Jessica Tyner  |  February 13, 2014

Category: Legal News

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Mirena IUD removal surgeryA North Carolina woman has filed a Mirena lawsuit, alleging that she was never warned that the IUD could migrate after implantation, which led her to incur expensive medical bills to remove the IUD after it perforated her uterus and embedded in her stomach lining. It’s a common allegation raised in over 100 Mirena IUD lawsuits pending against Bayer.

According to the North Carolina woman’s Mirena IUD lawsuit, she “was implanted with the Mirena on or about February 2008. Plaintiff tolerated the procedure well and neither Plaintiff nor her physician had any reason to suspect that the Mirena perforated her uterus. Plaintiff’s physician was unable to visualize the strings to the IUD and was unable to retrieve the device. A CT scan of the pelvis revealed the IUD to be between the umbilical and left lower quadrant ports embedded in the omentum. On or about May 17, 2010 at New Hanover Regional Medical Center, Plaintiff underwent laparoscopic surgery with retrieval of the Mirena IUD.”

While the labeling for Mirena warns that the IUD may migrate and perforate the uterus during implantation, which is why OBGYNs check the IUD a few weeks later, there was allegedly no warning that such movement could occur years later, the Mirena lawsuit asserts.

“The package labeling recommends that Mirena be used in women who have had at least one child, suggesting that carrying a child to term may be complicated after Mirena use. Mirena’s label does not warn about spontaneous migration of the IUS, but only states that migration may occur if the uterus is perforated during insertion. Defendant has failed to alter their product packaging to reflect the growing number of MedWatch Adverse Event reports related to embedment of and perforation through the uterine lining and/or migration of the IUD through the uterine lining after the period of insertion. Defendant has a history of overstating the efficacy of Mirena while understating the potential safety concerns,” the Mirena lawsuit alleges.

Mirena is a plastic intrauterine device (IUD) from Bayer that was popular in the early aughts, even up to now. It’s no surprise that Mirena was extremely profitable for Bayer, with over 15 million women worldwide opting for an IUD.  Five years ago, a government agency even stepped in and issued a warning.

“In or around March 2009, the Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications (DDMAC) issued a warning regarding Defendant’s 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.”

The warning came late for the plaintiff and other women like her. She already had her IUD implanted for a year by the time DDMAC made a move, requesting that Bayer immediately cease the dissemination of the violative materials.

Had she and/or her doctor been aware of the Mirena migration problem, the lawsuit claims that she could have opted for a different form of birth control or known what to watch for when it comes to IUD perforation and movement. Doctors also depend on the warnings provided by drugmakers in order to choose the right options for their patients. If Bayer didn’t adequately list warnings, the plaintiff’s doctor probably didn’t have the necessary information to make the best recommendation.

The Mirena IUD lawsuit claims that, “as a direct and proximate result of the Defendant’s 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.”

Learning the Hard Way

Bayer has also been in trouble with DDMAC for a particular campaign that was said to be misleading.

“In or around December 2009, Defendant was 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 Defendant,” the Mirena lawsuit explains.

“The Simple Style program script also intimated that Mirena use can help patients look and feel great. Again, DDMAC noted these claims were unsubstantiated and that Mirena can cause a number of side effects, including weight gain, acne, and breast pain or tenderness. 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, Defendant falsely claimed that Defendant’s system required no compliance with
a monthly routine in contradiction of patient instructions.”

The North Carolina woman is suing Bayer for defective design, manufacturing defect, failure to warn, breach of warranties, negligence and punitive damages.

The case is Amber Lefler v. Bayer Healthcare Pharmaceuticals Inc., Case No.: 7:13-cv-07275-CS, in the United States District Court District of New Jersey.

Do You Have a Similar Story?

Do you relate to this woman’s experience? 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. Find out more by visiting the Birth Control Lawsuits: Mirena IUD Injury Class Action Lawsuit Settlement Investigation. Once your information is received, an attorney will contact you if you have a case for a free Mirena claim review.

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One thought on Bayer Asked to Pay Up for Mirena IUD Removal Surgery

  1. Lisa says:

    I asked a dr two years ago when I went in for my exam to remove my IUD she refused because it was five months early with me being a single parent work in a school and need to get kids from school and no baby sitter to watch them so I could go to the dr at that five years when it finally got here I was not able to make it well after seven years of having it I finally had the chance to have it removed all exited then I found out it was embedded to my cercvex and might need it surgically removed.

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