FDA Requires Essure to Carry Black Box Warning Label
Posted on behalf of D'Amico & Pettinicchi, LLC on Mar 10, 2016 in Product Liability
The U.S. Food & Drug Administration (FDA) is now requiring the birth control device Essure to come with a “black box” warning label, the strongest label possible, to indicate the device carries significant risk of adverse events.
More than 5,000 women have filed grievances with the FDA between November 2002 and May 2015. Their grievances reveal a multitude of serious side effects after being implanted with the birth control device.
Along with the black box warning, the FDA is requiring Bayer, the manufacturer of the birth control device, to perform a post market surveillance study. The FDA hopes the study will provide better data to understand the risks associated with using Essure. Bayer will be required to provide information on complications like unintended pregnancy and device problems that require corrective surgery. The study must include information on how these complications affected a woman’s quality of life.
Another requirement from the FDA is the creation of a Patient Decision Checklist. The checklist would be provided to doctors in order to properly discuss the benefits and risks associated with the birth control device. Furthermore, doctors will be required to discuss with patients the importance of a “confirmation” test, which will determine if the device was placed properly and is working correctly.
The FDA has issued a draft guidance, which will allow the public to make comments and suggestions on what the labeling for Essure should include. The open period for comments began March 4 and will close after 60 days.
Though the FDA is making an effort to ensure the safety of Essure users, many women feel it is too little too late. Thousands of women have suffered medical complications; some women allegedly died as a result of the birth control device.
A study published in 2015 revealed that women who used Essure were 10 times more likely to need follow-up surgeries than those who underwent tubal ligation.
The product liability lawyers at D'Amico & Pettinicchi are ready to help you if you have suffered injuries or illness after using a defective medical device. Our team will work hard to help you fight for your rights.