Mirena obtains approval on new insertion device
Executive Summary
Bayer HealthCare Pharmaceuticals has received Food and Drug Administration approval for a new inserter for its Mirena intrauterine contraceptive.
• The new inserter uses the same insertion steps as its sister intrauterine contraceptive, Skyla, and the two share a uniform insertion technique.
• The new inserter features a thin, flexible insertion tube. The inserter is preloaded with a small, rounded, flexible T-body and enables single-handed loading. Centimeter markings are now on both sides of the insertion tube.
• At press time, the new inserter was scheduled for shipment in late summer of 2014.
Bayer HealthCare Pharmaceuticals recently received Food and Drug Administration approval for a new inserter for its Mirena intrauterine system (IUS). The new inserter uses the same insertion steps as its sister intrauterine contraceptive, Skyla, and the two share a uniform insertion technique.
The new inserter features a thin, flexible insertion tube. The inserter is preloaded with a small, rounded, flexible T-body and enables single-handed loading. The diameter of the insertion tube is 3.8 mm for Skyla and 4.4 mm for Mirena.
According to package labeling, Mirena is indicated for intrauterine contraception for up to five years. Mirena also is indicated to treat heavy menstrual bleeding in women who choose to use intrauterine contraception as their birth control method. Mirena is recommended for women who have had a child. The device should be replaced after five years if continued use is desired.
Skyla’s package labeling indicates it might be used for the prevention of pregnancy for up to three years. The device should be replaced after three years if continued use is desired, package labeling states.
At press time, the Bayer inserter for Mirena was scheduled to be available later in the summer of 2014, says Tara DiFlumeri, a Bayer spokesperson. "There will be a transition period when we will ship product with the original inserter and the Bayer inserter," says DiFlumeri. "We will work to minimize this transition period so that the Bayer inserter for Mirena will be shipping exclusively as soon as possible."
What is different about the new inserter? Some highlights are: The threads are contained within the handle, which makes it non-reloadable. The T-body of the levonorgestrel IUS is pre-loaded and secured in position on the insertion tube. Centimeter markings are now on both sides of the insertion tube. The insertion tube outer diameter is now thinner, measuring 4.4 mm. (Download a copy of the new prescribing information at http://bit.ly/1znsRjr.)
The insertion device for the smaller Skyla IUS does not have external strings. It is easier, as well as quicker, to load, than the older insertion device used with the Mirena IUS, observes Andrew Kaunitz, MD, University of Florida Research Foundation professor and associate chairman of the Department of Obstetrics and Gynecology at the University of Florida College of Medicine — Jacksonville. "My sense is that updating the Mirena insertion device will facilitate placement of this IUS," states Kaunitz. "In addition, having the same insertion mechanism for both the Skyla and the Mirena will minimize confusion and missteps for clinicians like myself, who place both devices."
Having one inserter device for Mirena and Skyla is a step forward for reducing confusion about placing these two devices, agrees Susan Wysocki, WHNP-BC, FAANP, president and chief executive officer of iWomansHealth in Washington, DC, which focuses on information on women’s health issues for clinicians and consumers. The fact that the inserter device for Mirena also is thinner than the previous inserter device is an additional plus, she states.
The copper-T 380A intrauterine device has a very different placement technique than the technique for Mirena or Skyla, observes Wysocki. "If there is any one take-home on placing intrauterine contraceptives, it is to read and follow the package insert to make sure that the placement technique is correct," states Wysocki. "Contact representatives from the companies that sell IUSs for training if you have any questions."
As with any intrauterine contraceptive method, Mirena should be inserted by a trained healthcare provider. Healthcare providers should become thoroughly familiar with the updated insertion instructions before attempting insertion with the Bayer inserter for Mirena, says DiFlumeri. Clinicians are encouraged to take advantage of the many resources and interactive education opportunities that became available for Mirena and Skyla as of July 2014, she notes.
These resources include Bayer inserter speaker programs, which provide an overview of the Bayer inserter and hands-on insertion education so clinicians can train on Mirena and Skyla in the same session. Resources also include one-on-one insertion consultations using pelvic models and "lunch & learn" sessions that are scheduled in clinicians’ offices. Also, interactive insertion and removal resources and an animated insertion video are scheduled to be available on the Mirena website at www.MirenaLearningCenter.com.
How is the company getting the word out to providers about the new inserter? According to DiFlumeri, sales consultants will provide customers with the updated prescribing information, which reflects the updated insertion procedure. The insertion steps for the original Mirena inserter will continue to be available on the Mirena website until at least six months after the initial shipment of the Bayer inserter for Mirena, says DiFlumeri.
With the July 2014 kickoff for the insertion education phase, the company will provide an updated inserter guide, which will give an overview of the characteristics of the original inserter and the Bayer inserter for Mirena, while highlighting the features of the new inserter. Combined IUS (Skyla and Mirena) healthcare provider educational kits will be available for insertion education. The websites, www.mirena-us.com/hcp and www.MirenaLearningCenter.com, will be updated with the updated inserter information, says DiFlumeri.
