• 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 ‘Panama City’

Taxotere Permanent Hair Loss Lawyers

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News, Permanent Baldness medication lawyer, Taxotere Lawyer

Taxotere Permanent Hair Loss Lawsuit Helpline

Did you suffer from permanent hair loss after using Taxotere?
Did you suffer from permanent hair loss after using Taxotere?

Our Taxotere lawyers are filing lawsuits for women who will have permanent hair loss from Taxotere

A lawsuit filed in California accused the makers of a popular breast cancer chemotherapy drug of hiding side effects, including permanent hair loss, and misrepresenting the drug’s benefits.

Ami Dodson filed a lawsuit against Sanofi-Aventis, the makers of the chemotherapy drug, Taxotere (docetaxel), claiming the drug caused her to suffer permanent hair loss (alopecia). Furthermore, she said the drug maker engaged in marketing schemes to drive up the sales of the drug while hiding the medication’s increased toxicity compared to other similar drugs.

Nearly 3 million women have a history of breast cancer in the U.S. Of these women, about 75 percent were prescribed Taxotere.

“Defendants [preyed] on one of the most vulnerable group of individuals at the most difficult time in their lives,” Dodson said in her complaint. “Defendants obtained billions of dollars in increased revenues at the expense of unwary cancer victims simply hoping to survive their condition and return to a normal life.”

The U.S. Food and Drug Administration (FDA) first approved Taxotere in 1996 and by 2004, it raked in $1.4 billion each year for Sanofi. The drug is approved for use in treating a variety of cancers. In 2004, the FDA approved the drug despite significant toxicity that could cause leukemia and congestive heart failure, according to the National Cancer Institute.

Dodson claims she would not have used Taxotere if she had known it could cause permanent hair loss, especially since other less toxic options were available.

“Permanent baldness (permanent alopecia) is a disfiguring condition, especially for women,” said Dodson. “Women who experienced disfiguring permanent alopecia as a result of the use of Taxotere suffer great mental anguish as well as economic damages, including but not limited to loss of work or inability to work due to significant psychological damage.”

If you or a loved one has permanent hairloss or baldness from Taxotere call us for a Taxotere lawyer.

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.

Gynecare Power Morcellator Lawyers | Power Morcellator Helpline

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

Gynecare Power Morcellator Lawyers Filing Lawsuits

Johnson & Johnson’s Ethicon is facing  a product liability lawsuits filed by  women diagnosed with leimoyosarcoma following a laparoscopic hysterectomy.  New studies show that the company’s Gynecare power morcellators can cause  hidden uterine cancer to be spread throughout the body.

A complaint  was filed  indicating that a female  victim  now must take oral chemotherapy to keep leiomyosarcoma cancer  from spreading  by the hysterectomy power Morcellator  from killing her.

The manufacturer failed to adequately disclose the risk of cancer following laparoscopic hysterectomy morcellation, as the device may take hidden sarcomas contained within the uterus and chop up the tissue, causing a rapid dissemination of the aggressive cancer.

Power Morcellator Lawsuit Filed

During her hysterectomy in November 2008, Davis indicates that doctors used a Gynecare morcellator to cut up the uterus through a small incision in the abdomen. However, a biopsy of the removed tissue taken during the surgery was found to contain leiomyosarcoma cancer cells, which doctors were unable to discover or diagnose before the procedure.

As a result of the leiomyosarcoma diagnosis, Davis underwent multiple cycles of chemotherapy, but by April 11, three large masses were detected in her abdomen and pelvis, confirming that the cancer had spread. She underwent additional chemotherapy and now continues to take harsh oral chemotherapy drugs.

Morcellators have become  popular for use during hysterectomy and uterine fibroid removal surgicsl procedures.  It was discovered that the Morcellators have a high risk of spreading aggressive cancer cells that may be hidden within the uterus of some women, which doctors are unable to detect or diagnose before the surgery.

Davis’s complaint is one of a growing number of laparoscopic morcellator cancer lawsuits filed against Ethicon and other manufacturers of devices sold in recent years. Each of the cases raise similar allegations, indicating that manufacturers sold a defective and unreasonably dangerous medical device, failing to warn about the link between uterine fibroid surgery and cancer.

Power Morcellator MDL

All Ethicon  power morcellator lawsuits  have been consolidated  under  District Judge Kathryn H. Vratil in the District of Kansas.

