• 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 ‘Mirena IUD class action’

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 .

Mirena IUD MDL Formed For Perforations In New York, Mirena IUD Lawyers Ready

Written by Mirena IUD Helpline on . Posted in mirena IUD multi district litigation

An MDL ( Multi district litigation ) has formed in New York. The Mirena multi district litigation will allow for all Mirena IUD pewrforation cases to be heard under one judge in one jurisdiction. This allows for an easy and quick filing of lawsuits and means you do not need a local lawyer to file your lawsuit as all the cases will be heard in New York.

This consolidation applies to all Mirena IUD injury perforation injury lawsuits and will include all  cases filed in the the federal court system. Dangerous drugs and devices lawsuits often end up as a multi district consolidation. Now the  Mirena IUD  perforation lawsuits will be centralized before one judge, U.S. District Judge Cathy Seibel in the Southern District of New York, for pretrial proceedings in Re: Mirena IUD Products Liability Litigation, MDL No. 2434). The Transfer Order, which was filed on April 8, 2013 states that the MDL currently consists of eight cases in eight different districts.

Mirena IUD Lawsuit Checklist

The Mirena IUD causes many symptoms and complications. However to file a Mirena IUD products liability lawsuit you must meet certain criteria. Now, although you were never told you had some of these issues and believe you do not qualify, you should see a physician to be sure. Perforation of the intestine leads to leakage of intestinal contents into the abdominal cavity. This causes inflammation called peritonitis. A uterine perforation is a hole made through the wall of the uterus. Some of the medical conditions that may imply a perforation of the uterus or abdomen, or that indicate your Mirena may have moved or become embedded in an organ include:

  • Inability to feel or locate the string
  • Bleeding from vagina or bowel
  • Severe sharp pain in the abdomen
  • Lower back pain
  • Sharp jabbing pain
  • 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

Mirena IUD Lawsuit Checklist

The Mirena IUD causes many symptoms and complications however, in order to file a Mirena IUD lawsuit your Mirena IUD lawyer will be looking for the following:

1. Mirena IUD must be the product implanted

2. You must have gone to your 4-6 week follow up appointment and your doctor has confirmed that your Mirena IUD was properly implanted.

3. The Mirena IUD has perforated your uterus or other organ. The Mirena must have moved out of position, gravitated and has become embedded in your uterus or an organ and/or there is a perforation injury.

4. This usually means the Mirena , needs to be or will be surgically removed.

A lot of Mirena women either don’t go to follow up appointment or by the time they go to follow up the Mirena has already moved. If that happens this becomes a med mal issue and not a products issue. The statute of limitations starts to run when you knew Mirena perforated an organ.

Of course, consult with your doctor if you are experiencing any of the symptoms listed above to see if the Mirena has moved and caused a perforation. Consult with one of our Mirena IUD lawyers to be sure.

We need to hear from you asap. Do not delay. Every state has a statute of limitations.

 

 

 

 

 

 

 

 

 

 

Mirena IUD Lawsuit Alert, What You Need To Know To File A Mirena Lawsuit

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News, Mirena IUD Uterine Perforation Lawyers

The Mirena IUD causes many symptoms and complications however, in order to file a Mirena IUD lawsuit your Mirena IUD lawyer will be looking for the following:

1. Mirena  IUD must be the product implanted
2. You must have gone to  your 4-6week follow up appointment the and doctor has confirmed that your Mirena IUD  was properly implanted
3. The Mirena IUD has perforated uterus or other organ. The Mirena must have moved out of position, gravitated and has become embedded  in your uterus or an organ and/or  there is a perforation injury.
 4. This usually means the Mirena , needs to be or will be surgically removed
A lot of Mirena women either don’t go to follow up appointment or by the time they go to follow up the mirena has already moved. If that happens this becomes a med mal issue and not a products issue. The statute of limitations starts to run when you knew mirena perforated an organ.
To find out more about the Mirena IUD lawsuits call the Mirena IUD Helpline. Mirena IUD Helpline  lawyers are accepting  Mirena side effect cases  for embedment in the uterine wall, uterine bleeding and IUD expulsion.  Mirena lawyers are offering a free consultation to women suffering from the Mirena IUD.

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.

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

 

Mirena IUD Helpline Launches Florida Mirena Outreach Campaign

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

The Mirena IUD Helpline is beginning the national outreach campaign with the sunshine state to start this mission to locate all women with perforations  from the Mirena IUD. The devise is migrating from position and becoming lodged or embedded in the Uterus or intestines. This results in a perforation, must be surgically removed by a physicians and results in infertility.

The Mirena IUD Helpline  has a mission to locate all Florida women with severe complications from the Mirena IUD where the IUD must be surgically removed.  This expanded outreach includes the entire state of Florida and Miami, Homestead, Florida Keys, Fort Lauderdale, Boca Raton, West Palm Beach, Delray Beach, Boynton Beach, Port St Lucie, Okeechobee, Melbourne, Titusville, Daytona, Jacksonville, Ocala, Orlando, Kissimmee, Ft Myers, Winter Park, Naples, Tampa, Clearwater, St Petersburg, New Port Richey, Pensacola, Panama City, Tallahassee and all of Florida. According to the helpline MSW, “We have particular concern for  women who have had the IUD surgically removed. The result for many is permanent disability. These women are of child bearing age. The horrors of the Mirena IUD  must reach the FDA amd women must be protected.”

 

The Mirena IUD Helpline  is encouraging all women who have had a uterus perforation  to file their  Mirena IUD lawsuits. The Mirena IUD Helpline is targeting the entire state of Florida as a part of the expanded Florida campaign with hopes of locating all women with permanent injury from the Mirena IUD. It is important that women file their  Mirena lawsuits immediately.