The FDA has approved Twirla (Agile Therapeutics), a transdermal contraceptive patch containing the estrogen ethinyl estradiol and the progestin levonorgestrel, for use in women with a BMI <30 kg/m². It is the second contraceptive patch to become available in the US; Xulane, a patch that delivers ethinyl estradiol and the progestin norelgestromin, has been available since 2014.

The FDA has approved Phexxi (Evofem), a nonhormonal prescription-only vaginal gel containing lactic acid, citric acid, and potassium bitartrate, for prevention of pregnancy. The gel is intended for on-demand contraception; it is not effective when used after intercourse. It was previously approved for use as a vaginal lubricant (Amphora), but was never marketed.

In our article on Slynd (Med Lett Drugs Ther 2020; 62:18), the drospirenone-only oral contraceptive, we mentioned that drospirenone has antiandrogenic activity that could improve acne and antimineralocorticoid activity that could cause hyperkalemia. We should have added that concurrent use of drospirenone with other drugs that increase potassium levels, such as the anti-androgen aldosterone receptor antagonist spironolactone (Aldactone, and generics), which is often used off-label for treatment of acne, can increase the risk of hyperkalemia.

The FDA has approved a progestin-only oral contraceptive ("minipill") containing drospirenone (Slynd – Exeltis). All other progestin-only oral contraceptives available in the US contain norethindrone (Camila, and others). Progestin-only oral contraceptives are similar in efficacy to combination oral contraceptives. They are used predominantly by breastfeeding women and by those in whom estrogen is poorly tolerated or contraindicated. Combination oral contraceptives containing drospirenone and ethinyl estradiol have been available for years.

Annovera (TherapeuticsMD), a contraceptive vaginal ring that releases segesterone acetate, a synthetic progestin, and ethinyl estradiol, was approved by the FDA in 2018 and is now available. It is the first product to contain segesterone and the second vaginal ring to become available in the US; NuvaRing, which delivers etonogestrel and ethinyl estradiol, was the first. Unlike NuvaRing, which requires use of a new ring each month, the Annovera ring can be used for an entire year, but it must be removed for one week each month.

Intrauterine devices (IUDs) and the etonogestrel implant are the most effective reversible contraceptive methods available. Hormonal oral contraceptives, patches, rings, and injectables are also highly effective in preventing pregnancy. When used alone, barrier and fertility-based methods generally have higher failure rates than other methods.

Essure (Bayer) is the only nonsurgical, permanent contraceptive available in the US. The coil-like devices are placed hysteroscopically in both fallopian tubes and, after several months, scar tissue causes tubal occlusion.1 In 2016, the FDA required Bayer to revise the device's labeling to include a patient decision checklist and a boxed warning about the risks of uterine and fallopian tube perforation, migration of the device to the abdominal or pelvic cavity, persistent pain, and hypersensitivity reactions. Some women were apparently not being informed of these risks before implantation of the device, which can only be removed surgically. As a result, the FDA is now restricting the sale and distribution of Essure to healthcare providers who agree to review the "Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement" with their patients before implantation. The checklist includes information about the device, its safety, and its effectiveness. Patients and physicians must sign the checklist before the device is implanted.

From its approval in 2002 through 2017, the FDA received 26,773 medical device reports related to Essure. The most common adverse effects reported with its use were abdominal pain, heavier menses/menstrual irregularities, headache, fatigue, and weight fluctuations. Nickel allergy, migration of the device, dislodged or dislocated device, and device breakage have also been reported. During this time period, there were 1863 pregnancies (365 live births, 875 miscarriages, 623 unspecified) and 13 deaths (8 adults, 4 infants after live birth, 1 unspecified).2

Bayer states that more than 750,000 women have received Essure worldwide, but the device was taken off the market in the United Kingdom, the Netherlands, Finland, and Canada, and Bayer stopped sales of Essure outside the US altogether in September 2017.

Some women with contraindications or intolerance to hormonal contraceptives are also poor candidates for laparoscopic tubal ligation, leaving them few options for highly effective contraception. For these women, in the US, Essure remains an option.

1. Choice of contraceptives. Med Lett Drugs Ther 2015; 57:127.
2. FDA activities: Essure. Available at: www.fda.gov. Accessed May 10, 2018.