<"http://www.yourlawyer.com/topics/overview/Mirena-IUD">Mirena, an intrauterine device (IUD) marketed by Bayer Inc. has been associated with some serious complications, including uterine perforation. Recently, health regulators in Canada reminded healthcare providers there of this risk. In the US, Bayer was issued a warning letter late last year by the US Food & Drug Administration (FDA) for a promotional program the FDA said overstated Mirena’s efficacy, made unsubstantiated claims about its benefits, and omitted and minimized the device’s risks.
Mirena (levonorgestrel-releasing intrauterine system) consists of a T-shaped polyethylene frame (Tbody) with a steroid reservoir (hormone elastomer core) around the vertical stem. The steroid reservoir contains the progestogen levonorgestrel, which is secreted slowly into the uterus over time upon the insertion of Mirena by a trained healthcare provider.
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 recommended for women who have had at least one child.
In addition to uterine perforation, the use of Mirena is associated with a number of other risks, including increased risk of pelvic inflammatory disease, ovarian cysts, and irregular bleeding and amenorrhea. Should a woman become pregnant while using Mirena, serious risks include pregnancy loss and a permanent loss of fertility.
This past June, Health Canada reminded healthcare providers there of important safety information regarding reports of uterine perforation in women using Mirena. Uterine perforation is a rare, but serious complication associated with intrauterine contraceptive devices, and occurs at a rate between 1/1,000 and 1/10,000 insertions. According to Health Canada, Bayer Inc. continues to receive post-market reports of uterine perforation associated with the use of Mirena. While the reporting rate of uterine perforation with Mirena has remained stable in Canada since 2001, the absolute number of incident reports has increased in accordance with the increased use.
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.
In December 2009, the US FDA issued Bayer a warning letter over an unusual promotional program for Mirena. 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, which Bayer said it discontinued in early 2009, was presented in a consumerâ€™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 for the program consisted of introductory statements to be presented by a Mom Central community member and information on Mirena to be presented by a nurse practitioner. It also included a questionnaire to be distributed to attendees at the end of the party. The FDA warning letter cited three major problems with the script for the presentation:
â€¢ The script included numerous statements inferring that use of Mirena would help with romance and intimacy. These claims were misleading and overstated Mirenaâ€™s proven efficacy because they were not supported by substantial evidence, the FDA said.
â€¢ The agency said the script omitted certain information regarding the risks of using Mirena. In addition, the script minimized the risks associated with the product by suggesting that Mirena helps women with â€œlooking and feeling great.â€
â€¢ The scriptâ€™s statement that Mirena â€œhas no daily, weekly, or monthly routines to comply withâ€ was false, the FDA charged.
Because of these issues, the FDA said the script for the program misbranded the drug in violation of the Federal Food, Drug, and Cosmetic Act, and the agency’s implementing regulations.