January 15, 2016 · FLEMING | NOLEN | JEZ, L.L.P.
Developed by Bayer, the Essure® permanent birth control device is a form of contraception where nickel-titanium coils are implanted into a woman’s fallopian tubes through the vagina. A woman’s body is to then grow tissue over the Bayer Essure® device within three months of implant, forming a permanent birth control. However, the metal coils, and the PET fibers on the Bayer Essure® device, may leave women with bad side effects.
In January 2016,The Doctors Show invited Bayer and an Essure® problem treating physician to discuss this permanent surgical birth control device. Dr. Zampaglione was interviewed on behalf of Bayer, and an Essure® problem treating physician Dr. Sills was also interviewed. When asked questions about Bayer Essure®, Bayer’s physician could not always provide a response. Essure® Victims wrote toThe Doctors to answer the questions Bayer failed to answer. ( Click here for the full letter)
Essure® victims quoted from the Food & Drug Administration Advisory Committee Meeting of September 2015 to adviseThe Doctors that:
- Despite Dr. Zampaglione stating there were tens of thousands of women studied on this product, Bayer’s clinical data on Essure® was only about 2,676 women, with only 557 women completing at 5 years at follow-up. Of that, Bayer only followed 493 women until 10 years. Bayer also had another study called SUCCESS II which added another 2,600 women studied until year 5, as an observational study.
- Bayer’s Essure® is supposed to be a permanent implanted birth control device, but Bayer followed few women after one year of implantation to determine any long-term effects of Bayer’s Essure®.
- Despite approximately 20% of women being allergic to nickel, and 55% of Bayer’s Essure® containing nickel, Bayer put on its package insert that there is no allergy. The FDA Panel criticized Bayer stating if there was no study to identify or determine what the allergic reaction would be, Bayer should not state women cannot have an allergy to Essure®.
- Bayer never collected family history of auto-immunity to determine if women were at a higher risk for auto-immune type responses to Bayer’s Essure®.
- Bayer has never tracked adverse events to determine the geographic locations in the United States where women have suffered adverse effects from Essure®.
Bayer’s Dr. Zampaglione clearly did not want to answer questions about Bayer’s Essure® permanent sterilization device as the evidence is not favorable. Fleming, Nolen & Jez is investigating Bayer’s Essure® and the dangers it poses to women.
If you have been harmed by Essure®, it is important to speak with a defective medical device attorney as soon as possible. You should be able to seek compensation for the pain and suffering you have suffered, as well as any costs that you have incurred because of medical visits.
Our Essure® lawyers work hard on your behalf and we are dedicated to helping you get through this difficult situation. We stand by your side form start to finish, planning the case based on your needs and goals. Trust that when you have our team on your side, you are in good hands. Call today to learn more about the Bayer Essure® lawsuit and what can be done for you.