Mirena

MIRENA Mirena is a small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy. The female hormone released by the device, levonorgestrel, thickens the cervical mucus to prevent sperm from reaching or fertilizing the egg. MANUFACTURER FDA APPROVAL (BAYER Bayer HealthCare The U.S. Food and Drug Administration (FDA) approved Mirena for use as a contraceptive in 2000 and for use in treating heavy menstrual bleeding in IUD users 2009 WARNING LETTERS The FDA's Division of Drug Marketing, Advertising and Communications (DDMAC, now known as the Office of Prescription Drug Promotion), sent warning letters to Bayer in 2009, alleging that Bayer was: Overstating Mirena's effectiveness Downplaying the serious health risks associated with Mirena usage Sponsoring misleading online links Failing to communicate risk information to women and doctors ADVERSE REACTION The FDA says the "most serious adverse reactions" reported by Mirena users are: Ectopic pregnancy (fertilized egg grows outside the womb) PID (Pelvic inflammatory disease) Intrauterine pregnancy Group A streptococcal sepsis (with Mirena device in place) Embedment of device in the Perforation of the uterine wall of the uterus wall or cervix ADVERSE EVENT REPORTS Adverse event reports received by the FDA through August 27, 2012 in which Mirena was the primary suspect in causing the event included: Total primary suspect reports: 45,700 | Total adverse event reports: 45,969 HEALTH OUTCOMES Based on adverse event reports received by the FDA through August 27, 2012 with Mirena as the primary suspect: Other Hospitalization Disability Life- Required Congenital anomaly Death threatening intervention 11,015 reports 2,500 reports 426 reports 350 reports 341 reports 64 reports 51 reports REPORT MIRENA SIDE EFFECTS Report negative Mirena side effects to the FDA at its MedWatch reporting site, or by calling (800) FDA-1088 the Driscollirm p.c. SOURCES AdverseEvents.com | FDA Announcement (March 2009)| Mayo Clinic FDA March 2009 and December 2009 Warning Letters DISLAIMER This information is provided for educational purposes only and is not intended to serve as medical or legal advice. Neither the Driscoll Firm P.C. nor ConsultWebs.com Inc. assumes responsibility for any healthcare decisions or treatment based on the information that is provided herein. Any patient concerned about the side effects of a drug, medical device or medical product should not discountinue or alter use of the drug, device or product in any manner without first consulting with their doctor Device expulsion 16,244 Device dislocation 4,333 Vaginal hemorrhage 3,922 Medical device complication 3,753 Abdominal Pain 3,020 MIRENA Mirena is a small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy. The female hormone released by the device, levonorgestrel, thickens the cervical mucus to prevent sperm from reaching or fertilizing the egg. MANUFACTURER FDA APPROVAL (BAYER Bayer HealthCare The U.S. Food and Drug Administration (FDA) approved Mirena for use as a contraceptive in 2000 and for use in treating heavy menstrual bleeding in IUD users 2009 WARNING LETTERS The FDA's Division of Drug Marketing, Advertising and Communications (DDMAC, now known as the Office of Prescription Drug Promotion), sent warning letters to Bayer in 2009, alleging that Bayer was: Overstating Mirena's effectiveness Downplaying the serious health risks associated with Mirena usage Sponsoring misleading online links Failing to communicate risk information to women and doctors ADVERSE REACTION The FDA says the "most serious adverse reactions" reported by Mirena users are: Ectopic pregnancy (fertilized egg grows outside the womb) PID (Pelvic inflammatory disease) Intrauterine pregnancy Group A streptococcal sepsis (with Mirena device in place) Embedment of device in the Perforation of the uterine wall of the uterus wall or cervix ADVERSE EVENT REPORTS Adverse event reports received by the FDA through August 27, 2012 in which Mirena was the primary suspect in causing the event included: Total primary suspect reports: 45,700 | Total adverse event reports: 45,969 HEALTH OUTCOMES Based on adverse event reports received by the FDA through August 27, 2012 with Mirena as the primary suspect: Other Hospitalization Disability Life- Required Congenital anomaly Death threatening intervention 11,015 reports 2,500 reports 426 reports 350 reports 341 reports 64 reports 51 reports REPORT MIRENA SIDE EFFECTS Report negative Mirena side effects to the FDA at its MedWatch reporting site, or by calling (800) FDA-1088 the Driscollirm p.c. SOURCES AdverseEvents.com | FDA Announcement (March 2009)| Mayo Clinic FDA March 2009 and December 2009 Warning Letters DISLAIMER This information is provided for educational purposes only and is not intended to serve as medical or legal advice. Neither the Driscoll Firm P.C. nor ConsultWebs.com Inc. assumes responsibility for any healthcare decisions or treatment based on the information that is provided herein. Any patient concerned about the side effects of a drug, medical device or medical product should not discountinue or alter use of the drug, device or product in any manner without first consulting with their doctor Device expulsion 16,244 Device dislocation 4,333 Vaginal hemorrhage 3,922 Medical device complication 3,753 Abdominal Pain 3,020