Was there a MIRENA RECALL?

describe the imageNo, there has not been a MIRENA RECALL, or market withdrawal involving the MIRENA IUD manufactured by BAYER HEALTHCARE PHARMACEUTICALS. There have been a series of letters from the FDA warning the manufacturer over certain marketing practices relating to the promotion of the MIRENA IUD.

In 2010, the MIRENA IUD was the subject of some discussion because the FDA discovered that some physicians had purchased non-FDA approved IUD’s, including the MIRENA, and placed them in unsuspecting women. This prompted alerts over this prohibited practice and criminal prosecutions of offending healthcare providers. Certain attorneys in our office have been investigating the MIRENA IUD since that time over safety concerns and risks.


What is a MIRENA IUD?


The MIRENA is an intrauterine device (IUD) or intrauterine system (IUS) manufactured by BAYER HEALTHCARE PHARMACEUTICALS. It is a “T” shaped device that is marketed and offered as a form of “long term” contraception because it is placed into the uterus and left for up to five (5) years. The MIRENA IUD is made of a soft flexible plastic that is put into place by a healthcare provider during an office visit. The MIRENA IUD delivers a small amount of hormone (LEVONORGESTREL) into the uterus which is believed to aid it in preventing pregnancy. The image above may be found on the manufacturer’s website promoting the device. In sum, MIRENA is simply a form of birth control and does not protect against HIV or any sexually transmitted disease. The manufacturer claims that nearly 2 Million U.S. Women choose to use the MIRENA IUD as their current form of contraception.

Notably, “MIRENA is recommended for women that have had a child“. Presumably, this is because the uterus changes following childbirth. As a result, anyone that has a MIRENA inserted and did not previously have at least one child needs to question whether or not they were a candidate for the MIRENA IUD and whether they may maintain a MIRENA LAWSUIT.

MIRENA is specifically not recommended for the following:

  • Anyone that has had a pelvic infection or has certain cancers or is prone to infections.
  • A girl or woman that might be pregnant.
  • Any girl or woman with a past medical history that includes Pelvic Inflammatory Disease (PID) unless they had successfully carried a child to term following a pregnancy.
  • A girl or woman that is allergic to Levonergestrel.
  • A girl or woman that is allergic to silicone or polyethylene.
  • A female with an untreated pelvic infection prior to insertion.
  • A female that had a serious pelvic infection within 3 months before insertion and following a pregnancy.
  • A girl or woman with more than one sexual partner.
  • An intravenous drug user.
  • A female that has problems with their immune system.
  • Any female that suspects she may have cancer of the uterus or cervix.
  • Have any liver disease or liver tumor.
  • A female that suspects she has breast cancer or had breast cancer in the past.
  • A female that already has an IUD.
  • A girl or woman that has any pre-existing condition that causes the uterus to change shape of the uterine cavity, including fibroid tumors.

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How Does MIRENA work?

While the manufacturer claims the MIRENA IUD is 99% effective it is not clear exactly how the MIRENA LEVONORGESTREL RELEASING INTRAUTERINE SYSTEM works. In fact, information found through the www.Mirena-US.com website provides the following on this very subject:

“MIRENA may work in several different ways. It may:

  • Thicken cervical mucus to prevent sperm from entering your uterus.
  • Inhibit sperm from reaching or fertilizing your egg.
  • Make the lining of your uterus thin.

MIRENA may stop the release of your egg from your ovary, but this is not the way it works in most cases. Most likely the above actions work together to prevent pregnancy”. (Emphasis on “may” not in original) In sum, how the MIRENA works is simply not clear despite claims of safety and effectiveness.


MIRENA has been marketed and accepted as a ‘set and forget’ contraceptive. The manufacturer promotes this idea with the following slogan: “Because you’re busy However, this is not the case and erroneous. Even a properly inserted MIRENA IUDrequires regular monthly monitoring by the user with annual visits. MIRENA was approved by the U.S. Food & Drug Administration (FDA), and is recommended for women who have had a least one child.

