FDA Issues New Essure Warnings After Reviewing Thousands Of Injury Reports
For over ten years, women have suffered severe and even irreparable injuries due to the Essure System, a permanent implant to prevent pregnancy. Many patients who were told that the device was a much easier and less painful alternative to sterilization surgery have experienced side effects they never expected—and in some cases were forced to undergo a hysterectomy to remove the device.
FDA Examines Essure Injury Reports
In 2015, the FDA conducted an evaluation of its Manufacturer and User Facility Device Experience (MAUDE) database and found over 9,000 reports related to Essure since its approval in 2002, mostly from women who received the implants. That same year, the FDA held an Advisory Committee meeting to address the serious complications of the Essure implant, including:
- Side effects. MAUDE reports indicated an overwhelming number of side effects, with many patients suffering several symptoms at once. The most common non-severe complications were abdominal pain, heavier periods, irregularities in the menstrual cycle, headaches, fatigue, and weight fluctuations.
- Migration and perforation. Over 2,000 patients reported incompatibility with the Essure device, due to a range of reasons from nickel allergies to unexpected performance of the device. Nearly a thousand more reported device migration and unintended movement of a device component, and an additional thousand suffered device breakage, improper positioning of the implant, and difficulty removing the device.
- Unintended pregnancy. The FDA has confirmed 631 reports of pregnancies in patients who were implanted with Essure, 150 of which resulted in live birth. The FDA acknowledged that the risk of unintended pregnancy in Essure users is highest in the first three months following implantation.
- Pregnancy loss. Of the 294 women who experienced a pregnancy loss, 96 were reported as ectopic pregnancies (a pregnancy that occurs outside the uterus).
- Death. There have been 26 confirmed reports of death due to the Essure system, including six reports accounting for a total of four adult deaths, 18 reports citing 15 incidences of pregnancy loss and two incidents of infant deaths following live birth.
FDA Orders More Research and Increased Patient Warnings on Essure Devices
In order to prevent further injuries, the FDA is taking steps to better inform patients of the risks of Essure, as well as demanding accountability from the maker of the device. In the next few years, the FDA has committed to:
- Require Bayer to conduct a post-market surveillance study. The FDA has ordered Bayer to provide additional clinical trial data, especially comparing the effects on women implanted with Essure to patients who undergo tubal ligation surgery. The FDA may take further action after the data from the new study is collected, since it will allow the FDA more information about Essure’s benefits and risks.
- Add a boxed warning to Essure devices. The FDA intends to implement a boxed warning on the labeling of the Essure device, especially regarding the permanence of sterilization and common reported side effects. The agency has invited the public to comment on proposed language to be used on the label and inside the product’s warnings.
- Require a Patient Decision Checklist for the product. The FDA expressed concerns that patients are adequately warned of the risks of Essure sterilization, either because they are not given reliable information or are not made to understand the information that is provided. As a result, they have recommended that patients complete a checklist to confirm that they have been informed of the potential side effects and future limitations posed by the Essure device.
- Evaluate complaints of clinical trial misconduct. The FDA has agreed to investigate and respond to patient allegations of modifying information in clinical trials, specifically the altering of clinical trial participants’ medical records. Records show that some participants’ answers involving adverse events and unusual pain were physically crossed out and replaced with more positive data.
If you or someone you love has suffered a loss due to an Essure implant, we can help you take action. The McGartland Law Firm represents clients who have been injured by defective medical devices and recovers fair and just compensation from the manufacturer. Contact ustoday to speak with a representative about your claim. We respect your privacy, and we do not charge legal fees unless we win your case.