• 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 lawyer’

Transvaginal Mesh Helpline, Get a Vaginal Mesh Lawyer

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News, mirena IUD multi district litigation, Vaginal Mesh lawsuit

The vaginal mesh is another device that has been harming women. The pelvic mesh lawyers of the Vaginal Mesh Helpline are filing lawsuits for women in 3, 4 ,5 and 6 year statute states. Women have been a target for drug and medical device manufacturers. The Pelvic Mesh Repair lawsuits effect 1000’s of women who have been injured by this Prolene mesh device.

You will be able to speak to a female medical social worker about your pelvic mesh complications and Get the support and information you need to understand your vaginal mesh complications and the vaginal mesh, pelvic repair system lawsuits. .

What Is A Prolene Mesh Implant?

Polypropylene mesh, also known as a Prolene mesh is a synthetic material, man made device,  used to treat pelvic organ prolapse or urinary incontinence.  It is used in bladder slings to treat incontinence and in prolapse repairs which use larger mesh in the form of a hammock.

Why Are  Mesh lawyers Filing Prolene Mesh Lawsuits?

The manufacturers of these pelvic  mesh implants  did not inform the public  of the potential complications associated with these mesh products. The device was approved under the FDA’s fast-track 510 (k) premarket notification process without sufficient testing.

FDA Warns And The Vaginal Mesh Lawsuits Statuter Dates Are Set

In July 2011, the FDA reported that it had received nearly 4,000 adverse incident reports. The FDA concluded that complications from vaginal mesh implants were of concern. The agency has informed the public that mesh procedures and surgeries can expose recipients to a greater risk complications.

But These Mesh PRODUCTS ARE  Still On The Market?

There have been few recalls of vaginal mesh products. In January 2012, the FDA issued postmarket surveillance study orders to all the manufacturers of surgical mesh products. On July 1, 2012, C.R. Bard stopped selling their Avaulta transvaginal mesh in the United States. In June 2012, Johnson & Johnson announced it was pulling four of its transvaginal mesh products off the market. These were not recalls. The first vaginal mesh recall occurred in 1999. Boston Scientific voluntarily recalled the ProteGen Sling due to its high failure rates.

How Do I File A  TransVaginal Mesh Lawsuit?

The pelvic repair mesh lawsuits are being filed for mesh with many different names. They could be called a transvaginal mesh lawsuit, sling lawsuit, OB tape, TVT lawsuit, pelvic mesh, or surgical mesh lawsuit. These are all part of the mesh lawsuits and our experienced Pelvic mesh attorneys are familiar with filing a lawsuit for all of these.

The Questions Your Lawyer Will Ask Are:

Why was your  mesh put in?

When was your Prolene  mesh implanted?

What state was the  product  implanted?

What is the brand and manufacturer of your  mesh?

What are your current complications?

Have you had any  revision surgeries?

Has your vaginal mesh been removed?

Pelvic Repair Mesh Multi District Lawsuits Have Been Consolidated Under Judge Goodwin in West Virginia

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

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

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

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

Pelvic mesh lawsuit Cook Medical Surgical will be the fifth MDL

Who Are The Manufacturers Involved In The Lawsuits?

Johnson & Johnson,Ethicon TVT Gynecare, TVT Gynemesh, PS Prolene Polypropylene Mesh, Patch Secur Bard Avaulta Plus™ BioSynthetic Support System Avaulta Solo TM, Synthetic Support System Faslata®, Allograft Pelvicol® ,Tissue PelviSoft®, Biomesh Pelvitex™, Polypropylene Mesh American Medical Systems or AMS SPARC®, Boston Scientific Advantage™, Sling System Obtryx®, Curved Single Obtryx®, Mesh Sling Prefyx Mid U™, Mesh Sling System Prefyx PPS™,Cook Medical Surgisis Biodesign Tension-Free Urethral Sling, Surgisis Biodesign Anterior Pelvic Floor Graft, Surgisis Biodesign Posterior Pelvic Floor Graft, Cook Urological Stratasis Urethral Sling or Stratasis Tension Free Urethral Sling.

Call Now to Speak to a Pelvic Mesh Repair Lawsuit Attorney For The Following Cities And States

Vaginal  mesh lawyers can help you in the 3,4,5 and 6 year statute of limitations states: Washington D.C.;Florida; Daytona; Fort Myers; Ft Lauderdale; Gainesville; Jacksonville; Keys; Lakeland; Miami; Ocala; Orlando; Tampa, Panama City; Pensacola; Sarasota; St. Augustine; IL; Massachusetts; Boston, Springfield Massachusetts; Worcester, Michigan ;Ann Arbor ; Detroit, Grand Rapids; Jackson; Lansing; Minneapolis; lawyers for: St Paul; North Carolina; Charlotte; Fayetteville; Greensboro; Raleigh,  Winston Salem NC; Fargo ND; Providence RI; East Providence; South Carolina; Charleston; Columbia; Florence; Greenville; Myrtle Beach; Washington;Seattle; Tacoma; Charleston; Wisconsin,Milwaukee;Wyoming, Cheyenne; Casper; Laramie; Gillette, ; Milwaukee, ;Montana, Billings, Springfield,; Michigan Detroit, Grand Rapids; Montana, ;Nebraska,Omaha ,; New Hampshire; Manchester;New Mexico, Albuquerque; North Carolina, Charlotte, Raleigh, Greensboro, Winston-Salem, Durham, Fayetteville, Providence, South Carolina: Charleston ;Washington; Seattle, ;Wisconsin; Milwaukee, Madison, Green Bay; Wyoming; Casper and Laramie transvaginal mesh lawsuits.

