I had surgery two weeks ago to remove my mirena, it was embedded in my uterus and the stings had fallen off. I can't believe how good I feel. I had the Mirena for two years. The first year I really did not have any problems, but the second year was horrible. The only thing I am depressed about now is that I lost a year of my life because of this stupid thing. I was not sure if it was the Mirena that was causing all of my problems, anxiety being the worst, but now I know it was the Mirena. If you are trying to decide to get the Mirena out or you know someone who is not sure if the Mirena is causing problems PLEASE take my advice and get it out. I am no longer tired all of the time, my anxiety and depression are gone, I had a lunp in my left breast that was causing me a lot of pain and it is gone, the cramping is gone. Best of all, my sex drive is back and this was a side effect I had had from the beginning!! I have a wonderful doctor that did admit that he is starting to see more of these side effects with the Mirena.

You can leave your side effects here to help others also.

FDA Safety Changes:

 Mirena, N ews Author:

 Yael Waknine CME Author: Yael Waknine Disclosures Release Date: September 5, 2008; 

Authors and Disclosures Yael Waknine Disclosure: Yael Waknine has disclosed no relevant financial relationships. Laurie Barclay, MD Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships. Brande Nicole Martin Disclosure: Brande Nicole Martin has disclosed no relevant financial information. This activity is part of an ongoing CME/CE initiative to provide information on labeling changes reported by the FDA.

 Activities of this nature will be posted on Medscape on a weekly basis.

September 5, 2008 —

The US Food and Drug Administration (FDA) has approved safety labeling revisions to provide updated information regarding the risks for ectopic pregnancy, sepsis, perforation, ovarian cysts, and breast cancer in women using a levonorgestrel-releasing intrauterine contraceptive system; drugs that are contraindicated in patients receiving linezolid therapy; and requirements for viral hepatitis screening and immunizations before treatment with abatacept is initiated.

Levonorgestrel IUD ( Mirena ) Labeling Updated Regarding Risks for Ectopic Pregnancy On May 28, the FDA approved safety labeling revisions for a long-acting levonorgestrel-releasing intrauterine contraceptive system (Mirena ; Bayer Healthcare Pharmaceuticals, Inc) to provide updated information regarding the risks for ectopic pregnancy, sepsis, perforation, ovarian cysts, and breast cancer. Women who become pregnant while using the intrauterine device (IUD) should be evaluated for ectopic pregnancy. According to the FDA, up to 50% of pregnancies that occur with the device in place are ectopic. Although ectopic pregnancy only occurred in 0.1% of women with no risk factors in clinical trials, the incidence rate may be increased in those with a previous history of its occurrence, tubal surgery, or pelvic infection.

Emphasizing the importance of aseptic technique, the FDA also warned of the risk for group A streptococcal sepsis, which had been reported in 9 of approximately 9.9 million users as of September 2006. In some cases, severe pain occurred within hours of IUD insertion and was followed by sepsis within days. Because treatment delays increase the risk for fatality, patients should be aware of the risk for this rare but serious infection, which can also occur postpartum, after surgery, and from wounds.

IUD placement has also been associated with a rare risk for perforation or penetration of the uterine wall or cervix that may not be detected until later. If perforation occurs, the device must be removed. Adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera have been reported with IUDs. To decrease perforation risk, postpartum insertion of the device should be delayed until uterine involution is complete.

 Lactating women are also at increased risk for perforation. Because the contraceptive effect of the levonorgestrel IUD is mainly because of its local mechanism of action, women using the device usually have ovulatory cycles with follicular rupture.

 In some cases, follicular atresia may be delayed, leading to enlarged follicles in approximately 12% of patients. Although most are asymptomatic, some follicles may cause pelvic pain or dyspareunia.

The majority of enlarged follicles spontaneously disappear during 2 or 3 months, and surgery is rarely required.

The FDA also warned that women with breast cancer or a history thereof should not use hormonal methods of contraception, such as the levonorgestrel IUD. Spontaneous reports of breast cancer have been reported during postmarketing use of the device, but the risk cannot be quantified nor a causal relationship established because of the voluntary nature of the reports from a population of uncertain size. The agency notes that 2 observational studies have not provided evidence of an increased risk for breast cancer during use of levonorgestrel IUD.