatening infections, pelvic inflammatory disease (PID), perforation and expulsion.

Important Safety Information for Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg

If you have a pelvic infection, get infections easily, or have certain cancers, don’t use Skyla. Less than 1% of users get a serious infection called pelvic inflammatory disease.

If you have persistent pelvic or stomach pain or if Skyla comes out, tell your doctor. If Skyla comes out, use back-up birth control. Skyla may attach to or go through the uterus and cause other problems.

Pregnancy while using Skyla is uncommon but can be life threatening and may result in loss of pregnancy or fertility. Ovarian cysts may occur but usually disappear.

Bleeding and spotting may increase in the first few months, and remain irregular. Over time, periods are likely to become shorter and lighter, or may stop.

Skyla does not protect against HIV or STDs.

Only you and your healthcare provider can decide if Skyla is right for you. Skyla is available by prescription only.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For additional information about Skyla, please see full prescribing information at www.skyla-us.com.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world’s leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals provides products for Diagnostic Imaging, General Medicine, Hematology, Neurology, Oncology and Women’s Healthcare. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

BAYER® and the Bayer Cross® are registered trademarks of Bayer. Skyla is a trademarkof Bayer.

Media Contact:

Marcy Funk,

 The Two Compared

Mirena

Initial levonorgestrel release rate is 20 mcg/day; rate reduced by 50% after 5 years

Must be removed or replaced after 5 years

Skyla

Levonorgestrel release rate is 14 mcg/day after 24 days and 5 mcg/day after 3 years

Must be removed or replaced after 3 years

 

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.