If you Have been injured by a Power Morcellator contact our new Power Morcellator Cancer Helpline.

 

Johnson and Johnson Talcum Powder- Ovarian Cancer

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

Talcum Powder Ovarian Cancer Lawsuit Helpline

Johnson & Johnson Talcum Powder Ovarian Cancer Lawsuit Helpline

Talcum powder has been a  trusted household product for years. Did you know that the talc in talcom powder may be responsible for having  caused your  ovarian cancer.

In  1971 a study  revealed  that talc particles  move and can become embedded in your ovarian tissues.  40  years without restrictions or warnings of any kind has resulted in unsuspecting victims developing ovarian cancer. Did your mom use Johnson’s baby powder to dry up?

We have a special helpline for  claims from women, like your mom or sister, who developed ovarian cancer after using a Johnson & Johnson powder product.

How Is Talcum Powder Related To Ovarian Cancer?
When Talc is  ground into powder is used on the genitals, talc particles can travel into the ovaries and remain trapped for years. These particles can cause inflammation and lead to the growth of ovarian cancer cells very similar to asbestos related mesothelioma in the lungs.

Lawsuit Won In Favor of the Plaintiff
The first  talc baby powder cancer lawsuit was  won in 2013. A federal jury recently found that talcum contained in some Johnson & Johnson powders contributed to a woman’s ovarian cancer.

The plaintiff in this case was diagnosed with ovarian cancer  after about 30 years of using  Shower-to-Shower body powder-as part of her personal hygiene routine. The jury found that Johnson & Johnson failed to warn her of a link between the use of talc-based powder for feminine hygiene and an increased risk of ovarian cancer.

This outcome sets the stage for thousands of women who have developed ovarian cancer after using talc-based products.

 

Lawyers For Justice For Women Transvaginal Mesh Lawsuit Attorneys

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

Transvaginal Mesh Lawyers  Declare Vaginal Mesh Complications Horrific

New Vaginal Mesh Lawsuit Department Opens

Women who have been implanted with a vaginal mesh are having complications that that are of great concern to our  mesh attorneys.

Because of the horrors of the mesh implanted in women for urinary incontinence and organ prolapse we have launched a special department to help locate women who should still be filing a vaginal mesh lawsuit. Many women are just finding out that the pain and suffering they are going thru is from the mesh implant. They are asking if they can sue the mesh manufacturers.

Yes, you can sue the manufacturers of your vaginal mesh implant in an MDL ( multi district litigation ) that has been formed under Judge Goodwin in West Virginia

We have Transvaginal mesh and bladder sling lawyers on our panel that know every step of this filing procedure and are here to help you.

Why use our Vaginal Mesh Lawyers?

Because they are lawyers experienced in drugs and devices harming women and most are female attorneys or have a a female in their office who listens and understands your situation.  If you need answers,  they have answers and in some instances can help you get a doctor for the removal of your vaginal mesh.

Call now for a local vaginal mesh attorney or a lawyer who is on top of the latest news in the MDL trials. Remember, these are centralized lawsuits. You do not need a local Vaginal mesh, TVT/TOT mesh sling or bladder sling attorney. If you are not sure if your mesh qualifies, call us now and find out.  We do not want any women with a failing Prolene mesh implant to be left out.

Vaginal Mesh Lawsuit Update, Vaginal Mesh Lawyer Helpline

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

Another medical device harming women is the vaginal mesh. Over 300,000 women have been implanted with a Prolene mesh product for either prolapse or urinary incontinence. Women are suffering and lawsuits have been filed under an MDL or multi district litigation very much like the MDL for the Mirena IUD.

Vaginal Mesh Multi District Lawsuit List Consolidated Under Judge Goodwin in West Virginia

MDL – 2325, IN RE: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation

MDL – 2326 IN RE: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation

MDL – 2327 IN RE: Ethicon, Inc., Pelvic Repair System Products Liability Litigation

MDL – 2387 IN RE: Coloplast Corp. Pelvic Support Systems Products Liability Litigation

A multi districrt litigation consolidates massive numbers of nationwide lawsuits under one judge.

If you or a loved one: a friend, mother, sister or loved one has been implanted with a vaginal mesh and is having complications and the doctor is telling them that it is not the mesh they should contact us immediately to speak to a medical social worker and vaginal mesh lawyer.

