The U.S. Food and Drug Administration has tightened the standards for Bayer AG's post-market study of the permanent birth control medical device Essure, which has come under scrutiny by the agency for causing severe side effects in some women.
The FDA made three major changes to what they call a post-market surveillance study, which is when the agency requires companies to continue studying medical device products even though they have been approved or cleared to be sold.
Bayer will now be required to conduct additional blood testing of patients enrolled in the study during follow-up visits so the agency can evaluate immune reaction to the device. The company will have to continue to enroll patients in the study for five years, rather than three. Bayer will also enroll women in the study who opt to have the device implanted before the product is removed from shelves as planned.
The post-market study was first required by the agency in 2016. But Essure was brought back into the spotlight by the 2018 documentary The Bleeding Edge. The documentary profiled women who have experienced serious risks and complications from the device years after insertion.
Essure, which was approved by the FDA in 2002, is the only contraceptive implant that does not require a surgical incision. The device is a metal coil that when placed into the fallopian tubes prevents pregnancy, and is designed as an alternative to tubal ligation.
Patients who have received the device have reported serious health risks such as persistent pain, bleeding of the uterus, and movement of the device's coils into the pelvis or abdomen.
The device is scheduled to go off the U.S. market on Dec. 31, 2018, but FDA Commissioner Scott Gottlieb said Dec. 20 that the agency's oversight of the device will continue. Since 2016, sales of Essure declined by 70%, according to the agency.
Along with the post-market study, the FDA has required Bayer to place a warning label and patient decision checklist on the box for the product advising users of potential risks. The FDA in April also required healthcare providers and facilities to provide women with information regarding the health risks of the device prior to its sale or distribution.
Bayer has defended the safety of the product and said that Essure was being pulled from the U.S. market because of the drop in sales. In a Dec. 20 press release about the FDA's changes to the post-market study, the company reaffirmed its position that the device is safe for use.
"Bayer has worked cooperatively with the FDA throughout the implementation of the study and on these study amendments, which provide a measure of flexibility for patient enrollment and allow us to collect additional and valuable long-term data," said Edio Zampaglione, vice president of U.S. medical affairs, women's healthcare and neurology at Bayer.