Essure Safety Review Continues At FDA, Details of Safety Study Released
Federal regulators indicate that they received more than 5,000 medical device reports involving problems with Essure birth control implants last year, and recently reported details for an ongoing study that is designed to better understand the risks associated with the controversial device.
The FDA issued an update to its ongoing investigation of Bayer’s Essure implant on April 18, confirming that the agency is still receiving and reviewing complaints from women and doctors nationwide who have experienced complications linked to the coil-shaped birth control devices.
According to the update, the FDA received 5,016 medical device reports involving the product in 2016, which is a decrease from the 6,176 reports received by the agency the year before. The FDA also noted that it has received 38 reports of deaths associated with Essure birth control, but noted that eight of those may were incorrectly coded, as there was no indication of death.
Among the remaining 30 deaths reported, there were six reports involving with four adult deaths, and 21 reports linked to 18 pregnancy loss incidents. The FDA also received two reports of infants dying after they were born, and one in which they are not sure if the newborn died before or after its birth.
In September 2016, the FDA approved a plan for a postmarket surveillance study on Essure health risks and benefits. The update provides details on the Essure study, which seeks to be a prospective observational cohort study involving 2,800 women; half of whom will receive the Essure, and the other half of whom will undergo laparoscopic tubal sterilization.
The study will look for instances of:
- Chronic lower abdominal or pelvic pain
- New or worsening abnormal uterine bleeding
- Allergic reactions and hypersensitivity, as well as autoimmune-like reactions
- The need for revision surgery or invasive gynecologic surgery linked to Essure devices
- Effectiveness
- Pregnancy rates
Essure Health Concerns
Essure is a medical device that is designed to provide women with permanent sterilization, involving coils that are placed in the fallopian tubes during an out-patient procedure. The Essure coils cause scar tissue to form and prevent pregnancy.
In November 2016, the FDA added a black box warning label to Essure implants, which is the strongest that the FDA can require a medical device carry.
The black box came after independent experts recommended that additional information be provided about the Essure procedure problems experienced by many women who received the coils, including perforation of the uterus and fallopian tubes, pain and allergic reactions. The new warnings also inform women that if Essure needs to be removed, it must be done through a surgical procedure.
Women who undergo the birth control procedure will now be presented with a patient checklist, which is designed ensure that they are aware of the potential side effects of Essure coils.
The warnings provide women with information about the permanent and possibly irreversible nature of the implant, the fact that there are alternative contraceptives available, the effectiveness of Essure coils and the risk of unintended and ectopic pregnancies, common adverse events, long-term risks, and what signs and symptoms they should look out for that may indicate a problem.