Bayer to Halt Essure Sales in the United States
In the past, women looking for a permanent birth control option had just one choice – a tubal ligation, which involves a major surgery. That changed in 2002, when the Food and Drug Administration (FDA) approved Essure. Essure is a flexible coil that is placed at the ends of the fallopian tubes. Scar tissue then forms over the coils, preventing pregnancy.
Many women opted for this form of birth control, as it was touted as an easier and less invasive procedure. However, Essure caused serious side effects for many women over the last 15 years. Many women suffered from constant pain and bleeding as the coil broke apart inside their bodies. Others experienced the coils perforating their uterus. In some cases, the coils migrated into the abdomen and pelvis.
Making things worse was the fact that Essure was not as effective at preventing pregnancy as promised. More than 5,000 women experienced unexpected pregnancies, miscarriages and stillbirths. Since 2013, nearly 1,000 adverse events have been filed. Seven women have died. Lawsuits have been filed. Because of this, the FDA issued a black box warning.
Essure sales outside of the United States were halted last fall. Earlier this year, the FDA put restrictions on Essure, allowing it to be sold only to doctors and healthcare facilities who used an FDA-approved checklist, reviewed it with patients and had the patients sign it. On July 20, Bayer – the manufacturer of Essure – announced that it would cease sales of the birth control in the U.S. as well. Bayer made the decision voluntarily, citing a decline in sales.
Ironically, the cessation of Essure sales comes one week before the Netflix premiere of the documentary The Bleeding Edge. The documentary discusses the topic of medical devices, which tend to go unchecked, even though they require FDA approval. Essure and hip replacements are just some of the devices discussed in the documentary. Some devices are favored over others due to relationships between the FDA and certain manufacturers, and this can lead to adverse medical events.
Some gynecologists are upset over the end of Essure sales. Granted, it was not the best choice for all women, given the adverse events experienced by thousands. However, it was the closest that women had to a vasectomy, the sterilization procedure done in men. Now, women do not have a surgery-free option for permanent birth control. They will have to opt for the risks of a tubal ligation or choose hormone-based birth control, which many women cannot tolerate.