Download your Mirena Information Package FDA’s Letter to Bayer - “Mirena Simply Style Statements Program”
Mirena IUD Side Effects Could Lead To Perforation Lawsuits
Mirena IUD | Lawsuits, Lawyers | Side Effects: Uterine Perforation, Migration, Embedment, Hysterectomy, Risk of Infertility, Intrauterine Pregnancy, Streptococcal Sepsis, Pelvic Inflammatory Disease, Severe Pain, Possible Risk of Rheumatoid Arthritis, Breast Cancer and Other Cancers.
Our firm is investigating potential lawsuits on behalf of users of the Mirena IUD. Bayer Inc., the maker of Mirena, has used deceptive tactics to market this drug and as a result, many women were left unaware of its potential risks and complications, some of which are very serious.
Mirena injuries can be extremely painful, and may impact the lives of victims and their families for years or more. Mirena's complications may include uterine perforation, pelvic inflammatory disease, ovarian cysts, irregular bleeding, and amenorrhea. Women who have become pregnant while using Mirena may suffer a miscarriage and their fertility can even be put at risk.
Bayer's Mirena Deception
The Mirena IUD was originally approved as an intrauterine contraceptive, and later as a treatment for heavy menstrual bleeding in women who gave birth. It works by slowly releasing the chemical progestogen levonorgestrel into the uterus. Mirena is indicated for intrauterine contraception for up to 5 years. At that point, the system should be replaced if continued contraception is desired. Mirena is only recommended for women who have had at least one child.
Bayer has marketed Mirena as a way "busy moms" can simplify their lifestyle. One of the ways it did so was through "Mirena Parties." Working with the social networking site Mom Central, Bayer had created a Mirena direct marketing program that consisted of a series of house parties hosted by members of the Mom Central community. The program was presented in a consumer’s home or other private setting (e.g. private restaurant party) by a representative from Mom Central (a social networking internet site) and a nurse practitioner. The script followed by the nurse practitioner at one of these Mirena Parties included phrases like "look and feel great", "simple ways to reconnect with ourselves and our partners," and "more likely to be more intimate.
According to an FDA Warning letter issued to Bayer in December 2009, the claims made in the script "clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena.
The letter went on to say that the FDA was "not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great." The agency also said the script omitted certain information regarding the risks of using Mirena, and minimized risks by utilizing the statement look and feel great." Finally, the FDA faulted the script for including a statement that Mirena “has no daily, weekly, or monthly routines to comply with," which the agency said was false.
Bayer stopped holding Mirena Parties in early 2009. But because of such misleading information presented at these events, many women who chose Mirena for its purported convenience may not have been aware of its many serious side effects.
Mirena Side Effects
Since its approval, serious Mirena side effects have included ectopic pregnancy, intrauterine pregnancy (a pregnancy in the uterus with the IUD in place), group A streptococcal sepsis, pelvic inflammatory disease (PID), embedment of the device in the uterine wall, and perforation of the uterine wall or cervix. Other common Mirena side effects include irregular spotting or bleeding, headaches, ovarian cysts, vaginitis, painful menstruation, pelvic pain, and breast tenderness.
In June 2010, the Canadian regulatory agency, Health Canada, reminded healthcare providers there of important safety information regarding reports of uterine perforation in women using Mirena. According to Health Canada, Bayer Inc. continues to receive post-market reports of uterine perforation associated with the use of Mirena.
According to Health Canada, some cases of Mirena uterine perforation were not detected during or immediately after the insertion. The risk of perforation may be increased with use in the post-partum period, during lactation, and in women with an atypical uterine anatomy (such as fixed retroverted uterus). Uterine perforation may occur with Mirena at the time of insertion or after the insertion with limited clinical symptoms, Health Canada said.
The highly experienced medical device attorneys at Parker Waichman LLP are investigating an association between Mirena IUD and a range of serious side effects, including the following cancers:
- Breast Cancer
- Endometrial Cancer
- Uterine Cancer
- Ovarian Cancer
- Thyroid Cancer
- Colon Cancer
- Gastric Cancer
- Cervix Cancer
- Prostate Cancer
- Pre-Cancerous Cells
- Rectal Cancer
- Anal Cancer
- Bladder Cancer
- Birth Defects
Bayer itself has warned about the potentially detrimental effects associated with Mirena’s hormones, cautioning against using the IUD “if you have a pelvic infection, get infections easily or have certain cancers. Less than 1% of users get a serious infection called pelvic inflammatory disease. If you have persistent pelvic or abdominal pain, see your healthcare provider.”
Legal Help for Victims of Mirena Injuries
It's impossible to know how many women chose to use Mirena because of Bayer's promises of an improved lifestyle without realizing that the contraceptive posed serious risks. Our Mirena injury lawyers are working right now to hold Bayer accountable for its deception.
If you or a loved one suffered from a uterine perforation, ectopic pregnancy, infection or other serious complication that might be tied to Mirena, you have valuable legal rights. Please fill out our online form or call one of our Mirena injury lawyers today at 1-800-YOURLAWYER (1-800-968-7529) for a free evaluation of your case.