States With 3,4,5 and 6 year Statute Of Limitations

Arkansas, D.C, Florida, Maine, Massachusetts, Michigan, Minnesota, Montana,Nebraska,  New Hampshire, New Mexico, N.Y, North Carolina, Rhode Island, Rhode Island, South Carolina, Washington, Wisconsin, and Wyoming are still good for a Pelvic mesh repair lawsuit. If you have a Boston Scientific or AMS mesh you may still be able to file your lawsuit even in a 2 year statute state. It is imperative that you discuss your options with a qualified vaginal mesh lawsuit attorney.

 

 

 

 

 

 

 

Vaginal Mesh Settlement For Injury To One Woman $3.35 Million

Written by Mirena IUD Helpline on . Posted in Vaginal Mesh lawsuit

The vaginal mesh lawyers are filing vaginal mesh lawsuits for women and the first settlement was big. This is another medical device  harming women. File your  vaginal mesh lawsuit today.

A vaginal mesh lawsuit against Johnson & Johnson subsidiary Ethicon will have a  a big impact on the future of vaginal mesh lawsuits and potential settlements. You must file your vaginal mesh lawsuit right away. The jury at the Superior Court of Atlantic County in New Jersey awarded Ms. Gross $3.35 million in compensatory damages. This is a huge blow to defendants Johnson & Johnson and Ethicon, as well as all the other vaginal mesh implant manufacturers.

Vaginal mesh, bladder sling, pelvic mesh, surgical mesh, mesh patch implants have caused severe complications and thousands of lawsuits are being filed

  • Erosion  thru the vagina wall
  • Perforation of  nearby organs
  • Severe relentless pain
  • Urinary tract infections
  • Lower back pain
  • Digestive disorders
  • Vaginal bleeding
  • Vaginal scaring

In  this case it took 18 surgeries so far to correct the side effects her Ethicon vaginal mesh implant caused. This was likely a huge factor in the jury’s decision as there were reports that the jury stopped their deliberation to have her testimony read back to them.

 

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 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.

Mirena News Update, MDL Hopes For Mirena IUD, March 21st Hearing

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

A MIrena IUD MDL, Multi District Litigation would be helpful for women and set a tone for thousands of Mirena lawsuits to be filed in one central location under one judge. A Multi District litigation for the Mirena IUD would mean you do not need a local lawyer to file in a local court. This would be at the Federal level. There would be lead counsels assigned to the litigation and you would need to locate an experienced dangerous devices lawsuit lawyer.

If the Mirena IUD side effects  warrant MDL this would be good for the thousands of women who have gotten uterine perforations from the Mirena IUD… Perforation cases are currently the ones lawyers are seriously looking at.  The Mirena must have gravitated from position, become embedded in the uterus and needed to be surgically removed. There must have been no complications with the original insertion. This has to do with a concept called ” science”. A uterine perforation can be easily traced back to the Mirena. The Mirena becomes dislodged and gravitates out of position and moves. It can become embedded in the uterus or a nearby organ. The result is perforation and usually permanent infertility. These are basic facts that can be proven. Many of the other tentative symptoms cannot be traced back to the Mirena easily. They may ne very real for you but, perforations are the key complication.

 Mirena MDL Overview

In January 2013, a motion for consolidation of Mirena lawsuits was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML). The motion requested the formation of a Mirena multidistrict litigation (MDL) or centralization of all Mirena lawsuits.   This proposed MDL could group together lawsuits that have uterine perforations as a result of Mirena.  The JPML is scheduled to hear arguments regarding the proposed MDL on March 21, 2013.

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 Lawsuit Moves Forward, Mirena IUD Helpline Watches

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

The Mirena IUD Helpline , Mirena IUD lawyers,  are  watching the progress of the Mirena IUD lawsuits. ” We believe the a multi district litigation consolidation will be announced shortly. This consolidation of lawsuits under one judge in one jurisdiction will help all women file their Mirena Injury lawsuits.  As the Mirena IUD Lawsuit continues to move forward emphasis is being placed on injury where the Mirena has gravitated from the original implantation site. The device migrates and becomes embedded in the uterus or abdomen. The result is organ perforation which can lead to permanent infertility. The Mirena IUD  is surgically implanted to be effective for five years.

Mirena IUD Lawsuits are being filed by women who have  used the Mirena IUD and experienced an injury.  The Mirena IUD Lawsuit has many similarities to other mass torts currently underway. Specidic injury related to the Mirena includes: infections, dangerous scar tissue known as an adhesion,  uterine perforations, organ perforations,and infertility, abscesses, birth of a child with a birth defect, erosion of adjacent areas such as the vagina, inflammation of the membrane that lines the abdominal cavity and internal organs, intestinal perforations or obstruction, and pelvic Inflammatory Disease. There have also been some related fatalities.

Contact us today by returning the contact form or calling to discuss your specific Mirena complications with a medical social worker and get connected with a Mirena IUD lawyer.

 

 

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.

 

 

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.

 

 

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.