Orlando, FL (PRWEB) December 19, 2012
Earlier this month, Bayer announced it would enter the European market with a new plastic contraceptive implant that can provide birth control for up to three years. The Jaydess device, which was recently approved by the EMA, also faces a decision from the FDA in the U.S. sometime in 2013.*
The news come as Bayer faces growing litigation over the misplacement of its similar Mirena IUDs. The German company has requested the New Jersey Superior Court to consolidate Mirena lawsuits in a court closer to its U.S. headquarters in Middlesex County, New Jersey.**
Anyone requiring surgery due to Mirena side effects is urged to visit the DrugRisk Resource Center or speak with a lawyer about their legal options as soon as possible.
The FDA recently disclosed thousands of reports of patients suffering Mirena side effects. According to the Adverse Events Report on November 20th tracking FDA AERS reports through June 30, 2012, the agency has received more than 45,000 reports of complications among women using the Mirena IUD.
Most often, the Mirena side effects reported were device expulsion, device dislocation and vaginal hemorrhage. In more than 6% of cases, patients required hospitalization or surgery.
Victims of these side effects have already filed Mirena lawsuits against Bayer for their injuries. Ayissi v Bayer Corp. et al, MRS-L-924-12, New Jersey Morris County Superior Court, Judge Stephan Hansbury.
In 2009, the FDA warned Bayer about the marketing of Mirena, which failed to disclose safety risks while claiming the devices 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 rights to file a claim. 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, visit http://www.DrugRisk.com.
***NDA 21-225, Mirena (levonorgestrel-releasing intrauterine system) MACMIS # 18166, 12/30/09