FDA Approves New Contraceptive Device for Women

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The Food and Drug Administration has approved a combined hormonal contraceptive for women. Called Annovera (segesterone acetate and ethinyl estradiol vaginal system), this reusable, donut-shaped device is the first vaginal ring that can be used to prevent pregnancy for a full year.

The FDA stated that the non-biodegradable, flexible vaginal system can be placed in the vagina for three weeks and then removed, washed, and stored for one week, during which time a woman may experience withdrawal bleeding similar to a menstrual period. This schedule can be repeated every four weeks for a year.

Annovera was studied in three clinical trials involving healthy women 18 to 40. Based on these studies, two to four women out of 100 may become pregnant during the first year of Annovera use. Like other hormonal forms of contraceptives, this vaginal ring carries some risks and includes a boxed warning about cardiovascular risks and smoking. Women should talk to their health care provider about these risks and whether this contraceptive is right for them.

Possible side effects include:

  • abdominal pain
  • breast tenderness
  • diarrhea
  • genital itching
  • headache
  • nausea and vomiting
  • painful menstruation (dysmenorrhea) and irregular bleeding

Sourced from: FDA