The Food and Drug Administration (FDA) is ordering Bayer to conduct a study aimed at providing insight into the “real world” risks associated with its controversial permanent birth control device Essure.
Essure was approved in 2002 and remains the only non-surgical birth control method on the market. It consists of two nickel alloy coils that are inserted into the fallopian tubes. Over the course of about three months, scar tissue builds up around the coils and creates a barrier that prevents pregnancy by blocking the sperm’s path to the egg.
Essure has been linked to tens of thousands of complications ranging from abdominal pain and unusual vaginal bleeding to allergic reactions and autoimmune reactions. The devices have also been associated with unintended pregnancies, miscarriages, still births and fetal death.
The coils can also migrate from the fallopian tubes and puncture internal organs such as the uterus or fallopian tubes. Removal requires surgery that in some cases has involved full hysterectomy.
In February, after launching a safety review, the FDA ordered that a black box warning – it’s strongest warning – be placed on the safety labels of Essure to warn doctors and women of the risks associated with the device. The agency also ordered Bayer collect safety data focusing on side effects suffered by women who have been implanted with the device to determine if there are any advantages to Essure over surgical tubal ligation.
This information will allow the FDA to “determine what, if any, further actions related to Essure are needed to protect public health.” Bayer is required by law to begin the study within 15 months or face potential action by the FDA.
Bayer currently faces a growing number of lawsuits from women who claim they have been injured by Essure and that Bayer failed to fully warn of the risks.
Source: Albany Daily Star