December 11, 2012 – German drug company Bayer announced this month that it will proceed with marketing of its new Jaydess contraceptive device in Europe after winning approval from the EMA.
The small, plastic device, which can provide pregnancy protection for up to three years after insertion, is also up for approval by the FDA in the United States later in 2013.
Many are wondering whether the push for the new product is an insurance policy for Bayer after the currently marketed Mirena device has received tens of thousands of complaints of side effects and sparked growing litigation.
The FDA recently released figures showing it has received over 45,000 adverse event reports associated with patients using the Mirena IUD. The most common Mirena side effects reported were device expulsion, device dislocation and vaginal hemorrhage. In over 6% of the events, patients required hospitalization or surgery.
The launch of the alternative device also comes as Bayer faces growing Mirena lawsuits. The company recently requested that the New Jersey Superior Court consolidate cases to a venue closer to its U.S. headquarters, which are in Middlesex County, New Jersey.
Qualified drug injury lawyers around the country are helping those injured seek a recovery. Anyone requiring surgery due to Mirena side effects is urged to contact the DrugRisk Resource Center or speak with a lawyer about their legal options as soon as possible.
This is not the first instance of controversy for Bayer surrounding Mirena. In 2009, the FDA warned the company about how it had marketed the devices, which failed to disclose safety risks and claimed they could help busy moms with intimacy and make them “look and feel great.”
Anyone affected by a Mirena device is urged to learn about their legal options. Due to the specialized nature of medical device injury cases, the Drug Risk Resource Center only recommends lawyers who are already handling Mirena lawsuits.
For more information on the research, side effects and litigation news related to Mirena and other medical devices, or to speak with a lawyer, contact us today.