Essure® is a permanent birth control option that came to market in 2002. It is a device constructed of two metal coils that are inserted into the fallopian tubes and trigger an inflammatory reaction. The resulting scar tissue is intended to block the fallopian tubes and prevent sperm from reaching and fertilizing an egg.
Unfortunately, there are many health problems associated with Essure® and a large group of users have experienced life-altering side effects, including pain, allergic reactions, perforation of the organs, prolonged menstrual bleeding, and unintended pregnancies, including ectopic pregnancies, miscarriages and stillbirths. Many users have been forced to undergo painful, invasive surgical intervention, including hysterectomies, to remedy the pain and suffering caused by Essure® use.
Brazil Bans Essure®
Most recently, Essure® deemed such a risk it was banned by Brazil’s national health agency. As of February 17, 2017, the device can no longer legally be sold in the country. The move has sparked hope for those in the United States who have advocated for a ban.
Brazil’s ban was instituted by the Agencia Nacional de Vigilancia Sanitaria (ANVISA), which is the country’s equivalent to the U.S. Food and Drug Administration (FDA). Authorities in Brazil had classified Essure® as “maximum risk” due to the numerous health problems the device has triggered, but it wasn’t until just recently the device was outright banned, which includes suspension of importation, distribution and marketing within the country.
Brazil is the first country to ban the birth control device, but it isn’t the only one looking into the severity of side effects and complications caused by Essure®. Essure®’s manufacturer, Bayer, faces hundreds of lawsuits in the United States. The FDA has received approximately 10,000 reports of adverse side effects from Essure® users, and most believe the adverse event rate is even higher than what has been reported.
Essure® Receives a Black Box Warning in the United States
On October 31, 2016, the FDA required Essure® to feature a “black box” warning on its label. The warning is the strongest issued by the agency and is intended to alert medical professionals and patients to severe consequences associated with a drug or device. It is the last step before a complete recall of a medical product. Essure will also include a lengthy Patient Decision Checklist in the packing of the device to inform patients of the use of, safety and effectiveness of the device.
We will be monitoring whether the FDA takes the same step as Brazil and remove Essure® permanently from the market due to the devastating effects the device has had on American’s lives.
Judge Denies Motion to Sever Essure® Cases in California
In early March 2017, a California judge denied a motion by Bayer to sever the claims of 86 plaintiffs filed in one complaint in Atia Adam, et al. v. Bayer Corp., et al., and the claims of 81 plaintiffs filed in another complaint in Janet Ramirez, et al. v. Bayer Corp., et al. The judge found in her tentative ruling that Bayer’s alleged conduct of “misrepresentations regarding safety and efficacy, and failures to report and concealment of complaints and complications,” met the requirement for permissive joinder of claims arising from the same series of transactions with the same basic misrepresentations, despite the fact that the plaintiffs had varying injuries and were residents of many different states. All plaintiffs’ claims will remain under the jurisdiction of Honorable Winifred Smith in the coordinated proceedings in Oakland, California.
If you or a loved one was injured by Essure®, you have a right to take legal action. For more information about legal action against Bayer, or to speak to someone who can answer your legal questions related to your use of the device, contact attorney Kim Dougherty at Andrus Wagstaff law firm at 866.534.5014 or visit the firm’s website at andruswagstaff.com.
Sources:
http://wric.com/2017/02/21/brazil-pulls-essure-from-the-market/
http://www.medscape.com/viewarticle/871955
