September 30, 2014
BAYER: First lawsuit filed against permanent birth control Essure
The first lawsuit has been filed against Bayer HealthCare because of alleged complications caused by permanent birth control device, Essure.
The lawsuit, filed in Philadelphia civil court, accuses the manufacturer of intentionally misleading women implanted with Essure and violating the conditions upon which the company received premarket approval from the Food and Drug Administration (FDA). The complaint states, Essure “should never have been marketed or sold” to Plaintiff, Heather Walsh.
Please read the complete charge.
The lawsuit is against Bayer, which purchased Essure from Conceptus, the original manufacturer of the device.
Famed consumer advocate, Erin Brockovich helps lead the campaign against Essure. She questions the premarket approval the device received from the FDA: “The company got premarket approval for studies that could clearly be questioned”. Normally, premarket approval shields a company from any product liability. But, this lawsuit claims that Essure’s manufacturer broke the conditions for that approval, making the Conditional Premarket Approval “invalid” and the product “adulterated.”
The lawsuit accuses the manufacturer of “actively concealing” negative reports about the device from the FDA. Lawyers are asking for $50,000 for both compensation and delay damages.
Common complaints include bloating, excessive bleeding, rashes and chronic pelvic pain. Women also told us about serious issues they say resulted from Essure, such as miscarriages and ectopic pregnancies.
After media reported, the manufacturer, Bayer Health Care, added warnings to the product label, and the Food and Drug Administration (FDA) conducted a review of the Adverse Events reported about the device.