High demand, production delay limit Skyla IUD
Providers might need to seek other long-acting reversible contraceptive methods other than the new smaller levonorgestrel intrauterine device (IUD), Skyla. Its manufacturer, Bayer HealthCare Pharmaceuticals of Wayne, NJ, has informed providers that it is experiencing limited inventory levels. According to a July 15, 2013, letter issued to providers, the company said it anticipated to be out of stock by the end of that month.1
"We are working to resolve this supply issue, and new stock is targeted to be available by year end," the letter states.
Since the successful introduction of Skyla earlier this year, Bayer has experienced a high level of demand for Skyla and a delay in production, says company spokesperson Rosemarie Yancosek. (Read the Contraceptive Technology Update article about the product’s approval; see "FDA approves smaller intrauterine system — a mini-Mirena,’" March 2013, p. 25.) The company is currently reviewing the situation and working to ensure there is appropriate product moving forward, she states.
"For additional information, [providers] can contact Bayer’s Medical Information Services at (888) 842-2937," says Yancosek. "Bayer will proactively notify customers when product is available."
Check the "mini-Mirena"
The Skyla IUD and its inserter are smaller in size than its sister product, the Mirena IUD, also manufactured by Bayer. Skyla’s small, flexible plastic T-shaped device measures 28 mm by 30 mm, as compared to Mirena’s 32 mm by 32 mm dimensions. Skyla has a smaller inserter diameter; it is 3.8 mm in diameter, compared to Mirena’s 4.75 mm diameter inserter.
Skyla contains 13.5 mg levonorgestrel. The drug is released at an average in vivo rate of approximately 6 mcg/day over three years. In comparison, Mirena contains 52 mg of levonorgestrel. Its drug is released at a rate of approximately 20 mcg per day, which decreases progressively to half that value after five years. Skyla is labeled for up to three years of effective use; Mirena carries labeling for up to five years of effective use.
One perceived advantage of Skyla lies in its specific labeling regarding use in nulliparous women. The product labeling for Skyla specifically states that it can be used whether or not a woman has had a child, whereas the labeling for Mirena states it is recommended for women who have had at least one child. Mirena has not revised its labeling regarding use in nulliparous women, even though it is generally seen as safe. The US MEC classes such use as a 2, where benefits generally outweigh any risks.
Donna Gray, CNM, WHNP, a clinician at the Wyoming County Health Department’s Men’s and Women’s Reproductive Health Center in Silver Springs, NY, has performed just one Skyla insertion in a nulliparous teen. There were no problems with device insertion, and the patient is doing well with the method, she states. She sees the device as a good option for nulliparous women or those who only want to wait three years between childbirth.
More providers might be looking at IUDs as appropriate birth control in adolescents following a 2012 committee opinion from the American College of Obstetricians and Gynecologists (ACOG). The ACOG opinion states that long-acting reversible contraceptives such as the intrauterine device and the contraceptive implant are safe, effective, and appropriate options for adolescents.2(CTU reported on the opinion. See "Long-acting methods safe for teens — include options in your counseling," December 2012, p. 133.)
What are your options?
If Skyla supply is unavailable, what options are open to clinicians? Clinicians should be reminded that often the women who would benefit from Skyla would be excellent candidates for the contraceptive implant, says Anita Nelson, MD, professor in the Obstetrics and Gynecology Department at the David Geffen School of Medicine at the University of California in Los Angeles.
The implant and IUD possess the highest rates of patient satisfaction and continuation of all available reversible contraceptives, according to the ACOG committee opinion.2With their long-acting effectiveness, both methods eliminate the problem of inconsistent use seen with other forms of reversible birth control.
"We need to always to remember all the alternatives and not get trapped inside the endometrium," says Nelson.
In talking about use of the intrauterine contraceptive or the contraceptive implant, remember to discuss potential bleeding changes associated with those methods. Women who use the contraceptive implant should be counseled to expect changes in menstrual bleeding throughout use of the method. In an analysis of 11 studies, the most common bleeding pattern was infrequent bleeding in 33.3% of 90-day cycles, followed by amenorrhea in 21.4% of cycles.3
A change in bleeding pattern is the most common reason for discontinuation of use of the implant, so anticipatory guidance regarding such changes might improve satisfaction and continuation. Tell patients that the bleeding pattern they experience in the first three months is broadly predictive of future bleeding patterns.4
- Bedard P. Dear valued healthcare provider. Letter. July 15, 2013.
- American College of Obstetricians and Gynecologists. Committee Opinion No. 539. Adolescents and long-acting reversible contraception: implants and intrauterine devices. Obstet Gynecol 2012; 120(4):983-988.
- Darney P, Patel A, Rosen K, et al. Safety and efficacy of a single-rod etonogestrel implant (Implanon): results from 11 international clinical trials. Fertil Steril 2009; 91(5):1,646-1,653.
- Mansour D, Bahamondes L, Critchley H, et al. The management of unacceptable bleeding patterns in etonogestrel-releasing contraceptive implant users. Contraception 2011; 83(3):202-210.