MIRENA LAWYERS are attorneys that are knowledgeable in contraceptive litigation and the MIRENA IUD and MIRENA INJURIES. Our office has experience in complex litigation, including the most recent hormonal contraception involving YAZ LAWSUITS. We are actively evaluating cases involving potential MIRENA LAWSUITS and MIRENA INJURIES. As victim advocates, our attorneys are passionate about undertaking the representation of girls and women that have suffered serious injuries from use of the MIRENA IUD. Specifically, we are evaluating and accepting the following types of cases:

  • MIRENA EMBEDMENT – These cases involve attachment of the MIRENA to the uterine wall which may lead to the need for surgical removal and related complications which may include other serious personal injuries.
  • MIRENA PERFORATION – These cases involve the MIRENA going through the uterine wall and possibly moving outside the uterus. Complications can include surgery, or other serious personal injuries.
  • MIRENA DEATH CLAIMS – Cases involving an embedment, perforation or migration that resulted in death from complications.

Complications from a MIRENA EMBEDMENT or MIRENA PERFORATION can include, but are not limited to the MIRENAadhering to other parts of the body or anatomy requiring invasive surgery, resulting in scarring and potential complications.

The first step in initiating any IUD LAWSUIT is to seek a FREE NO OBLIGATION CASE EVALUATION by calling 1-800-400-1098 or submitting a contract form.

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Technically, MIRENA LAWSUITS are not the subject of a traditional class action lawsuit or class action litigation. Rather,MIRENA INJURY LAWSUITS are the subject of a growing number of “mass tort” cases. “Mass Torts” are different from class action litigation and often involve medical devices or drugs. The MIRENA INTRAUTERINE DEVICE is a hormone releasingINTRAUTERINE DEVICE or INTRAUTERINE SYSTEM. Generally, each potential MIRENA INJURY LAWSUIT is evaluated independently with regard to a specific type of injury or potential cause of action. The cases are not all handled by any singleMIRENA MEDICAL ATTORNEY or MIRENA LAWYER, but rather by different law firms and lawyers across the country. Those lawyers may ultimately share information, pool resources or even seek that the cases progress together in the investigative process against the manufacturer, BAYER HEALTHCARE PHARMACEUTICAL. However, the cases are not considered a “class action” but rather a “mass tort”. Granted, a lawyer may seek to apply class action law on behalf of women that used MIRENA but cases involving different personal injuries are not likely to be considered in any such potential class action. Rather, such cases are most likely to be treated and progress as mass torts in specific designated courts, or jurisdictions, where it is legally appropriate to maintain such an action and pursue compensable damages against the manufacturer. Please contact us with any questions regarding the above or MIRENA LAWSUITS.


Will Class Action Law apply to MIRENA INJURY LAWSUITS?

MIRENA IUD cases may not be a viable class action because individual differences in the injuries suffered by women may make the resulting lawsuits unsuitable as a class action. Class actions typically involve a large group of individuals who have been harmed in a common way. However, class actions may not be viable in instances where different injuries have been suffered by different people or the extent of injury varies significantly from one person to another. Class action lawsuits treat every person’s individual claim in one lawsuit. It is likely that each potential MIRENA LAWSUIT is too individualized to proceed as part of a class case under class action law. Class action cases involve common questions of law and fact. Cases are more easily certified under Rule 23 if they have identical or nearly identical facts – for example all consumers suffered the exact same harm or type of harm from a uniform product defect.




As girls and women come forward with injuries they allege are linked to use of the MIRENA IUD they often ask how they will pay to explore their legal remedies. Our office is offering FREE MIRENA LAWSUIT CASE EVALUATIONS and investigating cases on a “contingency fee” basis. This means that we will investigate and handle the case without any fee being charged “up front”. Rather, we are paid a contingency fee based upon a percentage from any recovery we obtain on your behalf. No recovery, no fee, is often used to describe these types of contracts.


For Additional Information Visit:

  • MIRENA Attorneys
  • MIRENA Lawyers
  • MIRENA Lawsuits

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