The Food and Drug Administration (FDA) is requiring Bayer to conduct a new clinical trial to gather more information about adverse events with its permanent birth control device Essure to determine what health risk the device poses “in a real-world environment.”
Essure was approved by the FDA in 2002 and remains the only non-surgical permanent birth control method on the market. The device consists of two nickel alloy coils that are inserted into each of the fallopian tubes where they work with the body create a natural barrier that prevents the sperm from fertilizing the egg.
Since the device was approved, more than 5,000 complaints have been filed with the FDA involving Essure including unintended pregnancies, miscarriages, and stillbirths. The agency’s database also includes health problems such as chronic pain, infections, allergic reactions, and autoimmune reactions. In some cases, the device has migrated from the fallopian tubes and punctured organs such as the uterine wall.
Mounting complaints and an aggressive social media campaign demanding Essure be banned from the market led to an FDA safety review of Essure. The agency opted to keep the contraceptive on the market but place its strongest warning – a boxed warning – on the safety label. The agency also ordered Bayer to collect safety data.
Bayer is required to follow more than 2,000 women for at least three years. The study will compare women who are using Essure to those who selected other methods of sterilization, such as tubal ligation. The FDA expects Bayer to submit a study protocol within 30 days and, by law, Bayer must begin the study within 15 months. Failure to follow the FDA’s requirements could result in the agency declaring the device misbranded, which can lead to the withdrawal of the contraceptive from the market.
The FDA is also asking Bayer to include a “patient decision checklist” in the Essure packaging “to ensure women receive and understand information regarding the benefits and risks of this type of device.”
Source: Albany Daily Star