Manufacturer of Mirena® IUD Failed to Warn of Certain Migration Risks
Bachus & Schanker, LLC is reviewing potential lawsuits for patients whose Mirena® IUD migrated and required surgical removal. Mirena®, an intra-uterine device (IUD) manufactured by Bayer Healthcare Pharmaceuticals, is inserted by a trained healthcare provider during an office visit and prevents pregnancy by releasing levonorgestrel into the uterus.
While the device includes warnings of risks such as ectopic pregnancy, pelvic inflammatory disease, and perforation of the uterus or uterine wall during insertion, the manufacturer failed to warn patients of the risk that Mirena® IUD may spontaneously migrate and perforate the uterus after insertion. Bayer further failed to warn that once the device has perforated the uterine wall, it may subsequently perforate other abdominal organs, become lodged in the intra-abdominal space and or/ become embedded in the omentum. Surgery is often required to remove the IUD and correct the perforations. Even with surgical intervention, a Mirena® IUD migration can lead to abscesses, scarring, infertility, emergency removal of affected organs, and even death.
More About Mirena® IUD
Mirena® IUD was first approved by the FDA in 2000 and is considered a drug because it releases the synthetic progestogen levonorgestrel ("LNG"). It prevents pregnancy by thinning the uterine lining and inhibiting sperm movement, and is recommended to women who have had at least one child. Mirena® IUD is approved to remain in the uterus to up to 5 years and should be removed after that time.
In 2010, the FDA issued a warning letter to Bayer regarding its promotion of Mirena® IUD through a live consumer-directed program. Through this program, representatives from Mom Central (a social networking internet site) hosted "parties" where they distributed promotional materials and gave a presentation on the benefits of a Mirena® IUD over other forms of birth control. The FDA warned that the script for these parties included false and misleading statements and requested that Bayer "immediately cease the dissemination of violative promotional materials for Mirena."
If you or someone you know required surgical removal of a Mirena® IUD IUD device because it migrated from its original position, please contact the lawyers at Bachus & Schanker, LLC. We will evaluate your case without cost to you and inform you of your legal rights and options. Call us today at 866-822-2358 or 303-586-5299. You can also fill out the form on this page, or email us at http://www.coloradolaw.net/html/contact.html. The experienced, compassionate personal injury lawyers at Bachus & Schanker, LLC are ready to represent you. There is no charge for your initial consultation to discuss your case.
from Mirena® IUD Implantation?
If you or any member of your family has experienced side effects from the implantation of a Mirena® IUD device, please contact the experienced Defective Devices attorneys at Bachus & Schanker, LLC right away at 303-953-6795.
All of our Colorado Mirena attorneys work on a contigency basis, which means you will pay no up front out-of-pocket money.