Bayer Manufactures The Mirena IUD
The Mirena IUD is manufactured by the Bayer AG subdivision Bayer Pharmaceuticals. Bayer AG is a German holding company and is one of the largest multinational corporations that focuses on medical drugs and products operating today. This particular division, which is responsible for the manufacturing of drugs and medical products, was formed in 2006 as a result of one the biggest takeovers in the healthcare industry when Bayer purchased the pharmaceutical research company, Schering AG, for $19.8 billion dollars.
FDA Approves The Mirena IUD
The Food and Drug Administration has approved a new intrauterine device (IUD) called Mirena. For 10 years Mirena, marketed by Berlex Laboratories, Inc., has been used in Europe by approximately two million women.
The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. This is the first intrauterine device approved by the FDA for this additional indication.
Mirena was approved as a contraceptive by the FDA in 2000.
It is a small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy. The device should be inserted by a trained health care professional.
Additional Approvals For the Mirena
“Women who suffer heavy, prolonged menstrual periods find the condition unpleasant, disabling, and frightening,” said Kathleen Uhl, M.D., director of the FDA’s Office of Women’s Health. “Bleeding can be so heavy that women must miss work, school, or social activities.” The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. This is the first intrauterine device approved by the FDA for this additional indication.
FDA Issues Warning Against Bayer
In 2009 the FDA issued a warning to Bayer about their advertising of Mirena. They were making false claims and now they have been forced to fix it–Mirena is no longer advertised as being ‘low-hormone’, and they’re doing a better job of advertising the possible side effects. So…someone heard us! Even more news–several court cases have been filed against Bayer for serious complications with the Mirena. 16 cases have been filed to date (10/1/12) in New Jersey (where Bayer’s corporate office is located).
Adverse Incident Reports Start Coming in
Over the last 15 years, there have been more than 45,000 adverse event reports filed over the Mirena IUD by women implanted with the birth control device, according to AdverseEvents.com.
The Lawsuits Begin
The first Mirena IUD lawsuit was filed on April 12, 2012, on behalf of an Ohio woman. Her complaint alleged that she required a hysteroscopy to remove the device. Considering over two million women have used Mirena in the U.S., many more injured women may be coming forward with complaints in the near future
January 2, 2013 – A Mirena IUD lawsuit has been filed by a woman in Kentucky who suffered a spontaneous uterine perforation and required surgical removal of Mirena. Click here to read more.
December 4, 2012 – A Florida woman has filed a Mirena lawsuit after the IUD migrated from its intended position, perforated her uterus, and required surgery to remove. Click here to read more.
Petition For A Consolidation of 1000′s Of Mirena IUD Lawsuits Lawsuits in Ohio Federal Court MDL
A petition has been filed to establish a multidistrict litigation (MDL) for all federally-filed claims. In the petition filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on Jan. 16, 2013.