A special ‘black box warning’ will be added to the packaging of the Essure contraceptive based on concerns over serious health complications, the U.S. Food & Drug Administration (FDA) has announced.
Free Confidential Lawsuit Evaluation: If you or a loved one was injured after receiving the Essure contraceptive, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and our lawyers can help.
What’s the Problem?
February 29, 2016 – In addition to enforcing the black box warning (PDF), FDA is requiring drugmaker Bayer AG to conduct a new post-marketing clinical study on Essure in order to better understand the potential health risks posed by the device.
Today’s announcement comes 5 months after an FDA panel hearing in Washington D.C. where women from across the U.S. testified about side effects they experienced after receiving the permanent birth control implant. The panel was convened after over 5,000 Essure users filed formal complaints with the FDA about a wide range of complications including bloating, bleeding, fatigue, miscarriage, ectopic pregnancy, perforation of the fallopian tubes, and removal of the implant.
“The agency intends to require a boxed warning and Patient Decision checklist be added to the product labeling to help to ensure that a woman receives and understands information regarding the benefits and risks of this type of device,” said FDA spokesperson Deborah Kotz.
Bayer will have 30 days from today to submit its plan to study Essure’s risks to the FDA. The agency must approve the plan before it can begin, after which the drugmaker will have 15 months to complete the research. FDA will work with Bayer to ensure that the study is conducted as quickly and efficiently as possible, according to Kotz.
When Essure was approved in 2002, it received a highly-coveted ‘Pre-Market Approval’ status from the FDA, meaning the agency was convinced the device had been put through rigorous safety testing over a 5-year period of study. It also meant that women who underwent the Essure procedure couldn’t file a lawsuit against Bayer.
Earlier this month, Congressman Mike Fitzpatrick (R-PA) lobbied the FDA to pull Essure off the market, citing data that showed over 300 fetal deaths reported by women who got pregnant after being implanted with the contraceptive.
Do I Have an Essure Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Essure lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you suffered complications after an Essure procedure, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.