With the much-publicized problem of birth control devices causing serious health problems for women and the infants they may bear many of them are wondering where to turn in order to preserve their health and any future offspring.
In the case of the Mirena intrauterine device a large number of women are turning to Mirena IUD migration lawyers who are aggressively seeking compensation for the health problems caused by these widely used contraceptives.
Free consultations are being offered to Mirena IUD victims who wish to join in litigation that has grown in such numbers that federal court officials are now considering consolidating the lawsuits into what could become a massive class-action case.
Pharmaceutical giant Bayer is now defending itself against claims filed by a growing number of women who allege the devices are faulty and have caused such devastating health problems as organ damage, ectopic pregnancies and infertility.
First approved by the U.S. Food and Drug Administration in 2000, the Mirena IUD is a t-shaped device that physicians implant into the uterus and is supposed to stay in place for up to five years and prevent conception.
The Mirena IUD also was the first such device approved by the FDA to treat women suffering from heavy menstrual bleeding. The device has been a huge commercial success for Bayer because millions of women have chosen it as their form of birth control.
However, warning signs about problems with the product soon began surfacing and thousands of women filed adverse event reports with the FDA complaining about serious complications as a result of their use of the Mirena IUD.
FDA internal statistics show that more than 45,000 such reports have been filed with the agency, and that about 6 percent have forced women to undergo surgery or hospitalization to treat their problems. Read about Mirena IUD
The numerous complaints caused the FDA in 2008 to announce labeling changes ordered to provide women increased information about these problems. Here are some of them:
- Ectopic Pregnancy
- Ovarian Cysts
Federal regulations also recommended precautions in which Mirena IUDs should be removed for:
- Pelvic Infection
- Drug Interactions
- Nursing Mothers
The FDA also provided this information to health care professionals:
Ectopic Pregnancy: Up to half of pregnancies that occur with Mirena in place are ectopic. The incidence of ectopic pregnancy in clinical trials that excluded women with risk factors for ectopic pregnancy was about 1 ectopic pregnancy per 1000 users per year.
Tell women who choose Mirena about the risks of ectopic pregnancy, including the loss of fertility. Teach them to recognize and report to their physician promptly any symptoms of ectopic pregnancy.
Sepsis: In some cases, severe pain occurred within hours of insertion followed by sepsis within days.
Perforation: Perforation or penetration of the uterine wall or cervix may occur during insertion although the perforation may not be detected until sometime later.
Ovarian Cysts: Surgical intervention is not usually required.
Then, in 2009, the FDA sent a warning letter to Bayer in which government officials said they had found that the Bayer’s advertising overstated the efficacy of Mirena while minimizing the health risks that women might suffer.
In the letter, the FDA warned Bayer:
“The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. Thus, the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(n), and FDA’s implementing regulations. See 21 CFR 202.1(e)(3)(i), (e)(5) & (e)(6)(i).”