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Mirena

Petition to the US Food and Drug Administration

more information Mirena Awareness
and the Petition site

We, the undersigned, respectfully request the U.S. Food and Drug administration do the following in regard to the Mirena IUD birth control:

1) Require the manufacturer of the Mirena UID, (Bayer Healthcare Pharmaceuticals), to revise the patient information for this device to include all potential Mirena side effects currently listed only in the physician information portion of the label.

2) Require all medical practitioners inserting the Mirena to provide the patient with this information BEFORE the Mirena is inserted.

3) Require all medical practitioners to forward this updated information, along with an explanation of the changes, to all Patients for which they have prescribed/inserted the Mirena.

4) Recommend investigation into the additional temporary and long term side effects being reported (as outlined here) that are not currently mentioned in either the doctor or patient information for the Mirena device.

Many women are reporting numerous, often debilitating healthcare problems after receiving the Mirena implant. Most are unaware of the potential for complications before the Mirena is inserted and have no idea that Mirena is the cause when they become sick.

The patient information for the device contains warnings for the following side effects ONLY:

Pelvic Inflammatory Disease, infection, embedment, perforation, discomfort during placement, expulsion, missed menstrual periods, changes in bleeding, ovarian cysts.

This is the only "adverse reaction" information the patient will typically receive.

The following adverse reactions appear ONLY on the physician information for the Mirena (perthe official physician information):
abdominal/pelvic pain, vaginal discharge, nausea, headache, nervousness, vulvovaginitis, dysmerorrhea (cramps), back pain, weight increase, breast pain/tenderness, acne, decreased libido, depressed mood, cervicitis (vaginal infection), hypertension, migraine, vomiting, anemia, dyspareunia (painful intercourse), alopecia (hair loss), eczema, pruritus (itchiness), rash, urticaria (hives), abdominal distension, altered mood, hirsutism (abnormal hair growth), edema (swelling).

Although doctors are instructed to share this information with the patient, they often do not. In many cases, even when specifically asked, doctors are denying a possible link between Mirena and these symptoms. Patients are consistently told there are "no side effects," and that the synthetic hormone (levonorgestrel) contained in the mirena cannot be harmful because the hormone release is localized to the uterus.

The reluctance of doctors to acknowledge the many possible adverse reactions to the Mirena, including the ones documented by the manufacturer, suggests that they are alarmingly ill-informed or purposely obtuse--resulting in prolonged patient suffering and extensive medical expenses while seeking diagnosis/treatment of Mirena-related issues.

In addition, Mirena users are reporting additional common side effects that are not documented in any of the Mirena information provided by the manufacturer.
These include, but are not limited to:

anxiety, mental fog, double-vision, tinnitus, appetite increase, constipation, flatulence, polyuria (frequent urination),chest pain/heart palpitations, shortness of breath, bronchitis, fatigue/drowsiness, fainting, loss of nerve sensation/tingling in extremities, tremor, weight loss, insomnia, cold intolerance, thyroid dysfunction, nonpuerperal lactation.

Patients have the right to make informed decisions regarding the use of the Mirena device. To do so, they are reliant on their doctors for full disclosure of potential risks/side effects as provided by the manufacturer. Doctors are responsible for understanding these risks, and properly diagnosing and treating side effects when they occur.

Since patients are NOT currently receiving appropriate counseling regarding the Mirena device/Levonorgestrel, or treatment and diagnosis for the resultant adverse effects, we ask that the FDA consider the above changes to prevent further debilitation, suffering and expense on the part of women using this device.

Thank you in advance for your attention to this matter.

Letter to the FDA
Ms. Carrie Newcomer
carrie.newcomer@fda.hhs.gov
Food and Drug Administration
Consumer Safety Officer
Silver Spring MD 20993

Dear Ms. Newcomer,

I read your warning letter to Bayer Healthcare, regarding their misleading marketing practices for the Mirena, with great appreciation. Because of that letter, I feel that placing the enclosed petition in your care is the right course of action, and I hope you will be able to give it the attention that it needs.

While that latest warning to Bayer specifically mentioned one marketing technique, we are hoping that BayerÂ’s disclosure of the possible side effects can be changed. These many side effects of the Mirena should also be required for the patient insert, not just the PhysicianÂ’s insert, since most women never see the information that Bayer provides to the doctors. Without this change in disclosure women will continue to be unaware of the majority of side effects they might encounter, a great many of which are more severe than any listed in the patient information.

As you read through this petition, you will find a very common thread. Most of these women, myself included, were completely unaware of these side effects and risks of using the Mirena. Many of our doctors also seemed unaware of the all the potential complications associated with the Mirena. The worst part about all of this is that our issues and sicknesses could have been prevented if we had only known of the possibilities. Subsequent health issues could have been averted with a timely diagnosis. In many cases the issues affected so many different areas of our health that a contraceptive implant causing the problems was not considered until too late.

Please help us to ensure that the women who are considering Mirena, as well as those currently using it, do not suffer like we have. All they need is information. We implore the FDA to make sure Bayer, as well as the physicians administering the Mirena, provide ALL information to the patients.

We entrust our doctors and our pharmaceutical companies to put our health as the top priority, however a situation like this shows that we cannot be all trusting. That is why we have government agencies like the FDA, to help us protect ourselves from those who fail to live up to our expectations. And that is why I have written this letter to you, so that you can involve the FDA, once again, to help protect thousands of people from inadequate or misleading information.

Please let me know if you need me to send a hard copy of the petition.

I personally want to thank you, in advance, for your attention to this, and I am positive that the many women, whose testaments you will read, will also greatly appreciate your involvement.

Jill Gallagher

2 attachments:
Mirena Awareness petition
Research links, for your information