Two vaginal mesh lawsuits have gone to trial. In March, a New Jersey Superior Court jury weighing claims in that litigation’s first Ethicon bellwether trial ordered Johnson & Johnson to pay more than $11 million in compensatory and punitive damages to a recipient of the Gynecare Prolift device. (Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey) Last July, a jury in California awarded $5.5 million to a woman and her husband in the nation’s first C.R. Bard vaginal mesh trial. (Scott v. Kannappan, S-1500-CV-266034-WDE, Superior Court for Kern County, California)

 

Mirena Perforation Lawsuits, Laproscopic Surgical Removal Lawsuit Lawyers

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

We are no longer accepting Mirena IUD Lawsuits

Attention Ladies: Mirena IUD lawyers are filing lawsuits where your device migrated, become embedded in and perforated your uterus and was  removed with laproscopic surgery.

Laparoscopic surgery is a minimally-invasive type of surgery that utilizes a tool called a laparoscope, which has a light, video camera, and surgical instruments on the end. A surgeon watches a video monitor to guide surgery. The benefit of this surgery is that it minimizes risks during surgery, reduces pain, and reduces recovery time.

 Ladies with a Perforation from Your Mirena IUD
Lawyers are filing Mirena IUD lawsuits for perforations where the device must be laproscopically removed.

If your Mirena IUD moved, migrated or gravitated out of the original insertion position after a followup found everything was ok we need to hear from you ASAP  to have your case reviewed for a  MIRENA IUD  Lawsuit .

Surgical Devices Harmful To Women, Lawyers For Stryker Hip Replacement

Written by Mirena IUD Helpline on . Posted in Stryker Hip Recall

The FDA reports that these metal on metal and metal component hip implants  put women at a higher risk. Both the Stryker Rejuvinate and ABG II are  dangerous surgical implants that have a greater failure rate and complications for women.

Many articles and reports have been released that discuss hip replacements having a greater failure rate in women.

Hip replacements like Stryker Rejuvinate and ABG II are slightly more likely to fail in women than in men, according to research published Monday in JAMA Internal Medicine.  The research was financed by the Food and Drug Administration. Another report discusses hip resurfacing and states a drawback for women because of the bone weakening that accompanies menopause. Meanwhile, even advocates of resurfacing acknowledge that they have yet to agree on how best to screen women for the procedure.

“We were surprised by the results, as studies suggest that larger heads should have  lower wear and a lower risk of dislocation. However, we have seen an increase in revisions for pain and loosening, particularly in women,” says Alison Smith, a study author and statistician at the University of Bristol in the U.K. Depending on patient age and implant head size, the revision rate for all-metal hips is three to four times higher in women and two to three times higher in men compared with other implants.

The FDA Reports Women At a Higher Risk For Failure

The Food and Drug Administration, along with its safety communication, has included a list of risk factors that can increase a patient’s chances of suffering from metal on metal hip implant complications. Patients who are overweight, female, or physically active are more likely to suffer complications related to these hip replacement systems, and patients who have a sensitivity to certain metals, have kidney failure, have a suppressed immune system, or take corticosteroids are also more at risk.

It seems women are always the victims for these manufacturers that choose profits over warnings.

Hip Replacement Failure More Likely In Women, Study Says Studies on Google News Today

Hip replacements are more likely to fail in women than in men, but the overall risk of implant failure is low–according to a study published in the Journal of the American Medical Association, JAMA, and that was funded by the U.S. Food and Drug Administration.

Women account for the majority of the more than 400,000 patients who undergo either full or partial hip replacements in the U.S. each year.

“This is the first step in what has to be a much longer-term research strategy to figure out why women have worse experiences,” said Diana Zuckerman, president of the nonprofit National Research Center for Women & Families.

It appears the smaller frame and difference in the curve of the hip and pelvic region accounts for this. Anatomy appears to play a role.  Women tend to have smaller joints and bones than men, and so they tend to need smaller artificial hips. Devices with smaller femoral heads  the ball-shaped part of the ball-and-socket joint in an artificial hip are more likely to dislocate and require a surgical repair.

I wonder why there cannot be two types of replacements, one for women and one for men. But, since they are all being recalled it would just mean more injured women. I am sure there would be extensive marketing to hook women in explaining how their lives would remain active and have a better quality. If you or a wife, mother, girlfriend or female loved one has been injured by these hip implants contact us and we will direct you to a Stryker Hip Replacement lawyer.

