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Mirena IUD FDA Warnings

When Bayer Pharmaceuticals first introduced the Mirena IUD in 2001, the company marketed the device as the perfect solution for “busy moms” – a birth control that would improve their sex life, promote intimacy, and that would help them “look and feel great.” There was little mention of the IUD’s potential side effects, like uterine perforation, pelvic inflammatory disease (PID), device expulsion, ectopic pregnancy, infection, and others.

The U.S. Food and Drug Administration (FDA) responded, reprimanding Bayer for misleading advertising and warning women of potentially dangerous, sometimes fatal side effects. Mirena IUD FDA warnings detail precautions and contraindications for the intrauterine device, and expound on severe complications associated with the IUD.

FDA updates Mirena side effects and warnings

In May 2008, the FDA required the first major update to the Mirena warning label. Labeling changes regard:

  • Pelvic infections: Warning that Mirena was contraindicated in women suffering from conditions associated with increased susceptibility to pelvic infections.
  • Ectopic Pregnancy: Cautioning that “Up to half of pregnancies that occur with Mirena in place are ectopic.”
  • Sepsis: Advising that, “In some cases, severe pain occurred within hours of insertion followed by sepsis within days.”
  • Uterine Perforation: Warning that “Perforation or penetration of the uterine wall or cervix may occur during insertion although the Mirena perforation may not be detected until some time later.”
  • Ovarian Cysts: Points out the risk of ovarian cysts, but that “surgical intervention is not usually required.”
  • Updated precautions:  The Mirena IUD should be monitored in nursing mothers and for interaction with other medications

In July 2008, the federal agency required additional safety label changes for the device.

These Mirena IUD FDA warnings include:

  • Intrauterine pregnancy: “If pregnancy should occur with Mirena in place, Mirena should be removed. Removal or manipulation of Mirena may result in pregnancy loss.”
  • Birth defects: Warned that in the case of pregnancy, observational data showed that there was an increased risk of, “masculinization of the external genitalia of the female fetus following exposure to progestins at doses greater than those currently used for oral contraception.”
  • Embedment: “Embedment may decrease contraceptive effectiveness and result in pregnancy… Embedment can result in difficult removal and, in some cases surgical removal may be necessary.”
  • Perforation: “If perforation occurs, pregnancy may result… Mirena must be located and removed; surgery may be required. Delayed detection of perforation may result in migration outside the uterine cavity, adhesions…”
  • Increased risk of perforation: The FDA warned that certain women ran an increased risk of uterine perforation. The risk increases in, “lactating women, in women with fixed retroverted uteri, and during the postpartum period.” To decrease the risk of perforation, the FDA recommended that Mirena insertion should be “delayed a minimum of 6 weeks after delivery or until uterine involution is complete. If involution is substantially delayed, consider waiting until 12 weeks postpartum…”
  • Expulsion: “Partial or complete expulsion of Mirena may occur… Symptoms of the partial or complete expulsion of any lUD may include bleeding or pain. However, the system can be expelled from the uterine cavity without the woman noticing it. Partial expulsion may decrease the effectiveness of Mirena.”
  • Breast cancer survivors: The FDA stated that “Women who currently have or have had breast cancer, or have a suspicion of breast cancer, should not use hormonal contraception” [including the Mirena IUD].
  • Additional precautions: Warned doctors of additional contraindications, and listed additional precautions to take before prescribing Mirena.

FDA blasts Bayer for “Busy Moms” Mirena advertising campaign

Mirena IUD FDA WarningsIn December 2009, the FDA decried Bayer’s Busy Moms ad campaign. The direct-to-consumer Busy Moms marketing campaign had been integrated into the Mom Central social networking site, and incorporated a series of advertisements with house parties. The goal: to convince mothers that the Mirena IUD was the most effective, best birth control for them. The claim: that Mirena would help women recapture intimacy with their partners; that the IUD could improve their sex life; and that Mirena would help moms “look and feel great.”

The FDA begged to differ. In a warning letter to Bayer, the federal agency cited Bayer for misleading advertising. The letter stated, “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.”

The letter continued, remanding Bayer for failing to thoroughly explain the possible side effects of Mirena. The agency also stated that Bayer had engaged in deceptive marketing regarding the measures necessary to ensure that Mirena would continue to work properly, thus inducing women to use the company’s IUD without full understanding of the requirements for use, or possible complications from Mirena.

Comprehensive list of Mirena side effects

Past Mirena IUD FDA warnings, patient complaints, and more than 45,000 FDA adverse event reports have put the contraceptive’s side effects under a microscope. Today, the list of possible complications is more comprehensive than it once was, although new warning label updates are always likely. As of mid-2013, no black box warning has been required.

Complications and side effects linked to the Mirena IUD:

  • Abscesses
  • Birth defects
  • Device expulsion or partial expulsion
  • Embedment in the uterine wall
  • Ectopic pregnancy
  • Infections
  • Migration of Mirena IUD
  • Intestinal perforations or obstruction
  • Intrauterine pregnancy
  • Ovarian cysts
  • Organ damage
  • Pelvic infection
  • Pelvic Inflammatory Disease (PID)
  • Peritonitis
  • Severe damage requiring a hysterectomy
  • Sepsis
  • Uterine perforation

Mirena IUD FDA Warnings affect litigation against Bayer

FDA warnings have a strong impact on pending and future Mirena lawsuits. To begin, the agency’s updated labeling help demonstrate that women implanted with the IUD before 2008 were unaware of certain serious complications. Additionally, the FDA’s warnings regarding the Busy Moms campaign is a strong indication of Bayer’s deceptive marketing practices, which are a central argument in many cases.