The Year's Don't-Miss News in Contraception

George W. Citroner

Disclosures

December 27, 2018

From a controversial implant recently pulled from the US market to new rules that will limit access to contraceptives previously ensured by the Affordable Care Act, 2018 brought major developments in contraception.

Bayer Stops Selling Essure

Essure is two small metal coils designed to cause sterilization. Once inserted into the fallopian tubes, which carry eggs to the uterus, scar tissue forms around the coils, blocking sperm from reaching the eggs.

Bayer received US Food and Drug Administration (FDA) approval to sell Essure in 2002, when the product was promoted to women as the only nonsurgical option for permanent birth control. Since then, however, thousands of women have reported complications associated with Essure.

In response, the FDA ordered Bayer to conduct a postmarket study in 2016, and then required a boxed warning and a "Patient Decision Checklist." US sales of Essure fell by about 70% after the warning label was added, prompting Bayer to end sales of Essure.[1]

"This decision is based on a decline in US sales of Essure in recent years and the conclusion that the Essure business is no longer sustainable," Bayer said in a statement.[2] Bayer also acknowledged complaints of "perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions," by women using the implants.[2]

Kecia Gaither, MD, double board-certified in obstetrics-gynecology and maternal-fetal medicine and director of perinatal services at Lincoln Medical and Mental Health Center in the Bronx, New York, a member of NYC Health + Hospitals System, warns, "It's generally advised that if the decision is made to remove Essure, it should be done within the first 3-4 months."

According to Gaither, each case is different. "Sometimes the coils can be easily removed, but after a few months the coils may become brittle and easily break, meaning a dissection within the uterus may be needed to assist in removal."

Currently, more than 16,000 women in the United States are suing Bayer over Essure, with claims of harm including device migration and perforation of the fallopian tube or uterus (causing injury, pain, and bleeding), nickel allergy, and unintended pregnancy.[2]

Annovera Enters the Ring

The Population Council, a global nonprofit research organization, has received FDA approval for Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive.

Annovera is the first and only contraceptive that provides 1 full year of protection against pregnancy.[3] The flexible, reusable, donut-shaped ring is placed in the vagina for 3 weeks at a time, followed by removal, washing, and storage for 1 week so women can experience their menstrual period. The cycle is then repeated for a year.

"Annovera will give women total control over when and for how long they wish contraception without multiple trips to the physician for invasive insertion or removal," Gaither said.

In open-label clinical trials, Annovera was 97.3% effective in preventing pregnancy, and satisfaction with the use of the vaginal ring was 89%.[4] Of note, Annovera has not been studied in women with a body mass index > 29 kg/m2 . Annovera poses the same risks as other hormonal contraceptives and will carry a boxed warning about cigarette smoking and serious cardiovascular events.[5]

The Population Council announced a license agreement with TherapeuticsMD to make Annovera available to women in the United States. They will also provide reduced pricing to federally designated Title X family planning clinics that serve lower-income women.[4]

But women who are looking for the long-lasting and affordable contraception offered by the vaginal ring will have to be patient; Annovera may not be available until the end of 2019 or early 2020.

There's an App for This

In August, Natural Cycles became the first FDA-approved birth control app in the United States. The "fertility awareness" app charts a woman's fertility so she knows on which days to avoid sex or use contraception. The app requires women to track their menstrual cycles and enter their body temperature into the app every morning upon waking.

On the basis of a study[6] involving of 22,785 women using the Natural Cycles app, the rate of pregnancies from cycles where the application erroneously flagged a fertile day as infertile was 0.5 per 100 woman-years. Overall, the app showed 93% efficacy in avoiding pregnancy with "typical use" and 99% with "perfect use" (never having unprotected sex on fertile days).[7] That's actually better than comparable rates for the birth control pill, which is around 91% effective. [8]

However, Gaither observed that "It's not really the most effective way to determine when it's safe to have sex while avoiding conception," adding that "It might be better to use basal body temperature charting with an ovulation predictor."

In a commentary for Medscape, Dr Andrew Kaunitz, professor and associate chair in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville, voiced concern about the high failure rates associated with fertility awareness methods in general. By receiving the FDA stamp of approval, couples might believe that the app is considered as effective in preventing pregnancy as traditional methods.

Birth Control Equality: Are Men Ready and Willing?

The burden of contraception has largely fallen on women. Birth control can have many adverse effects on a woman's body, from nausea and weight gain to mood swings and more serious health risks such as thromboembolism. Responsibility for birth control also has financial and social implications that men aren't subject to. Until now, only about 25% of men have expressed a willingness to take a hormonal contraceptive to prevent a partner's pregnancy.[9]

However, that might change. A new product for male contraception is inching closer to reality. It's a topical gel containing testosterone and a potent, nonandrogenic progestin (Nestorone), which transdermally suppresses gonadotropin levels, thereby inhibiting spermatogenesis.[10] Combining this with a testosterone gel further reduces sperm production and prevents adverse effects (such as lower libido, mood swings, acne, and weight gain) of fluctuating testosterone levels.[11] The product being studied now is applied daily to the upper arms and shoulders and lasts about 72 hours, reducing sperm counts to less than 1 million/mL.[11]

A clinical trial of the male contraceptive gel (Nestorone-testosterone) began in April 2018 and will run for about 4 years, in sites in the United States, the United Kingdom, Italy, Sweden, Chile, and Kenya. It's the largest-ever US effort to test a hormonal form of male birth control. A separate trial is also under way to ensure that stray gel rubbing onto a partner isn't cause for alarm.

Questions linger about whether this male birth control product will be acceptable to men. One study found that after trying the transdermal gel, slightly more than half of the men (56%) were satisfied with this product as a form of contraception, and about one third said they would use it if it were commercially available.[12]

Nelson Bennett, MD, associate professor of urology at Northwestern University Feinberg School of Medicine in Chicago, Illinois, cautions that testosterone-based male contraceptives have been tried before and the results were less than stellar.

"It's easy to stop production of sperm; the problem has been restarting it after prolonged contraceptive use," Bennett said. He also foresees compliance issues, adding, "The challenge will be getting men to consistently use this on a daily basis." The male birth control product will be subject to the same problem that often causes female contraception to fail—forgetfulness.

Even if the trials are successful, it could be several years before this male contraceptive becomes available to the public.

A Setback for Birth Control Coverage

One year after a federal rule creating moral exemptions for birth control coverage was blocked in court, the Trump administration has published new rules with similar "conscience protections" for employers.

One rule will allow employers to claim "sincerely held" religious objections, whereas a second rule offers an exemption based on moral grounds.

"The religious and moral exemptions provided by these rules also apply to institutions of education, issuers, and individuals. The Departments are not extending the moral exemption to publicly traded businesses, or either exemption to government entities," the US Department of Health and Human Services said in a statement.

Under the Affordable Care Act, employers were required to provide birth control coverage with only a few permitted exemptions. The rules released October 14, 2018, and finalized in November will significantly erode that protection.

Brigitte Amiri, deputy director of the American Civil Liberties Union's Reproductive Freedom Project, said, "If a court doesn't block the final rules, hundreds of thousands of people could lose birth control coverage because of their employers' religious or moral objection to contraception." She added, "While everyone is entitled to their religious beliefs, those beliefs should not be used to discriminate against another, block a benefit guaranteed by law, or otherwise create harm."

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