Mirena & Perforation
Mirena Intrauterine Device Linked to Potentially Serious Risks, Including Uterine Perforation and Some Types of Cancers
Mirena IUD Video Script
Thousands of women have used the Mirena intrauterine contraceptive device. Light and flexible, it is touted as an easy way to control family planning, helping to prevent pregnancy for up to 5 years. It has also been used as a way to treat heavy bleeding and other menstrual problems.
However, many women who received the Mirena IUD soon found that they were facing more problems as a result, including potentially serious side effects such as uterine perforation and pelvic inflammatory disease.
The Facts: Mirena Contraceptive Device
- Mirena is a flexible, T-shaped piece of plastic that contains the hormone levonorgestrel, which releases slowly in the body over a period ofup to 5 years to prevent pregnancy.
- Mirena is manufactured by Bayer Healthcare Pharmaceuticals. It was approved by the Food and Drug Administration as a contraceptive device in 2000. It received additional approval as a treatment for heavy menstrual bleeding in 2009.
- The FDA sent warning letters to Bayer twice in 2009 for misleading marketing practices, saying that the manufacturer overstated the product's effectiveness and downplayed its potential risks.
Mirena IUD Side Effects
Many potentially serious side effects have been linked to the Mirena IUD since it was approved for market. Some of those side effects include:
- Uterine or cervical perforation (puncture in the wall of the uterus or cervix)
- Device migration or expulsion
- Embedment of the device in the uterine wall
- Intestinal perforation
- Pelvic inflammatory disease (PID)
- Ectopic pregnancy
Some reports have even suggested a link between the drug and an increased risk of cervical or breast cancer, though studies have been inconclusive.
Mirena IUD Lawsuit
The Food and Drug Administration has cited Bayer for overstating the effectiveness of the Mirena IUD while also downplaying its potentially serious side effects.
In April 2009, the FDA sent Bayer a letter warning about its misleading marketing practices for its products Levitra, Yaz, and Mirena. The letter said that sponsored links used to promote these products were "misleading because they make representations and/or suggestions about the efficacy of Levitra, Yaz, and Mirena, but fail to communicate any risk associated with the use of these drugs."
Later that year, in December, the FDA sent another letter warning specifically about the marketing of Mirena through parties held in homes and other private settings. A script that was used for these parties said that women who received the Mirena IUD could "look and feel great" and were "more likely to be intimate" because the device offered "simple ways to reconnect with ourselves and our partners."
The FDA said that it was "not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great" and that the statement minimized the risks associated with the device. The agency said the claims in the script overstated Mirena's efficacy and downplayed the risks associated with it.
North Carolina Mirena Lawyers
The Mirena IUD was marketed deceptively for years, misleading women about its potentially serious risks. As a result, thousands of women may have received the device and suffered serious health complications.
If you received the Mirena IUD and believe you suffered serious side effects as a result, you may be entitled to compensation for your injuries. Call the North Carolina defective drugs lawyers at the Law Offices of James Scott Farrin today at 1-866-844-4262 for a free evaluation of your case. You can also chat with a representative now or fill out a confidential intake form on this page. Find out how we may be able to help you!