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Essure sterilization coils were approved for use in the United States by the Food and Drug Administration in 2002. The less-invasive surgery involves placing the coils inside the fallopian tubes, causing scar tissue to form, thereby blocking the tubes and preventing fertilization. Essure was marketed as a simple and safe alternative to the conventional surgical sterilization procedure (tubal ligation). It is becoming increasingly evident that the procedure is not as safe as initially purported.
According to the FDA’s adverse events reporting system, there have been an alarming number of complications since 2009 for women who underwent the Essure procedure. The reporting system reveals that more than 15,000 adverse event reports were filed between 2009 to 2017. Some reported complications include miscarriages, fetal deaths, and hysterectomies to remove coils that had perforated the uterus or fallopian tubes, causing pain and bleeding. More than 9,000 women have had the Essure coils removed since 2009 and as of the first quarter of this year, the FDA has already received approximately 2,000 reports of removal.
Advocacy groups have gathered a significant social media following and have been attempting to persuade the FDA to take Essure off the market since 2013. Supporters of the measure note that several countries in Europe have either removed, or plan to remove, Essure from their markets and has asked the FDA to do the same. Essure has not been taken off the U.S. market, however the FDA has taken some steps to inform women of its potential risks. Last year, the FDA ordered Essure’s manufacturer, Bayer Healthcare, to add a Black Box Warning advising of potential adverse effects and to create a Patient Decision Checklist for doctors to present to patients.
Most believe that the FDA’s efforts thus far have been largely futile. At least 80 women who were implanted with Essure have complained they were never given the checklist nor the full Black Box Warning. The problem, some argue, is that implementation of the warning and the checklist is not mandatory, therefore doctors are implanting patients without informing them of the associated risks. This is a problem, not only from a medical standpoint, but also from a legal standpoint.
Healthcare professionals have a legal duty to inform patients of the risks involved in tests, medications and procedures. They must obtain informed consent in order to proceed, meaning that the patient must be made aware of the known benefits and risks associated with the procedure as well as any available alternatives. Therefore, if a doctor fails to warn a patient about the risks associated with a procedure and that patient consequently suffers an injury from that procedure, the doctor’s negligence may constitute medical malpractice.
If you have suffered adverse effects from sterilization coils, you may be entitled to monetary compensation for your damages. The South Jersey medical malpractice lawyers at Folkman Law Offices, P.C. can assist you in evaluating and filing your medical malpractice claim. We have offices in Cherry Hill, New Jersey, Philadelphia and King of Prussia, Pennsylvania and we represent clients throughout both states. To receive a free case evaluation, contact us online or call 856-354-9444 today.