Bayer to Launch New IUD Despite Adverse Effects
- Ennis & Ennis News
01/15/2013 - Bayer, the manufacturer of the controversial intrauterine device (IUD), Mirena, announced that it has received FDA approval for a new IUD called Skyla. The Skyla contains 13.5 mg of levonorgestrel to prevent pregnancy for up to 3 years as compared to the Mirena, which contains 52mg of levonorgestrel and prevents pregnancy for up to 5 years. The device is made of T shaped plastic, measuring 1.10” x 1.18” and is inserted by a physician with a placement tube. Bayer noted that the Skyla is the first IUD to be approved by the FDA in more that 10 years.
To gain FDA approval, a clinical trial involving 1,432 women in the U.S., Canada, Europe and Latin America was conducted. Unfortunately 22% of all trial participants receiving the Skyla device had it removed because of adverse effects. Of the 22% who had the Skyla IUD removed, 20% of the women suffered from vulvovaginitis, over 18% suffered from abdominal or pelvic pain, 15% incurred acne or seborrhea, 13.2% suffered from ovarian cysts, 12.4% headaches, 8.6% dysmenorrhea, 8.6% breast pain, 7.8% increased bleeding and 5.5% suffered from nausea. Other more rare, but serious sided effects included perforation of the uterine wall, expulsion, severe infections, pelvic inflammatory disease and ectopic/uterine pregnancy.
Bayer’s other IUD, Mirena also has exhibited dangerous side effects, including: perforation of the uterus, Pelvic Inflammatory Disease, infertility, abscesses, erosion of adjacent areas such as the vagina, ectopic pregnancy and embedment in the uterus. Some or more of these injuries occur because the device may become dislodged and perforate or imbed itself into the uterus. It may also travel outside of the uterine cavity, which can cause scarring, adhesions, or more devastating, infertility.
Over a dozen lawsuits for injuries caused by the Mirena IUD have been filed in New Jersey and court records show that Bayer Healthcare Pharmaceuticals is seeking to consolidate all of the Mirena IUD lawsuits in the New Jersey Superior Court in Middlesex County.
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