Essure is a non-surgical permanent contraceptive implant which can be done in a physician’s office. The Essure device is composed of a metal coil or spring, with a stainless steel core and a nickel titanium outer coating. Once Essure is inserted into a woman’s fallopian tubes, the coil irritates the tubes and creates scar tissue that then blocks a woman’s eggs from reaching her womb. The device is inserted vaginally without the use of general anesthesia or a surgical incision, and is supposed to last a lifetime.
Essure was manufactured and marketed by Conceptus, Inc. and approved through the FDA’s Premarket Approval (PMA) process in November 2002. In June 2013, the German chemical and pharmaceutical company Bayer AG bought Conceptus in order to add Essure to its lineup of devices and drugs related to women’s health.
Since the device went on the market fourteen years ago, the Food and Drug Administration has received thousands of complaints about serious complications related to Essure. They include chronic pack and pelvic pain, painful intercourse, irregular periods, chronic fatigue, and autoimmune disease. The FDA has also received numerous reports about the metal coil piercing the fallopian tubes and becoming lodged in internal organs, requiring complete hysterectomies and other surgeries.
In September 2015, the FDA held a daylong meeting about the device, and its expert panelists harshly criticized Bayer for not collecting data that could have helped predict the risks for women using the device. Many critics have demanded that the FDA pull Essure off the market entirely, but the FDA has responded with a more conservative approach. The agency says that it will require Bayer to undertake new safety studies on Essure, as well as require a “black box” label to warn of potential side effects. The “black box” label would also provide a checklist of potential risk factors for physicians to discuss with their patients.
For those women suffering from complications related to Essure, general surgery to remove the fallopian tubes and/or other reproductive organs is the only way remove the implant and resolve those symptoms. Essure has required a high rate of re-operations that is ten times as high as more traditional, minimally invasive sterilization procedures.
If you or a loved one had Essure implanted and suffered as a result, please call us now for a FREE REVIEW of your medical records. You may be entitled to recover money for your injuries. Please be aware that there are time limitations for filing any kind of lawsuit. If you fail to file your case within the required time window, you will be unable to recover any money for your damages. Please contact us now so we can devote proper time and attention to your case. If you qualify, we want to represent you and help you get all you deserve.
Attorney Gary C. Johnson has been representing people who have been harmed by the negligence of others in eastern and central Kentucky for more than 40 years. Gary has won several multimillion dollar jury verdicts and settlements over his long and distinguished career, including the eighth-largest verdict in the United States for 2002. He has the largest personal injury jury verdict of any lawyer in the state of Kentucky.
Our team of attorneys, working in conjunction with the law firm of Bubalo Law PLLC, are devoted to protecting the rights of our clients with integrity and honesty. We will work hard to ensure that your case received the care and attention it deserves, and that you receive the money and benefits to which you’re entitled. Coping with problems related to Essure is hard enough without additional legal stress. Let our Kentucky Essure lawsuit attorneys take the burden off your shoulders and navigate the legal system on your behalf.
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