Mirena IUD Side Effects May Lead To Perforation Lawsuits, Pseudotumor Cerebri Lawsuits
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 Mirena and, as a result, many women were left unaware of its potential risks and complications, some of which are very serious.
Mirena (levonorgestrel-releasing intrauterine system), also known as LNG-IUS, is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to five years. Mirena is also used in the treatment of heavy periods in women who choose intrauterine contraception.
Mirena injuries may be extremely painful, and may impact the lives of victims and their families for years. Some injuries are lifelong and life altering, and Mirena's complications may include uterine perforation, pseudotumor cerebri, pelvic inflammatory disease (PID), ovarian cysts, irregular bleeding, and amenorrhea. Women who have become pregnant while using Mirena may suffer a miscarriage and their fertility may be put at risk.
Mirena and Pseudotumor Cerebri Injuries
According to the Mayo Clinic, pseudotumor cerebri occurs when the intracranial pressure (pressure in the skull) increases for no obvious reason. Such pressure typically occurs when excess cerebrospinal fluid is present. Symptoms appear to be similar to those of a brain tumor; however, no tumor is present.
Increased intracranial pressure associated with pseudotumor cerebri may lead to swelling of the optic nerve, which may lead to vision loss or blindness, among other injuries. In some cases, surgery is necessary. The makers of Mirena are facing lawsuits involving allegations that they minimized the tie between Mirena and neurological side effects that include pseudotumor cerebri. Symptoms of this disorder may include:
- Back pain
- Blurred vision, double vision
- Neck pain
- Shoulder pain
- Tinnitus (buzzing, ringing in the ears)
- Vision loss
Mirena and Breast Cancer
In June 2015, the journal Acta Oncologica published a study investigating the link between breast cancer and the use of levonorgestrel-releasing intrauterine system such as Mirena. The authors of the study sought to test whether devices such as Mirena increase the risk of lobular breast cancer; they noted that, while prolonged steroid hormone therapy is associated with an increased risk, the link to LNG-IUS is uncertain. The researchers found that LNG-IUS "is not only related to an excess risk of lobular cancer but also, contrary to previous assumptions, to an excess risk of ductal breast cancer."
The researchers used data from the national Medical Reimbursement Registry of Finland to identify women between the ages of 30 and 49 who used levonorgestrel-releasing IUDs to treat or prevent menorrhagia (abnormally heavy menstrual bleeding) between 1994 and 2007. Women diagnosed with breast cancer before the age of 55 and by the end of 2012 were identified using data from the Finnish Cancer Registry. In a cohort of 93,843 women using LNG-IUS, a total of 2,015 were diagnosed with breast cancer. Use of LNG-IUS was associated with a higher risk of both lobular cancer and ductal breast cancer compared to the general population. The highest risk was found in women who were implanted with the Mirena contraceptive at least twice.
Bayer's Mirena Deception
The Mirena IUD was originally approved as an intrauterine contraceptive (IUD), and later, as a treatment for heavy menstrual bleeding in women who had given birth at least once. Mirena works by slowly releasing the chemical progestogen levonorgestrel into the uterus and is indicated for intrauterine contraception for up to five years. At that point, the Mirena 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 in which "busy moms" may simplify their lifestyles. One of the ways Bayer did so was through "Mirena Parties." Working with the social networking site, Mom Central, Bayer 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 set up to be presented in a consumer's home or other private setting (e.g. private restaurant party) by a representative from Mom Central 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 a U.S. Food and Drug Administration (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 indicated that 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 stated 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
In addition to pseudotumor cerebri , since its approval, serious Mirena side effects have long included ectopic pregnancy, intrauterine pregnancy (a pregnancy that occurs 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 insertion with limited clinical symptoms, Health Canada indicated.
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 uterine perforation and Breast Cancer.
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 percent of users are diagnosed with a serious infection called pelvic inflammatory disease (PID). If you have persistent pelvic or abdominal pain, see your healthcare provider."