Lawsuits over the birth control implant, Essure, have been allowed to proceed in state courts after recent rulings from judges in Illinois and California. After trying desperately to shield themselves from liability under federal pre-emption laws, pharma giant Bayer now potentially faces thousands of lawsuits over this defective and dangerous birth control device.
Nationwide thousands of women have come forward complaining of devastating pain and injury caused by Essure birth control. These complaints include a range of symptoms ranging from mild to severe, including pain, weight fluctuation, menstrual irregularities, hemorrhaging, headaches, and issues related to device migration. In many cases complications have led to the need for a total hysterectomy to remove the implant.
Essure was approved by the FDA in 2002 and originally manufactured by Conceptus Inc., which was purchased by Bayer for $1.1 billion in 2013. The device was developed to prevent pregnancy on a permanent basis and be used by women who had no desire to become pregnant but didn’t have the option of hysterectomy or other permanent procedure due to safety or inconvenience. Essure is implanted through the vagina in an outpatient procedure. The device consists of two coils, which are inserted into the fallopian tubes and over time cause scar tissue to form and prevent eggs from passing through the tubes.
In March 2016, after six months of deliberation over the Essure complaints, the FDA ordered Bayer, to launch new clinical trials for the device. The agency also called for a boxed warning on packaging and for development of a “decision checklist” that patients would sign before receiving the device to show that they understand its potential risks. This directive came after more than 10,000 women formally complained to the agency of side effects after receiving the Essure implant.
Even after the FDA directive, and as lawsuits continue to mount, Bayer still advertises the Essure implant as safe and “100 percent” effective. This has led to an intense social media campaign driven by women who experienced bad reactions to an Essure implants. Facebook sites related to the issue have raised awareness and called upon the FDA for the Essure device to be removed from the market.
As these initial state lawsuits are allowed to move forward, thousands more are expected to be filed. Bayer can no longer dodge their responsibility for producing this defective medical device and of failing to warn women of the risks associated with having it implanted.
At Saunders & Walker we have a long history of representing patients harmed by dangerous and defective drugs and medical devices. If you have used Essure for birth control and suffered any side effects or injuries after the device was implanted you may be entitled to financial compensation. Please do not hesitate to contact us for a free consultation.