Mirena IUD Help, Mirena IUD Florida Resources, Florida Mirena Lawyer

Written by Mirena IUD Helpline on . Posted in Florida Mirena IUD resources, Mirena IUD Helpline, Mirena IUD Lawsuit News

Mirena IUD medical resources thru Planned Parenthood of Florida.

If you are experiencing Mirena IUD side effects you may contact these locations for help. Mirena IUF lawyers are here to help you file your Mirena IUD lawsuit.

Florida Mirena IUD lawyers are concerned about women in Florida with uterine perforations and complications from the Mirena IUD. Contact the physician the implanted the Mirena. If you need additional help you may find it here:

Boca Raton Health Center

Boca Raton

8177 Glades Rd.

Bay 25

Boca Raton, FL 33434

P: 561.226.4116

F: 561.939.1344

Manatee Health Center, Bradenton

1105 53rd Avenue East, Suite 201

Bradenton, FL 34203

P: 941.567.3800

F: 941.753.3804

Fort Myers Health Center, Ft. Myers

8595 College Parkway, Suite 250

Ft. Myers, FL

P: 239.481.9999

F: 239.481.9346

Gainesville Health Center, Gainesville

914 NW 13th Street

Gainesville, FL 32601

P: 352.377.0881

F: 352.374.6823

Immokalee Center, Immokalee

419 N First Street

Immokalee, FL 34142

P: 239.262.0301

F: 239.262.7658

Jacksonville Health Center, Jacksonville

3850 Beach Blvd

Jacksonville, FL 32207

P: 904.399.2800

Lakeland Health Center

2250 E Edgewood Drive

Lakeland, FL 33803

P: 863.665.5735

F: 863.665.4422

Jean Shehan Health Center, Miami

3119A SW 22nd Street

Miami, FL 33145

P: 305.285.5535

F: 305.285.6956

Kendall Health Center, Miami

11440 SW 88th Street, Suite 109

Miami, FL 33176

P: 786.263.0001

F: 786.263.0004

7900 N.W. 27 Ave. #E240

Miami, FL 33147

P: 305.423.7933

F: 786.517.6138

Naples Center, Naples

1425 Creech Road

Naples, FL 34103

P: 239.262.0301

F: 239.262.7658

North Miami Health Center, North Miami

681 N.E. 125 Street

North Miami, FL 33161

P: 305.895.7756

F: 305.895.7763

Orlando – Eastside Clinic

11500 University Blvd

Suite B

Orlando, FL 32817

P: 321.235.5513

F: 321.235.6125

Orlando Westside Clinic, Orlando

726 South Tampa Ave

Orlando, FL 32805

P: 407.246.1788

F: 407.246.8466

Pembroke Pines Health Center, Pembroke Pines

263 North University Drive

Pembroke Pines, FL 33024

Sarasota Health Center

736 Central Avenue

Sarasota, FL 34236

P: 941.953.4060

F: 941.366.1899

Pinellas Health Center, St. Petersburg

8950 Dr. Martin Luther King Jr. Street North, Suite 102

St. Petersburg, FL 33702

P: 727.898.8199

Martin County Health Center, Stuart

1322 NW Federal Hwy., Emerald Plaza

Stuart, FL 34994

P: 772.692.2023

F: 772.692.1555

The Sally Bellamy Health Center, Tallahassee

2121 W Pensacola Street

STE B-2

Tallahassee, FL 32304

P: 850.574.7455

F: 850.575.4335

Tampa Health Center, Tampa

8068 North 56th Street

Tampa, FL 33617

P: 813.980.3555

F: 813.341.1111

Indian River (Vero Beach) Health Center, Vero Beach

3106 20th Street

Vero Beach, FL 32960

P: 772.778.0037

F: 772.778.1050

Wellington Health Center, Wellington

10111 Forest Hill Blvd, Suite 340

Wellington, FL 33414

P: 561.296.4919

F: 561.721.3474

West Palm Beach Health Center

931 Village Blvd. Suite 904

West Palm Beach, FL 33409

P: 561.683.0302

F: 561.683.9823

Winter Haven Health Center, Winter Haven

908 Havendale Blvd

Winter Haven, FL 33881

 

 

 

 

 

 

 

 

 

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