Citing a decrease in sales, Bayer announced it would stop selling its Essure birth control implant in the United States. The German pharmaceutical giant billed the implant as an effective non-surgical sterilization method for women, but thousands have blamed the device for horrific complications including organ perforations, autoimmune problems and chronic pain.
Over the past several years, Bayer has been slapped with thousands of product liability lawsuits, claiming it misrepresented the safety of the Essure device and downplayed the risks. Bayer had already pulled the birth control implant off shelves in Europe, the U.K. and Canada as demand fell and complaints escalated.
Public health advocates have questioned Essure’s safety for years. Today, an estimated 16,000 American women are suing Bayer over Essure birth control complications and injuries.
FDA orders Black Box warning on Essure label
The Essure contraceptive device was approved by the FDA in 2002. Comprised of two micro-thin metal coils, the implant is placed inside the fallopian tubes, where it triggers scar tissue formation that blocks sperm from reaching the ovaries. Bayer promoted Essure as a safe non-invasive alternative to tubal ligation, but soon after hitting the marketplace, complaints of troublesome side effects began to pour in.
Spurred by mounting reports of serious injuries and adverse events related to the Essure implant, the FDA ordered Bayer to add a “Black Box” on its product label and also ordered Bayer to provide a checklist to doctors of potential risks that must be discussed with patients prior to implantation.
Since its launch in 2002, more than 750,000 women have been implanted with Bayer’s Essure device. But according to the FDA, demand dropped significantly after the Black Box warning was instated.
Diana Zuckerman, President of a nonprofit think tank focused on health research told ABC News “The FDA should have required a moratorium on sales and requested that new data be submitted in a much more timely fashion.” Her sentiments are not unique. Patient-driven rallies concerning Essure injuries and risks have been organized around the country.
In April of this year, the FDA said it would hold Bayer accountable for assuring that potential patients were being informed about the implant’s risks.
Reports of complications linked to Essure
One of the primary complaints in litigation against Bayer is that Essure can migrate inside the body, moving from the fallopian tubes to the uterus, where it can cause lasting damage. One woman, Angie Firmalino, experienced Essure migration and had the implant removed. She says the device ravaged her reproductive system and left behind toxic metal particles. Like many others, she suffered from constant bleeding, pain and other debilitating symptoms.
Other side effects cited in Essure lawsuits:
- Uterine perforation
- Device migration
- Persistent bleeding
- Autoimmune disorders
- Pelvic pain
- Hair loss
- Ectopic pregnancy
- Bowel and bladder injury
Do you have a claim for damages?
Medical device injury attorney Bart Bernard offers skilled representation to women who have suffered complications or injuries from the Essure birth control implant. To learn more about your rights to compensation, call our offices toll-free at 1-888-GET-BART.
- Washington Post, Sales of Essure birth control implant to be halted by Bayer; U.S. last to sell controversial device https://www.washingtonpost.com/news/to-your-health/wp/2018/07/20/sales-of-essure-birth-control-implant-halted-by-bayer-u-s-was-last-to-sell-controversial-device/?noredirect=on&utm_term=.7776813f4bc0
- NY Times, Bayer Will Stop Selling the Troubled Essure Birth Control Implants https://www.nytimes.com/2018/07/20/health/bayer-essure-birth-control.html?smid=nytcore-ios-share