Market Removal of Essure
Bayer Pharmaceuticals announced on July 20, 2018, that distribution of Essure, the controversial and permanent birth control device, will wind down by the end of this year. The voluntary removal was described as numbers driven due to a sharp decline in sales. While discontinuing Essure has been communicated as a business decision, the years of corporate greed and debate surrounding the device tell a different story.
Bayer AG purchased the maker of Essure in 2013, making way for an opportunity to increase revenue. The company reintroduced Essure as preferred to a tubal ligation procedure and began actively promoting the product. This sales tactic included financial incentives for healthcare providers. Since the notice of Essure’s market removal, it has been estimated millions of dollars were spent by Bayer to compensate doctors for recommending and using Essure. Doctors implanting Essure were found to be issued $500-2,500 for each 10-minute insertion. Considering the low manufacturing cost of small metal coils, Essure was very profitable for Bayer Pharmaceuticals. This contraceptive secured Bayer’s position as one of the largest life science companies.
Since 2013, prioritizing bottom lines of businesspeople and physicians has succeeded over the reality of Essure’s side effects. Bayer Pharmaceuticals certainly knew of women experiencing complications from the procedure before acquiring Essure. In the same year, adverse reports from patients increased by 50% and the U.S. Food and Drug Administration (FDA) issued an updated warning label to include migration and chronic pain. External pressures on Bayer Pharmaceuticals to resolve Essure related problems have been constant. The past five years have included many surprising occurrences related to Essure, including:
- An FDA requirement of patient checklist signoff before usage;
- A growing 37,000 member Facebook group entitled Essure Problems;
- Roughly 16,000 claims filed on behalf of women injured by Essure;
- Findings of fraud in clinical trials and post-market studies; and,
- The ultimate removal from all markets except the United States.
Bayer Pharmaceuticals’ encouragement of Essure usage is contradictory to present knowledge and public opinion alike. During the week surrounding July 20, 2018, the FDA released a statement outlining the serious risks of using the device. Further, Netflix released a documentary film entitled The Bleeding Edge stressing the dangers of medical devices including Essure. Still, Bayer Pharmaceuticals defends Essure as safe and attributes poor sales to third parties circulating untrue information. This labeling of Essure’s findings as “false” not only invalidates the experience of thousands of women but expresses the Bayer’s desire to avoid responsibility.
The use of Essure is estimated at about 750,000 women worldwide since its market approval in 2002. While women will not be harmed by new Essure devices in 2019, they may continue to learn their symptoms are attributed to the product. The Yost Legal Group believes Bayer Pharmaceuticals should be held accountable for their promotion of this unsafe permanent birth control to women. If you or a loved one has undergone the Essure implant procedure and has suffered unexpected conditions, contact our dangerous device attorneys today at 1-800-YOST-LAW for a free consultation.