Members of an FDA committee stated today that Essure, the birth control device made by Bayer AG, should be cataloged as a surgical procedure on its product labeling. Also, the device should come with better instructions and guidelines for its proper use.
Patients, specialists, members of the FDA committee, and Bayer representatives discussed the safety of Essure this Thursday during a 12-hour hearing. Studies, testimonies, opinions, and even marketing data was taken into account.
The patients testimonies got special attention from the FDA after the pressure of groups like Essure Problems. They ratified their complaints about heavy bleeding, allergies, abdominal pain, headaches and unintended pregnancy.
In addition, the FDA noticed an increase of medical reports indicating adversative effects on women who had the procedure done. After listening and evaluating all points of view, the FDA committee made the following recommendations, according to MedPage Today:
- Developing a protocol that includes interoperative imaging to ensure correct device placement.
- Establishing guidance for practitioners to be able to identify long-term complications earlier.
- Supporting early intervention analysis if abnormal bleeding occurs following the procedure.
- Requiring a checklist or signed an informed consent form to ensure clinicians discuss risks, benefits, and alternatives.
- Developing a patient registry for tracking the rate of pregnancies and adverse events.
- Strengthening training programs for device implantation and placement.
- Developing training around removal.
“The company looks forward to working with the FDA on the recommendations”, said Edio Zampaglione, MD, the Vice President of U.S. Medical Affairs for Bayer HealthCare to Healio. He added that company representatives “learned a lot” from the patient testimony, and that it underscores the need for “more options, not less” in the field of female birth control, according to Helio.
The importance of ‘Essure Problems’
Ensure Problems is a facebook group created for women who had experienced problems with Essure, and it counts with the help of Erin Brockovich-Ellis, the famous American legal clerk, and environmental activist. Also, the website is filled with first-hand testimonies, stories, and coverage of the FDA announcements. This is an example of many stories that can be read on their website:
“I had the Essure implanted in 2007 and was told it was a safe and effective form of Birth Control for sterilization in comparison to tubal ligation. Today, July the 5th of the present year, after 8 years of lower back pain and cramping that has been debilitating at times I have been told because of this device I will have to have a Hysterectomy because the coils are expelling into my uterus”, signed Karen, a collaborator from the Facebook group.
Source: MedPage Today