Although 5-year data collected by the makers of Essure (and posted on their Web site) show a very high rate of efficacy and a failure rate of 0.17%, these data come from women who completed all of the required steps for successful sterilization and study follow-up.
How hysteroscopic sterilization compares with the laparoscopic approach
Gariepy and colleagues created an evidence-based clinical decision analysis to estimate the probability of successful sterilization after a hysteroscopic procedure in the operating room (OR) or office versus laparoscopic sterilization. A decision analysis, which includes the range of data available to assess different outcomes, is the best methodology to provide population-level information about likelihoods, including rare events (eg, pregnancy after sterilization), in the absence of a randomized trial.
A decision analysis assigns women to outcomes based on their intended method of sterilization, mimicking real-life situations created by the multiple steps required for successful completion of the procedure and confirmation of sterilization. When the probabilities of failing these steps are taken into account, 94% and 95% of women choosing hysteroscopic sterilization in the office and OR, respectively, would be successfully sterilized within 1 year, compared with a success rate of 99% in those who opt for laparoscopic sterilization. The estimates of hysteroscopic success include 6% of women who would attempt hysteroscopy but ultimately be sterilized via laparoscopy, and 5% of women who would decline further sterilization attempts after hysteroscopic sterilization fails.
| WHAT THIS EVIDENCE MEANS FOR PRACTICE Hysteroscopic sterilization has its advantages, including a very high efficacy rate among women who meet all the criteria for successful occlusion. Among these criteria is confirmation, by hysterosalpingography, of occlusion 3 months after deployment of the microinserts.10 However, the efficacy of hysteroscopic sterilization is inferior at a population level; therefore, it should not be used indiscriminately. Rather, hysteroscopic sterilization may be a better option for women for whom laparoscopy itself carries a high risk, such as women with complicated diabetes or severe cardiopulmonary disease. While we await similar studies or further trials that evaluate population-based estimates of pregnancy rates, women considering sterilization should be counseled accordingly. |
How limits on access can prevent widespread use of effective contraception
American College of Obstetricians and Gynecologists. Access to emergency contraception. Committee Opinion No. 542. Obstet Gynecol. 2012;120(5):1250–1253.
Ulipristal acetate as emergency contraception (EC) was introduced to the market in 2010. As was noted in this Update in 2011, ulipristal acetate is more effective than progestin-only emergency contraception and maintains this efficacy for a longer period of time.11 Despite these clear advantages, ulipristal acetate is unlikely to realize its full potential.
Data related to EC as a public health benefit have been largely disappointing. Increased access and availability have not yet reduced the unintended pregnancy rate in the United States. Although use of EC increased from 4.2% in 2002 to 11% in 2008,12 even women with a knowledge of EC do not always use it when needed.13,14
Use of ulipristal acetate, in particular, remains limited because it lacks one important requirement for rapid diffusion—access. Although it is clinically superior to the progestin-only method of EC, is compatible with current practice, and has both high trialability and high observability, access to the drug remains too complex for easy dissemination due to its prescription-only status. Because women can now obtain progestin-only EC over the counter, the use of ulipristal acetate is likely to remain low unless the access barrier to this effective oral EC regimen is reduced.
| WHAT THIS EVIDENCE MEANS FOR PRACTICE When counseling women of reproductive age about contraception, offer them an advance prescription for ulipristal acetate and advise them of its greater efficacy, compared with progestin-only emergency contraception. |
Skyla versus other IUDs: What the data reveal
Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril. 2012;97(3):616–622.e1–e3.
The 13.5-mg levonorgestrel-releasing intrauterine system (Skyla) boasts a smaller frame and a narrower inserter than the two intrauterine devices (IUDs) already on the market (ParaGard and Mirena), a lower amount of levonorgestrel than the other levonorgestrel-releasing IUD (Mirena), and 3 years of continuous contraception. Both of the IUDs that predated Skyla are backed by data supporting their efficacy and safety in nulliparous women,15-18 but a number of clinicians and opinion leaders have stated that Skyla’s smaller frame and inserter make it an ideal IUD for the narrower cervical canal and smaller endometrial cavity of nulliparous women,19 including Gemzell-Danielsson and colleagues.