Young Woman Sues Bayer after Mirena IUD Perforates Uterus

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The plaintiff in a new Mirena IUD lawsuit, Ashley Bonanno, was barely 20 years old when she had her IUD implanted. The intrauterine device is usually reserved for women who have had at least one child, but the sheer popularity of the Mirena IUD has had women of all ages— even as young as teens— flocking to their OBGYN to get it.

Made of plastic, Mirena is good for five years and releases very small amounts of hormones. Except for abstinence, the IUD is the most effective form of birth control and there’s no remembering to take a pill or swap out a device each month like other forms of contraception. Unfortunately, Mirena victims like Bonanno were not allegedly aware of the risks of Mirena, which many patients claim they weren’t warned about or were under-warned.

Bonanno filed her Mirena lawsuit on Dec. 6, 2013. Now 21 years old, Bonanno says she was implanted with the Mirena IUD in July 2010 without any complications. “Plaintiff tolerated the procedure well and neither Plaintiff nor her medical provider had any reason to suspect that the Mirena allegedly perforated her uterus,” her Mirena lawsuit states. Two years later, however, her physician was unable to see the IUD on exam and unsuccessfully attempted to remove the Mirena IUD. This was just the beginning of her ordeal.

“On or about November 07, 2012, Plaintiff underwent hysteroscopic removal of the Mirena IUD which was found in the endometrial cavity in a diagonal position and embedded in the anterior and posterior walls,” the lawsuit states.

The only warnings on the Mirena device at the time were that perforation and/or migration were possible during the insertion— but in Bonanno’s case, she had the device for over two years before surgery was required and the IUD was found embedded inside her. Sometimes “things happen” during or immediately after insertion, which is why OBGYNs perform a follow-up check a few weeks after insertion. But there was no warning that perforation could occur months or even years later.

According to her Mirena lawsuit, “as a direct and proximate result of the Defendants’ negligence and wrongful conduct, and the unreasonably dangerous and defective characteristics of the subject product, Plaintiff suffered severe and permanent physical injuries, and has endured substantial pain and suffering. She has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. Plaintiff has lost past earnings and has suffered a loss of earning capacity. Plaintiff has suffered and will continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. Plaintiff’s injuries and damages are permanent and will continue into the future.”

Mirena IUD Complications

In some instances, a migrating Mirena can even result in infertility when the scarring is so severe. For women who don’t have any biological children, this can be devastating.

At the heart of Mirena lawsuits and Mirena class action lawsuits is the claim that the warnings for Mirena IUD migration weren’t adequate to match the risks. In her Mirena lawsuit, Bonanno states that “Defendants had an obligation to comply with the law in the manufacture, design and sale of Mirena. Upon information and belief, Defendants violated the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et. seq.”

Had she known about the real Mirena risks, she could have chosen another form of birth control (such as the copper-T IUD) or kept a closer eye on the placement of her IUD so that she may have noticed the embedment earlier.

Bonanno certainly isn’t alone in her situation. Hundreds of women have sued Bayer, alleging that they were seriously harmed after their IUD migrated and perforated their uterus, embedding in nearby organs.

Bayer has been in hot water before about their popular Mirena device, and “have a history of overstating the efficacy of Mirena while understating the potential safety concerns,” the Mirena lawsuit states.

“In or around March 2009, the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) issued a warning regarding Defendants’ advertising materials for Mirena that constituted misbranding of the IUD in violation of the Federal Food, Drug and Cosmetic Act and FDA implementing regulations. Specifically, DDMAC pointed out that Bayer failed to communicate any risk information, inadequately communicated Mirena’s indications, and overstated the efficacy associated with the use of Mirena in Bayer-sponsored on internet search engines.”

However, that didn’t help Mirena sufferers like Bonanno who had no clue that Mirena was at the core of a back and forth battle with the FDA. She thought that the device was safe, especially after having a cleared followup appointment, and had no idea that the IUD would eventually cause intense pain, suffering and lead to mounting medical bills.

A Litany of Complaints

Bayer wasn’t finished with the complaints lobbed their way yet.

“Then, in or around December 2009, Defendants were again contacted by DDMAC regarding a consumer-directed program entitled ‘Mirena Simple Style Statements Program,’ a live presentation designed for ‘busy moms.’ The Simple Style program was presented in a consumer’s home or other private setting by a representative from Mom Central, a social networking internet site, and Ms. Barb Dehn, a nurse practitioner, in partnership with Defendants.”

However, “The portion of the Simple Style script regarding risks omitted information about serious conditions, including susceptibility to infections and the possibility of miscarriage if a woman becomes pregnant on Mirena. Finally, Defendants falsely claimed that Defendants’ system required no compliance with a monthly routine in contradiction of patient instructions.”

In Bonanna’s case, she is suing Bayer for negligence, defective design, manufacturing defect, failure to warn, defect due to non-conformance with presentations, defect due to failure to adequately test, breach of warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, and fraud and deceit.

“Defendants had a duty to exercise reasonable care in the designing, researching, manufacturing, marketing, supplying, promoting, packaging, sale and/or distribution of Mirena into the stream of commerce, including a duty to assure that the product would not cause users to suffer unreasonable, dangerous side effects,” she says in the Mirena IUD lawsuit.

The case is Ashley Bonanno v. Bayer Healthcare Pharmaceuticals Inc. et al, MDL No. 2434, in the United States District Court for the District of New Jersey.

Do You Have a Mirena Story?

If you or a loved one had a Mirena IUD inserted after January 1, 2000 or later and had to have surgery – or will be required to have surgery – to have it remove because it migrated, you may be eligible to take legal action against the manufacturer. Filing a Mirena IUD lawsuit may help you recover compensation for medical bills, pain and suffering and other damages. See if you qualify by filling out the short form at the Mirena IUD Injury Class Action Lawsuit Settlement Investigation.