The Food and Drug Administration took a “big tent” method earlier this month when it accredited two new types of contraception that forestall being pregnant in very alternative ways.
Women’s well being advocates applauded the provision of a new vaginal ring that may very well be used for as much as a 12 months. But some questioned the approval of a mobile phone app that helps girls keep away from being pregnant by monitoring their physique temperature and menstrual cycle, a sort of contraception referred to as “fertility awareness.”
Critics pointed to reports that three dozen girls in Sweden received pregnant regardless of monitoring their cycle with the app. They additionally worry that the FDA approval of the app could encourage sufferers to suppose that fertility awareness methods, which embody a spread of practices to trace ovulation, and keep away from unprotected intercourse throughout that point, are simply pretty much as good at stopping being pregnant as some extremely efficient kinds of contraception, just like the intrauterine system, or IUD. While “natural” strategies will be profitable, they typically require shut day by day consideration.
There’s nonetheless room for enchancment in contraceptive use by men and women. Nearly half of the 6.1 million pregnancies within the United States — 45 % — in 2011 have been unplanned, according to a study printed within the New England Journal of Medicine. That determine is decrease than the 51 % charge in 2008, however is greater than the speed in lots of different industrialized nations.
The FDA has accredited almost two dozen contraceptive strategies, together with the capsule, the patch, IUDs and hormonal implants and photographs, amongst others. Insurance is required to cowl all FDA-approved strategies with out charging girls something out-of-pocket.
The new vaginal ring, Annovera, releases hormones that forestall ovulation and must be removed after three weeks for seven days, then reinserted. It can be utilized for a 12 months. The system won’t be in the marketplace till no less than late 2019, and the value hasn’t been launched by the producer.
The Natural Cycles app instructs girls to take their temperature on the similar time each morning after they awake and file it within the app. They additionally observe details about their menstrual cycle. When a slight temperature improve signifies they’re ovulating, the app indicators that ladies ought to keep away from unprotected intercourse. It prices about $80 per 12 months.
Both of the brand new strategies require extra consideration on the a part of the consumer than say, an IUD, which as soon as inserted will be ignored and is designed to stop being pregnant for 5 to 10 years, relying on the model.
Still, some girls’s well being specialists fear that the FDA stamp of approval could also be misinterpreted by some girls.
“People will interpret this to mean that the FDA approves this and thinks it’s a good method,” mentioned Dr. Christopher Zahn, vp of follow actions for the American College of Obstetricians and Gynecologists.
“That’s why counseling is so important,” he mentioned, noting that docs ought to focus on all types of contraception with girls, and the dialog ought to embody the efficacy of various strategies.
But Dr. Gillian Dean, senior director of medical companies at Planned Parenthood Federation of America, welcomes the approval of each new strategies.
“More options are always better,” she mentioned. “It isn’t one size fits all, and more options increases the likelihood that women will find a method that works for their needs.”
The proper contraceptive is dependent upon a girl’s targets, Dean mentioned, together with her reproductive plans, what her menstrual cycle is like, the variety of companions she has and the way vital it’s for her to not get pregnant. She mentioned most ladies who go to Planned Parenthood clinics ask for and obtain contraception tablets, however an rising quantity are asking for long-acting reversible strategies of contraception, comparable to IUDs and hormonal implants.
The IUD and hormonal implants have a “failure rate” of lower than 1 %, making them among the many only ways of preventing pregnancy (on par with everlasting sterilization). Birth management tablets, the patch and the vaginal ring have effectiveness charges of about 91 %, in response to the federal Centers for Disease Control and Prevention.
Fertility consciousness strategies, however, have a failure charge of about 24 %, in response to the CDC. But that determine is extensively misunderstood, mentioned Chelsea Polis, a senior analysis scientist on the Guttmacher Institute, a sexual and reproductive well being analysis and advocacy group.
Polis co-authored an analysis of studies of fertility awareness-based contraceptive strategies that was printed in August within the journal Obstetrics and Gynecology.
The 24 % determine, she mentioned, primarily displays the anticipated failure charge for ladies who used the rhythm methodology, a calendar-based method to calculating when ovulation happens, reasonably than newer biometric strategies that observe physique temperature, cervical mucous or urinary hormones. Some of these strategies could also be simpler, she mentioned.
Based on a evaluation of printed research, Polis and colleagues reported that the Natural Cycles app had a 9.eight % unintended being pregnant charge. The FDA announcement, which incorporates the outcomes of a further research, famous a 6.5 % charge.
Polis mentioned her research indicates that about three % of ladies who use contraception follow fertility awareness-based strategies, both alone or with different kinds of contraception, and their numbers are growing.
“I think [the app approval] is largely a positive step forward,” Polis mentioned. “I’m relieved that the FDA has a regulatory pathway to evaluate these uses and claims.”
